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UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF INDIANA 

SOUTH BEND DIVISION 

DORIS WRIGHT, 

Plaintiff, 

v. 

BIOMET, INC.; BIOMET ORTHOPEDICS, 

LLC; BIOMET U.S. RECONSTRUCTION, 

LLC; BIOMET MANUFACTURING CORP., 

Defendants. 

Case No: 

Dkt. No. 3:12-md-2391 

MDL 2391 

JURY TRIAL DEMANDED 

COMPLAINT

 COMES NOW Plaintiff Doris Wright, by and through her attorneys, Carey Danis & 

Lowe, and for her amended complaint against Defendants, and each of them, states as follows: 

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

Doris Wright, had a Biomet M2a Magnum Metal-on-Metal Hip System (“M2a Magnum Hip 

System”) implanted in both her right hip and her left hip. The M2a Magnum Hip System suffers 

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

surfaces of the acetabular cup, the femoral head, and the taper sleeve, which in turn causes the 

hip implant to fail and the surrounding tissue and bone to die. As a result of these defects, 

Plaintiff’s M2a Magnum Hip System has an unreasonably high risk of failing, causing toxic 

levels of cobalt and chromium, tissue and bone destruction, and the need for Plaintiff to undergo 

a complicated and risky surgery to remove and replace the defective implant. 

PARTIES 

2. Plaintiff Doris Wright is over the age of majority and is a citizen and resident of 

Las Vegas, Nevada, which is located in Clark County. 

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3. Defendant Biomet, Inc. is and at all times relevant to this Complaint was, an 

Indiana Corporation with its principal place of business in Warsaw, Indiana. 

4. Defendant Biomet, Inc. designed, manufactured, marketed, promoted, and sold 

the M2a-Magnum Hip system that is the subject of this lawsuit. 

5. Defendant Biomet Orthopedics, LLC is, and at all times relevant to this 

Complaint was, a wholly owned subsidiary of Defendant Biomet US Reconstruction, LLC, an 

Indiana Corporation with its principal place of business in Warsaw, Indiana. 

6. Defendant Biomet Orthopedics, LLC designed, manufactured, marketed, 

promoted, and sold the M2a-Magnum Hip system that is the subject of this lawsuit. 

7. Defendant Biomet US Reconstruction, LLC is, and at all times relevant to this 

Complaint was, a wholly owned subsidiary of Defendant Biomet, Inc., an Indiana corporation 

with its principal place of business in Warsaw, Indiana. 

8. Defendant Biomet US Reconstruction, LLC designed, manufactured, marketed, 

promoted, and sold the M2a-Magnum Hip system that is the subject of this lawsuit. 

9. Defendant Biomet Manufacturing Corp. is, and at all times relevant to this 

Complaint was, a wholly owned subsidiary of Defendant Biomet, Inc., an Indiana Corporation 

with its principle place of business in Warsaw, Indiana. 

10. Defendant Biomet Manufacturing Corp. designed, manufactured, marketed, 

promoted, and sold the M2a-Magnum Hip system that is the subject of this lawsuit. 

11. Defendants Biomet, Inc., Biomet Orthopedics, LLC, Biomet US Reconstruction, 

LLC and Biomet Manufacturing Corp. are collectively referred to herein as “Biomet” or 

Defendants. 

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12. At all times relevant herein, Defendants were the agents of each other, and in 

doing the things alleged herein, each defendant was acting within the scope and course of its 

agency and was subject to and under the supervision of its Codefendants. 

13. Upon information and belief, at all times herein mentioned, the employees of all 

Defendants, their subsidiaries, affiliates, and other related entities, as well as the employees of 

the Defendants’ subsidiaries, affiliates, and other related entities, were the agents, servants and 

employees of Defendants, and at all relevant times, were acting within the purpose and scope of 

said agency and employment. Whenever reference in this Complaint is made to any act or 

transaction of Defendants, such allegations shall be deemed to mean that the principals, officers, 

employees, agents, and/or representatives of the Defendants committed, knew of, performed, 

authorized, ratified and/or directed such act or transaction on behalf of Defendants while actively 

engaged in the scope of their duties. 

