DePuy Orthopaedics, Inc., a Johnson & Johnson company, recalled two hip implant products in July; the ASR XL Acetabular System and the ASR Hip Resurfacing System. The devices were implanted in patients worldwide, however, the ASR XL system was only sold in the United States.
Whether you or your loved one has been affected by the DePuy hip recall, it’s important to know the basic facts. As a hip recall laywer and dealing with patients who received a recalled hip implant, I’m taking this recall very seriously.
The U.S. Food and Drug Administration issued the DePuy recall after years of reports that the ASR device was failing prematurely. Since 2008, the FDA has received nearly 400 complaints of early failure rates, giving it an average 12-13% failure rate in the first five years over the industry standard of 5%. There were approximately 93,000 ASR XL hips implanted in patients around the world.
As the metal-on-metal implant wears out the artificial joint can become detached from the bone, becoming misaligned and possibly introducing metal debris within patients’ bloodstream.
Evidence Shows DePuy Kept Problems With Hip Implant Hidden
A major hip manufacturer may have been aware of defects with its hip implant, but they did not inform patients or doctors about the issue and continued to promote the devices. The metal-on-metal implants had a high-rate of failure and led to many painful symptoms and surgeries for patients. They are made using a metal ball and cup design, which were believed to be better than plastic, and around half-a-million people had the devices implanted during the past 12 years. After getting fast-tracked through the Food and Drug Administration’s approval process, and during an aggressive marketing campaign, the implants began failing, requiring replacement surgery and leading to many problems for patients including metal poisoning.
Many patients sustained painful symptoms and internal damage due to the implants. During the trial process, it was revealed that DePuy Orthopaedics hid news about the implant which was experiencing many failures. They were recalled officially in 2010, but as early as 2008 executives were informed the device had flaws. Doctors were not informed about these flaws and the internal studies which showed defects in the device, as well. The device was implanted in 93,000 people by the time the company announced a recall. The company now faces around 10,00 lawsuits, according to news reports.
Former DePuy Employee Testifies
During the second trial in the Depuy hip implant case, a former employee explained that he got an email from a co-worker who said there were problems the company found with the design of the implant. The email was received nearly a year before the device was recalled due to a high rate of failure. The trial is the second lawsuit of 10,000 in total, the first concluded with a $8.3 million verdict for the victim of the implant, which was recalled for many reasons, including bone loss, pain, metal ions shedding into the bloodstream, and fluids around the hip joint, according to news reports.
Committee Chair Says DePuy Deserves Criminal Investigation
Reports recently released by DePuy allegedly shows that their metal-on-metal hip implants failed after two and half years. The Telegraph also revealed they continued to market the implant after a surgeon warned the executive of manufacturing about painful symptoms patients were experiencing. The surgeon said they were suspected for putting metal ions into the bloodstream, which resulted in many revision surgeries. The chair of the Science and Technology Committee described the Telegraph’s disclosure as “appalling.” He believes the disclosure should call for a criminal investigation, rather than a civil one. All products used in the United Kingdom must be tested and should not be purchased if there are any doubts involving its safety, according to the chair.
Telegraph’s disclosure was revealed during the court case in Los Angeles, where the court will decide if patients should be compensated for the defective hip implants. Documents put on display revealed that DePuy was warned about the complaints involving the implant. 10,000 British citizens received the implant, which was suspected of putting hazardous metal ions into the bloodstream. In 2010, the product was taken off the market. The Daily Telegraph said that patients were being put at risk by regulators who sold the hip implants. In 2003, the implant was first introduced, and by 2006, an orthopedic surgeon was reporting dangerous side-effects. A year later, he stated he would not use the implants.
By 2007, the company released figures that showed the implants failed 10% of the time after two years. In 2008, the marketing department used different data to claim they had a 99% rate of success. 2008 tests by DePuy revealed that the ASR was not performing well compared to other hip replacement products, and that the ASR was susceptible to releasing metal ions. Another internal memo was released and said that the overall rate of complaints was eight times higher compared to the Pinnacle.
Loren Kransky is currently suing DePuy for failing to warn him that his metal hip implant could be faulty, and that the marketing claim that 99% of the hips were successful encouraged him to get the ASR implant. Another patient said she was angry they allowed the hip to be implanted despite the risks. The Medicines and Healthcare Products Regulatory Agency said they are currently investigating the safety of the metal-on-metal ASR hips by DePuy, according to news reports.
