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IN THE UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

WESTERN DIVISION (at Cincinnati)

ANGELA BUECHEL : Case No.

388 Marian Lane #9 :

Florence, KY 41042 :

:

:

Plaintiff, : Judge 

:

v. :

: COMPLAINT FOR DAMAGES WITH 

ABUBAKAR ATIQ DURRANI, M.D., : JURY DEMAND ENDORSED

Serve: Orthopedic & Spine Institute : HEREON

203 Canal Road :

Lahore 54000 Pakistan :

(Serve by regular mail) :

:

and :

:

CINCINNATI CHILDREN’S :

HOSPITAL MEDICAL CENTER :

3333 BURNET AVENUE :

CINCINNATI, OH 45229 :

:

Serve: Frank C. Woodside III :

1900 Chemed Center :

Cincinnati, OH 45202 :

(Serve via Certified mail) :

:

and :

:

CENTER FOR ADVANCED SPINE :

TECHNOLOGIES, INC. :

Serve: Orthopedic & Spine Institute :

203 Canal Road :

Lahore 54000 Pakistan :

(Serve by regular mail) :

Plaintiff, Angela Buechel, for his Complaint for Damages with Jury Trial 

Demand Endorsed Hereon (the “Complaint) against defendants Abubakar Atiq Durrani, M.D. 

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and Cincinnati Children’s Hospital Medical Center and Center for Advanced Spine 

Technologies, Inc. (together, the “defendants”), states and alleges as follows:

I. PARTIES.

1. The incidents giving rise to this action and the subject matter of the Complaint arise out 

of medical treatment, fraud, acts and omissions, and conduct that occurred in Hamilton 

County, Ohio. 

2. At all times relevant, Plaintiff was a resident of and domiciled in the State of Kentucky.

3. At all times relevant, Dr. Abubakar Atiq Durrani (hereinafter “Dr. Durrani”) was licensed 

to and did in fact practice medicine in the State of Ohio. 

4. At all times relevant, Cincinnati Children’s Hospital Medical Center (hereinafter 

“Children’s Hospital”), was authorized to transact business and perform medical services 

in the State of Ohio and operate under the trade name Children’s Hospital Medical 

Center.

5. At all times relevant herein, Children’s Hospital held itself out to the public, and 

specifically to Plaintiff, as a hospital providing competent and qualified medical and 

nursing services, care and treatment by and through its physicians, physicians in training, 

residents, nurses, agents, ostensible agents, servants and/or employees.

II. JURISDICTION AND VENUE.

1. At all times relevant, Center for Advanced Spine Technologies, Inc. (hereinafter 

“CAST”), was licensed to and did in fact perform medical services in the State of Ohio, 

and was and is a corporation authorized to transact business in the State of Ohio and 

Kentucky.

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2. The amount in controversy exceeds the jurisdictional threshold of this Court. 

3. This Court is thus the proper venue to grant Plaintiff the relief sought.

4. This Court has jurisdiction based upon diversity under 28 U.S.C. § 1332.

III. FACTS.

1. Plaintiff has been experiencing back pain for many years and decided to seek treatment 

for her pain.

2. Plaintiff started treating with her Primary Care Physician Dr. Craig Sanders. Dr. Sanders 

ordered physical therapy for Plaintiff; however, the physical therapy did not help with 

Plaintiff’s pain. 

3. Dr. Sanders ordered MRI’s and the images came back normal.

4. Dr. Sanders then referred Plaintiff to Dr. Durrani at Children’s Hospital, in spring of 

2008.

5. At the first office visit, at CCHMC, Plaintiff told Dr. Durrani that she was experiencing 

sharp mid back and lower back pain.

6. At the first office visit, at CCHMC, Dr. Durrani told Plaintiff that she needed surgery 

because she had degenerative disk disease and disks. Dr. Durrani recommended a spinal 

fusion at T10-T11. 

7. Plaintiff inquired as to why this problem was not seen why the previous set of MRI’s. 

Dr. Durrani responded that the radiologist and surgeon look at different things. Dr. 

Durrani told Plaintiff radiologist only look at the images from one angle. 

8. Dr. Durrani told Plaintiff her only option was search if she wanted the pain to end. 

9. Plaintiff asked what the success rate of the surgery was. Dr. Durrani’s staff informed 

Plaintiff that Dr. Durrani’s success rate was 95% for this surgery. 

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10. On or around September 17, 2008, Dr. Durrani performed surgery on Plaintiff’s at 

Children’s Hospital. 

11. Upon information and belief, Dr. Durrani used Infuse/BMP-2 “off-label,” without 

Plaintiff’s knowledge or consent, causing Plaintiff harm. 

12. The use of BMP-2 increases a person’s chance of cancer by 3.5%.

13. Due to the unnecessary surgeries Dr. Durrani performed, Plaintiff has a 3.5% increased 

chance of cancer because of the use of BMP-2.

14. As a direct and proximate result of the use and implementation of Infuse/BMP-2 

Plaintiff has incurred a 3.5% increase in the risk of cancer. As a result, Plaintiff has an 

increased fear of cancer. 

15. After surgery, Plaintiff woke up in pain; Plaintiff had pain while talking, breathing, and 

pain in her lungs from Dr. Durrani collapsing them during surgery. 

16. Plaintiff was in the hospital for 4 days.

17. At a follow up appointment, at Children’s Hospital, Dr. Durrani told Plaintiff everything 

looked good.

18. Dr. Durrani also ordered physical therapy and also prescribed pain management for 

Plaintiff’s pain.

19. At follow-up appointments, at CAST, Plaintiff complained of the same pain as before the 

surgery, loss of flexibility, and a new pain, continued lung pain. 

20. Dr. Durrani told Plaintiff that it would take as year for her spine to fuse and for the pain 

stop. 

21. Now Plaintiff experiences mid to upper back pain, and shooting pain in her lower back. 

Plaintiff still has pain in her lungs.

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22. After the surgery with Dr. Durrani, Plaintiff has a three-inch scar that she is very insecure 

about, loss of flexibility, trouble standing up and bending down, difficulty sitting Indian 

style and difficulties with other household chores. 

23. Upon information and belief, the surgery performed by Dr. Durrani was medically 

unnecessary and improperly performed. 

24. As a direct and proximate result of this surgery and Dr. Durrani’s negligence, the 

Plaintiff has suffered harm.

25. Plaintiff did not become aware of Dr. Durrani’s use of Infuse/BMP-2 until legal counsel 

informed Plaintiff of Dr. Durrani’s propensity to use BMP-2.

ADDITIONAL ALLEGATIONS ON THE ISSUE OF STATUTE OF LIMITATIONS, 

STATUTE OF REPOSE AND FRAUD REGARDING CHILDREN’S

1. From the time of the surgery and/or surgeries Dr. Durrani performed on Plaintiff, to the end of 

his treatment of Plaintiff, through his flight from the United States in November 2013, Dr. 

Durrani lied to Plaintiffs’ primary care physician and directly to Plaintiff about the outcome of 

the surgery. Dr. Durrani informed Plaintiff and Plaintiffs’ primary care physician the surgery 

was successful and perfect, knowing the surgery on Plaintiff was a failure.

2. Dr. Durrani, from the date of his surgery until his flight in November 2013, had a duty to inform 

Plaintiff of the truth about the unsuccessful surgery and failed to do so. 

3. Dr. Durrani also failed to disclose to Plaintiff not only that he placed BMP-2 in Plaintiff without 

their consent, but he failed to place BMP-2 with the proper cage resulting in ectopic bone growth 

and other ongoing harm to Plaintiff which is ongoing to this day.

4. Dr. Durrani also lied to Plaintiff about the results of post-op radiology, which reflected the 

failure of the surgery. Nor did he order additional radiology to properly evaluate Plaintiff’s 

condition from after the surgery through his flight in November 2013. 

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5. Dr. Durrani never revealed hardware failure to Plaintiff from after the surgery through his flight 

in November 2013.

6. Children’s Hospital knew Dr. Durrani practiced all of this deception described in the five prior 

paragraphs and did not disclose it to the Plaintiff. In addition, Dr. Durrani was an employee of 

Children’s through 2008. Children’s duties to Plaintiff with information they knew did not end 

with Dr. Durrani leaving Children’s. 

7. Dr. Durrani and Children’s Hospital intentionally left BMP-2 off all their consent forms so 

Plaintiff would not know it was placed in their spine. 

8. Children’s Hospital concealed from Plaintiff that Dr. Durrani served repeated suspensions for 

misconduct while Dr. Durrani was still caring for Plaintiff. 

9. Children’s Hospital concealed from Plaintiff that health insurance companies were rejecting 

payment for BMP-2 leaving Plaintiff unknowingly stuck with a medical bill for a substance they 

never knew was placed in them. 

10. No one from Children’s EVER informed Plaintiff of anything negative related to Dr. Durrani 

before or after the surgery or during Dr. Durrani’s treatment of Plaintiff after surgery. 

11. Dr. Zeeshan Tayeb signed an affidavit on August 22, 2017 and it is filed in this case. The 

content of that affidavit is as follows:

a. I worked for Dr. Atiq Durrani as I have detailed in several depositions in the Dr. Durrani 

malpractice cases for Deters Law.

b. What was not covered in these depositions was the issue I am addressing in this affidavit. 

I do so based upon personal knowledge from working with Dr. Durrani’s patients and 

reviewing patient charts after-the-fact.

c. No matter their medical condition or what the outcome of the surgery, Dr. Durrani, after 

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his patient’s surgeries, would always inform those patients it took time to heal no matter 

the condition or the reason for the condition. I learned after-the-fact from discussions 

with patients, reviewing patient charts and from investigations that he would make 

misrepresentations to his patients to keep them from going to other doctors or leaving his 

care. I believe Dr. Durrani may have done this so his patients would not learn of any 

malpractice or fraud on his part in performing the surgeries. However, I did not know 

this until after-the-fact based on discussions with his patients, reviewing patient charts 

and from information obtained from investigations. 

d. As a post-surgery pain doctor employee on his staff, he used me to treat his post-surgical 

patients, I believe from my conversations with patients, review of those patient charts and 

information obtained from investigations that his patients did not suspect Dr. Durrani did 

anything wrong.

e. I believe based upon my conversation with patients, review of those patient charts and

information provided from investigations after-the-fact that patients of Dr. Durrani were 

left in poor medical condition following surgery. Additionally, I believe these patients 

may have been deceived by Dr. Durrani into believing that “all was fine.” I believe Dr. 

Durrani to avoid any issues, attempted to and in some cases successfully, convinced 

patients to believe that he had not done anything wrong, which may have resulted in postsurgery issues experienced by many of his patients. 

f. While treating Dr. Durrani’s patients, none of the patients ever brought up BMP-2 or 

PureGen to me. I am unaware whether Dr. Durrani informed his patients that these 

devices were placed in them. It could be discovered if the patient reviewed the 

intraoperative reports but I am uncertain if patients ever did this.

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12. Dr. Durrani did in fact do C-F on Plaintiff.

13. Dr. Durrani and Children’s Hospital intentionally deceived Plaintiff and concealed information 

in an attempt to avoid civil liability by creating a statute of limitations and/or statute of repose 

defense. 

14. The statute of limitation and statute of repose issues are all about notice. Dr. Durrani and 

Children’s Hospital had NOTICE of what was going on and concealed it from Plaintiffs. 

15. From January 12, 2005 to March 7, 2009, Dr. Durrani performed 645 spinal surgeries at 

Children’s.

16. Deters Law has over 100 cases against Children’s. This means over 15% of Dr. Durrani’s 

surgeries at Children’s became a Deters Law case. This is a remarkable statistic, unheard of in 

medicine or law.

17. On July 1, 2014, Dr. Keith Wilkey, a board-certified spine surgeon, performed a review of 

Children’s cases for Plaintiff and issued a report. That report included the following:

a. “It is important to look at these cases as a whole as they show the lack of supervision of 

Dr. Durrani by this facility during the five years that he was on staff.”

b. “From my previous medical experience, being a member of a peer review committee at 

two other facilities and serving as a former orthopedic department chairman, I am 

appalled by the lack of supervision from this facility.”

c. “Taken as a whole, it is beyond my comprehension that this surgeon was allowed to 

operate as long as he was given the poor patient selection, complication rates, and use of 

contraindicated medication. There appears to be a complete failure of the peer review 

process with respect to Dr. Durrani.”

d. “Dr. Durrani performed novel surgeries in which he was inadequately trained with 

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regards to their indications.”

e. “Alarmingly, greater than 100 percent of the patients reviewed had been exposed to 

Infuse during their surgery which is contraindicated due to their young age.”

f. “One has to ask why this was allowed to happen at an institution such as Cincinnati 

Children’s Hospital.”

18. There is either attached to Plaintiff’s Complaint or filed in the record, a specific comprehensive 

Affidavit or Merit for this case. 

19. Children’s Hospital admits they collected the following sums from Dr. Durrani’s billings:

2005 $1,508,555.83

2006 $2,202,192.13

2007 $3,154,595.72

2008 $3,610,137.58

20. These extraordinary billings by Dr. Durrani is why Children’s Hospital allowed Dr. Durrani to 

do as he chose, regardless of patient harm. The motive was money and greed. 

21. Dr. Durrani “resigned” from Children’s in an August 8, 2008 resignation letter to Dr. Azizkhan, 

Dr. Durrani referenced “inhospitable working environment in the diversion.” Dr. Azizkhan 

claims this was the moving of Dr. Durrani’s lover, Jamie Moor, his P.A. from Dr. Durrani. In 

his deposition, Dr. Durrani lied and claimed he left for a financial opportunity. It is important to 

note, Children’s NEVER fired Dr. Durrani. He resigned. 

22. Plaintiff had NO reason to believe Dr. Durrani and Children’s committed malpractice or fraud 

upon them or that they concealed it. Until Plaintiff saw the news of Dr. Durrani’s arrest in 2013, 

Plaintiff had no idea what Dr. Durrani might have done at Children’s and it was rational or 

reasonable for Plaintiff, upon seeing Dr. Durrani arrested for unnecessary surgeries to retain 

Deters Law at that time. 

23. On January 16, 2017, Deters Law requested the deposition of Children’s hospital employees they 

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previously requested and were denied. They were denied again based upon Defendants’ Motion 

to Dismiss. 

24. On November 25, 2005, Children’s employee, Powell, sent an email complaining about unsigned 

Orders of Dr. Durrani. This is the first evidence of this problem with Dr. Durrani, which he 

never changes. It is never known by Plaintiff or any Plaintiff. Children’s never releases this to 

any Plaintiff and Children’s conceals it. It is not discovered until discovery and emails are 

produced. For all the emails referenced in this pleading, this allegation is the same. It was 

unknown to Plaintiff until discovery. 

