Federal Legislation Introduced to Repeal Supreme Court Ruling Barring Injuries Caused by Defective Medical Devices

Democratic leaders have followed through on their word to change the law protecting makers of defective medical devices from state personal-injury lawsuits for injuries caused by heart defibrillators, replacement hips, and other types of medical devices.

The Medical Device Safety Act of 2009, prompted by a 2008 Supreme Court decision protecting medical device companies from such lawsuits, was introduced this week in both the U.S. Congress and Senate, marking the first steps toward becoming law.

Lawmakers have vowed to introduce the legislation ever since the nation’s highest court ruled that makers of medical devices could not be sued in state courts for injuries caused by their defective products. The act would effectively reverse that controversial court ruling and reinstate the rights of thousands of injured patients to seek financial compensation for their injuries.

The legislation is being sponsored in the House by Reps. Henry Waxman (D-Cal.) and Frank Pallone, Jr. (D-NJ). A companion bill was introduced in the U.S. Senate by Sens. Edward Kennedy (D-MA), Chairman of the Senate Health, Education, Labor & Pensions Committee, and Patrick Leahy, Chairman of the Senate Judiciary Committee.

Drug and Medical Device Companies Hit Hard

Overall, it was a pretty bad week for the pharmaceutical and medical device industry. On March 5, 2009, the Supreme Court ruled in favor of a Vermont woman who lost part of an arm from infection after receiving an injection of Phenergen, a Wyeth drug for nausea. That closely watched case would have similarly shielded drug companies from lawsuits stemming from injuries caused by defective drugs, the same blanket protection afforded to makers of medical devices that legislators are now seeking to reverse.

With that victory and the introduction of legislation to reinstate their rights to sue makers of medical device makers, people across the United States who are injured or killed by prescription drugs and medical devices had a great week.

Riegel v. Medtronic

The case which led to the introduction of the proposed federal legislation involved injuries caused by heart defibrillator leads made by Medtronic, Inc. The devices, called Medtronic Sprint Fidelis leads, are tiny wires which connect a patient’s heart to a defibrillator. Studies showed the wires tended to fracture, causing defibrillators to send unnecessary electrical shocks to a patient’s heart or fail to send life-saving jolts when needed to prevent or stop a heart attack.

Thousands of the Medtronic defibrillator leads were implanted in patients, many of whom began suffering deadly and severe injuries as a result of the wires malfunctioning within months of receiving the devices. Medtronic and the U.S. Food and Drug Administration recalled the products in October 2007 after receiving reports of injuries and deaths linked to the defective leads.

Reinstating Patients’ Rights

The Medical Device Safety Act of 2009 would reverse the Supreme Court’s ruling by explicitly stating that state product liability laws are not pre-empted by federal laws for the regulation of medical devices. Medtronic had successfully argued to the Supreme Court that FDA approvals of the Sprint Fidelis leads prevailed over state lawsuits for injuries caused by the devices.

For more than a year since the Supreme Court ruled in the Medtronic case, thousands of people injured by defective medical devices and their loved ones have been caught in a legal limbo. Unable to seek financial compensation for their mounting medical bills, pain and suffering, and other damages from injuries blamed on defective products, injured American consumers were locked out of court.

However, with the introduction of the Medical Device Safety Act of 2009, lawmakers have made the first steps toward kicking the courthouse doors open once again for injured consumers of defectively dangerous medical devices.

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