Executive’s Involvement with Defective Hip Implant Questioned
A new executive was hired to lead Johnson & Johnson’s orthopedics division after the company’s artificial hip implants were recalled in an effort to help clear their image. However, the executive who was hired knew about the defects three years before the implants were recalled and supervised the introduction of the implant in the US. He was previously in a marketing role when the company proclaimed they would not inform officials outside the US about the refusal of sales of the hip inside the US. During the recent patient trial in the Los Angeles Superior Court, more information was revealed concerning the involvement of executive Andrew Ekdahl.
Over 10,000 lawsuits have been filed so far against DePuy Orthopaedics and their Articular Surface Replacement (ASR) device. Ekdahl’s involvement with the product leads to many suspicions the company will not be able to clear their image just yet. The videotape testimony of the executive was shown at the most recent testimony, and more execs will testify in the near future. When Ekdahl was questioned about why the implant was recalled, he stated that it did not meet the standards they wanted.
Despite Ekdahl’s claims the device was performing well, internal documents uncovered reveal that may not be true. A surgeon told a consultant for DePuy and marketing personnel that he was not certain about the safety of the cup component. Meanwhile, DePuy was promoting the device throughout the US.
DePuy began selling the device in 2003 outside the US, and two years later sold the ASR version in the US as a standard hip replacement. 93,000 patients had the device implanted, and it was predicted they would fail in 40% of patients within five years. The videotape testimoy of Ekdahl revealed he was receiving reports saying the device was failing early at higher rates within three years of being put in charge of the 2005 introduction of the ASR hip. He participated in a meeting that resolved to redesign the implant, but the redesign project was stopped because sales were too low. Surgeons complained about the product increasingly, and by 2009 an executive told Ekdahl that the problem was with its design.
In 2009, executives declared they would sell current inventories and phase out the products. The FDA requested safety data and told them it would not help sell the device due to concerns it released metal ions into patient’s bloodstreams. Ekdahl continued to oversee sales in Europe, according to news reports.
DePuy Executive Asked Why Plans to Re-Design ASR Hip Halted
The president of the orthopedic division of Johnson & Johnson, Andrew Ekdahl, said the company recalled their all-metal implant due to it not meeting “clinical needs for the product.” He testified at a trial recently due to claims the company failed to issue warnings about the risks involved with the implants. He was questioned by a representative for a patient adversely affected by their hip implant about whether they recalled the implants because they were not safe, but he continued to answer that they did not meet clinical needs.
In 2010, the company said 12% of devices failed. By 2011, a study showed 37% failed, and in 2012 44% were found to fail within seven years. Ekdahl was asked how many hip revision surgeries due to failure were expected, and what they considered acceptable. He said they didn’t know the acceptable rate.
He was also asked about their handling of complaints filed by surgeons because thousands stated the device caused them painful symptoms. A surgeon stated the hips were poorly designed. Ekdahl was also questioned about their plans to re-design the implant that were scrapped, according to news reports.
Witness Testimony Says J&J Altered Safety Tests
While designing the all-metal hip implant, Johnson & Johnson failed safety tests they set forth, according to witness testimony, then altered the protocol rather than fixing the flaw itself. Loren Kransky is suing them for defects involved with their metal hip implants. Johnson & Johnson recalled 93,000 ASR hips in 2010 when they announced that 12% of the devices failed within the first five years. Last year, data showed the hips failed at a rate of 44% after seven years. Consultant George Samaras explained to jurors that the DePuy metal hip implants did not meet the safety standards they established, and cited an internal document that shows the ASR produced 16 times the chromium and cobalt debris than another product made by DePuy. The company passed the implant through the tests, even though it would have failed. “It’s horrible practice,” said Samaras. “That’s not what good engineers do. You are playing games with what the requirements for the device are.”