25. On December 28, 2005, Children’s employee Robinson emailed employee Probst, Dr. Durrani’s 

administrative assistant that Dr. Durrani needs to dictate an operative report. Dr. Durrani is 

never made by Children’s to correct this practice of not dictating an operative report or dictating 

it timely. It jeopardized Plaintiff’s health in post-operative medical care. 

26. In 2006, the FDA began releasing to Children’s Hospital, all hospitals, Dr. Durrani and all spine 

surgeons, adverse reports and studies pertaining to BMP-2. This proves that as of 2006, the 

hospitals knew there were issues relating to BMP-2. Despite that knowledge, and based upon 

money and greed, Dr. Durrani and Children’s still used BMP-2 in Plaintiff and countless other 

patients. 

27. Based upon Deters Law knowledge, 72.8% of Dr. Durrani’s patients at Children’s had BMP-2 

placed. Considering BMP-2 was not to be placed in minors, this is shocking. All of this 

happened with Children’s full knowledge and consent. BMP-2, of course, increases the risk of 

cancer and causes countless other issues. 

28. From 2005 through 2009, Dr. Alvin Crawford, leader of Children’s Orthopaedics, spine and 

mentor of Dr. Durrani, knowing about Dr. Durrani’s issues described in this pleading, 

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recommended him in writing, defended him and protected him, all to the detriment of Plaintiff. 

29. On January 30, 2007, on an Ohio Medical Board form necessary for Dr. Durrani to have an Ohio 

license, Dr. Durrani lied about malpractice awards by denying there were no payments made for 

him on malpractice cases. This includes Children’s settlements. 

30. From 2000 through 2009, Children’s Hospital was involved in settling Dr. Durrani cases and 

NEVER reported them to the National Practitioner Bank. Had they reported them, Dr. Durrani 

may have NEVER been able to perform the surgery on Plaintiff and Plaintiff never injured.

31. On April 23, 2007, Children’s employee Anderson emails to Probst, reporting Dr. Durrani’s 

failure to do reports.

32. On April 25, 2007, Children’s employee Probst emails Doxsey regarding problematic issues 

regarding Dr. Durrani.

33. On May 21, 2007, a Children’s email reflects Dr. Durrani needs to send a note to Peter Clayton, 

Children’s management, regarding an issue. 

34. On May 31, 2007, a Children’s email reflects a problematic issue regarding Dr. Durrani.

35. On June 5, 2007, a Children’s email reflects a problematic issue regarding Dr. Durrani.

36. On June 11, 2007, a Children’s email reflects a problematic issue regarding Dr. Durrani.

37. On June 12, 2007, Children’s email reflects a problematic issue regarding Dr. Durrani.

38. On June 16, Children’s email reflects a problematic issue regarding Dr. Durrani.

39. On June 21, 2007, there is a Children’s email, which reflects Children’s management wanting to 

meet with Dr. Durrani’s “team” without Dr. Durrani to discuss his problematic issues. 

40. On June 29, 2007, there is an email exchange between Doxsey and Probst that states: “Oh my 

gosh. Such a man.” This is regarding Dr. Durrani. 

41. On July 11, 2007, there is a group Children’s email, which includes Dr. Durrani and Probst 

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referencing many issues about Dr. Durrani.

42. On July 16, 2007, Williams and Probst exchange emails regarding complaints about Dr. Durrani.

43. On November 2, 2007, an email at Children’s states Dr. Durrani missed without reason an 

important conference at Children’s.

44. In December 2007, Probst stated her and Dr. Durrani relationship changes based upon Dr. 

Durrani’s personal conduct.

45. On December 13, 2007, there is a Children’s email exchange including Dr. Durrani and Probst 

about surgery scheduling issues. 

46. On December 20, 2007, there is an email at Children’s stating Anthem is rejecting BMP-2 as 

experimental. Children’s never informs Plaintiff or any patient or stops its use at Children’s. 

47. On January 16, 2008, Dr. Tim Cripe, Children’s doctor, complains to Dr. Durrani regarding 

patient issues.

48. On January 17, 2007, there is an email at Children’s stating Anthem is rejecting BMP-2 as 

experimental.

49. On January 22, 2008, there is a Children’s email regarding Dr. Durrani missing an important 

meeting.

50. On January 24, 2008, there is a Children’s email regarding an issue with Dr. Durrani and his 

patients.

51. On April 24, 2008, there is a Children’s email including Dr. Durrani that states BMP-2 is being 

denied for payment as investigational. 

52. On April 25, 2008, there is a Children’s email reporting BMP-2 is denied for surgery by 

insurance. The email reports Dr. Crawford and Dr. Durrani were the main users of BMP-2 at 

Children’s.

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53. On May 2, 2008, there is a Children’s email reporting BMP-2 is denied for surgeries by 

insurance.

54. On May 28, 2008, a lawsuit filed by Alexander Ranus against Dr. Durrani is settled by 

Children’s. It is never reported to the National Practitioner Data Bank.

55. On May 28, 2008, a Children’s email reflects problematic issues with Dr. Durrani.

56. On May 30, 2008, billing manager at Children’s, Singleton, is “blindsided” by more Dr. Durrani 

issues.

57. On May 30, 2008, Krissy Probst resigns as Dr. Durrani’s administrative assistant based upon Dr. 

Durrani having an affair with Jamie Moor, his physician’s assistant. Probst testified under oath 

that Dr. Durrani would begin surgeries, leave the surgery and allow unsupervised fellows to 

perform the surgery, and be in his office with Jamie during the entire time of the surgery. Probst 

gives Children’s this as the reason her resignation to management. Probst saved Dr. Durrani 

information on her Children’s Q drive. Much of the information such as emails referenced here 

is from her saved information. 

58. Plaintiff had no idea Dr. Durrani allowed a fellow unsupervised to perform the surgery and 

would have never consented to this. 

59. On June 25, 2008, Dr. Durrani is suspended by Children’s for not properly completing and 

signing medical records. Without disclosing this to Plaintiff or any patient, Dr. Durrani does 

surgeries at Christ.

60. On June 26, 2008, in an email, Dr. Durrani refers to Probst as “a piece of crap.”

61. On June 27, 2008, there is a Children’s email reflecting an issue of Jamie Moor, Dr. Durrani’s 

P.A. and lover, seeing his patients post-op rather than him. 

62. On July 22, 2008, Dr. Durrani is still suspended at Children’s. Yet, Children’s allowed him to do 

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surgeries on June 27, 28, 30; July 5, 6, 7. No patient or Plaintiff is told this. 

63. On August 7, 2008, Dr. Durrani resigns from Children’s for “inhospitable atmosphere.”

64. On August 12, 2008, an email by Probst details Dr. Durrani mistreatment of her.

65. On August 18, 2008, an email at Children’s references patient letter “turn arounds” are 12 days 

for Dr. Durrani, not the required 48 days.

66. On September 17, 2008, Dr. Wall of Children’s sends a letter to Dr. Durrani patients informing 

them that Dr. Durrani is leaving Children’s. He fails to inform them of ANY of the issues 

documented in this pleading.

67. On November 24, 2008, there is a Children’s hospital email regarding a letter to Children’s 

patients from Dr. Durrani announcing his departure and welcoming them to follow him to his 

new spine center for care. It is on Children’s letterhead. Every Dr. Durrani patient, including 

Plaintiff, follows Dr. Durrani to CAST not knowing ANY issue of Children’s. 

68. January 1, 2009 is the effective date of Dr. Durrani’s resignation and Dr. Durrani opens CAST. 

MORE SPECIFIC ALLEGATIONS BASED UPON DISCOVERY AND DEPOSITION 

TESTIMONY

1. This information is to demonstrate the overall negligence and inappropriate actions of Dr. 

Durrani and the hospitals he worked with and/or for and/or in an individual capacity. 

2. Krissy Probst was Dr. Durrani’s professional and personal assistant handling 

professional, academic, travel, surgery scheduling, his journals, his Boards, his 

credentialing, his personal affairs and his bills.

3. Krissy Probst worked as Dr. Durrani’s assistant for three years at Children’s Hospital 

from 2006, 2007, and 2008. 

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4. Krissy Probst reported Dr. Durrani to Sandy Singleton, the Business Director at 

Children’s for his having an affair with Jamie Moor, his physician assistant.

5. Krissy Probst resigned in 2008 from Dr. Durrani and remained working for three other 

surgeons in the Orthopedic Department.

6. Krissy Probst worked in the Orthopedic Department for eleven years from 2002-2013. 

She retired in May 2013.

7. Krissy Probst confirmed Dr. Durrani claims being a Prince, when he is not.

8. According to Krissy Probst, Dr. Crawford, an icon in pediatric orthopedics treated Dr. 

Durrani “like a son.”

9. According to Krissy Probst, Dr. Crawford, Chief of Orthopedics at Children’s 

unconditionally supported Dr. Durrani no matter the issues and problems Dr. Durrani 

faced. 

10. Dr. Durrani’s patient care at Children’s Hospital dropped off considerably after Jamie 

Moor became his physician assistant and they began their affair.

11. Dr. Durrani was the only orthopedic spine surgeon at Children’s who would perform a 

dangerous high volume of surgeries.

12. At Children’s, Dr. Durrani would begin a surgery, leave and have fellows and residents 

complete a surgery or do the full surgery while he was in his office with Jamie Moor, his 

physician assistant for four or five hours. 

13. Children’s Board and administration knew about Dr. Durrani doing too many surgeries 

and not properly doing the surgeries. They did nothing.

14. Dr. Durrani argued to Children’s administration when they complained to him that he 

made them money so Children’s tolerated him and allowed him to do what he wanted.

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15. Dr. Durrani, when told by Children’s that Jamie Moor had to leave, told Children’s that 

he would leave too.

16. Dr. Agabagi would do one spine patient a day at Children’s because it takes normally 

eight hours for a full fusion.

17. Dr. Durrani would schedule two to three spine surgeries a day at Children’s Hospital.

18. Dr. Durrani would repeatedly have the Business Director, Sandy Singleton, or OR 

Director allow him to add surgeries claiming they were emergencies when they were not.

19. Dr. Durrani would leave a spine surgery patient for four or five hours in the surgery suite 

under the care of fellows or residents, unsupervised and sit in his office and check on the 

surgery as he pleased. 

20. Dr. Peter Stern did not like Dr. Durrani while Dr. Durrani was at Children’s because he 

knew all about his patient safety risk issues. Yet, Dr. Stern supported, aided and abetted 

Dr. Durrani’s arrival at West Chester. It defies comprehension, but was for one of the 

world’s oldest motives—greed of money.

21. There is also a Dr. Peter Sturm, an orthopedic at Children’s who also had no use for Dr. 

Durrani. 

22. Dr. Durrani chose his own codes for Children’s billing which he manipulated with the 

full knowledge of Children’s Board and management. 

23. Dr. Durrani was dating and living with Beth Garrett, a nursing school dropout, with the 

full knowledge of his wife Shazia.

24. Dr. Durrani was close with David Rattigan until David Rattigan pursued Jamie Moor and 

Dr. Durrani would not allow David Rattigan in the OR at Children’s for a long time.

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25. Dr. Durrani, while claiming to have riches, does not. Dr. Durrani’s wife’s family paid for 

Dr. Durrani’s education and it is her family with the significant wealth. 

26. Medtronics paid for Dr. Durrani’s trips and paid him $10,000 fees for speaking or simply 

showing up at a spine conference.

27. Krissy Probst’s business director told her to save all Dr. Durrani related documents and 

information and she did.

28. While doing research at Children’s, Dr. Durrani would misstate facts regarding his 

research. Children’s knew he did this.

29. Dr. Durrani ended on such bad terms with Children’s Hospital he was not allowed on the 

premises after his departure in December 2008, yet he performed a spine surgery there in 

February 2009.

30. Eric J. Wall, MD was the Director of Surgical Services Division of Pediatric Orthopedic 

Surgery when Dr. Durrani left Children’s.

31. Sandy Singleton, MBA was the Senior Business Director of Surgical Services Division of 

Pediatric Orthopedic Surgery when Dr. Durrani left Children’s.

32. On information and belief, Dr. Durrani used his relationships with Children’s officials to 

purge his Children’s file of all patient safety and legal issues, which had occurred as part 

of his departure “deal” which Defendants hide with privilege.

INFUSE/BMP-2

I. BACKGROUND INFORMATION

1. The Deters Law Firm, P.S.C., represents approximately 500 Plaintiffs in medical 

malpractice actions against a former Northern Kentucky/Cincinnati-area spine surgeon 

named Abubakar Atiq Dr. Durrani (Dr. Durrani), his company, Center for Advanced Spine 

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Technologies, Inc. (CAST), and several area hospitals including, but not limited to, West 

Chester Hospital (WCH), University of Cincinnati Health (UC Health), Cincinnati 

Children’s Hospital Medical Center (CCHMC), Christ Hospital, Deaconess Hospital, Good 

Samaritan Hospital and Journey Lite of Cincinnati, LLC (Journey Lite) (collectively 

Hospitals). 

2. Dr. Durrani performed unnecessary, fraudulent, dangerous, and ultimately damaging 

surgeries on these Plaintiffs while working for and with these Hospitals.

3. The scheme and artifice to defraud that Dr. Durrani devised, executed, and attempted to 

execute while working for and with the Hospitals included the following patterns and 

practices:

a. Dr. Durrani persuaded the patient that surgery was the only option, when in fact 

the patient did not need surgery.

b. Dr. Durrani told the patient that the medical situation was urgent and required 

immediate surgery. He also falsely told the patient that he/she was at risk of grave 

injuries without the surgery.

c. Dr. Durrani often told his cervical spine patients that they risked paralysis or that 

his/her head would fall off if he/she was involved in a car accident, ostensibly,

because there was almost nothing attaching the head to the patient’s body.

d. Dr. Durrani often ordered imaging studies such as x-rays, CT scans, or MRIs for 

patients but either did not read or ignored the resulting radiology reports.

e. Dr. Durrani often provided his own exaggerated and dire reading of the patient’s 

imaging study that was either inconsistent with or was plainly contradicted by the 

radiologist’s report. At times, Dr. Durrani provided a false reading of the imaging.

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f. Dr. Durrani often dictated that he had performed certain physical examinations and 

procedures on patients that he did not actually perform.

g. Dr. Durrani often ordered a pain injection for a level of the spine that was 

inconsistent with the pain stated by the patient or with that indicated by the imaging. 