JURISDICTION AND VENUE 

14. This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332(a) as the 

parties are citizens of different States, and the amount in controversy exceeds the sum or value of 

$75,000, exclusive of interest and costs. 

15. Proper venue for this case is appropriate in the United States District Court for the 

District of Nevada – Las Vegas Division. However, pursuant to and in accordance with CMO #2 

(doc. 242) dated February 15, 2013, any case subject to transfer to MDL No. 2391 by the 

Judicial Panel on Multidistrict Litigation pursuant to its October 2, 2012 In re Biomet M2a 

Magnum Hip Implant Prods. Liab. Litig. Transfer Order may file her or her case directly in the 

Northern District of Indiana. Further pursuant to Case Management Order #2 (doc. 242), 

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Defendants agree to accept a waiver of service of summons by mailing same to 56 East Bell 

Drive, P.O. Box 587, Attn: Legal Department, Warsaw, Indiana 46581-0587. 

FACTUAL BACKGROUND 

A. The M2a Magnum Hip System is Defective and Was Not Adequately Tested 

16. 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. 

17. 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. 

 18. While most hip replacements use a polyethylene plastic 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 Plaintiff—have been 

forced to undergo surgeries to replace the failed hip implants. 

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 19. 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 

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. 

 20. 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. 

21. 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 Plaintiff After It Knew It Was 

Defective, That It Had Injured Others, And That It Would Injure Plaintiff. 

 22. 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 

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System because it had become loose after only 3 years. Biomet closed its investigation of this 

complaint. 

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

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. 

 24. By the time Biomet sold the M2a Magnum Hip System to Plaintiff, 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 

Plaintiff. At minimum, Biomet should have stopped selling the defective implant when it 

became aware that it had catastrophically failed in several patients. 

 25. 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 Plaintiff and 

Plaintiff’s doctor—and misrepresented that that the M2a Magnum Hip System was a safe and 

effective medical device. 

26. 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 

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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. 

27. 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.” 

 28. 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. Plaintiff’s M2a Magnum Hip Systems Are Defective. 

29. On or about June 12, 2006, Plaintiff Doris Wright underwent a right hip 

replacement surgery and on June 29, 2009, Plaintiff Doris Wright underwent a left hip 

replacement surgery. Both surgeries took place in Henderson, Nevada, and during both surgeries, 

a Biomet metal-on-metal M2a Magnum prosthesis was used and implanted in her 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. But Biomet refused to disclose that 

information to Doris Wright, her physicians, or the public. Instead, Biomet misrepresented to 

Doris Wright and her orthopedic surgeon that the M2a Magnum Hip System was safe and 

effective. In reliance on these representations, Ms. Wright’s orthopedic surgeon made the 

decision to use the M2a Magnum Hip System for both hip replacements. If it were not for the 

misrepresentations made by Biomet, Ms. Wright’s orthopedic surgeon would not have used the 

M2a Magnum Hip System in Ms. Wright’s hip replacement surgeries. 

 30. 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), 

Plaintiff’s right hip implant has caused her severe pain and she was forced to undergo costly and 

painful revision surgery to replace her right metal-on-metal hip device, on March 23, 2015 by 

Dr. Robert Tait, in Henderson, Nevada. In addition, Plaintiff is at risk of having to undergo 

revision of her left metal-on-metal hip device. 

 31. Having to go through a revision surgery on the right has subjected Plaintiff 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 

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Charlotte Phillips and her 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.) 

 32. As a direct and proximate result of the failure of Plaintiff’s defective M2a 

Magnum Hip System and Biomet’s wrongful conduct, Plaintiff sustained and continues to suffer 

economic damages (including lost wages, medical and hospital expenses), severe and possibly 

permanent injuries, pain, suffering and emotional distress. As a result, Plaintiff 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. 

