DePuy, J&J "Cashed In" On Defective HipsApr 17, 2017
A marketing director at DePuy Orthopaedics, a subsidiary of Johnson & Johnson,-the companies behind allegedly defective hip implants which left thousands of patients in pain and in need of revision surgery-bragged about its sales figures being "on fire" due to revision surgeries to remove and replace defective metal-on-metal hip device implant device.
Internal documents, which were obtained by the Telegraph reveal that Paul Berman, the then-director of hip marketing at DePuy, boasted that "revisions are fueling our above market growth." In an email to colleagues in April 2009 he wrote that DePuy Orthopaedics should "dominate" the market for revision surgery "in the same way we did the primaries." Primaries refer to the initial hip replacement surgeries.
In fact, in one of Mr. Berman's April 2009 emails entitled "DePuy Revision Hips," he wrote, in part "Great data Derek. Team, it's time to dial up the volume around DePuy's Hip Revisions portfolio. Clearly revisions are fuelling our above market growth. This revision sector is on fire and we must dominate it in the same way we did primaries. Derek and his team are partnering with Development to ensure a solid cadence of new products kicking off in Q1," the Telegraph reported. Mr. Berman's email was written in response to a group message from Derek Edgar, group product director at DePuy on April 1 2009. Mr. Edgar reported figures that revealed an increase in sales of "revision hips," which he described as "a segment of the hip portfolio that has been quietly but steadily gaining momentum."
According to the Telegraph, many revision surgeries conducted at the time in the National Hospital System (NHS) and private hospitals in Great Britain were undertaken to replace parts from DePuy Orthopaedics' metal-on-metal devices, which are now known to leak toxic metal ions into patients' bodies.
Revision surgeries are more complex, more expensive procedures that are riskier and require longer healing times and, as the Consumers Union has noted, revision surgeries involve longer hospital stays. Despite that revision surgeries are typically performed to remove a device maker's faulty device, costs are assumed not by the device maker, but by consumers and insurers, including Medicare.
The product liability attorneys at Parker Waichman LLP have decades of experience representing clients in medical device litigation, including litigation involving metal-on-metal hip devices. The firm continues to offer free legal consultations to individuals with questions about filing a metal-on-metal hip replacement lawsuit.
The disclosure of Mr. Berman's email comes after the Telegraph also recently revealed how Graham Isaac, a senior DePuy Orthopaedics engineer, issued a 1995 warning that metal-on-metal constructions were "unpredictable" and its parts were prone to "catastrophic breakdown." Yet, five years later, DePuy produced a new metal-on-metal hip device implant. Currently, more than 23,000 DePuy metal-on-metal hips have been implanted in U.K. patients since 2003.
Norman Lamb, the Liberal Democrat health spokesman, described the disclosures as "scandalous," noting that DePuy appeared to be "making a profit from hiding the truth."
A surgeon who assisted in the invention of the DePuy Orthopaedics metal-on-metal Pinnacle hip devices described in a 2011 presentation how "hip surgeons were seduced into using MoM [metal-on-metal]." DePuy paid the surgeon, Thomas Fehring. He defined "seduction" as "1) to lead astray; 2) to lead someone into a behavioral choice they might otherwise not have made."
Mr. Berman's email and the documents written by Dr. Fehring and Dr. Isaac were filed in a United States court where lawyers for patients suing DePuy suggested the email appeared to show that "the company was really excited" to find that one part was "failing and they get to sell another one." For his part, Andrew Ekdahl, DePuy's president, told a Texas court that he "disagree[d] with that characterization completely." The court heard that British Surgeon, Tony Nargol, repeatedly advised DePuy from 2008 concerning problems with its metal-on-metal hip implants, according to the Telegraph report.
Mr. Berman was advised in a September 26, 2008 email that was read in court and indicated that a number of metal-on-metal cases had been discussed at a large meeting of senior hip surgeons that day that "looked alarming and concerning.... The images for metal-on-metal reaction looked bad," a colleague reported, according to the Telegraph.
Metal-on-metal implants were introduced in the U.K. in the 1990s and were promoted as offering improved mobility than devices constructed with a metal ball and plastic socket. Documents obtained by the Telegraph appear to reveal that DePuy knew of potentially serious problems that might be caused by the devices.
United States Has Reported Issues with Metal-on-Metal Implants
To date, approximately 500,000 Americans have undergone hip replacement surgery, potentially having been implanted with a metal-on-metal hip device, including the DePuy ASR hip implant or the Pinnacle hip implant. The popular hip replacement devices have been the focus of thousands of lawsuits and the DePuy ASR was been at the center of a massive DePuy ASR hip recall in August 2010. Metal hip devices have been associated with an array of adverse health reactions, including:
- Cancer: Increased risk of cancer due to toxic substances leaking from metal-on-metal implants
- Cobalt poisoning
- Degenerative heart disease, including cardiomyopathy
- Dislocated hip
- Failure of the metal-on-metal hip implant device, requiring early device replacement
- Loss of bone strength or structure which may cause bone fractures
- Metallosis (metal poisoning) due to chromium or cobalt particles from the hip implant shedding into area tissue or the bloodstream
- Non-cancerous tumors or pseudotumors near the hip implant site which may lead to pain, swelling, inflammation, and severe discomfort
- Release of toxic substances in your bloodstream from the hip implant such as chromium or cobalt
- Tissue death surrounding the implant
The U.S. Food and Drug Administration (FDA) announced on August 23, 2010, a voluntary DePuy ASR recall of 93,000 DePuy ASR hip implants worldwide. This included 37,000 in the United States. The recall followed then-newly released data from the United Kingdom joint registry that discovered that 13 percent of DePuy ASR hip implants required hip revision surgery to correct incapacitating complications.
DePuy ASR hip replacement complications are similar to the metal-on-metal hip implant side effects reported by patients who were implanted with the DePuy Pinnacle metal-on-metal hip replacement and other all-metal hip implants. The Pinnacle device has not been recalled.
A loophole in the FDA's regulations known as the 510(k) enabled DePuy to be "able to market the Pinnacle Device with virtually no clinical ... trials or FDA review of the implant for safety and effectiveness," according to at least one complainant's allegations. Allegations also included that, had the Pinnacle Acetabular Cup system undergone clinical trials, the manufacturer would have known about the "high percentage of patients developing metallosis, biologic toxicity, and an early and high failure rate due to the release of metal particles ... implantation of the Pinnacle Device results in nearly immediate systemic release of high levels of toxic metal cobalt-chromium ions into every hip implant patient's tissue and blood stream," according to the complaint.
Filing a DePuy Metal-on-Metal Hip Implant Lawsuit
If you or someone you know suffered injuries related to the use of a DePuy Pinnacle or ASR metal-on-metal hip implant device, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).