A Closer Look at Recent Testimony Before the U.S. House Energy and Commerce Subcommittee on Health



Bridgett Robb had a heart condition (arrhythmia). Five years ago, she had a defibrillator implanted to prevent her from dying. More than two months before her medical device fractured and repeatedly shocked her, the lead had been recalled by the manufacturer.

These fibrillators are not cheap, even with health insurance. Nor are they so prevelent that keeping track of the patients carrying one in their chest is a difficult task. Wouldn’t you think the severity of the condition and the amount of time, energy, money, and care needed to get one would entitle Bridgett  to a little customer service? Two months is more than enough time when the case is this serious.

And then there is Nick Evola with another defibrillator. Nick  is an Army veteran. The surgery to replace the lead was paid with coverage from Medicare and insurance, and not by the manufacturer, Medtronic. 

So the maker of a faulty device is left unaccountable and taxpayers have to make up the difference. Mr. Evola deserves a working medical device, but does that right have to come at the public’s expense? The answer becomes even clearer when Mr. Evola’s attorney points out that Medtronic was aware the device was failing at “abnormally high rates but continued to market it…”.

It is not so surprising that a company like Medtronic would prioritize profits. They are a business. However, their business is unique in the amount of trust their customers must invest in their business practices. This makes medical devices a lucrative business. In 2008, Medtronic made $10 billion in profits, and is ranked first among medical products and equipment companies. As an industry leader, Medtronic sets an example, and this should mean more than the $6 million in lobbying for corporate immunity since 2008.

There is only one option to rectify this imbalance in American business and public safety. Congress must pass the Medical Device Safety Act. Over 14 thousand patients have been denied justice this year alone. Don’t take our word for it. Listen to U.S. District Court Judge Richard Kyle, who stated in his ruling, “The Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. … Plaintiffs’ remedy, therefore, lies with Congress, and not with this Court.”

Michael E. Seelie, PA has represented people in Jacksonville, Florida and the surrounding communities of Orange Park, St. Augustine, Green Cove Springs, Callahan, Palatka, Fernandina Beach, Gainesville, and Lake City ininjury cases since 1978.