Congress urged to allow drug suits

Actor Dennis Quaid is urging lawmakers to push back against efforts by the Food and Drug Administration to preempt state drug safety tort claims against drugmakers.

Quaid, whose newborn twin daughters were accidentally given a nearly lethal dose of the blood-thinning drug Heparin, told members of the House Reform and Government Oversight Committee that without the right to sue pharmaceutical companies, consumers will become “uninformed and uncompensated lab rats.”

“Like many Americans, I believed that a big problem in our country was frivolous lawsuits,” Quaid said at the Congressional hearing. “But now I know that the courts are often the only path to justice.

“Since this brush with tragedy, I have found out that medication errors are unfortunately all too common,” said Quaid, citing data suggesting roughly 100,000 Americans die annually from drug errors. (For an article about the many types of lawsuits that can result from medication errors, see “Medication errors are prescription for lawsuits,” Massachusetts Medical Law Report, Spring 2008.)

But Randall Lutter, the FDA’s deputy commissioner for policy, told lawmakers that the limits on state-based tort claims are necessary in order to best ensure drug – and patient – safety.

“If a plaintiff claims to have been harmed by a sponsor’s failure to meet the conditions of FDA’s approval for a drug [then] state-law liability on that basis would not interfere with federal law and manufacturers would get no protection from such claims,” Lutter said. “But to both protect the public health and as a matter of law, state-law claims are preempted if they challenge a design or labeling that FDA approved … based on its expert weighing of the risks and benefits of requiring additional or different warnings.”

The hearing was called by House Democrats as the FDA has increasingly stepped into suits against drugmakers, arguing that its regulatory authority in approving drugs supersedes state laws – including civil tort claims that drugs are unsafe.

The U.S. Supreme Court is set to weigh in on the issue next year.

This year, the Court held that state-law tort claims alleging unsafe medical devices are barred if the FDA has approved the device.