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A recent investigative report in the United Kingdom suggests that DePuy Orthopaedics knew or should have known about serious dangers associated with their metal-on-metal hip replacement systems as early as 1995, raising questions about the decision to continue to market and promote their DePuy Pinnacle and DePuy ASR implants, which have been linked to thousands of reports involving catastrophic failures and complications..
The Daily Telegraph has released a series of internal documents that appear to reveal concerns that date back decades, with senior engineers even then warning that the metal-on-metal hips may shed metal debris.
Those same complaints have been made by thousands of individuals in the United States have have filed DePuy Pinnacle hip lawsuits, DePuy ASR hip lawsuits, and cases against other manufacturers of metal-on-metal hip designs in recent years.
Metal-on-metal hip replacements have been sold by a number of different manufacturers in recent years, featuring a metal femoral head that rotates within a metal acetabular cup.
Most of the devices were introduced through the controversial fast-track 510(k) approval process, which only required that the device be a “substantial equivalent” to an already existing device approved by the FDA. However, the snowball effect of the substantial equivalence test has allowed many devices now considered unreasonably dangerous and defective to be implanted in thousands of Americans.
Unlike other artificial hip designs, which typically feature metal-on-ceramic or metal-on-plastic, the metal-on-metal hips have been found to release microscopic metallic debris as the parts rub against each other. This has been linked to reports of loosening and failure, often within a few years after the artificial hip is implanted.
In one letter disclosed by the Daily Telegraph, a doctor indicated that he warned DePuy about metal-on-metal (MOM) hip problems for more than a decade.
“I do not feel DePuy is doing enough to understand the extent of Pinnacle MOM hip disease,” Dr. John F. Irving wrote in one of the recently revealed documents. “I believe it borders on unethical to continue to market the product until the issues are elucidated. These products are harming patients.”
Minutes from a 1995 meeting show that there were concerns even back then. The minutes mention high volume particle generation, metal ion release and poor wear results as current issues even back then.
Ignoring those early warnings appear to now be costing DePuy, a subsidiary of Johnson & Johnson, in the court room.
A federal jury awarded over $1 billion in damages during a DePuy Pinnacle hip bellwether trial in early December, including punitive damages designed to punish the manufacturer for their actions involving the design and sale of the controversial implant, which is the subject of nearly 10,000 similar product liability lawsuits pending nationwide.
Each of the lawsuits filed over DePuy Pinnacle hip problems are pending before U.S. District Judge Ed Kinkeade, raising nearly identical allegations that the metal-on-metal implant is prone to loosen and fail as metallic debris is released into the body, resulting in severe pain and the need for revision surgery to remove the artificial hip.
In addition to the recent $1 billion verdict, which involved a group of plaintiffs from California, an earlier bellwether trial involving a group of five plaintiffs from Texas resulted in a $500 million verdict in March 2016, including $140 million in combined compensatory damages and another $360 million in punitive damages. However, that verdict was reduced to $151 million under Texas state laws, which has more stringent damage caps.
Another DePuy Pinnacle bellwether trial is expected to go before a juryl in September 2017, unless the manufacturer takes steps to settle the hip lawsuits before then.
Johnson & Johnson previously agreed to pay more than $2.4 billion to settle DePuy ASR metal hip lawsuits, resolving about 8,000 cases brought on behalf of individuals who received this newer metal-on-metal hip design, which was recalled from the market in 2010. However, the manufacturer has refused to settle DePuy Pinnacle cases.
While Johnson & Johnson has maintained that it intends to defend the DePuy Pinnacle cases at trial and through appeals, the manufacturer may face substantial liability if future juries respond in the same way to the evidence and testimony presented during the first two bellwether trials.