New Laws to Reinstate Suits for Injuries Caused by Defective Medical Devices Expected Soon
Federal legislation designed to nullify a controversial U.S. Supreme Court decision granting companies that make heart defibrillators, stints, and other approved medical devices total immunity from state personal injury liability lawsuits is expected to be introduced soon, national leaders said.
Separate bills forming in the U.S. Congress and Senate would once again give plaintiffs the right to sue medical-device makers for injuries, even when the Food and Drug Administration has approved the devices which caused the injuries.
In Congress, Henry A. Waxman (D-Cal.), chairman of the House Energy and Commerce Committee, and Frank Pallone Jr. (D-N.J.), the head of its health subcommittee, reportedly plan to revive legislation they first introduced in 2008 in an effort to reverse the Supreme Court decision.
U.S. Senators Edward M. Kennedy (D-Mass.) and Patrick J. Leahy (D-Vermont) are working on sponsoring similar legislation to be unveiled soon, officials said.
Both pieces of legislation are expected to have the support of Democratic President Barack Obama, who has made reforming the nation’s healthcare system a top priority for his administration.
2008 Supreme Court Ruling is at Issue
The proposed laws are in direct response to a February 2008 Supreme Court ruling, which held that 1976 amendments to the Food, Drug, and Cosmetic Act serve to shield medical-device manufacturers from state damages claims by injured patients.
In Riegel v. Medtronic, the nation’s highest court ruled that once a medical device has received FDA approval, injured parties have no legal path to seek damages from the manufacturer, since personal injury claims rely on state laws, which are preempted – or voided – by federal laws in the area.
The controversial decision left thousands of patients who were injured or killed by defective medical devices out in the cold.
Are FDA-Approved Drugs Next?
The Supreme Court is now considering a case which could result in similar personal-injury immunity for makers of FDA-approved drugs. A Vermont musician, Diana Levine, lost part of an arm when an intravenous injection of the Wyeth pain medication, Phenergan, caused an infection in her arm. Levine argued that Wyeth, had failed to provide proper warnings about how to administer the drug.
A Supreme Court ruling in the Levine-Wyeth case is expected soon.
Some court watchers are bracing for a similar outcome in Levine v. Wyeth as was reached in the Riegel-Medtronic case – meaning that Wyeth and others would be shielded from personal-injury suits for injuries caused by FDA-approved drugs. However, there are key differences between the two cases which should spell a different result.
Most notably is that in the Food, Drug, and Cosmetic Act amendments which were at issue in the Riegel-Medtronic litigation, the law included an express pre-emption provision favoring the federal rules. So, the question of whether federal laws should prevail over state laws in that case was clear.
However, Levine’s case against Wyeth involves an entirely separate body of law, FDA approvals, which do not expressly state that federal rules prevail over conflicting state claims. Therefore, the outcome in the Levine-Wyeth case is expected to be better for consumers.
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