Why People Filed Hip Replacement Lawsuits
Thousands of plaintiffs claim hip implant manufacturers made defective products and failed to warn the public about the risks. Metal-on-metal implants are at the center of litigation today because plaintiffs say the implants caused various complications that led to painful surgeries to correct problems and replace the implants.
People file product liability or wrongful injury lawsuits when companies sell dangerous products or fail to warn the public of the risks associated with the devices. Hip implant manufacturers claimed their implants were safe and more effective than previous models. However, the devices were less effective and caused a range of injuries.
Injuries described in hip replacement lawsuits include:
- Decreased mobility
- Severe pain in the hip, groin or thigh
- Inflammation and swelling
- Loosening of the device
- Bone damage
- Metal poisoning
- Hip joint failure
Hip replacements with metal-on-metal components can cause metal poisoning when metal debris from the device is absorbed in the person’s bloodstream. Individuals who require revision surgery claim the devices’ design is to blame for causing their injuries.
People with legal claims against hip implant manufacturers include those who experienced unexpected complications or device failure before the expected life of the implant, which is usually between 10 and 15 years.
Hip replacement makers are under a legal duty to properly design, manufacture and test the safety of their devices. They are also accountable for marketing their products accurately and warning the public about health risks associated with their devices. When companies fail or ignore those duties, the patients who suffer from their negligence deserve compensation for their injuries.
Past Lawsuits Involving Hip Implants
In 2000, Sulzer Orthopedics recalled 40,000 hip replacement sockets, including 31,000 components that had already been implanted. The company estimated that 12,000 of those implants were at risk for dislocation. By 2001, 2,286 people had received a revision surgery to remove Sulzer’s implant. More than 1,000 people had filed lawsuits against the company.
The company claimed that a manufacturing error caused a tiny amount of mineral oil to contaminate the sockets. The oil acted as a lubricant that prevented the hip bone from attaching to the implant. The loose sockets caused severe pain.
The company was notified of the problems with its implant in July 2000 by Dr. Lawrence Dorr, a surgeon at the Bone and Joint Institute in Los Angeles. On August 29, 2000, Dorr wrote a letter to the president of Sulzer. The company began investigating the problem in September. It discovered the problem in November and recalled the products in December.
In September 2001, three women won a $15.4 million verdict against Sulzer. The company wanted to avoid more lawsuits that were scheduled in state courts, so it sought a class-action settlement. In February 2002, Sulzer agreed to settle 4,000 lawsuits for an estimated $1 billion. Eligible claimants received an average of $200,000 in compensation for their injuries.
Current Hip Implants Involved in Lawsuits
The majority of hip implants named in lawsuits have metal-on-metal designs. These implants were marketed to active, younger patients. Manufacturers claimed the devices are more durable and would last longer than devices already on the market, such as metal-on-polyethylene and ceramic-on-ceramic models.
The FDA classifies metal-on-metal hip systems as Class III (higher risk) devices, but the agency regulates them under the 510(k) premarket notification program. The program allows companies to get their products on the market without rigorous testing if they are similar enough to an already-approved product.
Implants Named in Lawsuits
|Biomet||M2a metal-on-metal hip devices|
|DePuy||ASR XL Acetabular System ASR Hip Resurfacing System Pinnacle|
|Smith & Nephew||Emperion Hip System Birmingham Hip Modular SMF Hip System (MIS Hip Stem) Modular Redapt Revision Femoral Hip System|
|Stryker||ABG II Modular-neck Hip Stems Rejuvenate|
|Wright Medical Technology||Conserve Plus Profemur Z Hip Stem|
Metal-on-metal implants have some of the highest failure rates among all types of hip replacements. Studies show these hip implants produce metal ions that enter a recipient’s bloodstream, creating metal poisoning known as metallosis. Other complications with these implants include loosening of the hip implant, joint dislocation and joint squeaking. Many people with these problematic artificial hips opt for revision surgery to receive a new hip implant.
In May 2011, the FDA ordered 21 manufacturers of metal-on-metal implants to conduct post-market studies. A year later, an FDA panel found that there was little reason for surgeons to continue to use these implant systems.
History of Metal-on-Metal Hip Replacement Litigation
Zimmer’s Durom Cup, an acetabular component made of metal, was one of the first devices to cause major complications. The company temporarily recalled the product in 2008, but it returned the device to the market until 2010. People harmed by the Durom Cup began filing lawsuits against Zimmer in 2008. The Judicial Panel on Multidistrict Litigation centralized Durom Cup lawsuits in multidistrict litigation in 2010. The purpose of an MDL is to avoid duplication and inconsistencies in the pretrial procedures and rulings, and to conserve the resources of the parties, their counsel and the courts.
That year, DePuy recalled its ASR hip replacements after reports of large numbers of adverse events including early failure. The subsidiary of Johnson & Johnson was a leader in the metal-on-metal hip replacement market in the early 2000s. Hundreds of people began filing lawsuits against DePuy after the recall, but DePuy continued to sell different metal-on-metal hip products in its Pinnacle line of products.
Lawsuits against other companies who sold metal-on-metal implants began to pile up. Claims involving Wright Medical’s Conserve hip implants were consolidated in an MDL in February 2012. Biomet’s M2a Magnum lawsuits were centralized in an MDL in October 2012.
Two companies also issued large recalls that year. Smith & Nephew recalled its R3 Acetabular System in June 2012, and Stryker recalled its Rejuvenate and ABG II hip implants in July 2012. Some companies never issued recalls, but they discontinued their products after they started causing problems.
