About the Author(s)

Recent Developments
Metal-on-metal Hip Implant Recalls and Multidistrict Litigation
Jin Hee Park


Abstract: This article gives a brief overview on the multitude of lawsuits associated with the metal-on-metal hip implant products which have caused injuries to thousands of people over the past five years. The all-metal hip implants have been linked to life-altering and sometimes life-threatening injuries. In 2012, the federal judges presiding over multidistrict litigation involving DePuy devices ordered the parties to select cases for bellwether trials to begin in October of 2013. Several cases have since settled. The total amount of settlement tops $4 billion and, according to Bloomberg News, the agreement will be the largest settlement of U.S. claims involving a medical device, pending court approval. The Multidistrict Litigation revolved around the issue of whether the medical device used in hip replacement surgery was defectively designed and/or manufactured, and whether defendants failed to provide adequate warnings concerning the device.

Keywords: Hip replacement surgery, metal-on-metal hip implant, all-metal hip implants, multidistrict litigation, bellwether trials, medical device, settlement, defective design, defective manufacture, inadequate warning, Medicare, metallosis, recalls, FDA regulation, 510(k) approval

Published: August 6, 2014
Cite as:
Park, J., Metal-on-metal Hip Implants Recalls and Multidistrict Litigation, Bull Health Pol’s & L., 2014; 3(1).

Introduction
A retired prison guard Loren Kransky was the first plaintiff to go to trial in California amongst thousands against Johnson & Johnson Depuy Orthopedics (“DePuy”).1 In the closing arguments of this California case, Michael Kelly, Kransky’s attorney, said: “This is not an imperfect hip; this is a public health disaster.”2 The faulty hip replacement devices affected so many people because they were used for one of the most popular surgeries in the United States.

Hip replacement surgery (“hip arthroplasty”) accounts for the second highest orthopedic surgery performed in the United States.3 About 270,000 hip replacement surgeries are performed each year in the U.S., accounting for nearly forty percent of all joint replacements according to the British Medical Journal.4 In 2003, DePuy introduced a new concept of using all-metal implants made of cobalt and chromium to enhance durability of the traditionally used metal-on-plastic or ceramic-on-plastic implants.5 This all-metal innovation in hip replacement surgery changed the demographics of surgery candidates to a much younger age than the standard 65-year-old age group.6 This move broadened the market and some top U.S. medical device companies including Stryker Corporation(“Stryker”), Wright Medical Technology Inc. (“Wright”), Zimmer Holding Inc. (“Zimmer”), Biomet Inc., and Encore Medical introduced their own models of all-metal hip implants.7

Until 2010, the metal-on-metal implants accounted for about one-third of the hip replacement procedures in the United States.8 These popular medical devices, which yielded one of the highest profit margins of any medical product, failed the expectations of the medical device companies, patients, and doctors.

Metal-on-Metal Hip Implant Complications
The complications started to show up on patients in as little as one to five years after the surgery. One-third of all-metal implant receivers experienced pain, dislocation, bone fracture, and lack of mobility due to loosening of the prosthesis and need for revision surgeries. Some of them also had metallosis, toxic levels of metal debris in their bloodstreams, which may cause infection and damage to the muscles, tendons, soft tissue and bone.9 "Soft tissue damage is more critical than bone damage. If the bone is damaged, we can do something. But if the muscle is dead because it has been poisoned by metal ions, we can't recreate it," said Dr. Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida.10

Whereas premature failure replacement surgery for the traditional implant is typically around two percent after one year or five percent at five years,11 the all-metal hips are failing at a faster rate. The U.S. does not have a tracking system for the hip implants but a recent study from the National Joint Registry of England and Wales showed triple the rate at about 6.2 percent of people with the metal-on-metal variety requiring revision surgery within five years.12 The rate went up to about 8 percent with larger-head implants and those used in women.13 These complications are more dire because the all-metal hip implants, whose durable material made it attractive to those who needed full range of motion for their activities, were aggressively marketed to candidates younger than 55-years of age.14

Failure Cost on Medicare, Insurance and Patients
The cost of replacing prematurely failed implants is about $15,000 each.15 While other common implants, like heart defibrillators, have warranties of more than 30 years or discounted replacements, the hip implants do not offer such remedies.16 Because the devices are sold directly to hospitals, the device is billed to Medicare or private insurers and the costs are often passed on to the tax payers.17 Additionally, the out-of-pocket expenses on patients with co-pay and extra expenses derived from complications add up to thousands of dollars per person.18 Therefore, the costs to taxpayers, policyholders and patients can run into tens of millions of dollars each year and yet orthopedic producers continue to make profit from failures because they sell replacements at full cost.19

