IN THE UNITED STATES DISTRICT COURT

FOR THE WESTERN DISTRICT OF NORTH CAROLINA

CHARLOTTE DIVISION

3:14-cv-178

JEFF BENTON, )

)

Plaintiff )

)

v. )

)

BIOMET ORTHOPEDICS, LLC, )

BIOMET, INC. & BIOMET, LLC, )

)

Defendants. )

COMPLAINT

(Jury Trial Demanded)

NOW COMES the Plaintiff, Jeff Benton, by and through his attorneys, and for his causes

of action, brings suit against the Defendants, Biomet Orthopedics, LLC; Biomet, Inc.; and

Biomet, LLC, stating and averring as follows:

INTRODUCTION

1. This is a product liability case involving a defective hip implant system. Plaintiff

Jeff Benton had a Biomet M2a Magnum Metal-on-Metal Hip System (“M2a Magnum Hip

System”) implanted in his hip. The M2a Magnum Hip System is defective because excessive

amounts of cobalt and chromium corrode and wear from the surfaces of the acetabular cup, the

femoral head, and the taper sleeve. The excessive wear in turn causes the hip implant to fail and

the surrounding tissue and bone to die. As a result of these defects, Mr. Benton’s M2a Magnum

Hip System failed in his body, causing metallosis, fluid build up, tissue and bone destruction, and

the need for Mr. Benton to undergo a complicated and risky surgery to remove and replace the

defective implant.

PARTIES

2. Plaintiff Jeff Benton is a citizen of the United States and a resident of the

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State of North Carolina. Mr. Benton’s home address is 6814 Pine Lane, Union County, Monroe,

North Carolina.

3. On information and belief, Defendant Biomet Orthopedics, LLC is a limited

liability corporation organized and existing under the laws of the state of Indiana with its

principal place of business in Warsaw, Indiana. Biomet Orthopedics, LLC designed,

manufactured, marketed, promoted, and sold the M2a Magnum Hip system that is the subject of

this lawsuit. Biomet Orthopedics, LLC does not maintain a principal local office in North

Carolina, but can be served at 56 East Bell Drive, P.O. Box 587, Warsaw, Indiana 46581-0587.

4. On information and belief, Defendant Biomet, Inc. is a corporation organized and

existing under the laws of the state of Indiana with its principal place of business in Warsaw,

Indiana. Biomet, Inc. designed, manufactured, marketed, promoted, and sold the M2a Magnum

Hip system that is the subject of this lawsuit. Biomet, Inc. does not maintain a principal local

office in North Carolina, but can be served at 56 East Bell Drive, P.O. Box 587, Warsaw, Indiana

46581-0587.

5. On information and belief, Defendant Biomet, LLC is a limited liability

corporation organized and existing under the laws of the state of Indiana with its principal place

of business in Warsaw, Indiana. Biomet, LLC designed, manufactured, marketed, promoted, and

sold the M2a Magnum Hip system that is the subject of this lawsuit. Biomet, LLC does not

maintain a principal local office in North Carolina, but can be served at 56 East Bell Drive, P.O.

Box 587, Warsaw, Indiana 46581-0587.

6. At all times mentioned, each of Biomet Orthopedics, LLC, Biomet, Inc., and

Biomet LLC was the representative, agent, employee, joint venturer, or alter ego of each of the

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other entities and in doing the things alleged herein was acting within the scope of its authority

as such. Specifically, each Defendant was but an instrumentality or conduit of the other in the

prosecution of a single venture, namely, the design, promotion, and sale of the M2a Magnum

Hip System. Therefore, it would be inequitable for any Defendant to escape liability for an

obligation incurred as much for that Defendant's benefit as for the other.

7. Biomet Orthopedics, LLC, Biomet, Inc., and Biomet LLC are collectively

referred to herein as “Biomet.”

