Zimmer has been involved in litigation regarding its Durom Acetabular Component, more commonly referred to as the Durom Cup, since 2008. The company temporarily recalled the device in 2008 after receiving reports that it was failing prematurely in patients.
The Durom Cup was designed to fuse to the hip socket without cement or screws, but the implant loosened prematurely in some people, causing pain, swelling and a number of other complications. People harmed by the device sued the company, claiming that the company failed to warn of the risks associated with implant.
In 2010, the Judicial Panel on Multidistrict Litigation transferred federal cases involving the Durom Cup to the U.S. District Court for the District of New Jersey. Zimmer settled numerous cases before they went to trial. Individual case settlements are private, but Zimmer’s financial statements indicate that the company has spent at least $479 million resolving Durom Cup claims.
The company and plaintiffs’ representatives established a settlement agreement to resolve pending claims in 2016. However, many plaintiffs have indicated they do not agree with the settlement terms and will not participate in the settlement program. Plaintiffs who do not agree to participate have to wait for the program to end before they can continue the legal process.
Why Zimmer Recalled the Durom Cup
The Durom Cup entered the market in 2006, and it was implanted in more than 12,000 people during the next two years. During that time, Zimmer received reports from numerous surgeons who said the cup was difficult to implant and was failing early.
Dr. Lawrence Dorr, an experienced surgeon and consultant for the manufacturer, told Zimmer in 2007 that a number of his patients required revision surgery. The doctor stopped using the device and notified the FDA before publicly warning other surgeons in April 2008.
In a letter to the American Association of Hip and Knee Surgeons, Dorr described problems with the device:
- Patients exhibited classic signs of a loose implant even if X-rays did not show problems.
- The fixation surface on the Durom Cup was not adequate.
- Implantation technique was not the problem.
Zimmer eventually issued a temporary recall of the device in July 2008. The company said the recall was to postpone hip replacements involving the Durom Cup until Zimmer could issue new implantation instructions. The FDA stated that the recall was caused by false and misleading labeling.
The company released new surgical instructions, and Zimmer officials said the device would remain available in the United States. However, Zimmer discontinued the product in 2010.
People Who Filed Lawsuits Against Zimmer
People who filed Zimmer hip replacement lawsuits claim that their injuries were caused by the device maker’s negligence. One complaint states the Durom Cup failure rate is as high as 30 percent and that Zimmer continued to market the defective product.
Matthew and Stephanie Cristino
Matthew Cristino received a Durom implant in 2006. Despite “ideal conditions for a hip replacement,” he experienced complications such as “extreme pain and weakness” following his surgery. He had to receive multiple revision surgeries. He alleged that Zimmer was aware of a high rate of failure associated with the device, but failed to warn his surgeon. He and his wife sued Zimmer in federal court in California. Their case was later transferred to the New Jersey MDL.
David and Lucinda Weaver
Lucinda Weaver received a total hip replacement in 2007. She later suffered loosening and separation of her Durom implant. She claimed that the implant was defective and “did not perform as safely as an ordinary consumer would expect.” She filed a personal injury lawsuit in California state court for damages, including medical expenses and loss of income. The Weavers reached a settlement with Zimmer in December 2010.
Durom Cup Verdicts
When lawsuits were consolidated into multidistrict litigation in June 2010, Zimmer established a settlement fund of $47.5 million. Courts consolidate similar cases in an MDL to increase efficiency and decrease costs.
The company began settling federal cases before they went to trial, but a few state lawsuits made it to a jury.
Zimmer Wins First State Trial
In December 2014, an Illinois jury ruled in favor of Zimmer in the first Durom Cup trial. John Pugliese received the hip implant in 2008, but the implant failed within months and he required revision surgery. Zimmer successfully argued that Pugliese developed an infection that prevented bone from growing into the cup to secure it. The defendants argued that the device would not have failed if it weren’t for the infection.
Zimmer Loses $9.2 Million Verdict
Zimmer lost its first verdict in July 2015 when Gary Kline successfully argued that Zimmer failed to warn of the risks associated with the Durom Cup and that the device had a design defect. Kline required two revision surgeries during the 15 months after his Durom Cup failed. The jury awarded Kline $150,000 to cover medical bills, $2.4 million for pain and suffering and $6.6 million for future damages. However, a judge reduced the award to $828,153 on appeal because she believed the compensation was excessive.
Proposed Settlement Agreement
In March 2016, a plaintiffs’ council and Zimmer agreed to a settlement process to resolve federal and state lawsuits involving the Durom Cup. The settlement applied to people who had a qualified revision surgery within nine years of receiving a Durom Cup implant.
Months earlier, Zimmer had estimated that it would cost $314 million to resolve pending claims. There were 414 cases pending in the MDL as of January 2016.
Terms of the Durom Cup Settlement Program
Claimants initially had to register for the settlement program by April 29, 2016, but the judge overseeing the MDL extended the deadline to May 31, 2016. Judge Susan D. Wigenton ordered all eligible claimants in the MDL to participate in the settlement program.
The base reward for plaintiffs who agreed to participate in the Durom Cup Settlement Program was $175,000. The claims could be reduced depending on several factors:
- Duration: Awards were reduced by $20,000 to $75,000 depending on how many years a claimant had the implant. Plaintiffs who had the cup for longer received less money.
- Implantation date: Claimants who received hip implants after July 22, 2008, incurred a $25,000 reduction
- Revision: If the cup was used during a revision surgery, the award was reduced by $50,000.
- Representation: Claimants who didn’t have an attorney received a 29 percent reduction.
Claims could also be enhanced if claimants met certain criteria:
- Multiple hips: Claimants with revision surgeries on both hips received a $75,000 enhancement.
- Additional revisions: Extra revisions boosted the reward by $50,000.
- Dislocation: Dislocated cups caused a $5,000 enhancement.
- Extraordinary loss: Complications that occurred within three days of hospital discharge or that caused severe disability could further enhance rewards.
- Lost wages: Disabilities that resulted in lost wages could enhance rewards by 20 percent of a person’s income.
A fixed reward of $25,000 was designated for qualified claimants who did not meet the criteria for a qualified revision surgery under the base reward. Fixed reward criteria applied to:
- Revision surgeries that occurred less than 180 days after implantation
- Deceased claimants
- Expired statute of limitations claims
- Trauma or infection unrelated to the Durom Cups
Zimmer had to notify claimants of the proposed award amounts by August 1, 2016, and claimants had to accept or reject the offer by September 15, 2016. If they rejected the offer, they had to establish a mediation date by February 28, 2017.
Zimmer had the option of terminating or finalizing the settlement agreement if less than 90 percent of claimants did not accept the terms of the settlement. Sixty-seven percent of claimants have to accept the offer by September 29, 2017, or Zimmer did not have to make payments.
Opposition to the Settlement
Several plaintiffs in the MDL objected to being forced to participate in the settlement process. Judge Wigenton stayed, or postponed, all MDL cases while the settlement process was active. That means all cases are on hold until at least September 29, 2017.
The judge also ordered all plaintiffs to participate in the settlement program. In a case management order, she wrote that she would end the stay on cases only if the plaintiffs and Zimmer filed a “Joint Notice of Unsettled Case.” Thus, cases would only become active again if plaintiffs participated in the settlement program, denied the award offer, participated in mediation and mediation failed.
Plaintiffs who did not participate in the settlement program risked having their cases dismissed by the court.
Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields.
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