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Bad Medical Devices Lead to Deaths, Maker Knew and Did Nothing

I have already pointed out this pamphlet as a valuable resource for consumers, however what many of these stories really highlight is how difficult it can be to know when a product is dangerous. These companies often deliberately hide what they know about their dangerous products. Further, in the wake of last week’s massive Maclaren stroller recall, discussing faulty and dangerous products is more timely than ever.

In 2002, the medical manufacturer Guidant knew that their heart defibrillators were faulty. Due to a bad seal, fluid could penetrate the devices and cause short circuits. When the time came for the defibrillator to serve its purpose and deliver a shock to an irregularly beating heart, the Guidant defibrillator would do nothing.

Guidant new of this problem and corrected it, however, the companies executives also decided that it was most cost effective to continue to sell the defective devices which they still had in their inventory. 37,000 of these defibrillators were sold by Guidant after they were aware of the flaw and the product was redesigned.

It was not until 2005 that Guidant finally issued a warning about its product. Prior to that, the company’s executives made no effort to warn doctors or regulators of dangers with this device.

But what happened in 2005 which changed this? As is unfortunately often the case in situations where a device people rely on to protect their lives is untrustworthy: tragedy.

In the spring of 2005, Joshua Oukrop went for a bike ride with his girlfriend on the canyon trails near Moab, Utah. Joshua was 21 years old and enjoying his spring break, and he suffered from a genetic heart disease. He had taken steps to control his disease, among them having a Guidant defibrillator surgically implanted. His defibrillator failed to work when it was needed, and Joshua died.

In the months after Joshua Oukrop’s death, it became clear that it was not a one of a kind malfunction. Representatives from Guidant met with his doctor, Barry Maron, and revealed that they were aware of at least twenty-five other instances where the same model of defibrillator had short circuited. They insisted that the likelihood of the devices malfunctioning was small. The company argued that the risks of surgery to replace the defibrillators.

Dr. Maron notified the media, fearing that it would be only a matter of time before someone else died as a result of the company’s practices.

The ensuing investigations by the FDA and the media began to uncover just what Guidant knew of their products and when they knew it. In May 2005, The New York Times was preparing to print a front page article about how Guidant had neglected the health of their customers, and finally they began warning doctors of the dangers of the device. They still balked to admit that their defibrillators should be replaced.

After a 2006 inquiry by the Department of Justice, Guidant offered to cover the cost of replacement defibrillators, but declined to cover the cost of the surgery to replace them.

If you have been injured by a defective product contact an experienced Georgia personal injury lawyer. Call MLN Law at 404-531-9700 to schedule a free consultation.