JURISDICTION AND VENUE

8. This is a civil action of which this Court has original jurisdiction under 28 U.S.C.

section 1332 because it is between citizens of different states and the amount in controversy

exceeds the sum or value of $75,000, exclusive of costs and interest.

9. Venue is proper pursuant to 28 U.S.C. §1391(c) because Defendants are all

corporations that have substantial, systematic, and continuous contacts in this District and they

are all subject to personal jurisdiction in this District. Moreover, the Plaintiff’s injuries occurred

in this District.

FACTUAL BACKGROUND

A. The M2a Magnum Hip System Is Defective And Was Not Adequately Tested

10. The hip joint is where the femur connects to the pelvis. The joint is made up of

the femoral head (a ball-like structure at the very top of the femur) rotating within the

acetabulum (a cup-like structure at the bottom of the pelvis.) In a healthy hip, both the femur

and the acetabulum are strong and the rotation of the bones against each other is cushioned and

lubricated by cartilage and fluids.

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11. A total hip replacement replaces the body’s natural joint with an artificial one,

usually made out of metal and plastic. A typical total hip replacement system consists of four

separate components: (1) a femoral stem (labeled as “hip implant” in the diagram to the left), (2)

a femoral head, (3) a plastic (polyethylene)

liner, and (4) an acetabular shell. After the

surgeon hollows out a patient’s femur bone,

the femoral stem is implanted. The femoral

head is a metal ball that is fixed on top of the

femoral stem. The femoral head forms the hip

joint when it is placed inside the polyethylene

liner and acetabular shell.

12. While most hip replacements use a polyethylene plastic or ceramic acetabular

liner, Biomet’s M2a Magnum Hip System has a critical difference: it is a monoblock system

which does not have an acetabular liner. Instead, the M2a Magnum Hip System forces metal to

rub against metal with the full weight and pressure of the human body. Because of Biomet’s

defective design for the M2a Magnum Hip System, hundreds of patients—including Mr.

Benton—have been forced to undergo surgeries to replace the failed hip implants.

13. The M2a Magnum Hip System suffers from a design or manufacturing defect that

cause excessive amounts of cobalt and chromium to wear and corrode from the surface of the

acetabular cup, from the femoral head, and from the taper adapter. These cobalt and chromium

fragments prompt the body to react by rejecting the hip implant. This rejection often manifests

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with symptoms of pain, looseness, dislocation, and squeaking and popping sounds. Inside the

hip joint, the metal reaction often causes fluids to accumulate and soft tissues and bone to die.

14. The design of the M2a Magnum Hip System was not sufficiently tested by

Biomet, and it was never approved by the FDA as being safe or effective for the products’

intended purpose.

15. On numerous occasions, Biomet met with orthopedic surgeons in cities

throughout the United States to promote the M2a Magnum Hip Implant. At some or all of these

meetings, a representative or representatives of Biomet was present. During these meeting,

Biomet assured the orthopedic surgeons that the M2a Magnum Hip System was safe, was the

best product on the market, had an excellent track record and a low and acceptable failure rate.

Biomet continued to “defend” the M2a Magnum Hip Implant even after they became aware of

numerous and serious complications with the M2a Magnum Hip System. Biomet did not reveal

(and instead concealed) their knowledge of numerous and serious complications and other “bad

data” during their meetings with orthopedic surgeons.

B. Biomet Sold the M2a Magnum Hip Implant To Mr. Benton After It Knew It

Was Defective, That It Had Injured Others, And That It Would Injure Him.

16. It was not long after Biomet launched the M2a Magnum Hip System that reports

of failures began flooding into Biomet. For example, in August 2004, Biomet received a

complaint that a patient had to undergo a surgery to remove and replace an M2a Magnum Hip

System because it had become loose after only three years. Biomet closed its investigation of

this complaint.

17. Biomet would go on to receive hundreds of similar complaints reporting that the

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M2a Magnum Hip System had failed and that the failure had forced patients to undergo painful

and risky surgeries to remove and replace the failed hip component. To date, more than 350

reports of adverse events associated with the M2a Magnum Hip System have been filed with the

FDA.

