Courts Best Suited To Oversee FDA, JAMA Commentary Says

The current issue of the Journal of the American Medical Association includes a commentary which states that the nation’s tort laws provide necessary oversight of the Food and Drug Administration while compensating people who are injured or killed by defective drugs and medical devices.

The commentary was written by Lawrence O. Gostin, an internationally acclaimed scholar and director of the O’Neill Institute for National and Global Health Law at Georgetown University. It focuses on two recent U.S. Supreme Court decisions which reached different results on the issue of federal-state preemption.

Preemption is the legal concept which holds that federal law prevails over conflicting or inconsistent state laws. In two landmark rulings, the nation’s highest court found that patients cannot use state personal-injury laws to sue makers of medical devices for injuries caused by the devices (Riegel v. Medtronic), but then refused to extend the same protections to makers of defective drugs (Wyeth v. Levine).

Federal lawmakers have since introduced new legislation to effectively reverse the court’s unpopular decision in Riegel and reinstate the rights of injured parties to seek damages in state courts for injuries caused by defective heart defibrillators, knee and hip replacements, and other medical devices.

A ‘Safety Net’ for Consumers

Gostin’s commentary says that state personal-injury lawsuits are necessary to protect consumers from injuries caused by the 11,000 FDA-regulated drugs and medical devices. Without such laws, Gostin writes, “patients would have no safety net in the event the FDA fails to detect or correct safety hazards.”

Unlike the FDA, Gostin further writes, “tort litigants … have subpoena power and discovery can be a potent way to inform the agency and the public of undisclosed risks.”

Recent court decisions to curtail consumers’ rights to seek damages for injuries caused by dangerous medical devices leave thousands of patients out in the cold, unable to be compensated for the costs of their medical bills, lost income, pain and suffering, and other damages. Gostin said civil courts can bring justice to injured parties.

“The civil justice system also can compensate patients who are wrongly harmed by drugs and medical devices,” Gostin said in his commentary. “Absent tort litigation, patients who sustain grievous injuries would have no recourse.”

FDA Has Hands Tied

The FDA is the first line of defense against dangerous and defective medical devices and drugs, but the agency can only do so much. It relies heavily on companies to conduct clinical trials of proposed devices and drugs and expects companies to essentially police themselves with regards to detecting and disclosing defects and potential problems from the products.

When companies hide negative findings from clinical studies or downplay the rate of side effects caused by drugs or medical devices, the FDA is left with a false impression of the proposed product. With such biased data and half-truths supplied to the agency in deciding whether or not the proposed product is safe and effective, civil suits provide essential oversight to the FDA approvals process.

“If … as too often appears to be the case (the medical device) industry conceals relevant information and the FDA lacks the capacity to do anything about it, the tort system becomes a failsafe, facilitating effective agency oversight and offering a remedy for patients who are wrongly harmed,” Gostin said.

No related posts.