COUNT I 

(Strict Product Liability) 

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

set forth here and further alleges as follows: 

34. Biomet designed, manufactured, promoted, distributed, marketed, and sold the 

M2a Magnum Hip System. 

35. At all times material hereto, the M2a Magnum Hip System that was designed, 

manufactured, promoted, distributed, marketed, and sold by Biomet was expected to reach, and 

did reach, prescribing physicians and consumers, including Plaintiff and Plaintiff’s physician, 

without substantial change in the condition in which it was sold. 

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36. At all times material hereto, the M2a Magnum Hip System that was designed, 

manufactured, promoted, distributed, marketed, and sold by Biomet was in a defective and 

unreasonably dangerous condition at the time it was placed in the stream of commerce. Such 

condition included, but is not limited to, one or more of the following particulars: 

(a) When placed in the stream of commerce, the M2a Magnum Hip System 

contained manufacturing defects, subjecting Plaintiff and others to risks, including the risk that 

the acetabular component would not properly grow into the bone, causing the hip system to 

prematurely fail and requiring a complex, risky, and painful surgery to remove and replace the 

defective product; 

(b) When placed in the stream of commerce, the M2a Magnum Hip System 

contained unreasonably dangerous design defects and was not reasonably safe for the intended 

use, subjecting Plaintiff and others to risks, including the risk that the acetabular component 

would not properly grow into the bone, causing the hip system to prematurely fail and requiring 

a complex, risky, and painful surgery to remove and replace the defective product; 

(c) The M2a Magnum Hip System was insufficiently tested; and 

(d) The M2a Magnum Hip System was not accompanied by adequate 

instructions and/or warnings to fully inform Plaintiff or Plaintiff’s physicians of the full nature or 

extent of the risks associated with its use. 

37. Biomet knew or should have known of the dangers associated with the use of the 

M2a Magnum Hip System, as well as the defective nature of the M2a Magnum Hip System. 

Despite this knowledge, Biomet continued to manufacture, sell, distribute, promote and supply 

the M2a Magnum Hip System so as to maximize sales and profits at the expense of the public 

health and safety. Biomet’s conduct was done in conscious disregard of the foreseeable harm 

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caused by the M2a Magnum Hip System and in conscious disregard for the rights and safety of 

consumers such as Plaintiff. 

38. Plaintiff and Plaintiff’s surgeon used the M2a Magnum Hip System as directed 

for its intended purpose. 

39. At all times herein mentioned, the M2a Magnum Hip System was defective, and 

Biomet knew that it was to be used by the user without inspection for defects therein. Moreover, 

at the time of the use of the subject products, neither Plaintiff nor Plaintiff’s physician knew or 

had reason to know of the existence of the aforementioned defects. Neither Plaintiff nor 

Plaintiff’s physicians could have discovered the defects in the M2a Magnum Hip System through 

the exercise of reasonable care. 

40. The M2a Magnum Hip System had not been materially altered or modified prior 

to its implantation in Plaintiff. 

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

System, Plaintiff suffered the injuries and damages as described herein. 

COUNT II 

(Negligence) 

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

set forth here and further alleges as follows: 

43. At all times herein mentioned Biomet had a duty to exercise reasonable 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. 

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44. Biomet maliciously, recklessly and/or negligently failed to exercise ordinary care 

in the design, manufacture, testing, inspection, labeling, promotion, marketing, and sale of the 

M2a Magnum Hip System. 

45. Biomet, maliciously, recklessly and/or negligently made misrepresentations about 

the safety and effectiveness of the M2a Magnum Hip System to Plaintiff and Plaintiff’s 

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 surgeries. 

46. Biomet maliciously, recklessly and/or negligently failed in their duty to exercise 

reasonable care in the provision of an adequate warning to Plaintiff and Plaintiff’s physicians as 

to the risks of the M2a Magnum Hip System. 