Dr. Durrani also scheduled patients for surgeries without learning of or waiting for 

the results of certain pain injections or related therapies. 

h. Dr. Durrani often dictated his operative reports or other patient records months after 

the actual treatment had occurred.

i. Dr. Durrani’s operative reports and treatment records contained false statements 

about the patient’s diagnosis, the procedure performed, and the instrumentation 

used in the procedure. 

j. When a patient experienced complications resulting from the surgery, Dr. Durrani 

at times failed to inform the patient of, or misrepresented the nature of, the 

complications.

k. All of the above-mentioned actions were done with the knowledge, cooperation, or 

intentional ignorance of the Hospitals because Dr. Durrani was one of the biggest 

moneymakers for the Hospitals.

4. In addition to the civil medical malpractice actions against Dr. Durrani, on August 7, 

2013, he was indicted by the Federal Government for performing unnecessary surgeries 

and for defrauding the Medicare and Medicaid programs. Specifically, the ten-count 

complaint charged Dr. Durrani with health care fraud, in violation of 18 U.S.C. § 1347, 

and making false statements in health care matters, in violation of 18 U.S.C. § 

1035. There was a subsequent superseding indictment adding over 30 counts. 

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5. Following these criminal indictments, in December of 2013 and prior to the first 

Plaintiff’s trial in these actions, Dr. Durrani fled the United States and returned to 

Pakistan. He has not returned to the United States to face allegations of either criminal or 

civil liability.

6. Among Dr. Durrani’s and the Hospitals’ professional failings was the use of a synthetic 

bone-morphogenetic protein called BMP-2, which was marketed under the trade name 

“Infuse.” Dr. Durrani used BMP-2/Infuse in ways that were either not approved by the 

federal Food and Drug Administration (FDA) or that were specifically contraindicated as 

noted on the FDA-approved product labeling. The Defendants had full knowledge of this 

fact. 

7. BMP-2/Infuse was, at the time of the surgeries in question, and currently still is 

manufactured by a company called Medtronic, Inc. (Medtronic).

8. Dr. Durrani predominantly used BMP-2/Infuse on patients at WCH, which is owned by 

UC Health. 

9. It is Plaintiffs’ position that this non-FDA-approved use of BMP-2/Infuse was not only 

negligent, and fraudulent, but criminal based upon the manner in which it was allowed to 

be used by Dr. Durrani at West Chester, all with the knowledge and full support of the 

Defendants. 

THE PLAYERS REGARDING BMP-2

1. Dr. Durrani is a citizen of the Republic of Pakistan and was a permanent resident of the 

United States who, from approximately 2005 to 2013, worked as a spine surgeon in and 

around Cincinnati, Ohio, until he fled the United States to escape civil liability and criminal 

prosecution.

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2. Medtronic is an Irish corporation, with its principal executive office located in Dublin, 

Ireland, and its operational headquarters located in Minneapolis, Minnesota. Medtronic is 

the world’s third largest medical device company and manufactures and markets BMP2/Infuse. Medtronic sales representatives were also present during the experimental 

surgeries performed on Plaintiffs, who are clients of the Deters Law Firm.

3. CAST was a corporation organized under the laws of Ohio and had business and medical 

offices in Florence, Kentucky and Evendale, Ohio. CAST was owned, in whole or in part, 

by Dr. Durrani.

4. Bahler Medical, Inc. is a manufacturer of medical implants and is a corporation located in 

the state of Ohio. 

5. David Rattigan is an Ohio resident and was and is a sales representative for Medtronic. 

Further, he is affiliated with Bahler Medical, Inc., was involved in many of the transactions 

involving BMP-2, and was present for the experimental surgeries in which BMP-2 was 

used. 

6. West Chester Hospital, LLC is a corporation organized under the laws of Ohio. It provides 

medical facilities and billing support to physicians, including Dr. Durrani, in the state of 

Ohio. WCH is owned by UC Health.

7. UC Health is a private, non-profit corporation organized under the laws of Ohio. It provides 

medical facilities, management, administrative, ancillary, and billing support to physicians, 

and it owns WCH. 

8. CCHMC is a medical facility in Ohio where Dr. Durrani was an employee until 

approximately 2008. 

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WHAT IS BMP-2/INFUSE?

1. The full name of BMP-2 is “Recombinant Human Morphogenetic Protein-2” (also called 

rhBMP-2). The following definitions apply:

a. Recombinant – Artificially created in a lab;

b. Morphogenetic – Evolutionary development of an organism;

c. Protein – Essential for growth and repair of tissue.

2. Recombinant human protein (rhBMP-2) is currently available for orthopedic usage in the 

United States.

3. Medtronic manufactured, marketed, sold, and distributed BMP-2 under the trade name 

“Infuse.”

4. BMP-2 has been shown to stimulate the production of bone. 

5. Implantation of BMP-2 in a collagen sponge induces new bone formation and can be used 

for the treatment of bony defects, delayed union, and non-union.

BMP-2 AS A BIOLOGIC

1. BMP-2 is not a device, but instead it is a biologic. See July 2009 American Medical 

Association Article and 2011 Stanford School of Medicine Article.

2. According to the FDA, “[a] ‘biological product’ means a virus, therapeutic serum, toxin, 

antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous 

product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic 

arsenic compound), applicable to the prevention, treatment, or cure of a disease or 

condition of human beings (Public Health Service ActSec.351(i)1.”Available 

http://www.fda.gov/ICECI/Inspections/IOM/ucm122535.htm. 

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3. BMP-2 is a Bone-Morphogenetic Protein that is used to promote bone creation and 

remolding and falls under the definition of a biologic. See AMA article (“bone forming 

properties”) and Stanford Article. BMP-2 differs from a medical device in that once 

implanted, it can only be removed days after surgery. If a patient had a complication due 

to BMP-2 and did not discover this complication until year after surgery, the patient could 

not have BMP-2 removed to reduce the complication because BMP-2 is so integrated into 

the patient’s bone.

4. A patient has a right to determine what happens to his or her body and the preservation of 

that right requires that the patient be informed when a bone growth product, that causes 

irreversible harm, is placed in his or her body. 

WHEN IS IT USED?

1. Recombinant human BMPs are used in orthopedic applications such as spinal fusions, nonunions, and oral surgery.

2. The bone graft contains two parts. The first is a solution of human bone growth protein or 

morphogenetic protein-2. This protein is found in the human body in small dosages and is 

important for the healing and formation of bones. The protein is genetically engineered to 

be utilized in the Infuse Bone Graft product, and it is employed for the stimulation of 

formation and growth in bones.

3. The second part of the bone graft is an absorbable collagen sponge.

4. Both components of the Infuse Bone Graft structure are used to fill the LT-Cage Lumbar 

Tapered Fusion Device. This chamber is intended to restore the deteriorated disc space to 

its original height.

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5. FDA-approved use for the Infuse Bone Graft product is only for lower back surgery using 

an anterior lumbar interbody fusion (ALIF), a technique where the operation on the spine 

is conducted through the abdomen.

6. In addition, the Infuse Bone Graft product must be used in conjunction with Medtronic’s 

LT-Cage. Use of BMP-2 without the LT-Cage is considered an “off-label” use.

CONTRAINDICATIONS OF USE

1. The FDA specifically warns against the use of Infuse in the cervical spine, citing reports 

of “life-threatening complications.”

2. Any use of Infuse other than in lumbar spine surgeries with the LT-Cage is considered 

“off-label” use

3. Infuse should never be used on the skeletally immature patient, i.e., in patients less than 18 

years of age or those with no radiographic evidence of epiphyseal closure.

4. Infuse should never be used in the vicinity of a resected or extant tumor.

5. Infuse should never be used in those patients known to have active infection at the surgical 

site.

RISKS ASSOCIATED WITH OFF-LABEL USE

1. When used in an off-label manner, patients may experience problems with pregnancy, 

including but not limited to: complications in fetal development; allergic reactions to 

titanium, bovine type I collagen, or bone morphogenetic protein–2; infection; the creation 

or intensification of tumors; liver or kidney disease; lupus or human immunodeficiency 

virus (HIV/AIDS); problems with radiation, chemotherapy, or steroids if a patient is 

malignant; paralysis; bowel and/or bladder dysfunctions; sexual disorders, including 

sterilization and incompetence; respiratory failure; excessive bleeding, and; death.

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THE REGULATORY PROCESS

1. The Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act, 

21 U.S.C. § 301 et seq., established two separate approval processes for medical 

devices: Pre–Market Approval (PMA) and Pre–Market Notification.1

2. The FDA's PMA process is lengthy and involves extensive investigation by the FDA. The 

PMA application requires manufacturers to submit extensive animal and human data to 

establish their devices' safety and effectiveness. 21 C.F.R. § 814.20. Frequently, an 

experimental program under close FDA scrutiny must be successfully completed before 

FDA approval can be obtained under this process. FDA regulations also 

require PMA applicants to submit copies of all proposed labeling for the device. 21 C.F.R. 

§ 814.20(b)(10). The FDA approves a PMA application only after extensive review by the 

agency and an advisory committee composed of outside experts. 21 C.F.R. § 814.40.

2

3. In contrast, the FDA’s Pre–Market Notification process is more abbreviated and involves 

less FDA oversight. This process requires applicants to submit descriptions of their devices 

and other information necessary for the agency to determine whether the devices are 

substantially equivalent. Pre–Market Notification applicants must also submit their 

proposed labeling. 21 C.F.R. § 807.87. If the FDA determines that a device is substantially 

equivalent to a device that was on the market prior to the enactment of the MDA in 1976, 

the applicant is free to market the device.

 

1 Fender v. Medtronic, 887 F.Supp. 1326 fn 1 (E.D. Cal.1995).

2 Fender v. Medtronic, 887 F.Supp. 1326 fn 1 (E.D. Cal.1995).

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4. BMP-2 received PMA (PMA number P000058) for the Infuse/BMP-2 Lumbar Tapered 

Fusion Device, which PMA provided for limited use with specific requirements for its use 

on individuals. See Medtronic Package Insert.

SCOPE OF THE PMA AND PRODUCT LABELING

1. The PMA for BMP-2 provided that the product may only be used in patients with the 

following characteristics:

a. Skeletally mature patient, AND

b. At levels L2-S1, AND

c. Confirmed degenerative disc disease (DDD), AND

d. Using only an open anterior or anterior laparoscopic approach, AND3

e. Six months of non-operative treatment prior to treatment with the device, AND

f. In combination with the metallic LT-CAGE.4

See Medtronic Package Insert, “INDICATIONS.”

2. According to Medtronic’s package insert for BMP-2/Infuse as well as other industry 

literature, the following risks are associated with the use of BMP-2/Infuse: 

a. Male Sterility

b. Cancer

c. Increased progression of cancer

d. Suffocation of the cervical region

e. Bone fracture

 

3 The anterior interbody fusion approach was developed because the risk of non-union (pseudarthrosis) is significantly 

higher in posterior approaches. The biggest risk factor for fusion surgery is non-union.

4 Instrumented fusions involve hardware and are more stable fusions with a shorter recovery time than noninstrumented fusions. 

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f. Bowel/bladder problems

g. Loss of spinal mobility or function

h. Change in mental status

i. Damage to blood vessels and cardiovascular system compromise 

j. Excessive bone mass blocking the ability to treat pain

k. Damage to internal organs and connective tissue

l. Death

m. Respiratory problems

n. Disassembly and migration of components

o. Dural tears

p. Ectopic and exuberant bone formation

q. Fetal development complications (birth defects)

r. Foreign body (allergic) reaction

s. Gastrointestinal complications

t. Incisional complications

u. Infection

v. Insufflation complications

w. Neurological system compromise

x. Non-union

y. Delayed union

z. Mal-union

aa. Change in curvature of spine

bb. Retrograde ejaculation 

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cc. Scars

dd. Tissue and nerve damage

ee. Itching

ff. Pain 

gg. Hematoma

hh. Anaphylactic reaction

ii. Elevated erythrocyte sedimentation rate 

3. Injury Percentages:

a. Ectopic Bone Growth-63%

b. Inflammatory Neuritis-15%

c. Osteolysis/Subsidence-13%

d. Acute Swelling-7%

e. Retrograde Ejaculation-2%

f. 85% of time, BMP-2 implanted in off-label use

4. Not a single one of these risks in the last two paragraphs were ever explained to a single 

patient at Children’s Hospital by Dr. Durrani. 

5. BMP-2 was NOT approved by the FDA for use in the cervical and thoracic spine and BMP2 was NOT safe or approved for use in children less than 21 years of age. These uses are 

considered “off-label.” 

“OFF-LABEL” USE

1. +A use of a device is considered “off-label” if it is not approved under the Pre-Market 

Approval process OR cleared for such use pursuant to 21 U.S.C. § 360c(f) (also known as 

“the 510k premarket notification process”). 

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2. Infuse can be implanted in an off-label manner in three ways:

a. Approach/position: Any approach other than an anterior approach;

b. Product: Failure to use LT-Cage (or any cage); mixing rhBMP-2 with other grafting 

products like Allograft or Autograft;

c. Discs: Use on multiple levels or on a level outside of L2-S1.

3. Dr. Durrani and the Hospitals in which he performed surgeries repeatedly used BMP-2 in 

these non-FDA-approved manners. 

THE NON-COMPLIANCE WITH THE REGULATORY PROCESS

1. The PMA 000058 “Conditions of Approval” specifies the following condition: “Before 

making any change affecting the safety or effectiveness of the device, submit a PMA 

supplement for review and approval by the FDA ... [a] PMA supplement or alternate 

submission shall comply with applicable requirements under 21 C.F.R. 814.39[.]”

2. 21 C.F.R. 814.39 requires a PMA supplement pursuant to subsection (a)(1) for new 

indications of use of the device and pursuant to subsection (a)(6) for changes in 

components.

3. The PMA 000058 “Conditions of Approval” notes the post-marketing reporting 

requirement imposed by 21 C.F.R. 814.84, particularly “Identification of changes 

described in 21 C.F.R. 814.39(a).” Medtronic did not comply with this requirement relating 

to the intended uses and componentry.

4. The FDA can impose post-approval requirements in the PMA pursuant to 21 C.F.R. 

814.82, and this fact results in the device being characterized as “restricted” pursuant to 21 

U.S.C. § 360j(e) for purposes of 21 U.S.C. § 352(q). Section 352(q) states that any 

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restricted device that is distributed or offered for sale with false or misleading advertising 

is “misbranded.”