18. By the time Biomet sold the M2a Magnum Hip System to Plaintiff in October

2008, numerous reports had been filed with the FDA reporting an adverse event associated with

the M2a Magnum Hip System. Consequently, Biomet was fully aware that the M2a Magnum Hip

System was defective and that dozens of patients already had been injured by that defect. Based

on this information, Biomet should have recalled the M2a Magnum Hip System before it was

sold to Mr. Benton. At minimum, Biomet should have stopped selling the defective implant

when it became aware that it had catastrophically failed in several patients.

19. Despite its knowledge that the M2a Magnum Hip System had a defect and that it

had failed hundreds of times, causing hundreds of patients to undergo the agony of another

surgery, Biomet continues to sell the defective M2a Magnum Hip System. In so doing, Biomet

actively concealed the known defect from doctors and patients—including Mr. Benton and his

doctor—and misrepresented that the M2a Magnum Hip System was a safe and effective

medical device.

20. As numerous failures of the M2a Magnum Hip Implant were reported to Biomet,

it continued to actively promote, market and defend the defective products. For example,

Biomet published marketing brochures touting the safety and durability of metal-on-metal

implants and specifically, the M2a Magnum Hip System. These brochures were given to doctors

around the world to encourage them to use the M2a Magnum Hip System.

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21. Despite its knowledge that the M2a Magnum Hip System was defective, Biomet

also made several false representations about specific design elements of the M2a Magnum Hip

System that they claimed made it superior to other more safe hip implants on the market. For

example, Biomet said:

• “The M2a-MagnumTM Large Metal Articulation System offers optimal

joint mechanic restoration and ultra low-wear rates in vivo.”

• Many studies conducted over the last several decades have shown no

definitive correlation of negative health issues to ion levels exhibited from

metal-on-metal implants.”

22. Biomet’s reason to conceal the defect in its M2a Magnum Hip System is clear.

Hip implant sales are critically important to Biomet, and the M2a Magnum is one of its most

profitable products. During the time period relevant to this Complaint, Biomet’s management

was trying to make Biomet look appealing to investors, and they ultimately were purchased by a

private equity firm in 2007 for $10 billion. Biomet was faced with a critical defect in one of its

most profitable hip implant systems. The last thing Biomet wanted to do was to admit that these

popular products had a critical defect that could cause a premature failure, forcing patients to

have to undergo another painful surgery. Focused on corporate profits, and at the expense of

patient safety, Biomet decided that it would continue to promote, market, and sell the M2a

Magnum Hip System despite the fact that it knew the product was defective. To this day,

Biomet continue to sell these defective implants to unsuspecting patients without any warning

about the risks or the failures that have been reported to the company.

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C. Mr. Benton’s M2a Magnum Hip System Was Defective And Failed, Forcing

Him To Undergo An Additional Painful And Risky Surgery.

23. On or about October 20, 2008, Plaintiff underwent a left hip replacement

surgery in Leesburg, Florida, during which a Biomet metal-on-metal Magnum prosthesis was

implanted in his body. By this time, numerous reports of adverse events associated with the M2a

Magnum had been filed with the FDA and Biomet knew that the product was defective. Biomet

failed to disclose that information to Mr. Benton, his physicians, or the public. Upon information

and belief, Biomet misrepresented to Mr. Benton and his orthopedic surgeon through its sales

representatives that the M2a Magnum Hip System was safe and effective. In reliance on these

representations, Mr. Benton’ orthopedic surgeon made the decision to use the M2a Magnum Hip

System. If it were not for the misrepresentations made by Biomet, Mr. Benton’ orthopedic

surgeon would not have used the M2a Magnum Hip System in Mr. Benton’ hip replacement

surgery.

24. By 2013, Plaintiff was residing in North Carolina and began experiencing pain in

his left hip.

