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Actor testifies to Congress on pre-emption debate

5/15/2008

WASHINGTON In front of Congress yesterday, actor Dennis Quaid asked the legislative branch to preserve patients’ rights to sue drugmakers for injuries, recounting how his newborn twins nearly died from an accidental drug overdose, according to Reuters.

At a the hearing, the actor said victims of harm from medicines should be able to seek damages from manufacturers in state court. Drug and medical-device makers argue that the Food and Drug Administration approval should preempt state liability suits in many instances, and the Supreme Court backed that view in a recent device case.

“I believe if preemption of lawsuits is allowed to prevail, it will basically make all of us, the public, uninformed and uncompensated lab rats,” Quaid said at a House of Representatives committee hearing. He urged Congress to pass legislation to protect patients’ ability to sue drugmakers if the Supreme Court further restricts the suits.

“FDA believes that the important decisions it makes about the safety, efficacy and labeling of medical products should not be second-guessed by state courts,” said FDA Deputy Commissioner Randall Lutter. Patients still could sue if companies sold devices that failed to meet FDA conditions of approval, Lutter said.

But Rep. Henry Waxman, D-Calif., called the FDA’s current view a “radical legal doctrine” that departed from the agency’s previous stances and would be harmful if allowed to stand. Waxman has said he will back legislation to reverse the Supreme Court’s ruling.

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