5. “Indications for use” is a necessary part of the PMA application and the “Indications for 

use” are required to be limited by the application. Any different use is inconsistent with the 

PMA. 

6. A device that fails to meet the requirements of the PMA or 21 C.F.R. 814 is “adulterated” 

as defined by 21 U.S.C. § 351(f).

7. 21 C.F.R. 801.6 defines a misleading statement related to a DIFFERENT device contained 

in the label delivered with the device intended to be used will render the device to be used 

misbranded. 

8. Medtronic did not apply for a PMA supplement, as required by the FDA generally and 

PMA 000058 specifically, for the off-label uses, nor did it provide warnings of the risks 

known about the off-label uses. All named Defendants in these cases knew about the 

occurrences of off-label use. 

9. The PMA requires an application prior to marketing for new indicated uses by 

incorporating the federal requirements and explicitly reciting the text of 21 C.F.R. 814.39 

and 814.84 and by specifically stating the range of indicated uses on the PMA.

MEDTRONIC

1. In or about 2001, Medtronic began preparing for the launch of two spinal fusion products, 

PYRAMID and INFUSE (BMP-2), which it projected would enjoy broad application with 

spinal surgeons and their patients on a nationwide basis. 

2. Medtronic anticipated that both products would initially be limited in application.

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3. Motivated by greed and a desire to gain competitive advantage in the marketplace, 

Medtronic began a course of conduct designed to broaden the application of both products 

by end-users. The course of conduct involved fraud, false statements, material 

misrepresentation, and deceit for the purpose of broadening the sales of these products 

beyond that which the usual acceptance within the scientific community or regulatory 

approval would otherwise allow.

4. On or after July 2, 2002, Medtronic received notification that its Pre-Market Approval 

application for its BMP-2/Infuse bone graft products had been approved by the FDA. 

However, such approval was limited to the application of the device from the L4 through 

S1 levels. Further, the approval mandated the conduct of post-approval studies to evaluate 

the long-term performance of the BMP-2 bone graft and to study the potential side effects 

and complications such as the promotion of tumors by the bone morphogenetic protein 

component of BMP-2. Other studies were conducted as well. See “Allegations against 

Medtronic in the Unsealed Mississippi False Claims Case.”

5. Medtronic engaged in a fraudulent course of conduct designed to maximize its revenues 

from BMP-2, regardless of whether it would eventually be allowed to remain on the 

market.

6. One of the physicians Medtronic co-opted into its fraudulent scheme was a Thomas A. 

Zdeblick, M.D. Dr. Zdeblick was an orthopedic surgeon whose invention, the LT-Cage, 

was the only approved device to act as the delivery vehicle for BMP-2 into the body. 

7. Dr. Zdeblick enjoyed a position within the scientific community as a Key Opinion Leader, 

and he was both a practicing orthopedic surgeon and professor at the University of 

Wisconsin. 

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8. In one of Dr. Zdeblick’s first attempts to tout his LT-Cage and rhBMP-2, which would 

become the active ingredient in the ultimate Infuse/BMP-2 product, he encountered some 

drawbacks to his goal of promoting his and Medtronic’s products, which arose from the 

policy of certain industry journals, including the journal Spine, which followed industry 

standards before printing peer-reviewed material. See article in the journal Spine, published 

in 2000.

9. Not only were the drawbacks related to industry publishing standards, but the National 

Consumer Health Information and Health Promotion Act of 1976 enacted certain 

provisions at 42 U.S.C. § 300u, et seq., whereby the Federal Government had entered the 

field of medical research publication. Such standards promulgated by the Secretary of the 

predecessor to the U.S. Department of Health and Human Services required that 

applications for grants and contracts must be subject to “appropriate peer review.” See 42 

U.S.C. § 300u-1.

10. The drawbacks encountered with the peer-reviewed Spine article were as follows:

a. Attribution that the study was “sponsored by Medtronic Sofamor Danek, Inc.;” 

b. The study was conducted under FDA regulations, and was “...designed as a 

prospective, multicenter, nonblinded, randomized, and controlled pilot study;” and

c. It was accompanied by a cautionary comment, or Point of View, which minimized 

the exuberance and import of the article. 

11. In the article, BMP-2 was touted by Zdeblick and the co-authors as the potential realization 

of a dream of Dr. Marshall Urist, a revered pioneer in the industry and discoverer of BMP, 

where it closed with the following: “...it is encouraging to note that Marshall Urist’s 

seminal observation made more than 34 years ago may finally come to clinical fruition.” 

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12. In the Point of View, a Dr. John O’Brien of London questioned whether there could be 

long-term problems associated with the product. He treated Zdeblick’s study with caution 

and pointed out that simple plaster of Paris has achieved the same or similar results more 

than 50 years prior. He posited that, “[p]erhaps vascularization...fixation procedures are 

as important as the biochemical composition of the ‘filler.’” 

13. Vascularization is achieved through removal of the disc material between two vertebral 

bodies and then the scraping of the surfaces of the vertebral bodies in a fusion procedure; 

fixation is the process of securing the motion segment through medical hardware. In other, 

if the alternative proposed by Dr. O’Brien proved to achieve equivalent or better results, 

Zdeblick and Medtronic’s Infuse/BMP-2 products would be useless and unnecessary. 

14. Certain efforts would follow in an attempt to alleviate the drawbacks encountered with the 

2000 Spine journal article.

15. In 2002, Dr. Zdeblick was installed as the sole editor-in-chief of a medical journal known 

prior to his installation as the Journal of Spinal Disorders. Prior to his installation, the 

journal enjoyed a fourteen-year history under the co-editorship of Dr. Dan Spangler and 

Dr. Tom Ducker. Once installed, Dr. Zdeblick successfully supplanted Drs. Dan Spengler 

and Tom Ducker and became the sole editor-in-chief, a position which would enable him 

to have greater control and would aid his participation in the fraudulent scheme. 

16. During this same time period, Dr. Zdeblick also enjoyed a position on the associate 

editorial board of the medical journal Spine, the leading publication covering all disciplines 

relating to the spine.

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17. In one of Dr. Zdeblick’s actions as editor-in-chief, he set about re-purposing the journal in 

a way that would aid him in the furtherance of the fraudulent scheme through the 

streamlining of the publication process.

18. In furtherance of the fraudulent scheme, Dr. Zdeblick re-purposed the journal and renamed 

it the Journal of Spinal Disorders and Techniques (JSDT), announcing that the new journal 

was “entering a new partnership with Spine.” As part of this partnership, Spine would 

“continue to function as a broad-based scientific journal” tailored to both clinicians and 

scientists. However, the Journal of Spinal Disorders and Techniques would be directed 

solely to physicians in clinical practice. 

19. Dr. Zdeblick’s stated goal was “to provide a forum for up-to-date techniques...”, and in 

furtherance of that goal, Dr. Zdeblick announced that his journal would publish Class II or 

better clinical articles but would “occasionally accept cutting edge articles with less than 

one year follow-up.” To justify this streamlined process, Dr. Zdeblick claimed as his goal 

the ability of his journal “to keep up with the fast pace of progress in the treatment of spinal 

patients.” 

20. Arm-in-arm with Medtronic and others, Dr. Zdeblick would in short order abuse his 

position of trust as the editor-in-chief of JSDT.

21. In the October 2002 edition, JSDT published an article entitled, “Anterior Lumbar 

Interbody Fusion using rhBMP-2 with Tapered Interbody Cages.” This article was coauthored by, among others, Curtis A. Dickman, M.D., who was a developer of Medtronic’s 

PYRAMID plate and who has been paid significant sums by Medtronic through royalty 

agreements, consulting agreements, and education training and speaking agreements.

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22. In addition to his interest in the PYRAMID plate, Dr. Dickman had assisted Medtronic in 

the approval process for Infuse/BMP-2. As part of the pre-approval hearing process, Dr. 

Dickman and his Barrow Neurological Associates Group of Phoenix, Arizona had 

submitted a letter to the meeting of the FDA’s Orthopedics and Rehabilitation Devices 

Advisory Panel, which met on January 10, 2002. In that letter, Dr. Dickman represented 

that “approval of BMP would provide a significant advance for patient outcome and 

satisfaction following spinal fusion.” 

23. In the October 2002 issue of JSDT touting the benefits of Infuse/BMP-2, Zdeblick and 

others failed to disclose their financial ties to Medtronic, though industry standards require 

such acknowledgement. Not only did Dr. Zdeblick fail to disclose that he profited from 

each and every surgery which Infuse/BMP-2 was used through rights in the exclusive 

delivery vehicle, his LT-Cage, but no reference whatsoever to their financial ties to 

Medtronic was made either by Dr. Zdeblick or Dr. Dickman. 

24. For years, the recognized gold standard for spinal bone grafts has been the use of 

autogenous bone, or bone harvested from the patient’s own iliac crest, or hipbone. 

Medtronic designed to have its Infuse/BMP-2 product supplant autogenous bone as the 

gold standard in the medical community, and utilized false statements, a fraudulent 

enterprise and the support of Federal funds to do so. 

25. As part and parcel of Medtronic’s fraudulent scheme, the October 2002 study was 

published in Dr. Zdeblick’s journal three months after Medtronic received FDA approval 

for Infuse. As the article shows, it was actually received on March 28, 2002 or after Dr. 

Zdeblick had accomplished installment as the editor-in-chief, and was accepted by Dr. 

Zdeblick’s journal for publication on July 30, 2002. 

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26. At the same time Dr. Zdeblick’s journal was publishing the initial article on Infuse, Dr. 

Zdeblick was already finalizing and preparing for subsequent publication a follow-up 

article to tout Infuse potentially as the new gold standard. A second article, co-authored by 

Dr. Zdeblick and two other co-authors of the original article, was entitled “Is Infuse Bone 

Graft Superior to Autograft Bone? An Integrated Analysis of Clinical Trials using the LTCage Lumbar Tapered Fusion Device.” 

27. This second article was published in Vol. 2 of 2003 and once again, there was no mention 

of Dr. Zdeblick’s financial ties to Medtronic. 

28. This second article would serve as the second covert advertisement for the Infuse product, 

and the article states that “the purpose of our analysis was to investigate the potential 

statistical superiority of Infuse bone graft to autograft...” 

29. This second article went on to announce the July 2002 FDA approval of rhBMP-2.

30. This article included as an “acknowledgment” an expression of gratitude to the physicians 

“who provided patients for this study and to the clinic research group at Medtronic Sofamor 

Danek for their help in data collection and statistical analyses.” However, the article still 

failed to advise the medical community that some or all of the authors reaching these 

conclusions touted as monumental had direct financial interests tied to those conclusions. 

31. Rather, the failure to report these clear conflicts of interest on the part of those holding 

positions of trust both within the medical community and over patients was part of 

Medtronic’s fraudulent enterprise. However, unchecked by appropriate peer review, 

Medtronic was able to systematically accomplish their goals. 

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32. In its 2003 Annual Report, and without recognizing that Zdeblick was being paid by 

Medtronic, Medtronic cited to Zdeblick’s 2003 as reporting that Infuse “...may become 

the new gold standard in spinal fusion surgery.”

33. By its 2006 Annual Report, if not earlier, Medtronic had removed all doubt, declaring that 

after its introduction in 2002, “Infuse Bone Graft quickly became the gold standard for 

certain types of lumbar fusion.”

34. Medtronic’s fraudulent scheme was successful and resulted in a revenue stream ranging 

from 700 to 900 million dollars per year.

35. It has been reported that around the same time these stories about Infuse were published, 

editors at the Spine Journal began receiving complaints from doctors around the country 

who were pointing out contradictions between papers published by doctors with financial 

ties to Medtronic and other data involving Infuse complications.’ See Journal Sentinel

article of John Fauber.

36. Through the use of these sham consulting, royalty and education/training agreements with 

its physician agents in this fraudulent enterprise, Medtronic has reaped windfalls in the 

billions of dollars. Medtronic has used this fraudulent enterprise and civil conspiracy to 

drive its vast profits and enhance its market position beyond that which it would have 

realized without engaging willfully, knowingly and potentially deliberate, conscious, or 

reckless indifference in the fraudulent enterprise and fraudulent concealment. See 

Mississippi case.

37. Defendants had full knowledge of all these facts pertaining to Medtronics. 

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FDA PUBLIC HEALTH NOTIFICATION

1. On July 1, 2008 the FDA issued a Public Health Notification entitled “Life-Threatening 

Complications Associated with Recombinant Human Bone Morphogenetic Protein in 

Cervical Spine Fusion.” 

2. This notification was sent to health care practitioners all across the United States warning 

of the complications associated with BMP-2, specifically when used in the cervical spine.

3. In the notification, the FDA stated they received at least 38 reports of complications during 

the prior four years with the use of BMP-2 in cervical spine fusions.

4. The complications were associated with swelling of the neck and throat areas, which 

resulted in compression of the airway and/or neurological structures in the neck.

5. Some reports describe difficulty swallowing, breathing or speaking and severe dysphagia 

following cervical spine fusion using BMP-2 products had also been reported.

6. The notification further stated that, “since the safety and effectiveness of rhBMP for 

treatment of cervical spine conditions has not been demonstrated, and in light of the serious 

adverse events described above, FDA recommends that practitioners either use approved 

alternative treatments or consider enrolling as investigators in approved clinical studies. 

7. The Notification further emphasized the importance of fully informing patients of these 

potential risks and said that patients treated with BMP-2 in the cervical spine should know:

a. The signs and symptoms of airway complications, including difficulty breathing 

or swallowing, or swelling of the neck, tongue, mouth, throat and shoulders or 

upper chest area

b. That they need to seek medical attention immediately at the first sign of an airway 

complication

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c. That they need to be especially watchful 2-14 days after the procedure when 

airway complications are more likely to occur

d. rhBMP-2 (contained in Infuse Bone Graft) has received pre-market approval for 

fusion of the lumbar spine in skeletally mature patients with degenerative disc 

disease at one level from L2-S1 and for healing of acute, open tibial shaft fractures 

stabilized with an IM nail and treated within 14 days of the initial injury

8. Additionally, BMP is not approved in any manner for use in patients who are skeletally 

immature (<18 years of age) or pregnant.

9. Dr. Durrani and the Hospitals ignored ALL of these warnings and used BMP-2 in cervical 

spine surgeries, children, and those with known compromising factors such as 

osteoporosis, smoking, and diabetes. 

10. Furthermore, the Notification stated that the FDA requires hospitals and other user facilities 

to report deaths and serious injuries associated with the use of medical devices. 

