I wrote this month as a defective medical device attorney about a lawsuit involving an allegedly defective hip replacement implant. So a recent article about a different implant and its defects caught my eye when it ran in the New York Times this week. The newspaper reported that Johnson & Johnson emails reveal internal discussions about significant numbers of failures of the DePuy ASR artificial hip. That stands in sharp contrast to public statements made by the company that no studies showed signs of problems. The hip was ultimately not approved by the FDA or sold in the United States, but it was sold abroad and implanted in an estimated 93,000 patients before its safety recall. A companion version of the product that was sold in the United States, and was recalled at the same time after use in 30,000 American patients.
The DePuy ASR hip is made entirely of metal, which was one of the novel things about it. Unfortunately, the device sheds metallic debris with use, the newspaper said, leading to injuries to patients. It also failed much faster than conventional hip implants — within a few years, instead of after 15 years or more. As a result, the company now faces more than 5,000 lawsuits over the safety of the recalled hip implant models. In defenses against those cases, and in at least one earlier statement to the Times, Johnson & Johnson had said the FDA had not found any safety issues with the implants, and that its internal studies refuted the concerns raised by independent studies. But in the newly released messages, a company executive reported internally that the FDA planned to not approve the implants due to significant numbers of failures.
As a dangerous medical device lawyer, I’d like to point out that this new information comes from the pending litigation against Johnson & Johnson over the hip implants. Regardless of whether those plaintiffs ultimately prevail, the messages should help them in court because they clearly contradict public statements by the company’s executives. No federal law required Johnson & Johnson to publicize the FDA’s rejection letter, but it’s clear from that letter’s existence that the company has not told the truth to the public — and that’s what matters in lawsuits like these. For example, the Times reports that internal documents say executives did not believe they could overcome the FDA’s objections to the rejected device, even with new data. Nonetheless, the company said in 2009 and recently that its decision not to sell this device in the U.S. was based on declining overseas sales.
At Carey, Danis & Lowe, we focus our practice on patients who have suffered injuries or a loss in the family because of defective or dangerous pharmaceutical products. All manufacturers have a legal duty to ensure that their products are safe when they offer them to the public; if they know of safety risks, they must warn potential users of those risks. When manufacturers seem to be covering up a safety risk by misleading the public into making potentially dangerous medical decisions, people who get hurt have the right to hold them legally and financially liable. Our pharmaceutical liability attorneys based in St. Louis represent clients across the United States who are pursuing individual or class actions against these companies. We help clients win the money they need to get medical treatment, make up for lost income and more.
If you or someone you love suffered an injury because of a medical device you thought you could trust, Carey, Danis & Lowe can help. For a free consultation, send us a message online or call toll-free at -877-678-3400.
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