WASHINGTON (Reuters) - Actor Dennis Quaid urged the U.S. Congress on Wednesday to preserve patients’ rights to sue drugmakers for injuries, recounting how his newborn twins nearly died from an accidental drug overdose.
Quaid and his wife have sued Baxter International Inc, the maker of the blood-thinning drug given to his twins in a hospital last year. The couple argued that the product was stored in bottles with confusing labels that contributed to the overdose and should have been recalled after three other infants died from a mix-up.
At a congressional 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 U.S. 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.
Quaid said his twins were two weeks old when they were twice given 1,000 times the recommended dose of Baxter’s heparin blood-thinner while being treated for an infection. Their blood “basically turned to the consistency of water,” causing massive bleeding, he said.
About 40 hours later, clotting started returning to normal and they recovered, although long-term effects are unknown, Quaid said.
Baxter said in a statement on Wednesday that the overdose resulted from human error at the hospital and was “unrelated to the safety and efficacy of Baxter’s product.”
The company had revised the heparin labels before the Quaid twins were treated. Baxter said it did not recall older bottles because that “may have disrupted the supply of a safe and critical medication.”
Baxter cited preemption in its motion to dismiss Quaid’s lawsuit.
The FDA, under the Republican George W. Bush administration, has advocated the preemption argument. At the hearing, a senior official said the position had been supported by previous administrations.
“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, a California Democrat, 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.
“One of the most powerful incentives for safety -- the threat of liability -- would vanish,” said Waxman, who chairs the House Oversight and Government Reform Committee.
Waxman has said he will back legislation to reverse the Supreme Court’s February ruling, which involved a New York man who was injured when a doctor inflated a Medtronic Inc balloon catheter during an artery-clearing procedure.
A similar case involving drugmaker Wyeth is expected to be heard by the high court in October.
Editing by Richard Chang
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