11. The Hospitals that allowed Dr. Durrani to use BMP-2 in their facilities failed to report any 

complications resulting from his use of BMP-2.

SENATE FINANCE COMMITTEE REPORT

1. Medtronic’s actions did not go unnoticed, and in June of 2011, the Senate Finance 

Committee began an investigation into the fraudulent actions of Medtronic. 

2. Medtronic produced more than 5,000 documents pertaining to 13 different studies of BMP2 for the investigation.

3. On October 25, 2012, Senate Finance Committee Chairman Max Baucus (D-Mont.) and 

senior member Chuck Grassley (R-Iowa) released the results of their 16-month 

investigation into Medtronic, which revealed questionable ties between the medical 

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technology company and the physician consultants tasked with testing and reviewing 

Medtronic products.

4. The investigation revealed that Medtronic employees collaborated with physician authors 

to edit and write segments of published studies on BMP-2/Infuse without publicly 

disclosing this collaboration. 

5. These fraudulently produced studies may have inaccurately represented BMP-2’s risks and 

may have placed added weight on the side effects of alternative treatments. 

6. The Senate investigation further found that Medtronic also maintained significant, 

previously undisclosed financial ties with physicians who authored studies about BMP-2, 

making $210 million in payments to physicians over a 15-year period. 

7. Senator Baucus stated, “Medtronic’s actions violate the trust patients have in their medical 

care. Medical journal articles should convey an accurate picture of the risks and benefits 

of drugs and medical devices, but patients are at serious risk when companies distort the 

facts the way Medtronic has. Patients everywhere will be better served by a more open, 

honest system without this kind of collusion.”

8. Senator Grassley stated, “The findings also should prompt medical journals to take a very 

proactive approach to accounting for the content of the articles along with the authorship 

of the articles and the studies they feature. These publications are prestigious and 

influential, and their standing rests on rigorous science and objectivity. It’s in the interest 

of these journals to take action, and the public will benefit from more transparency and 

accountability on their part.”

9. Major findings of the investigation include:

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a. Medtronic was involved in drafting, editing, and shaping the content of medical 

journal articles authored by its physician consultants who received significant 

amounts of money through royalties and consulting fees from Medtronic. The 

company’s role in authoring or substantially editing these articles was not disclosed 

in the published articles. Medical journals should ensure that any industry role in 

drafting articles or contributions to authors is fully disclosed.

b. Medtronic paid a total of approximately $210 million to physician authors of 

Medtronic-sponsored studies from November 1996 through December 2010 for 

consulting, royalty and other arrangements.

c. An e-mail exchange shows that a Medtronic employee recommended against 

publishing a complete list of adverse events, or side effects, possibly associated 

with BMP-2/Infuse in a 2005 Journal of Bone and Joint Surgery article. 

d. Medtronic officials inserted language into studies that promoted BMP-2 as a better 

technique than an alternative by emphasizing the pain associated with the 

alternative.

e. Documents indicate that Medtronic prepared one expert’s remarks to the FDA 

advisory panel meeting prior to BMP-2 being approved. At the time, the expert was 

a private physician but was later hired to be a vice president at Medtronic in 2007. 

f. Medtronic documents show the company successfully attempted to adopt weaker 

safety rules for a clinical trial studying BMP-2 in the cervical spine that would have 

allowed the company to continue the trial in the event that patients experienced 

severe swelling in the neck. 

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YODA STUDY

1. In response to the various controversies surrounding BMP-2/Infuse, including a June 2011 

article in the journal Spine, the Yale University Open Data Access (YODA) team reached 

an agreement for Medtronic to provide full individual participant data from all their trials 

of rhBMP-2 and allow unrestricted independent re-analysis of this data.

2. The YODA study involved research teams at two universities – the University of York and 

the Oregon Health and Science University.

3. The review focused exclusively on the use of rhBMP-2 in patients undergoing spinal fusion 

surgery for treatment of degenerative disc disease, spondylolisthesis, or any other relevant 

spinal condition. 

4. The three main objectives of the study were: 1) to examine the potential benefits of BMP2, 2) to examine the potential harms of BMP-2, and 3) to assess the reliability of the 

published evidence base. 

5. Medtronic submitted data from 17 studies, including 12 randomized controlled trials 

(RCTs).

6. In total, the YODA study analyzed the data from 1,409 participants.

7. Though the results showed moderate success with fusions as a result of BMP-2, the study 

found that BMP-2 results in several different complications including arthritis, implantrelated events, retrograde ejaculation, wound complications, and neurological, urogenital, 

and vascular events. 

8. In regard to the alleged tampering with the peer-reviewed studies by Medtronic, the YODA 

study found that only two out of twenty peer-reviewed journal publications reported a 

comprehensive list of all adverse events that occurred during the studies. 

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9. Furthermore, the way in which adverse event data was presented in the literature was 

inconsistent, and the rationale for presenting some adverse events but not others was rarely 

clear. 

10. The study concluded that for the period up to 24 months after surgery, treatment with BMP2 increases the probability of successful fusion (according to Medtronic definitions and 

reports, which the study noted “were subjective so it is not possible to confirm whether 

reported successful fusions truly were successful” see YODA Study, p. 35) but this does 

not translate to clinically meaningful benefits in pain reduction, function, or quality of life. 

The small benefits in these outcomes observed from six months onward come at the 

expense of more pain in the immediate post-operative period and a possible increased risk 

of cancer. 

11. Even more relevant to the case against Dr. Durrani and the Hospitals is the YODA study’s 

conclusion that, “[i]t is very important that these findings are expressed clearly and 

discussed with patients so that they can make informed choices about the type of surgery 

they would prefer.” Id.

12. The University of Oregon Study determined that Infuse/BMP-2 is not better than Autograft, 

while the University of York study determined that Infuse/BMP-2 offers only a slight and 

not statistically significant advantage over Autograft.

13. The YODA study concluded that Medtronic “misrepresented the effectiveness and harms 

through selective reporting, duplicate publication, and underreporting.”

14. Adverse event categories such as heterotopic bone formation, osteolysis, and radiculitis 

were not included in participant databases or internal reports; therefore, the safety profile 

was not fully assessed. 

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15. The YODA study further concluded that Medtronic was involved in drafting, editing, and 

shaping the content of medical journal articles on Infuse/BMP-2 authored by its physician 

consultants who received significant amounts of money through royalties and consulting 

fees from Medtronic. The company’s significant role in authoring or substantively editing 

these articles was not disclosed in the published articles. 

16. Medtronic paid a total of approximately $210 million to the physician authors of 

Medtronic-sponsored studies on Infuse from November 1996 through 2010 for consulting, 

royalty and other arrangements.

17. An email exchange showed that a Medtronic employee recommended against publishing a 

complete list of adverse events or side effects possibly associated with Infuse in a 2005 

Journal of Bone and Joint Surgery article. 

18. Medtronic officials inserted language into studies that promoted Infuse as a better 

technique than an alternative procedure by overemphasizing the pain associated with the 

alternative procedure. 

19. Medtronic’s actions violated the trust patients have in their medical care. Medical journal 

articles should convey an accurate picture of the risks and benefits of drugs and medical 

devices, but patients are at serious risk when companies distort the facts the way Medtronic 

has. See United States Senate Committee on Finance, October 2012. 

20. Infuse was intended for a single level anterior lumbar interbody fusion performed with all 

three components in a specific spinal region. The three components are a tapered metallic 

spinal fusion cage (NOT PLASTIC), a recombinant human (BMP) bone Morphogenetic 

Protein, and a carrier/scaffold for the BMP and resulting bone. The Infuse product is 

inserted into the LT-CAGE Lumbar tapered Fusion Device component to form the 

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complete Infuse Bone Graft/LT–Cage Lumbar Tapered Fusion Device. These components 

must be used as a system. The Infuse Bone Graft component must not be uses without the 

LT-Cage Lumbar Tapered Fusion Device component. 

21. BMP-2 is not supposed to be used in minors.

22. BMP-2 is not supposed to be used with smokers and diabetics because of vascular slowing. 

23. BMP-2 should not be used with women in childbearing years. 

24. BMP-2 is contraindicated for patients with a known hypersensitivity to rhBMP-2 and 

should not be used in the vicinity of a resected or extant tumor, in patients with active 

malignancy, or in patients undergoing treatment for a malignancy.

DR. DURRANI AND BMP-2

1. Despite all of these warning signs, Dr. Durrani, with the full knowledge of the Defendants, 

continued to use BMP-2 in ways not approved by the FDA, or in an “off-label” manner.

2. As early as 2007, Dr. Durrani and UC Health knew there were issues with BMP-2 because 

insurance companies such as Anthem were refusing to pay for BMP-2.

3. Medtronic provided in writing to Dr. Durrani and CAST the approved uses for 

Infuse/BMP-2. 

4. However, Dr. Durrani and the Defendants continued to use BMP-2 in off-label ways, 

including but not limited to:

a. Using BMP-2/Infuse in children, despite Medtronic specifically requiring it be 

used only in “skeletally mature patients;”

b. Using it outside the L2-S1 level of the spine;

c. Ignoring the requirement that BMP-2/Infuse only be used for Grade 1 

spondylolisthesis or Grade 1 retrolisthesis;

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d. Not requiring at least six months of non-operative treatment prior to the use of 

BMP-2/Infuse;

e. Using BMP-2/Infuse without the required cage;

f. Not using the “carrier scaffold” in conjunction with BMP-2/Infuse as required;

g. Using BMP-2/Infuse without proper training despite Medtronic’s warning, 

“Caution: Federal (USA) law restricts this device to sale by or on the order of a 

physician with appropriate training or experience.”

5. Dr. Durrani was a paid consultant for Medtronic.

6. According to Dr. Durrani’s own deposition testimony in several cases, Medtronic required 

one of their representatives to be present in the operating room when its product BMP2/Infuse is used. 

7. Because Medtronic representatives were present in these surgeries, Medtronic knew when 

Dr. Durrani used BMP-2/Infuse outside the approved uses according to Medtronic’s own 

guidelines.

8. Dr. Durrani was encouraged by Medtronic to obtain peer review and published studies from 

Medtronic sales representatives to support his use of BMP-2/Infuse.

9. Dr. Durrani was encouraged by Medtronic to be an advocate for his patients and describe 

how BMP-2/Infuse technology can benefit them.

10. When asked how he got his Medtronic grant, Dr. Durrani responded, “You apply to the 

Medtronic’s corporate and say this is what we want to do, like everybody else in the country 

applies, and then they come and evaluate the thing and say, “Okay, we think it’s worthy. 

We’ll give you the grant.”

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11. In regard to his role as a Medtronic consultant, Dr. Durrani stated, “If there are certain 

products that they help us in developing, then they will come to us for a certain consultant 

role for a certain product development.”

12. Dr. Durrani also stated, “I was involved in the development of the minimally invasive spine 

instrumentation.” 

13. Dr. Durrani gave conflicting reports on his financial relationship with Medtronic.

14. In a deposition, when asked when his relationship with Medtronic began, Dr. Durrani 

responded “2000-it’s 2003, ’04. Something in that category. I’m not sure. It’s on the 

Medtronic website. You can go look at it.”

15. Medtronic’s website has no information regarding their relationship with Dr. Durrani.

16. In another deposition, Dr. Durrani stated he began his relationship with Medtronic in “2005 

or ’06.”

17. Dr. Durrani also gave conflicting reports on how much compensation he received from 

Medtronic for his consultation services.

18. In one deposition, Dr. Durrani stated in response to an inquiry as to how much payment he 

received, “It’s a standard compensation. Again, it’s on the website, how much they’ve paid 

us.” 

19. Again, this information is not available on the Medtronic website.

20. In another deposition, when asked if he received income from Medtronic, Dr. Durrani 

replied, “No, I don’t.”

21. When questioned further if he received a fee as a consultant, he stated, “If you do a work, 

there is a contractual obligation that they have to pay you. As I told you in my last 

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deposition, they did declare it on their website, so you can actually go on the website and 

see how much they paid.”

22. In another deposition, Dr. Durrani stated that he received, “less than $10,000 in ten years” 

from Medtronic.

23. An email dated July 30, 2008 from Medtronic Senior Product Manager Katie Stamps to 

Dr. Durrani states that she “is in the process of working on the renewal of your [Dr. 

Durrani’s] consulting agreement.” As stated, this information is not available on 

Medtronic’s website, nor is any information relating to Dr. Durrani’s role as a consultant 

for Medtronic.

24. A CCHMC packet relating to its Orthopedics department indicated that Dr. Durrani 

received $60,000 in grants, contracts, or industry agreements from Medtronic Sofamor 

Danek in FY 2008. 

25. Financial information discovered concerning Dr. Durrani’s relationship with Medtronic 

was found in Dr. Durrani’s biography on the website for the Orthopaedic & Spine Institute, 

which Dr. Durrani currently operates in Pakistan. The biography states that “Dr. Atiq Dr. 

Durrani has also received the Clinical Spine Fellowship Grant by the Department of 

Orthopaedic Surgery which was funded by Medtronic Sofamor Danek with a budget of 

$59,170 per year.” See http://www.osi.com.pk/doctor/dr-atiq-Dr. Durrani-md/.

26. When a request was made to Medtronic regarding its affiliation with Dr. Durrani, the 

Medtronic Supplier Relations Team stated that Dr. Durrani’s “name [is] not listed in our 

system.”

27. Medtronic further responded to the Deters Law Firm’s request that the firm would need a 

“Vendor I.D. Number,” which neither Medtronic nor any other party has provided.

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28. David Rattigan, was Dr. Durrani’s main Medtronic representative from Bahler Medical.

29. David Rattigan and Medtronic have the same lawyer. Despite the Deters Law Firm’s 

willingness to cooperate in scheduling the date for a deposition, they have refused until 

recently. Mr. Rattigan’s deposition was taken June 5, 2015.

30. In summary, clients of the Deters Law Firm, with the full knowledge and intentional 

consent of all Defendants, became unsuspecting experiments for real world testing of 

Medtronic hardware and BMP-2, by and through Dr. Durrani who had secret financial 

connections to Medtronic, improper motives, and submitted false claims. The government 

paid for many of these improper and unregulated experiments as a result of the false claims 

made by Dr. Durrani, with the knowledge of Medtronic, under the veil of “medically 

necessary” surgeries.

31. Despite repeated requests, Medtronic has refused to cooperate in providing any requested 

information and is actively downplaying their connections to Dr. Durrani.