Recalls
The Zimmer Durom Cup, which was approved by the FDA in 2006,20 was recalled in 2008 due to inadequate training of surgeons in placing the implants.21 After amending their company website by adding a surgical training program and updating the product labeling the Durom Cup implants were back on the U.S. market.22

In 2010, DePuy recalled its Articular Surface Replacement device (“ASR”) after an alarming report of twelve percent (12%) failure rate within five years from the National Joint Registry of England and Wales.23 And Australia’s joint registry was reporting a forty-four percent (44%) failure rate within seven years.24 DePuy hired a third-party workers compensation and insurance claim processor, Broadspire Services, Inc., to handle recall claims.25 It offered compensation to those who promised to accept an agreement “avoiding the complex and lengthy lawsuit process.”26

In 2012, Stryker recalled its hip implant devices, Rejuvenate and ABG II modular-neck hip stems.27 While a recall has not been issued yet, the CONSERVE Plus of Wright, another hip implant device is facing the same problems as DePuy’s ASR.28 Some recalls provide compensation for revision surgeries but they does not cover the extensive expenses of pain and suffering.29

Lawsuits and Settlement
Many people suffering debilitating conditions from hip implants filed lawsuits against the manufacturers claiming that the all-metal hip implants are defectively designed and/or manufactured, and that the defendants failed to provide adequate warnings concerning the devices.30 In 2008, Zimmer created a $69 million fund to pay claims for the liability of Durom Cup.31 The Victims of the Wright CONSERVE Plus and the PROFEMUR Z model’s stem failure started the lawsuit against the company in 2011.32 According to Drugwatch these lawsuits were consolidated under one judge in the U.S. District Court of Northern Georgia.33 The multi-district litigation in 2012 related to the M2a 38 or M2a Magnum hip replacement system from Biomet settled at $56 million in Jan of 2014.34

About 12,000 lawsuits were filed against DePuy.35 Approximately 7,000 of the A.S.R. lawsuits have been consolidated in a federal court in Ohio and approximately 2,000 cases have been consolidated in a California state court.36 While other claims were consolidated, Kransky’s claim was tried in March of 2013 in California because he had a short life expectancy.37 Revealing information was exposed: DePuy executives were reported that the failure rate would soar up to 37 percent within five years;38 the company only tested its performance on laboratory equipment at one angle of implantation for this allegedly durable full range of motion device;39 DePuy’s president, Andrew Ekdahl, was warned about the A.S.R.’s problems nearly three years before it was recalled.40 Los Angeles Superior Court jury found that the hip implants were defective but no negligence on the company.41 DePuy was ordered to pay more than $338,000 in medical costs and $8 million for pain and suffering to plaintiff Loren Kransky.42 No punitive damages were awarded. On the other hand, DePuy successfully defended a Chicago case in August of 2013 where the jury sided with DePuy.43

Three representative cases were scheduled to go as bellwether trials in October of 2013 to provide a guideline for the holding of the pending cases.44 Instead, DePuy announced a settlement of the multi-litigation lawsuits for about $4 billion.45 Under the agreement, $2.5 to $3 billion would be paid in compensation to an estimated 8,000 patients who underwent hip revision surgeries.46 The plaintiffs will be paid with base amounts of $250,000 each and there will be additional payments depending on the severity of their medical condition.47 It is unclear how many claimants will accept the plan because the award will be increased or reduced by factors such as the claimant’s age, weight, severity of the medical condition, and the length of use of the implant.48 For those who have not yet received the revision surgery, there is a provision to add $250,000 to the settlement for each patient who undergoes a replacement procedure before the plan is completed.49 Currently, out of the 12,000 plaintiffs, about 8,000 of those claimants had the revision surgery and 4,000 patients are pending.50 The proposed settlement must be claimed by 94 percent of eligible claimants to go forward.51 People who do not qualify for the settlement will proceed with individual lawsuits. 52

Lawsuits and Settlement
In the wake of these recall phenomena, the U.S. Food and Drug Administration (“FDA”) conducted comprehensive research on all-metal hip implants led by Dr. Art Sedrakyan of Weill Cornell Medical College in New York City.53 The FDA acknowledged that the all-metal implants can shed metal where the ball and the cup connect when they slide against each other from walking or running.54 The researchers noted the flawed regulation of the fast-track 510(k) process which allowed the all-metal hip implants to be in the market without an adequate clinical data55 and tracking system to monitor the performance of the devices once it was in the stream of commerce.56 Ashley Blom of the University of Bristol told Reuters, "In this case, with the benefit of hindsight, I think that tighter regulation may have prevented this."57 The FDA is actively devising to amend the flawed regulation to prevent future mishaps.58

Conclusion
The innovation of the all-metal implant for hip replacement surgery ultimately led to devastating results as it negatively affected the lives of more than 12,000 people in the US. The plaintiffs suffering from severe pain to disabling muscle tissue destruction were claiming recovery for damages. Despite the companies’ offer of a record settlement, some victims will be left out due to some of the constraints of the settlement. This situation also revealed the flaws of the fast-track 510(k) approval system.