25. By 2013, the pain had become severe and he developed a large fluid collection. 

26. Upon the advice of his physician, Mr. Benton agreed to have his metal-on-metal

prosthesis removed and replaced using a prosthesis using polyethylene or ceramic components.

27. On August 27, 2013 in North Carolina, Plaintiff underwent a complex, risky, and

painful surgery (known as a “revision surgery”) to remove the failed M2a Magnum Hip System

from his body. Revision surgeries are generally more complex than the original hip replacement

surgery, often because there is a reduced amount of bone in which to place the new hip implants.

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Revision surgeries also usually take longer than the original hip replacement surgery and the

revision surgery has a higher rate of complications. Post-surgical pathology reports indicated that

the acetabular head and lining were surrounded by fibroconnective tissue and bone with necrosis,

granulation, acute and chronic inflammation. During the surgery, metalosis fluid and a pseudo

tumor was found in Plaintiff’s joint.

28. As a result of the defective design, manufacture and composition of the M2a

Magnum Hip System, and its accompanying warnings and instructions (or lack thereof), Mr.

Benton’s hip implant failed, causing his severe pain.

29. Having to go through a revision surgery has subjected Mr. Benton to much

greater risks of future complications than she had before the revision surgery. For example,

several studies have found that a revision surgery causes a much higher risk of dislocation

compared with an original hip replacement surgery. In one study conducted by Charlotte

Phillips and his colleagues at Brigham and Women's Hospital in Boston, 14.4 percent of patients

who underwent a revision surgery suffered from a dislocation compared with 3.9 percent of

patients who underwent a original hip replacement surgery. In other words, hip replacement

patients who have undergone a revision surgery are almost four times more likely to suffer from

a hip dislocation than those who have not. (Phillips CB, et al. Incidence rates of dislocation,

pulmonary embolism, and deep infection during the first six months after elective total hip

replacement. American Journal of Bone and Joint Surgery 2003; 85:20–26.)

30. As a direct and proximate result of the failure of his defective M2a Magnum Hip

System and Biomet’s wrongful conduct, Mr. Benton sustained and continues to suffer economic

damages (including medical and hospital expenses), severe and possibly permanent

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injuries, pain, suffering and emotional distress. As a result, Mr. Benton has sustained and will

continue to sustain damages in an amount to be proven at trial, but which will far exceed $75,000

jurisdictional minimum of this court.

FRAUDULENT CONCEALMENT

31. Defendants’ failure to document or follow up on the known defects in their

product, and concealment of known defects, constitutes fraudulent concealment that equitably

tolls applicable statutes of limitation.

32. Defendants are stopped from relying on the statute of limitations defense

because Defendants actively concealed the defects, suppressing reports, failing to follow through

on FDA notification requirements, and failing to disclose known defects to physicians. Instead of

revealing the defects, Defendants continued to represent their device as safe for its intended use.

33. Defendants are and were under a continuing duty to disclose the true character,

quality, and nature of risks and dangers associated with their device. Because of Defendants’

concealment of the true character, quality and nature of the product, Defendants are stopped

from relying on any statute of limitations defense.

34. Defendants furthered this fraudulent concealment through a continued and

systematic failure to disclose information to the Plaintiff, his physician and the public.

35. Defendants’ acts before, during and/or after the act causing Plaintiff’s injuries

prevented Plaintiff from discovering the injuries or cause thereof.

36. Defendants’ conduct, as described in the preceding paragraphs, amounts to

conduct purposely committed, which Defendants must have realized was dangerous, heedless

and reckless, without regard to the consequences or the rights and safety of the Plaintiff.

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COUNT I

(Negligence)

37. Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully

set forth herein and further alleges as follows:

38. At all times herein mentioned Biomet had a duty to exercise reasonable care and

to comply with the existing standards of care in the design, manufacture, testing, inspection,

labeling, promotion, marketing, and sale of the M2a Magnum Hip System to ensure that it would

be safely used in a manner and for a purpose for which it was made.

