Lax Regulation of Medical Devices Can Kill You!
Metal-on-Metal Hip Replacements Are #1 Offender
[From www.nytimes.com] More than 9,000 patients filed suit against J&J due to problems with its metal-on-metal hip called the ASR XL. On Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers, specifically cobalt leaking from the ASR hip that can destroy not only local muscle, tendons and ligaments, but harm a patient's heart and brain as well.
These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.
About 32 million Americans - or about one in 10 - have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.
Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.
While Johnson & Johnson withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013. The company was ordered by a Texas jury to pay more than $1 billion to patients who claimed the company hid flaws in its Pinnacle artificial hips that had to be surgically removed, in J&J's second loss linked to the implants. Read "Johnson & Johnson Guilty Again! Ordered to Pay $1 Billion in Putative Damages".