Product News and Recalls

Fatal heart attack blamed on faulty approval process

CBS Sunday Morning did a report this week spotlighting the inadequate process by which the federal Food and Drug Administration approves medical devices.

The report, titled “When Medical Implants Fail,” examined the case of 21-year-old Joshua Oukrop, who died of a heart attack in 2005.

Oukrop suffered from a congenital heart condition, and depended on a cardiac defibrillator called an ICD that was implanted in his chest to keep him alive. But after his fatal heart attack, Oukrop’s father learned that the ICD was defective. What’s more, he discovered the manufacturer had known that variety of defibrillator was faulty since 2002.

The report quotes a spokeswoman with the Government Accountability Office, the federal government’s watchdog agency, as saying the FDA’s oversight of medical devices has urgently needed reform for decades.

She said many types of important medical devices don’t have adequate regulations.

Among them are metal-on-metal hip implants that were recalled in 2010. The devices were approved on the basis of their ostensible similarity to another type of implant already on the market, despite the fact that they were never safety tested in humans.

Thousands of patients who received the implants have since filed suit over their high early failure rate, as well as toxic metal shavings breaking off and lodging in the soft tissues.

DePuy/Johnson & Johnson, the company responsible, is offering compensation in the form of covering medical expenses. Physicians are being told to refer their patients to DePuy’s claims settlement company, Broadspire. But these “settlements” do not cover all potential damages, or future injuries that might arise. You may be unknowingly signing your rights away by agreeing to settle for past medical expenses only.

Contact Lopez McHugh for a free case evaluation if you received a DePuy Orthopaedics hip implant and experienced complications.

See the report here:;contentBody