Early Lawsuits Involving Metal-on-metal Hip Implants
When cases are consolidated in MDL courts, plaintiffs retain the right to have individual trials. The first trials, called bellwether trials, against a company usually determine the fate of the litigation. If companies win bellwether trials, they continue to fight lawsuits in court. If plaintiffs win multiple bellwether trials, companies usually decide to settle cases out of court to save time and money.
- March 2013 — Kransky v. DePuy: The first major metal-on-metal hip replacement trial was rescheduled for an earlier date because the plaintiff was suffering from terminal cancer. Loren Kransky won an $8.3 million verdict against DePuy because the company’s ASR implant gave him metal poisoning.
- April 2013 — Strum v. DePuy: DePuy won a lawsuit filed by Carol Strum who claimed an ASR hip implant failed after three years, forcing her to have revision surgery.
- September 2014 — Herlihy-Paoli v. DePuy: The plaintiff in the first bellwether trial in DePuy’s Pinnacle implant MDL claimed she received metal poisoning from her hip implant. Kathleen Herlihy-Paoli lost her case against DePuy.
- December 2014 — Pugliese v. Zimmer: In the first Durom Cup trial, John Pugliese claimed he required revision surgery within months of receiving the Durom Cup. The jury sided with Zimmer, which claimed an infection caused the implant failure, not defective design.
- June 2015 — Warner v. Wright: Wright lost its first Profemur hip implant lawsuit to Alan Warner, who claimed his implant snapped within three years of implantation. A jury awarded Warner $4.5 million, but an appeals judge later reduced the reward to $1 million.
Some companies continue to fight lawsuits in court despite multiple losses. Continuing to fight the cases instead of settling claims can increase court costs and delay plaintiffs from receiving compensation. Judges usually urge plaintiffs and companies to settle claims after multiple trials to resolve burdens on courts.
Biggest Hip Implant Verdicts
When companies lose multiple cases, juries usually increase punitive damage awards. Punitive damages are designed to punish companies for wrongdoing and prevent them from misconduct in the future. The damages usually account for the majority of money awarded to plaintiffs.
July 2015 — Kline v. Zimmer
Gary Kline won a $9.2 million verdict against Zimmer when a jury believed the Durom Cup that Kline received had a design defect. Kline’s hip implant failed after 15 months. An appeals judge later reduced Kline’s award to $828,000.
November 2015 — Christiansen v. Wright
Wright lost an $11 million verdict involving its Conserve implant. The plaintiff, Robyn Christiansen, proved that her metal implant caused tissue damage after six years. Her reward was eventually reduced to $2.1 million on appeal.
January 2016 — Aoki et al. v. DePuy
Five plaintiffs won a joint case against DePuy in the second Pinnacle bellwether trial. DePuy was told to pay $502 million to the claimants who said their Pinnacle implants were defective. The award was later reduced to $151 million.
December 2016 — Andrews et al. v. DePuy
Six plaintiffs won a $1 billion verdict in the third Pinnacle bellwether trial. They claimed the hip implants caused metal to enter their blood and tissue, causing a number of complications.
Large jury verdicts can be reduced by an appeals judge if the judge believes the compensation ordered by the jury was excessive. Many states also have limits on the amount of punitive damages that can be awarded, which often forces appeals judges to reduce awards.
Status of Metal-on-Metal Hip Lawsuits
Most lawsuits involving metal-on-metal hip implants have been resolved, but a few companies are still fighting cases in court. Most settlements only cover claimants who had qualified revision surgeries. People who did not have a revision surgery or who filed a lawsuit after the statute of limitations expired may be ineligible for some settlements.
- Stryker: Stryker settled most cases against it in 2014. The agreement was expected to total about $1.4 billion. The settlement was extended in December 2016 to cover additional plaintiffs.
- DePuy’s ASR Lawsuits: Johnson & Johnson settled more than 8,000 lawsuits for $4 billion in November 2013. In March 2015, DePuy extended the settlements to cover an addition 1,800 claims. The estimated cost to the company was an additional $420 million.
- Zimmer: Zimmer settled almost all of its Durom Cup lawsuits in March 2016 for an estimated $314 million. There were 466 cases still pending in the MDL as of March 2016.
- Biomet: Biomet settled all of its M2a Magnum cases for $56 million in January 2015. Zimmer bought Biomet in 2015, and the company estimated that it would take $33.4 million to resolve pending claims in its annual report.
- Wright: Wright settled 1,292 claims involving its Conserve, Dynasty and Lineage implants for $240 million in November 2016. There were 586 cases were still pending in the Georgia MDL in March 2015.
- Smith & Nephew: An estimated 31 plaintiffs had filed lawsuits against Smith & Nephew by February 2017. Eight of those plaintiffs asked the Judicial Panel on Multidistrict to consolidate the cases in an MDL. The request was still being considered as of March 2017. In its 2015 annual report, Smith & Nephew claimed it had a budget of $203 million for litigation involving its hip implants.
- DePuy’s Pinnacle Lawsuits: After one bellwether win and two bellwether losses, DePuy continues to fight lawsuits involving its Pinnacle hip implants. A case involving 10 plaintiffs is scheduled to begin in September 2017.
More than 13,000 metal-on-metal hip cases were still pending in MDLs across the country as of March 2017. Most of those cases should be resolved through settlement agreements, but hundreds of people who aren’t covered by the settlements are still waiting on their day in 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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