As if the more than $500 million fallout from lawsuits regarding its vaginal mesh devices weren't bad enough, American Medical Systems must now deal with an FDA warning letter on its process validation, risk analysis, and corrective and preventative action procedures at its Minnetonka, MN, facility.
Add two more Abbott Laboratories diabetes products to the list of items deemed potentially deadly by the FDA. Five of the company's diabetes offerings have now been subject to the agency's most serious recall label in the past year.
Covidien is recalling more than 650 units of its Pipeline Embolization Device and Alligator Retrieval Device due to concerns over the coating on their delivery wires, which could delaminate and detach from the device.
Medical device companies with renal denervation platforms are facing yet another obstacle, as U.S. and European heart doctors are calling for a decrease or halt in the use of the devices to treat high blood pressure.
Johnson & Johnson's Ethicon arm has been ordered to pay $1.2 million in damages in a trial alleging it produced faulty vaginal mesh that was implanted into a 64-year-old woman.
A formal recall of Thoratec's backup power device used with its HeartMate pumps is now in place, and the FDA slapped a Class I status on the effort, its most serious designation, which means the issue can result in serious injury or death.
It's bad news for Johnson and Johnson's Ethicon division in its ongoing vaginal mesh saga: The company paid out $11.1 million to settle one of the first of many cases to go to court over its transvaginal mesh products, Lawyers and Settlements reported.
In February, a U.S. magistrate judge ruled that J&J wrongly eliminated thousands of key documents relating to the legal fight over allegations that it sold faulty vaginal mesh implants that harmed women, due to apparent negligence. Now, a patient advocacy group is demanding a federal investigation into the matter.
St Jude Medical got hammered with a new lawsuit from a Pennsylvania man who claims the company's now-recalled Riata cardiac defibrillator leads injured him. The latest Riata legal fight underscores the reality that fallout from the product's problems won't be going away any time soon.
"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal 's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.