Kransky claims that Johnson & Johnson was negligent by failing to warn and creating a defective design. Samaras stated that DePuy’s criteria for the device had to be just as good as previous devices. Due to failing those tests, they instead found other devices that would make the ASR device look better. “They changed the test,” Samaras said. “They didn’t do what they were supposed to do, which is change the design.” An epidemilogist from the Dartmouth Medical School also testified that the Australian national registry data revealed the hip implant failed at a rate of 22% after five years passed, and 44% seven years after the device is implanted. Data was also reviewed from countries including Wales, Sweden, and England, noting the failure rate there is “extraordinarily high.” The ASR XL total hip replacement fails at a rate much higher than a typical hip replacement, according to the epidemilogist. He said that despite J&J’s claims that the rate of replacement rose due to publicity, a surgeon would not perform surgery without the right reasons. The jury also viewed a video-testimony from someone who led the design team for DePuy and oversaw a group that conducted failure mode and effect analysis, and he claimed DePuy used financial reasons to not conduct the re-design and DePuy never explained to surgeons the ASR failed and required revision surgeries at a larger rate than any other hip implant device, according to news reports.
Closing Arguments Heard in J&J Hip Case
Closing arguments were heard today in the case of a metal-on-metal hip implant patient, Loren Kransky, who claims the company designed a defective device and failed to warn patients and surgeons about the risk associated with the implant. In the first of 10,750 lawsuits over a recall metal hip implant, hit attorney argued that Johnson & Johnson’s desire for profits caused them to sell a defective device. His attorney stated that the company failed to warn patients about the device before all 93,000 units were recalled. As few as 12% of the devices were failing within five years of getting them implanted, leading to hazardous replacement surgeries. The rate of failure rose to 44% last year in Australia, according to news reports.
The company continually denies creating a defective device or failing to warn others about the many risks associated with them. They could pay billions of dollars to resolve the many lawsuits. Jurors were asked by the victim’s attorney to award the victim with $338,000 for medical expenses and $5 million for pain and suffering. His legal team also argues that punitive damages of $72 million to $179 million should be imposed on DePuy, or a total of 2-5% of the company’s entire worth. The legal team stated that DePuy needs to accept responsibility for their wrongdoings. Before it was sold in 2005 throughout the United States, his attorney argues they ignored complaints from several major surgeons about problems with the device. The company covered up the truth, rather than address the issues that surgeons were discovering with the device, the attorney stated. The company needs a definite message delivered to them from the justice system, and other companies can learn from them to prevent this from happening again. DePuy, the orthopedic division of J&J, became more influenced by the desire to earn more money, explained the attorney.
Johnson & Johnson Faces Thousands of Lawsuits
During the first settlements for the case against Johnson & Johnson, who face over 8,000 lawsuits for recalled hip implants, they paid around $600,000 to resolve those cases. Another case involving a Nevada resident who sued the company was settled recently and the company will pay $200,000 for that case. They negotiated at a “low end” according to a business professor, who said they should be expected to pay more, up to $500,000 per case. The company recalled nearly 93,000 hip implants because around 12% were failing during the first five years, resulting in pain for many customers who faced surgery, infection, and dislocation.
Another patient claimed that metal debris harmed tissue and heightened metal ions in their bloodstream. The company is not saying whether they will settle more lawsuits. They face around 8,000 cases and a judge in Ohio is overseeing 6,000 lawsuits after getting cosolidated under one court There are also 2,000 cases filed in various courts throughout California, Maryland, and others. The first cases were settled in Las Vegas by three recipients who had one surgeon do all their hip surgeries. One patient experienced health issues due to metal in her bloodstream. “Each of these plaintiffs has incurred a painful and debilitating hip-revision surgery as a result of the failure of their DePuy ASR Hip,” their lawyers stated. The company said they did not result in life-threatening injuries and they were generally healthy.
J&J said they spent $800 million on the recall, and they face a trial in Maryland involving three recipients, and this case will go to trial if they aren’t settled. The potential costs of the entire recall and liability may cost the company up to $2 billion once all lawsuits are resolved. “They’re looking at a giant number before it’s done because there are a giant number of cases,” Gordon said. The biggest benefit to J&J from the settlements that happened in Nevada is that the company “anchored settlement expectations at the low end of the range,” the business professor said. The Nevada cases are called Rundle v. DePuy Orthopaedics Inc., A-11-636272, Clark County District Court (Las Vegas), while the federal cases are DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo), according to news reports.
Greenberg & Bederman Now Accepting DePuy ASR Hip Implant Cases
If you or a loved one you know is suffering from pain, discomfort or difficulties due to a DePuy ASR Hip implant device, please visit our DePuy ASR Hip Implant Legal Page to discover what options are available.