39. In violation of its obligation to exercise due care and comply with existing

standards of care, Biomet was negligent in the design, manufacture, testing, inspection, labeling,

promotion, marketing, and sale of the M2a Magnum Hip System.

40. In further violation of the duties set forth above, Biomet negligently made

misrepresentations about the safety and effectiveness of the M2a Magnum Hip System to

Plaintiff and his orthopedic surgeon. In reliance on these misrepresentations, Plaintiff’s

orthopedic surgeon decided to use the M2a Magnum Hip Implant in Plaintiff’s surgery. If it was

not for the misrepresentations by Biomet, Plaintiff’s orthopedic surgeon would not have used the

M2a Magnum Hip System in Plaintiff’s surgery, and Plaintiff would not have been injured in the

manner set forth with particularity, above.

41. In further violation of the duties set forth above, Biomet negligently failed in their

duty to exercise reasonable care in the provision of an adequate warning to Mr. Benton and his

physicians as to the risks of the M2a Magnum Hip System.

42. In further violation of the duties set forth above, Biomet negligently failed to

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exercise reasonable care in the post-marketing warnings as to the risks of the M2a Magnum Hip

System when they knew or should have known of said risks.

43. As a proximate cause of Biomet’s wrongful conduct, Plaintiff suffered injuries

and damages as alleged herein.

COUNT II

(Breach of Implied Warranties)

44. Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully

set forth here and further alleges as follows:

45. Prior to the time that the M2a Magnum Hip System was used by Mr. Benton,

Biomet impliedly warranted to Mr. Benton and his physicians that the M2a Magnum Hip

System was of merchantable quality and safe and fit for the use for which it was intended.

46. Mr. Benton and his physician were and are unskilled in the research, design and

manufacture of the M2a Magnum Hip System, and they reasonably relied entirely on the skill,

judgment and implied warranty of Biomet in using the M2a Magnum Hip System.

47. The M2a Magnum Hip System was neither safe for its intended use nor of

merchantable quality, as warranted by Biomet, in that it had dangerous propensities when put to

its intended use and would cause severe injuries to the user.

48. Biomet, by selling, delivering and/or distributing the defective M2a Magnum Hip

System to Mr. Benton, breached the implied warranty of merchantability and fitness and caused

Mr. Benton to suffer severe pain and emotional distress, incur medical expenses and incur a loss

of earning capacity.

49. Plaintiff, within a reasonable time after the occurrence and breach complained of,

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notified and informed Defendants of their breach as required by N.C. Gen. Stat. section 25-2-

607(3).

50. As a result of the aforementioned breach of implied warranties by Biomet,

Plaintiff suffered injuries and damages as alleged herein.

COUNT III

(Breach of Express Warranty)

51. Plaintiff incorporates all of the preceding paragraphs of this Complaint as if fully

set forth here and further alleges as follows:

52. At all times herein mentioned, Biomet expressly warranted to Mr. Benton and

Mr. Benton’ physicians, by and through statements made by Biomet or their authorized agents

or sales representatives, orally and in publications, package inserts and other written materials

intended for physicians, medical patients and the general public, that the aforementioned M2a

Magnum Hip System was safe, effective, fit and proper for its intended use.

53. In utilizing the aforementioned M2a Magnum Hip System, Mr. Benton and his

physician relied on the skill, judgment, representations and foregoing express warranties of

Biomet.

54. Said warranties and representations were false in that the aforementioned M2a

Magnum Hip System was not safe and was unfit for the uses for which it was intended.

55. As a result of the foregoing breach of express warranties by Biomet, Plaintiff

suffered injuries and damages as alleged hassan.