THE DEFENDANTS AND BMP-2

1. The purpose of the background information on the following Defendants and BMP-2 

concerning other hospitals is to show the egregious methods, which upon information and 

belief were used at all hospitals. 

2. The Defendants allowed and encouraged these practices by Dr. Durrani for the sole purpose 

of money and greed. 

3. David Rattigan was always present in Dr. Durrani’s operating rooms as a representative 

of Medtronic. 

4. David Rattigan’s sole job was to deliver the BMP-2/Infuse to the Hospitals and make sure 

that it was inserted correctly into the patient. 

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5. David Rattigan’s presence in the OR further supports the Defendants awareness of Dr. 

Durrani’s fraudulent use of BMP-2/Infuse.

6. Informed Consent for Surgical or Medical Procedure and Sedation:

It is the responsibly of the attending physician to obtain informed consent prior to the 

procedure. The patient, or his/her representative, will be advised by his/her physician of:

a. The explanation of the procedure

b. The benefits of the procedure

c. The potential problems that might occur during recuperation

d. The risks and side effects of the procedure, which could include but are not limited 

to severe blood loss, infection, stroke or death. 

e. The benefits, risks and side effect of alternative procedures including the 

consequences of declining this procedure or any alternative procedures.

f. The likelihood of achieving satisfactory results

Completion of the “Consent to Hospital and Medical Treatment” form to examine and treat 

is NOT sufficient as consent to perform a surgical procedure, invasive procedure, or for 

medical regimens of substantial risk or that are the subject of human investigation or 

research. 

7. The Defendants had the responsibility to carry out these consent rules. 

8. Dr. Durrani oftentimes used BMP-2 “off-label” when performing surgeries.

9. BMP-2 is manufactured, marketed, sold and distributed by Defendant Medtronic under the 

trade name “Infuse.” 

10. Dr. Durrani is a consultant for Medtronic. 

11. Defendants did not inform Plaintiffs of Durrani's financial interest, conflicts of interest or 

consulting arrangement with Medtronic. 

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12. Medtronic, provided in writing to Dr. Durrani the approved uses for BMP-2, the substance 

also referred to as Infuse, which is a bone morphogenic protein, used as an artificial 

substitute for bone grafting in spine surgeries.

13. BMP-2 is not approved by the Food and Drug Administration for use in the cervical and 

thoracic spine.

14. BMP-2 is neither safe nor approved for use on children less than twenty-one (21) years of 

age.

15. For use in spinal surgery, BMP-2/Infuse is approved by the FDA for a limited procedure, 

performed on a limited area of the spine, using specific components. Specifically, the FDA 

approved Infuse for one procedure of the spine: Anterior Lumbar Interbody Fusion 

(“ALIF” or "Anterior" approach); and only in one area of the spine: L4 to S1; and only 

when used in conjunction with FDA-Approved Components: LT-CAGE Lumbar Tapered 

Fusion Device Component (“LT-CAGE”)

16. Use of Infuse in cervical or thoracic surgery, or use through the back (posterior), or side 

(lateral), or on areas of the spine outside of the L4-S1 region (e.g., the cervical spine), or 

using components other than or in addition to the LT-CAGE is not approved by the FDA, 

and thus such procedures and/or use of non-FDA approved componentry is termed “offlabel.”

17. When used off-label, Infuse frequently causes excessive or uncontrolled (also referred to 

as “ectopic” or “exuberant”) bone growth on or around the spinal cord. When nerves are 

compressed by such excessive bone growth, a patient can experience, among other adverse 

events, intractable pain, paralysis, spasms, and cramps in limbs.

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18. The product packaging for BMP-2/Infuse indicates it causes an increased risk of cancer 

four (4) times greater than other bone graft alternatives. 

19. Dr. Durrani and Children’s Hospital personnel did not disclose to Plaintiffs their intent to 

use BMP-2/Infuse, and further, did not disclose their intent to use BMP-2/Infuse in a way 

not approved by the FDA. 

20. Dr. Durrani used BMP-2 in Plaintiff in a manner not approved by Medtronic or the FDA.

21. Defendants did not inform Plaintiffs that Dr. Durrani used Infuse/BMP-2 in his surgeries.

22. Plaintiffs would not have allowed BMP-2 to be used by Dr. Durrani in his surgery in a 

manner that was not approved by the FDA or Medtronic, Infuse/BMP-2’s manufacturer. 

23. Plaintiffs would not have consented to the use of BMP-2 in Plaintiff’s body if informed of 

the risks by Dr. Durrani or any Children’s Hospital personnel.

24. The written informed consent of Dr. Durrani signed by Plaintiffs lacked the disclosure of

Infuse/BMP-2’s use in his procedures.

25. Plaintiffs never received a verbal disclosure of Infuse/BMP-2 from Dr. Durrani or any 

Children’s Hospital personnel.

26. Medtronic specifically required Infuse/BMP-2 only be used in "skeletally mature patients" 

with degenerative disc disease. 

27. Medtronic required at least six (6) months of non-operative treatment prior to use of 

Infuse/BMP-2. 

28. Dr. Durrani regularly used Infuse/BMP-2 without this six (6) month non-operative 

treatment. 

29. Medtronic required BMP-2 always be used in conjunction with a metal LT cage.

30. Dr. Durrani regularly used BMP-2 without a proper LT cage in his surgeries.

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31. . Dr. Durrani oftentimes used BMP-2 “off-label” when performing surgeries.

32. BMP-2 is manufactured, marketed, sold and distributed by Defendant Medtronic under the 

trade name “Infuse.” 

33. Dr. Durrani is a consultant for Medtronic. 

34. Defendants did not inform Plaintiff of Durrani's financial interest, conflicts of interest or 

consulting arrangement with Medtronic. 

35. Medtronic, provided in writing to Dr. Durrani and CAST the approved uses for BMP-2, 

the substance also referred to as Infuse, which is a bone morphogenic protein, used as an 

artificial substitute for bone grafting in spine surgeries.

36. BMP-2 is not approved by the Food and Drug Administration for use in the cervical and 

thoracic spine.

37. BMP-2 is neither safe nor approved for use on children less than twenty one (21) years of 

age.

38. For use in spinal surgery, BMP-2/Infuse is approved by the FDA for a limited procedure, 

performed on a limited area of the spine, using specific components. Specifically, the FDA 

approved Infuse for one procedure of the spine: Anterior Lumbar Interbody Fusion 

(“ALIF” or "Anterior" approach); and only in one area of the spine: L4 to S1; and only 

when used in conjunction with FDA-Approved Components: LT-CAGE Lumbar Tapered 

Fusion Device Component (“LT-CAGE”).

39. Use of Infuse in cervical or thoracic surgery, or use through the back (posterior), or side 

(lateral), or on areas of the spine outside of the L4-S1 region (e.g., the cervical spine), or 

using components other than or in addition to the LT-CAGE is not approved by the FDA, 

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and thus such procedures and/or use of non-FDA approved componentry is termed “offlabel.”

40. When used off-label, Infuse frequently causes excessive or uncontrolled (also referred to 

as “ectopic” or “exuberant”) bone growth on or around the spinal cord. When nerves are 

compressed by such excessive bone growth, a patient can experience, among other adverse 

events, intractable pain, paralysis, spasms, and cramps in limbs.

41. The product packaging for BMP-2/Infuse indicates it causes an increased risk of cancer 

four (4) times greater than other bone graft alternatives. 

42. Dr. Durrani, CAST staff and employees, and Christ Hospital personnel did not disclose to 

Plaintiff their intent to use BMP-2/Infuse, and further, did not disclose their intent to use 

BMP-2/Infuse in a way not approved by the FDA. 

43. Dr. Durrani used BMP-2 in Plaintiff in manners not approved by Medtronic or the FDA.

44. Defendants did not inform Plaintiff that Dr. Durrani used Infuse/BMP-2 in his surgeries.

45. Plaintiff would not have allowed BMP-2 to be used by Dr. Durrani in his surgeries in a 

manner that was not approved by the FDA or Medtronic, Infuse/BMP-2’s manufacturer. 

46. Plaintiff would not have consented to the use of BMP-2 in his body if informed of the risks 

by Dr. Durrani, CAST staff and employees, or any Christ Hospital personnel. 

47. The written informed consent of Dr. Durrani, CAST, and Christ Hospital signed by 

Plaintiff lacked the disclosure of Infuse/BMP-2’s use in his procedure.

48. Plaintiff never received a verbal disclosure of Infuse/BMP-2 from Dr. Durrani, CAST staff 

and employees, or any Christ Hospital personnel. 

49. Medtronic specifically required Infuse/BMP-2 only be used in "skeletally mature patients" 

with degenerative disc disease. 

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50. Medtronic required at least six (6) months of non-operative treatment prior to use of 

Infuse/BMP-2. 

51. Dr. Durrani regularly used Infuse/BMP-2 without this six (6) month non-operative 

treatment. 

52. Medtronic required BMP-2 always be used in conjunction with a metal LT cage. 

53. Dr. Durrani regularly used BMP-2 without a proper LT cage in his surgeries.

PUREGEN

54. Dr. Durrani oftentimes used PureGen when performing surgeries. 

55. PureGen is a product produced by Alphatec Spine. 

56. Dr. Durrani was and is a paid consultant for Alphatec Spine.

57. Dr. Durrani has an ownership stake in the Alphatec Spine.

58. PureGen has never been approved by the FDA for any human use. 

59. PureGen is now removed from the market for any use.

60. Dr. Durrani used the product PureGen as bone graft substitute similar to Infuse/BMP-2 

during spinal surgeries. 

61. Dr. Durrani, CAST staff and employees, and Christ Hospital personnel did not disclose 

their intent to use PureGen, nor did they inform Plaintiff that it was a product that was not 

approved by the FDA for human use. 

62. Dr. Durrani used PureGen in Plaintiff in manners not approved by the FDA.

63. Plaintiff was not informed by Dr. Durrani, CAST staff and employees, or any Christ 

Hospital personnel that Dr. Durrani used PureGen in Plaintiff’s surgery.

64. Plaintiff would not have allowed PureGen to be used by Dr. Durrani in her surgery in a 

manner that was not approved by the FDA. 

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65. Plaintiff would not have consented to the use of PureGen in her body if informed of the 

risks by Dr. Durrani, CAST staff and employees, or any Christ Hospital personnel. 

66. The written informed consent of Dr. Durrani and CAST signed by Plaintiff lacked the 

disclosure of PureGen’s use in his procedures.

67. Plaintiff never received a verbal disclosure of PureGen from Dr. Durrani, CAST staff and 

employees, or any Christ Hospital Personnel. 

IV. CAUSES OF ACTION.

DR. DURRANI COUNTS:

COUNT I: NEGLIGENCE

1. Defendant Dr. Durrani owed his patient, Plaintiff, the duty to exercise the degree of skill, 

care, and diligence an ordinarily prudent health care provider would have exercised under 

like or similar circumstances. 

2. Defendant Dr. Durrani breached his duty by failing to exercise the requisite degree of 

skill, care and diligence that an ordinarily prudent health care provider would have 

exercised under same or similar circumstances through, among other things, negligent 

diagnosis, medical mismanagement and mistreatment of Plaintiff, including but not 

limited to improper selection for surgery, improper performance of the surgeries, and 

improper follow-up care addressing a patient’s concerns. 

3. As a direct and proximate result of the aforementioned negligence and deviation from the 

standard of care on the part of the Defendant Dr. Durrani, Plaintiff sustained all damages 

requested in the prayer for relief. 

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COUNT II: BATTERY

1. Dr. Durrani committed battery against Plaintiff by performing surgery that was 

unnecessary, contraindicated for Plaintiff’s medical condition, and for which he did not 

properly obtain informed consent, inter alia, by using Infuse/BMP-2, PureGen and/or 

Baxano in ways and for surgeries not approved by the FDA and medical community, and 

by the failure to provide this information to Plaintiff. 

2. Plaintiff would not have agreed to the surgery if she knew the surgery was unnecessary, 

not approved by the FDA, and not indicated.

3. As a direct and proximate result of the aforementioned battery by Dr. Durrani, Plaintiff 

sustained all damages requested in the prayer for relief. 

COUNT III: LACK OF INFORMED CONSENT

1. The informed consent forms from Dr. Durrani and CAST, which they required Plaintiff 

to sign, failed to fully cover all the information necessary and required for the procedures 

and surgical procedures performed by Dr. Durrani. Dr. Durrani and CAST each required 

an informed consent release. 

2. In addition, no one verbally informed Plaintiff of the information and risks required for 

informed consent at the time of or before the Plaintiff’s surgeries.

3. Dr. Durrani failed to inform Plaintiff of material risks and dangers inherent or potentially 

involved with his surgeries and procedures. 

4. Plaintiff subsequently developed severe and grievous injuries as a direct and proximate 

result of lack of informed consent.

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5. Had Plaintiff been appropriately informed of the need or lack of need for surgeries and 

other procedures and the risks of the procedures, Plaintiff would not have undergone the 

surgeries or procedures. 

COUNT IV: INTENTIONAL INFLICTION OF EMOTIONAL DISTRESS

1. Dr. Durrani’s conduct as described above was intentional and reckless. 

2. It is outrageous and offends against the generally accepted standards of morality.

3. It was the proximate and actual cause of Plaintiff’s psychological injuries, emotional 

injuries, mental anguish, suffering, and distress. 

4. Plaintiff suffered severe distress and anguish so serious and of a nature that no reasonable 

man or woman would be expected to endure. 

COUNT V: FRAUD

1. The complaint and amended complaints in Warren County Common Pleas Court in 

Ruther did not plead any claim of fraud or a fraud exception to the statute of repose. 

2. Plaintiff, based upon all which is pled in this Amended Complaint and Complaint should 

be entitled to a fraud exception to the statute of repose.

3. Dr. Durrani made material, false representations to Plaintiff and her insurance company 

related to Plaintiff’s treatment including: stating the surgery was necessary, that Dr. 

Durrani “could fix” Plaintiff, that more conservative treatment was unnecessary and 

futile, that the surgery would be simple or was “no big deal”, that Plaintiff would be 

walking normally within days after surgery, that the procedures were medically necessary 

and accurately reported on the billing to the insurance company, that the surgery was 

successful, and that Plaintiff was medically stable and ready to be discharged. 

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4. Dr. Durrani also concealed the potential use of Infuse/BMP-2 and/or PureGen in 

Plaintiff’s surgery when he had a duty to disclose to Plaintiff his planned use of the same. 

5. These misrepresentations and/or concealments were material to Plaintiff because they 

directly induced the Plaintiff to undergo her surgery. 

