Patients head to D.C. to lobby for right to sue Medtronic

Diana Levine sees a double-standard in the law. As her own case proves, people can sue when they are harmed by pharmaceuticals, but individuals hurt by defective medical devices cannot. She appears in a new video that targets Twin Cities-based defibrillator manufacturer Medtronic to support passage of the Medical Device Safety Act, which would effectively overturn the 2008 Supreme Court ruling in Riegel v. Medtronic that prevents patients receiving faulty devices from suing. The video came out just a day before Tuesday’s Patient Lobbying Day, in which patients using Medtronic defibrillators head to the nation’s capitol to push for the act.

Nine years ago next week, Diana Levine went to the doctor to get treatment for a migraine. The dual medicines she was given didn’t help, so on a return visit, she was given another dose intravenously. But due to what Levine calls bad labeling by the drug manufacturer, the medicine, injected into her artery, caused gangrene in her arm — and ultimately she lost most of the limb. She sued the doctor first, then the drug company, finally prevailing, earlier this month, in the Supreme Court.

She appears in a new Alliance for Justice video that focuses on “preemption,” which states that consumers can’t seek damages caused by a flawed medical device when they’ve been properly approved by the Food and Drug Administration (FDA). The video features Don Hickey, a Kansas grandfather who was shocked repeatedly by his implanted heart device; after undergoing surgery, he was surprised to find the faulty device had been replaced with the same model.

“If you can’t hold a corporation responsible when a product with FDA approval hurts you, that’s like giving a corporation a license to hit and run,” says Levine. “What’s really crazy is now there are two laws. The Supreme Court has said that people like me who are hurt by bad drugs can sue. But people like Don who are hurt by bad medical devices cannot. It’s time we finish the job. We need to all work together to pass the Medical Device Safety Act.”

Today, patients with Medtronic implanted cardiac defibrillators (ICDs) are converging on Washington, D.C., to lobby for passage of the act. The bill was introduced by Democratic Reps. Frank Pallone, Jr.,  of New Jersey and Henry Waxman of California.

According to StopCorporateImmunity.org, courts nationwide have been throwing out cases of patients seeking compensation from companies manufacturing faulty medical devices, including one such instance earlier this year:

1,496 individuals, harmed by their malfunctioning Medtronic defibrillators, were left without any legal recourse when a Minnesota federal district court dismissed their cases. The Medtronic defibrillator contains a Sprint Fidelis Lead (wire) that has “been shown to fracture and dispatch potentially lethal shocks without warning.”