Competing Interests: None reported.

Author(s)
Jin Hee Park is a third year law student at California Western School of Law and the co-vice president of Health Law Society. She received her M.S.in Oriental Medicine from Pacific College of Oriental Medicine in San Diego, California and M.A. and B.A. in English Language and Literature from Ewha Womans University in Korea. She is a member of the California Society for Health Care Attorneys and the American Health Lawyers Association.

References (Bluebook)

1In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Prods. Liab. Litig., 787 F. Supp. 2d 1358, 1360 (J.P.M.L. 2011).

2Michelle Llamas, J&J Ordered to Pay $8.3M in First DePuy ASR Hip Implant Trial, Drugwatch.com , March 11, 2013, http://www.drugwatch.com/2013/03/11/depuy-hip-implant-verdict/. 

3Natalia A. Wilson et al., Hip And Knee Implants: Current Trends And Policy Considerations,27Health Affairs, no.6.  1587-98 (2008) http://content.healthaffairs.org/content/27/6/1587.full.pdf+html?sid=82bf3417-a527-4215-9cd5-2a921e8201c5.

4UPDATE 2-FDA seeks more advice on metal hip implants, Reuters, Mar. 29, 2012, http://www.reuters.com/article/2012/03/29/usa-fda-hips-idUSL3E8ET6X820120329.

5Barry Meier, Johnson & Johnson in Deal to Settle Hip Implant Lawsuits, N.Y. Times, Nov. 13, 2013, http://www.nytimes.com/2013/11/13/business/johnson-and-johnson-said-to-agree-to-4-billion-settlement-over-hip-implants.html.

6Richard Knox, Prone To Failure, Some All-Metal Hip Implants Need To Be Removed Early, National Public Radio, Mar. 19, 2012, http://www.npr.org/blogs/health/2012/03/19/148769073/prone-to-failure-some-all-metal-hip-implants-need-to-be-removed-early; see also, Hip Replacement Complications & Implant Failure, Drugwatch.com, Jan. 20, 2014, http://www.drugwatch.com/hip-replacement/complications.

7Toni Clarke, UPDATE 1-FDA moves to tighten controls on all-metal hip implants, Reuters, Jan. 17, 2013, http://www.reuters.com/article/2013/01/17/us-fda-hips-idUSBRE90G0W520130117.

8Barry Meier, Hip Makers Told to Study More Data, N.Y. Times , May 11, 2011, Section: B, http://www.nytimes.com/2011/05/11/business/11hip.html?action=click&module=Search&region=searchResults&mabReward=relbias%3Ar&url=http%3A%2F%2Fquery.nytimes.com%2Fsearch%2Fsitesearch%2F%23%2FHip%2BMakers%2BTold%2Bto%2BStudy%2BMore%2BData%2F.

9Stryker says hip recall to cost up to $390 mln, Reuters, Jan. 9, 2013, http://www.reuters.com/article/2013/01/09/stryker-recall-idUSL1E9C95FG20130109.

10Stryker says hip recall to cost up to $390 mln, Reuters, Jan 9, 2013, http://www.reuters.com/article/2013/01/09/stryker-recall-idUSL1E9C95FG20130109; see Barry Meier, F.D.A. Seeks to Tighten Regulation of All-Metal Hip Implants, N.Y. Times, Jan. 16, 2013, http://www.nytimes.com/2013/01/17/business/fda-to-tighten-regulation-of-all-metal-hip-implants.html.

11Barry Meier, Maker Aware of 40% Failure in Hip Implant, N.Y. Times, Jan. 22, 2013, http://www.nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-in-thousands-more.html?action=click&module=Search&region=searchResults&mabReward=relbias%3Ar&url=http%3A%2F%2Fquery.nytimes.com%2Fsearch%2Fsitesearch%2F%23%2FHip%2BMakers%2BTold%2Bto%2BStudy%2BMore%2BData%2F.

12National Joint Registry of England and Wales, 8th Annual Report 2011: Surgical Data to 31st December 2010, (2011), available at http://www.njrcentre.org.uk/NjrCentre/Portals/0/Documents/NJR%208th%20Annual%20Report%202011.pdf.

13Ben Hirschler, Study prompts call for wider ban on metal hips, Reuters, Mar. 12, 2012, http://www.reuters.com/article/2012/03/13/us-hips-idUSBRE82C00T20120313.