47. Biomet maliciously, recklessly and/or negligently failed to 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. 

48. Biomet’s conduct was done in conscious disregard of the foreseeable harm caused 

by the M2a Magnum Hip System and in conscious disregard for the rights and safety of 

consumers such as Plaintiff. 

49. As a result of Biomet’s wrongful conduct, Plaintiff suffered injuries and damages 

as alleged herein. 

COUNT III 

(Breach of Implied Warranties) 

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

set forth here and further alleges as follows: 

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51. Prior to the time that the M2a Magnum Hip System was used by Plaintiff and 

Plaintiff’s physician, Biomet impliedly warranted to Plaintiff and Plaintiff’s physicians that the 

M2a Magnum Hip System was of merchantable quality and safe and fit for the use for which it 

was intended. 

52. Plaintiff and Plaintiff’s 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. 

53. 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. 

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

System to Plaintiff, breached the implied warranty of merchantability and fitness and caused 

Plaintiff to suffer severe pain and emotional distress, incur medical expenses and incur a loss of 

earning capacity. 

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

Plaintiff suffered injuries and damages as alleged herein. 

COUNT IV 

(Breach of Express Warranty) 

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

set forth here and further alleges as follows: 

57. At all times herein mentioned, Biomet expressly warranted to Plaintiff and 

Plaintiff’s 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 

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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. 

58. In utilizing the aforementioned M2a Magnum Hip System, Plaintiff and 

Plaintiff’s physician relied on the skill, judgment, representations and foregoing express 

warranties of Biomet. 

59. 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. 

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

suffered injuries and damages as alleged herein. 

COUNT V 

(Violation of Nevada Unfair Trade Practices and Consumer Protection Law) 

 61. Plaintiff realleges and reincorporates each of the allegations above as if set forth 

fully herein. 

 62. Defendants are liable to the Plaintiff pursuant to the Nevada Unfair Trade 

Practices and Consumer Protection Law. Defendants were in the business of manufacturing and 

marketing the implant. Defendants and/or their agents designed, formulated, manufactured, 

assembled, prepared for sale, distributed, and/or sold the implant which was in a defective 

condition unreasonably dangerous when applied to its intended use in the usual and customary 

manner. 

 63. Privity existed between Plaintiff and Defendants. 

 64. Plaintiff, while using the product in the usual and customary manner as it was 

intended to be used, suffered substantial injuries as a proximate result of Defendants placing the 

product on the market, which was unreasonably dangerous and defective at the time it was 

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placed on the market by Defendants. 

 65. The implant, at the time of the Plaintiff’s injuries and damages, was in 

substantially the same condition as it was at the time the implant was marketed by the 

Defendants. 

 66. As a direct and proximate result of Defendants’ conduct, Plaintiff was injured and 

is entitled to recover damages for her bodily injuries, lost wages, physical and mental pain, past 

and future medical expenses, past and future pain and suffering, increased risk of future harm 

and permanent injury. Additionally, Plaintiff is entitled to recover treble damages and 

reasonable attorney fees. 

PRAYER FOR RELIEF

WHEREFORE, Plaintiff demands judgment for the following: 

A. Past and future lost wages, medical, permanency and incidental expenses, 

according to proof; 

B. Past and future general damages for pain and suffering, according to 

proof; 

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

D. Prejudgment and post judgment interest; 

E. Costs to bring this action including attorney fees; and 

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

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August 11, 2015 Respectfully submitted, 

 CAREY DANIS AND LOWE 

 /s/Jeffrey J. Lowe 

 Jeffrey J. Lowe #35114 (Mo Bar) 

 jlowe@careydanis.com 

 8235 Forsyth Blvd., Ste. 1100 

 Clayton, MO 63105 

 (314) 725-7700 or (314) 678-3400 

 Facsimile: (314) 678-3401 

Certificate of Service

 The undersigned hereby certifies that the foregoing Complaint has been filed using the 

Court’s CM/ECF system this 11th day of August, 2015, thereby serving all registered parties. 

 /s/Jeffrey J. Lowe 

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