St Jude's Handling of Recent Recalls Raises Questions About Heart Device Industry

Seven years ago, medical device manufacturer Guidant failed to warn doctors about potentially fatal flaws in the design of their heart defibrillators. In the wake of that incident, the entire heart device industry vowed to make sweeping safety reforms to prevent such unethical behavior from recurring. But as St. Jude Medical Inc. faces recalls of several different heart device products, the way they are handling the problems raises questions as to whether promised industry reforms ever took place.

The safety of several different St. Jude heart devices are currently under review, but the most serious recall affecting the manufacturer involves their Riata leads (wires placed in defibrillators that have been shown to break through insulation, potentially causing defibrillators to malfunction.) While St. Jude took the Riata leads off the market in 2010, they have spent more time trying to discredit studies that showed the dangers of the product than trying to warn the estimated 128,000 individuals still using Riata leads about the potential dangers they are facing.

After the Guidant scandal of 2005, heart device manufacturers promised that they would employ independent medical advisory boards to quickly investigate any device malfunction and alert physicians to potential problems. While St. Jude spokeswoman Amy Jo Mayer said the company regularly reports to a panel of outside safety specialists, had they really been examining each death associated with their devices, the estimated 20 Riata-related deaths might have been prevented.

Individuals with life-threatening conditions like heart disease rely on medical devices to save their lives. It is bad enough when these devices are poorly designed, but when manufacturers do not properly report or, worse, conceal those flaws, they put patients in extreme danger. If you or a loved one has been injured by a dangerous medical device, a medical injury lawyer from our office can review your case. With an injury such as this, you may be entitled to monetary compensation. Contact a medical injury attorney from Arnold & Itkin today for a free and confidential consultation regarding your case.