14Hip Replacement Complications & Implant Failure, Drugwatch.com, Jan. 20, 2014, http://www.drugwatch.com/hip-replacement/complications.

15Barry Meier, Implant at Own Risk, N.Y. Times, Apr. 3, 2010, http://www.nytimes.com/2010/04/03/business/03ortho.html?_r=0.

16Id.

17Id.

18Id.

19Id.

20Zimmer Hip Replacement, Drugwatch.com , Jan. 20, 2014, http://www.drugwatch.com/hip-replacement/zimmer/.

21Id.

22Id.

23Meier, supra note 15.

24Llamas, supra note 2.

25Understanding Your Hip Recall Letter, Drugwatch.com, Jan. 3, 2014, http://www.drugwatch.com/hip-replacement/recall-letter/.

26Id.

27Stryker Initiates Voluntary Product Recall of Modular-Neck Stems
Action Specific to Rejuvenate and ABG II Modular-Neck Stems,
Food & Drugs Admin., http://www.fda.gov/safety/recalls/ucm311043.htm (last updated Jul. 9, 2012).

28Wright Medical Hip Replacements, Drugwatch.com , Feb. 12. 2014, http://www.drugwatch.com/hip-replacement/wright-medical/.

29Hip Replacement Lawsuit, Drugwatch.com, Dec. 10, 2013, http://www.drugwatch.com/hip-replacement/lawsuit/eplacement Lawsuit.

30In re DePuy Orthopaedics, Inc., supra note 1.

31Zimmer Holdings, Inc. (2008). Annual Report,  http://google.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHtmlSection1?SectionID=6444420-12098-77734&SessionID=3-P6WHHAD_jDaR7.

32New Lawsuit Filed on Wright Profemur Hip Replacement Fracture: AttorneyOne.com Warns the Threat from Wright Profemur Hip Replacement Severe Adverse Events Remains, PRWeb, Mar. 13, 2012, http://www.prweb.com/releases/2012/3/prweb9272013.htm.

33Wright Hip Replacements, Drugwatch.com, Feb. 12, 2014, http://www.drugwatch.com/hip-replacement/wright-medical/.

34Sakthi Prasad, Biomet reaches $56 mln settlement over faulty hip replacements, Drugwatch.com, Feb. 3, 2014, http://www.reuters.com/article/2014/02/04/us-biomet-settlement-idUSBREA1305Y20140204; see Court Document, http://www.innd.uscourts.gov/millermdl2391.asp.

35Barry Meier, supra note 11.

36Id.

37Id. 

38Deena Beasley, Trial plaintiff says J&J hips defective, company says not liable, Reuters, Feb. 28, 2013, http://www.reuters.com/article/2013/02/01/us-jj-hip-trial-idUSBRE91019V20130201.

39Barry Meier, Implant Risk Was Assessed Inadequately, Court Is Told, N.Y. Times, Jan. 31, 2013, http://www.nytimes.com/2013/02/01/business/hip-implants-risks-inadequately-assessed-depuy-report-found-in-2010.html?action=click&module=Search&region=searchResults&mabReward=relbias%3Ar&url=http%3A%2F%2Fquery.nytimes.com%2Fsearch%2Fsitesearch%2F%23%2FImplant%2BRisk%2BWas%2BAssessed%2BInadequately%2F.

40Id. 

41Meier, supra note 5.

42Id. 

43Id. 

44Case Funding Inc., First California DePuy ASR Bellwether Trial Settles, JDSupraAdvisors, Oct. 10, 2013, http://www.jdsupra.com/legalnews/first-california-depuy-asr-bellwether-tr-05707/.

45Meier, supra note 5.

46Id. 

47Id. 

48Id. 

49Id. 

50Id. 

51Id. 

52Id. 

53Art Sedrakyan, Sharon-Lise T Normand et al. Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal of evidence, British Medical Journal (BMJ), Nov. 29, 2011, http://www.bmj.com/content/343/bmj.d7434.

54Esha Dey, All-metal hip implants can damage soft tissue: FDA, Reuters, Jan. 17, 2013, http://www.reuters.com/article/2013/01/17/us-fda-hips-idUSBRE90G0W520130117.

55Medical Device Failures on the Rise, Drugwatch.com, Jan. 18, 2012, http://www.drugwatch.com/2012/01/18/fda-510k-program-controversy/.

56Michelle Llamas, New FDA Database Will Track All Medical Devices, Drugwatch.com, Sep. 26, 2013, http://www.drugwatch.com/2013/09/26/fda-tracking-dangerous-devices/.

57Ben Hirschler, Study prompts call for wider ban on metal hips, Reuters, Mar. 12, 2012,
http://www.reuters.com/article/2012/03/13/us-hips-idUSBRE82C00T20120313.

58Llamas, supra note 56.



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