6. Dr. Durrani knew or should have known such representations were false, and/or made the 

misrepresentations with utter disregard and recklessness as to their truth that knowledge 

of their falsity may be inferred. 

7. Dr. Durrani made the misrepresentations before, during, and after the surgery, with the 

intent of misleading Plaintiff and her insurance company into relying upon them. 

Specifically, the misrepresentations were made to induce payment by the insurance 

company, without which Dr. Durrani would not have performed the surgery, and to 

induce Plaintiff to undergo the surgery without regard to medical necessity and only for 

the purpose of receiving payment. 

8. The misrepresentations and/or concealments were made during the Plaintiff’s office visits 

at Dr. Durrani’s CAST offices and/or Christ Hospital. 

9. Plaintiff was justified in her reliance on the misrepresentations because a patient has a 

right to trust their doctor and that the facility is overseeing the doctor to ensure the 

patients of that doctor can trust the facility. 

10. As a direct and proximate result of the aforementioned fraud, Plaintiff did undergo 

surgery, which was paid for in whole or in part by her insurance company, and suffered 

all damages requested in the prayer for relief. 

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COUNT VI: SPOLIATION OF EVIDENCE

1. Dr. Durrani willfully altered, destroyed, delayed, hid, modified and/or spoiled (“spoiled”) 

Plaintiff’s records, billing records, emails, paperwork and related evidence. 

2. Dr. Durrani spoiled evidence with knowledge that there was pending or probable 

litigation involving Plaintiff. 

3. Dr. Durrani’s conduct was designed to disrupt Plaintiff’s potential and/or actual case, and 

did in fact and proximately cause disruption, damages and harm to Plaintiff.

CHILDREN’S HOSPITAL COUNTS:

COUNT I: VICARIOUS LIABILITY

1. At all times relevant, Defendant Dr. Durrani was an agent, apparent agent, and/or 

employee of Children’s Hospital.

2. Dr. Durrani is in fact, a partial owner or shareholder of Children’s Hospital. 

3. Defendant Dr. Durrani was performing within the scope of his agency, real or apparent 

with Children’s Hospital during the care and treatment of Plaintiff.

4. Defendant Children’s Hospital is responsible for harm caused by acts of its agents and 

apparent agents for conduct that was within the scope of agency under the theory of 

respondeat superior.

5. Defendant Children’s Hospital is vicariously liable for the acts of Defendant Dr. Durrani 

alleged in this Complaint including all of the counts asserted against Dr. Durrani directly.

6. As a direct and proximate result of Defendant Children’s Hospital’s acts and omissions, 

Plaintiffs sustained severe and grievous injuries, prolonged pain and suffering, emotional 

distress, humiliation, discomfort, loss of enjoyment of life, and loss of ability to perform 

usual and customary activities and incurred substantial medical expenses and treatment. 

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COUNT II: NEGLIGENT CREDENTIALING & RETENTION

1. As described in the Counts asserted directly against Dr. Durrani, the actions of Dr. 

Durrani with respect to Plaintiffs constitute physician negligence and medical 

malpractice. 

2. Children’s Hospital negligently credentialed and retained Dr. Durrani as a credentialed 

physician by:

a. Allowing Dr. Durrani to repeatedly violate the Children’s Hospital bylaws with its 

full knowledge of the same;

b. Failing to adequately review, look into, and otherwise investigate Dr. Durrani’s 

educational background, work history, and peer reviews when he applied for 

privileges at Children’s Hospital;

c. Ignoring complaints about Dr. Durrani’s treatment of patients reported to it by 

Children’s Hospital staff, Dr. Durrani’s patients, and by others;

d. Ignoring Dr. Durrani’s previous privilege terminations from other Cincinnati area 

hospitals, including Deaconess Hospital, Good Samaritan Hospital, Christ Hospital 

and West Chester Hospital. 

3. The Safe Medical Device Act required entities such as Children’s Hospital to report 

serious injuries, serious illnesses, and deaths related to failed medical devices to the FDA 

and the manufacturer; this was never done. 

4. Such disregard for and violations of federal law represents strong evidence that 

Children’s Hospital negligently granted and retained privileges for Dr. Durrani. 

5. As a direct and proximate result of the negligent credentialing and retention of Dr. 

Durrani, Plaintiffs sustained severe and grievous injuries, prolonged pain and suffering, 

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emotional distress, humiliation, discomfort, loss of enjoyment of life, and loss of ability 

to perform usual and customary activities and incurred substantial medical expenses and 

treatment that Plaintiffs would not otherwise have incurred had Dr. Durrani not been 

credentialed by Children’s Hospital. 

COUNT III: FRAUD

1. The complaint and amended complaints in Warren County Common Pleas Court in 

Ruther did not plead any claim of fraud or a fraud exception to the statute of repose. 

2. Plaintiff, based upon all which is pled in this Amended Complaint and Complaint should 

be entitled to a fraud exception to the statute of repose.

3. Children’s Hospital made material, false representations to Plaintiff and their insurance 

company related to Plaintiff’s treatment including: stating the surgery was necessary, that 

Dr. Durrani “could fix” Plaintiff, that more conservative treatment was unnecessary and 

futile, that the surgery would be simple or was “no big deal”, that Plaintiff would be 

walking normally within days after each surgery, that the procedures were medically 

necessary and accurately reported on the billing to the insurance company, that the 

surgery was successful, and that Plaintiff was medically stable and ready to be 

discharged. 

4. These misrepresentations and/or concealments were material to Plaintiff because they 

directly induced the Plaintiff to undergo their surgery(ies). 

5. Children’s Hospital knew or should have known such representations were false, and/or 

made the misrepresentations with utter disregard and recklessness as to their truth that 

knowledge of their falsity may be inferred. 

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6. Children’s Hospital made the misrepresentations both before, during and after the 

surgery(ies) with the intent of misleading Plaintiff and their insurance company into 

relying upon them. Specifically, the misrepresentations were made to induce payment by 

the insurance company, without which Dr. Durrani would not have performed the 

surgery(ies), and to induce Plaintiff to undergo the surgery(ies) without regard to medical 

necessity and only for the purpose of receiving payment. 

7. The misrepresentations and/or concealments were made during the Plaintiff’s office visits 

at Dr. Durrani’s Children’s Hospital office.

8. Plaintiff was justified in their reliance on the misrepresentations because a patient has a 

right to trust their doctor and that the facility that is overseeing the doctor to ensure the 

patients of that doctor can trust the facility. 

9. As a direct and proximate result of the aforementioned fraud, Plaintiff did undergo 

surgery(ies) which were paid for in whole or in part by their insurance company, and 

suffered severe and grievous injuries, paralysis, new and different pain, prolonged pain 

and suffering, emotional distress, humiliation, discomfort, loss of enjoyment of life, loss 

of ability to perform usual and customary activities, and incurred substantial medical 

expenses and treatment.

10. Plaintiff relied on the facility holding Dr. Durrani out as a surgeon and allowing him to 

perform surgeries at its health care facility as assurance the facility was overseeing Dr. 

Durrani, vouching for his surgical abilities, and further was appropriately billing 

Plaintiffs for Children’s Hospital’s services in association with Dr. Durrani’s surgeries. 

11. As a direct and proximate result of this reliance on the billing of Children’s Hospital, 

Plaintiffs incurred medical bills that they otherwise would not have incurred. 

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12. Children’s Hospital also either concealed from Plaintiffs facts they knew about Dr. 

Durrani, including that Infuse/BMP-2 or PureGen would be used in Plaintiff’s surgery, or 

misrepresented to Plaintiffs the nature of the surgery, and the particular risks that were 

involved therein.

13. Because of its superior position and professional role as a medical service provider, 

Children’s Hospital had a duty to disclose these material facts to Plaintiffs and a duty to 

refrain from misrepresenting such material facts to Plaintiffs.

14. Children’s Hospital intentionally concealed and/or misrepresented said material facts 

with the intent to defraud Plaintiffs in order to induce Plaintiff to undergo the surgery, 

and thereby profited from the surgeries and procedures Dr. Durrani performed on 

Plaintiff. 

15. Had Plaintiffs known before Plaintiff’s surgeries that Infuse/BMP-2 or PureGen would be 

used in Plaintiff’s spine and informed of the specific, harmful risks flowing therefrom, 

and/or had Plaintiffs known that her surgery was medically unnecessary and/or that 

material misrepresentations were made to Plaintiff, Plaintiffs would not have undergone 

the surgery with Dr. Durrani.

16. Children’s Hospital billed Plaintiff, Angela Buechel aka Angela Lang, for “HB MISC 

SUPPLY” in the amount of $11,810.00; upon information and belief, Plaintiff believes 

that “HB MISC SUPPLY” is Infuse/BMP-2 or PureGen used in Plaintiff’s September 17, 

2008.

17. As a direct and proximate result of the fraud upon Plaintiffs by Children’s Hospital, 

Plaintiffs sustained all damages requested in the prayer for relief. 

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COUNT IV: SPOLIATION OF EVIDENCE

1. Children’s Hospital through its agents and employees, willfully altered, destroyed, 

delayed, hid, modified and/or spoiled (“spoiled”) Plaintiff’s records, billing records, 

paperwork, and related evidence. 

2. Children’s Hospital through its agents and employees, spoiled evidence with knowledge 

that there was pending or probable litigation involving Plaintiffs. 

3. Children’s Hospital’s conduct was designed to disrupt Plaintiff’s potential and/or actual 

case, and did in fact and proximately cause disruption, damages, and harm to Plaintiff.

COUNT V: OHIO CONSUMER SALES PROTECTION ACT

1. Although the Ohio Consumer Sales Protection statutes O.R.C 1345.01 et seq. exempts 

physicians, a transaction between a hospital and a patient/consumer is not clearly 

exempted.

2. Children’s Hospital’s services rendered to Plaintiffs constitute a “consumer transaction” 

as defined in ORC Section 1345.01(A).

3. Children’s Hospital omitted suppressed and concealed from Plaintiffs facts with the 

intent that Plaintiffs rely on these omissions, suppressions and concealments as set forth 

herein. 

4. Children’s Hospital’s misrepresentations, and its omissions, suppressions and 

concealments of fact, as described above, constituted unfair, deceptive and 

unconscionable acts and practices in violation of O.R.C 1345.02 and 1345.03 and to 

Substantive Rules and case law.

5. Children’s Hospital was fully aware of its actions.

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6. Children’s Hospital was fully aware that Plaintiffs were induced by and relied upon

Children’s Hospital’s representations at the time Children’s Hospital was engaged by 

Plaintiffs.

7. Had Plaintiffs been aware that Children’s Hospital’s representations as set forth above 

were untrue; Plaintiffs would not have used the services of Defendants.

8. Children’s Hospital, through its agency and employees knowingly committed the unfair, 

deceptive and/or unconscionable acts and practices described above. 

9. Children’s Hospital’s actions were not the result of any bona fide errors.

10. As a result of Children’s Hospital’s unfair, deceptive, and unconscionable acts and 

practices, Plaintiffs have suffered and continues to suffer damages, which include, but are 

not limited to the following:

a. Loss of money paid

b. Severe aggravation and inconveniences

c. Under O.R.C. 1345.01 Plaintiffs are entitled to:

i. An order requiring Children’s Hospital to restore to Plaintiffs all money 

received from Plaintiffs plus three times actual damages and/or 

actual/statutory damages for each violation;

ii. All incidental and consequential damages incurred by Plaintiffs;

iii. All reasonable attorneys’ fees, witness fees, court costs, and other fees 

incurred;

COUNT VI: PRODUCTS LIABILITY

1. At all times Infuse/BMP-2 is and was a product as defined in R.C. § 2307.71(A)(12) and 

applicable law.

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2. Children’s Hospital (aka supplier) supplied Medtronic’s (aka manufacturer) Infuse/BMP2 for surgery performed by Dr. Durrani on Plaintiffs.

3. Children’s Hospital, as a supplier, failed to maintain Infuse/BMP-2 properly.

4. Children’s Hospital did not adequately supply all components required to use 

Infuse/BMP-2 properly.

5. Children’s Hospital knew or should have known the FDA requirements and Medtronic's 

requirements for using Infuse/BMP-2. 

6. Children’s Hospital stored Infuse/BMP-2 at its facility.

7. Children’s Hospital ordered Infuse/BMP-2 for surgery performed by Dr. Durrani.

8. Children’s Hospital did not adequately warn Plaintiffs that Infuse/BMP-2 would be used 

without all FDA and manufacturer required components.

9. Children’s Hospital did not gain informed consent from Plaintiffs for the use of 

Infuse/BMP-2, let alone warn of the supplying of the product without FDA and 

manufacturer requirements.

10. Children’s Hospital failed to supply Infuse/BMP-2 (aka product) in the manner in which 

it was represented.

11. Children’s Hospital failed to provide any warning or instruction in regard to Infuse/BMP2, and failed to make sure any other party gave such warning or instruction.

12. Plaintiffs suffered physical, financial, and emotional harm due to Children’s Hospital's 

violation of the Ohio Products Liability act. Plaintiff’s injuries were a foreseeable risk

13. Plaintiffs did not alter, modify or change the product, nor did Plaintiffs know that the 

product was being implanted without all required components.

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14. Children’s Hospital knew or should have known that the product was extremely 

dangerous and should have exercised care to provide a warning that the product was 

being used and that the product was being used outside FDA and manufacturer 

requirements. The harm caused to Plaintiffs by not providing an adequate warning was 

foreseeable.

15. Children’s Hospital knew that the product did not conform to the representation of the 

intended use by the manufacturer yet permitted the product to be implanted into 

Plaintiffs.

16. Children’s Hospital, as a supplier, acted in an unconscionable manner in failing to supply 

the product without all FDA and manufacturer required components.

17. Children’s Hospital, as a supplier, acted in an unconscionable manner in failing to warn 

Plaintiffs that the product was being supplied without all FDA and manufacturer required 

components.

18. Children’s Hospital intentionally billed Infuse/BMP-2 as “Miscellaneous” to prevent 

discovery of the use of Infuse/BMP-2 by Plaintiffs.

19. Children’s Hospital's actions demonstrate they took advantage of the Plaintiffs inability, 

due to ignorance of the product, to understand the product being implanted without FDA 

and manufacturer required components.

20. Children’s Hospital substantially benefited financially by the use of the product as the 

product allowed for Children’s Hospital to charge more for the surgery.

21. Plaintiffs suffered economic loss as defined in R.C. § 2303.71(A)(2) and applicable law.

22. Plaintiffs suffered mental and physical harm due to Children’s Hospital's acts and 

omissions.