COUNT VI 

(UNFAIR AND DECEPTIVE TRADE PRACTICES)

56. Plaintiff incorporates by reference all of the paragraphs of this Complaint as if

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fully set forth herein at length, and further alleges:

57. Defendants represented that the hip system, and specifically, the hip system

purchased or used by the Plaintiff, would be free from defects and fit for its intended purpose,

under normal conditions of use, wear and exposure.

58. Defendants marketed and represented that the hip system contained a superior

design, was a true value, and was otherwise safe for use in the application used for the Plaintiff.

59. Defendants knew or should have known that the hip system did not or would not

conform to Defendant’s representations and promises.

60. By making these false and misleading misrepresentations and omissions, and by

concealing the true facts from the Plaintiff and his doctors, the Defendants intended that the

Plaintiff and his doctors would rely on its false statements and material omissions, and intended

to induce the Plaintiff and his doctors to purchase and use the hip system.

61. The Defendants’ unfair and deceptive conduct, as herein alleged, occurred in the

course of the sale of a good, to wit, the hip system, and was in or affecting commerce, for the

purpose of establishing liability under Chapter 75 of the North Carolina General Statutes.

62. Based upon Defendants’ misrepresentations, material omissions, and business

practices, Plaintiff and his doctors believed that Defendants were selling and providing a safe and

reliable hip system for use in plaintiff’s surgery. Furthermore, Defendant’s practices, as alleged

hassan, are such that reasonable patients and their doctors, would likewise believe that the hip

system would be free from defects and fit for its intended purpose under the conditions of use to

which it was being put.

63. Upon information and belief, the Defendants’ unfair and deceptive representations

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and omissions regarding the hip system, as herein alleged, are all pursuant to policies, practices

and procedures created and adopted by Defendants, and implemented throughout the United

States and North Carolina by Defendants.

64. Defendants’ misrepresentations, material omissions, and business practices, as

alleged in this Complaint, constitute unfair and/or deceptive acts or practices in violation of the

provisions of Chapter 75 of the North Carolina General Statutes.

65. Defendants’ misrepresentations, concealment, and unfair and deceptive acts or

practices proximately caused injury to the Plaintiff.

66. Plaintiff is entitled to receive compensation for these injuries, in an amount to be

determined at trial.

67. As a direct and proximate result of Defendants’ unfair and/or deceptive acts and

practices, in or affecting commerce, Plaintiff is entitled to recover treble damages from

Defendants, pursuant to N.C. Gen. Stat. 75-16, and to recover his reasonable attorneys fees as

provided for in N.C. Gen. Stat. 75-16.1.

PUNITIVE DAMAGES

68. Defendants' conduct, as described above, was done with actual malice, that is, evil

motive, intent to injure, ill will and/or fraud. Defendants risked the lives of consumers and users

of their products, including the Plaintiff, with knowledge of the safety and efficacy problems and

suppressed this knowledge from the general public. Defendants by and through their officers and

manager made conscious decisions not to redesign, re-label, warn or inform the unsuspecting

consuming public, all to the detriment of the purchasers of the product, generally, and Jeff

Benton, in particular.

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PRAYER FOR RELIEF

WHEREFORE, Plaintiff demands judgment, jointly and severally, against the Defendants

for the following:

1. Past and future medical, permanency and incidental expenses,

according to proof;

2. Past and future general damages for pain and suffering, according to proof;

3. Punitive and exemplary damages in an amount to be determined at trial;

4. Prejudgment and post judgment interest;

5. Costs to bring this action; and

6. Such other and further relief as the court may deem just and proper.

JURY DEMAND

Plaintiff demands a trial by jury on all issues raised herein.

Respectfully submitted this the 11 day of April, 2014. th

LAW OFFICE OF MICHAEL W. PATRICK

BY: /s/ Michael W. Patrick

N.C. Bar #7956

312 West Franklin Street

Post Office Box 16848

Chapel Hill, North Carolina 27516

mpatrick@ncproductslaw.com

(919) 960-5848 (919) 869-1348 - fax

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