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23. Plaintiffs suffered emotional distress due to acts and omissions of Children’s Hospital 

and is entitled to recovery as defined in R.C. § 2307.71(A)(7) and applicable law.

24. Children’s Hospital violated the Ohio Products Liability Act R.C. § 2307.71-2307.80

25. Children’s Hospital violated R.C. § 2307.71(A)(6)

26. Children’s Hospital violated The Ohio Consumer Sales Practices Act R.C. § 1345.02-.03.

27. Children’s Hospital provided inadequate warnings are defined in R.C, § 2307.76(A) and 

applicable law.

COUNT VII: O.R.C. 2923.32 ENGAGING IN A PATTERN OF CORRUPT 

ACTIVITY; FINES; PENALTIES; FORFEITURE; RECORDS AND REPORTS; 

THIRD-PARTY CLAIMS TO PROPERTY SUBJECT TO FORFEITURE (State 

RICO)

28. Pursuant to, O.R.C 2923.32 (A),

(A)(1) No person employed by, or associated with, any enterprise shall 

conduct or participate in, directly or indirectly, the affairs of the enterprise 

through a pattern of corrupt activity or the collection of an unlawful debt.

(2) No person, through a pattern of corrupt activity or the collection of an 

unlawful debt, shall acquire or maintain, directly or indirectly, any interest 

in, or control of, any enterprise or real property.

(3) No person, who knowingly has received any proceeds derived, directly 

or indirectly, from a pattern of corrupt activity or the collection of any 

unlawful debt, shall use or invest, directly or indirectly, any part of those 

proceeds, or any proceeds derived from the use or investment of any of 

those proceeds, in the acquisition of any title to, or any right, interest, or 

equity in, real property or in the establishment or operation of any 

enterprise.

A purchase of securities on the open market with intent to make an 

investment, without intent to control or participate in the control of the 

issuer, and without intent to assist another to do so is not a violation of this 

division, if the securities of the issuer held after the purchase by the 

purchaser, the members of the purchaser's immediate family, and the 

purchaser's or the immediate family members' accomplices in any pattern 

of corrupt activity or the collection of an unlawful debt do not aggregate 

one per cent of the outstanding securities of any one class of the issuer and 

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do not confer, in law or in fact, the power to elect one or more directors of 

the issuer.

Ohio Rev. Code Ann. § 2923.32 (West)

29. The Ohio Revised Code goes on to state that “Person,” is defined as, “(G) “Person” 

means any person, as defined in section 1.59 of the Revised Code, and any governmental 

officer, employee, or entity.” Ohio Rev. Code Ann. § 2923.31 (West)

30. Children’s Hospital (hereinafter Children’s) was a limited liability company authorized to 

transact business and perform medical services in the State of Ohio and operate under the 

trade name Children’s Hospital.

31. Children’s would be considered an entity and according to the Ohio Revised Code 

definition of a person.

32. The Ohio Revised Code also states that, 

(C) “Enterprise” includes any individual, sole proprietorship, partnership, 

limited partnership, corporation, trust, union, government agency, or other legal 

entity, or any organization, association, or group of persons associated in fact 

although not a legal entity. “Enterprise” includes illicit as well as licit enterprises.

Ohio Rev. Code Ann. § 2923.31 (West)

33. Dr. Atiq Abubakar Durrani (hereinafter “Dr. Durrani”), was licensed to and did in fact 

practice medicine in the State of Ohio.

34. Dr. Durrani received privileges to practice medicine at Children’s. Dr. Durrani was 

employed by Children’s and therefore directly associated with Children’s. 

35. Dr. Durrani is an enterprise per the definition, which specifically states “includes any 

individual.” Dr. Durrani is an enterprise. 

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36. Children’s Hospital was in charge of overseeing that Dr. Durrani performed up to par on 

his patients. 

37. Dr. Durrani continued to see new clients and/ or perform unnecessary surgeries; Dr. 

Durrani performed unnecessary surgeries on the Plaintiffs.

38. Children’s had knowledge or should have known that Dr. Durrani was performing 

unnecessary surgeries.

39. Children’s had knowledge that Infuse/BMP-2 was being used and that Children’s was 

concealing the use from the Plaintiff’s. Children’s had this knowledge through operative 

reports and through the patient charts, yet Children’s failed to bill for Infuse/BMP-2 in 

the billing in an explicit manner. 

40. Children’s allowed the surgeries to continue. Children’s billed for these fraudulent 

surgeries and aided and conspired with Dr. Durrani, by allowing his unnecessary 

surgeries to continue, to achieve these acts. 

41. Children’s allowed for Dr. Durrani to perform more unnecessary surgeries and then billed 

Plaintiffs for those surgeries. Children’s billing states, for an example, “SPINAL BONE 

GRAFT,” thereby concealing the use of Infuse/BMP-2 on Plaintiffs. 

42. Dr. Durrani would see Plaintiffs at his Children’s offices.

43. Dr. Durrani would tell Plaintiffs that without surgery, immediately, they would suffer 

paralysis, “there head would snap off,” or death. Plaintiffs would then have the surgery. 

44. Children would schedule the surgery. 

45. Children’s would then allow Dr. Durrani to perform the unnecessary, surgery on the 

Plaintiffs and bill for those unnecessary surgeries. 

46. Children’s allowed for and participated in the fraudulent billing practices, battery due to 

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the unnecessary surgeries, and conspired to aid Dr. Durrani in these corrupt activities. 

47. Children’s profited from Dr. Durrani’s unnecessary surgeries.

48. Children’s through the fraudulent billing practices and collected unlawful debt collection, 

from unnecessary surgeries, had an interest in helping Dr. Durrani continue to lure 

Plaintiffs into unnecessary surgeries and allow the unnecessary surgeries to occur. This 

corrupt practice started in July 2005 through at least February 2009, for the purpose of 

these particular Plaintiffs. 

49. Children’s billed Plaintiffs for the unnecessary surgeries, and used the proceeds in the 

operation of the enterprises. 

CAST COUNTS:

COUNT I: VICARIOUS LIABILITY

1. At all times relevant, Defendant Dr. Durrani was an agent, and/or employee of CAST.

2. Dr. Durrani is in fact, the owner of CAST. 

3. Defendant Dr. Durrani was performing within the scope of his employment with CAST 

during the care and treatment of Plaintiff.

4. Defendant CAST is responsible for harm caused by acts of its employees for conduct that 

was within the scope of employment under the theory of respondeat superior.

5. Defendant CAST is vicariously liable for the acts of Defendant Dr. Durrani alleged in 

this Complaint including all of the counts asserted against Dr. Durrani directly.

6. As a direct and proximate result of Defendant CAST’s acts and omissions, Plaintiff 

sustained all damages requested in the Prayer for Relief.

COUNT II: NEGLIGENT HIRING, RETENTION, AND SUPERVISION

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1. CAST provided Dr. Durrani, inter alia, financial support, control, medical facilities, 

billing and insurance payment support, staff support, medicines, and tangible items for 

use on patients. 

2. CAST and Dr. Durrani participated in experiments using BMP-2 and/or PureGen bone 

graft on patients, including Plaintiff, without obtaining proper informed consent thereby 

causing harm to Plaintiff. 

3. CAST breached its duty to Plaintiff, inter alia, by not supervising or controlling the 

actions of Dr. Durrani and the doctors, nurses, staff, and those with privileges, during the 

medical treatment of Plaintiff at CAST. 

4. The Safe Medical Device Act required entities such as CAST to report serious injuries, 

serious illnesses, and deaths related to failed medical devices to the FDA and the 

manufacturer; this was never done. 

5. Such disregard for and violations of federal law represents strong evidence that CAST 

negligently hired, retained, and supervised Dr. Durrani. 

6. As a direct and proximate result of the acts and omissions herein described, including but 

not limited to failure to properly supervise medical treatment by Dr. Durrani, Plaintiff 

sustained all damages requested in the Prayer for Relief.

COUNT III: FRAUD

1. The complaint and amended complaints in Warren County Common Pleas Court in 

Ruther did not plead any claim of fraud or a fraud exception to the statute of repose. 

2. Plaintiff, based upon all which is pled in this Amended Complaint and Complaint should 

be entitled to a fraud exception to the statute of repose.

3. CAST sent out billing to Plaintiff’s insurance company after the surgeries.

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4. The exact dates these medical bills were sent out are reflected in those medical bills. 

5. These bills constituted affirmative representations by CAST that the charges related to 

Plaintiff’s surgeries were medically appropriate and properly documented. 

6. The bills were sent with the knowledge of CAST that in fact Plaintiff’s surgeries were not 

appropriately billed and documented and that the services rendered at West Chester 

Hospital/UC Health associated with Dr. Durrani were not appropriate. 

7. The bills sent by CAST to Plaintiff falsely represented that Plaintiff’s surgeries were 

appropriately indicated, performed and medically necessary in contra-indication of the 

standard of care. 

8. Plaintiff relied on the facility holding Dr. Durrani out as a surgeon and allowing him to 

perform surgeries at its health care facility as assurance the facility was overseeing Dr. 

Durrani, vouching for his surgical abilities, and further was appropriately billing Plaintiff 

for CAST’s services in association with Dr. Durrani’s surgery. 

9. As a direct and proximate result of this reliance on the billing of CAST, Plaintiff incurred 

medical bills that she otherwise would not have incurred. 

10. CAST also either concealed from Plaintiff that they knew about Dr. Durrani, including 

that Infuse/BMP-2 and/or PureGen would be used in Plaintiff’s surgeries, or 

misrepresented to Plaintiff the nature of the surgeries, and the particular risks that were 

involved therein.

11. CAST’s concealments and misrepresentations regarding Infuse/BMP-2 and/or PureGen

and the nature and risks of Plaintiff’s surgeries were material facts.

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12. Because of its superior position and professional role as a medical service provider, 

CAST had a duty to disclose these material facts to Plaintiff and a duty to refrain from 

misrepresenting such material facts to Plaintiff.

13. CAST intentionally concealed and/or misrepresented said material facts with the intent to 

defraud Plaintiff in order to induce Plaintiff to undergo the surgeries, and thereby profited 

from the surgeries and procedures Dr. Durrani performed on Plaintiff.

14. Plaintiff was unaware that BMP-2 and/or PureGen would be used in Plaintiff’s surgeries 

and therefore, was unaware of the health risks of Infuse/BMP-2 and/or PureGen’s use in 

Plaintiff’s spine.

15. Had Plaintiff known before Plaintiff’s surgeries that Infuse/BMP-2 and/or PureGen

would be used in Plaintiff’s spine and informed of the specific, harmful risks flowing 

therefrom, Plaintiff would not have undergone the surgery with Dr. Durrani.

16. Upon information and belief, Plaintiff believes the bills requested by Plaintiff will 

indicate that CAST falsely represented that Plaintiff’s surgery was appropriately 

indicated, performed, and medically necessary in contra-indication of the standard of 

care. 

17. Plaintiff is still awaiting ITEMIZED billing from CAST reflecting the exact totals 

charged for the use of BMP-2 on Plaintiff. 

18. As a direct and proximate result of the fraud against plaintiff by CAST, Plaintiff 

sustained all damages requested in the prayer for relief.

COUNT IV: OHIO CONSUMER SALES PROTECTION ACT

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1. Although the Ohio Consumer Sales Protection statutes O.R.C 1345.01 et seq. exempts 

physicians, a transaction between a hospital and a patient/consumer is not clearly 

exempted.

2. CAST’s services rendered to Plaintiff constitute a “consumer transaction” as defined in 

ORC Section 1345.01(A).

3. CAST omitted suppressed and concealed from Plaintiffs facts with the intent that 

Plaintiffs rely on these omissions, suppressions and concealments as set forth herein. 

4. CAST’s misrepresentations, and its omissions, suppressions and concealments of fact, as 

described above, constituted unfair, deceptive and unconscionable acts and practices in 

violation of O.R.C 1345.02 and 1345.03 and to Substantive Rules and case law.

5. CAST was fully aware of its actions.

6. CAST was fully aware that Plaintiffs were induced by and relied upon CAST’s

representations at the time CAST was engaged by Plaintiffs.

7. Had Plaintiffs been aware that CAST’s representations as set forth above were untrue;

Plaintiffs would not have used the services of Defendants.

8. CAST, through its agency and employees knowingly committed the unfair, deceptive 

and/or unconscionable acts and practices described above. 

9. CAST’s actions were not the result of any bona fide errors.

10. As a result of CAST’s unfair, deceptive and unconscionable acts and practices, Plaintiffs 

have suffered and continues to suffer damages, which include, but are not limited to the 

following:

a. Loss of money paid

b. Severe aggravation and inconveniences

c. Under O.R.C. 1345.01 Plaintiffs are entitled to: 

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i. An order requiring that CAST restore to Plaintiffs all money received 

from Plaintiffs plus three times actual damages and/or actual/statutory 

damages for each violation;

ii. All incidental and consequential damages incurred by Plaintiffs;

iii. All reasonable attorneys’ fees, witness fees, court costs and other fees 

incurred;

V. PRAYER FOR RELIEF.

WHEREFORE, Plaintiff requests and seeks justice in the form and procedure of a jury, 

verdict and judgment against Defendants on all claims for the following damages: 

1. Past medical bills; 

2. Future medical bills;

3. Lost income and benefits;

4. Lost future income and benefits;

5. Loss of ability to earn income;

6. Past pain and suffering;

7. Future pain and suffering;

8. Plaintiff seeks a finding that her injuries are catastrophic under Ohio Rev. Code 

§2315.18;

9. All damages permitted under Ohio Products Liability Act R.C. § 2307.71-2307.80 and all 

other applicable law;

10. All incidental costs and expenses incurred as a result of her injuries; 

11. The damages to her credit as a result of her injuries;

12. Punitive damages;

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13. Costs;

14. Attorneys’ fees;

15. Interest;

16. All property loss;

17. All other relief to which she is entitled including O.R.C. 1345.01

Based upon 1-17 itemization of damages, the damages sought exceed the minimum jurisdictional 

amount of this Court.

Respectfully Submitted,

/s/ Frederick Johnson

Frederick Johnson (0083071)

5247 Madison Pike 

Independence, Ky 41051

Phone: (859) 363-1900

Mobile: (513) 448-7024

Fax: (859) 363-1444

bmaraanlaw@yahoo.com

Counsel for Plaintiffs

JURY DEMAND

Plaintiffs make a demand for a jury under all claims.

/s/ Frederick Johnson____

Frederick Johnson (0083071)

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