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Dennis Quaid Supports Patient Lawsuits

Posted on: Thursday, 15 May 2008, 12:58 CDT

Recalling how his newborn twins were nearly killed from an accidental drug overdose, actor Dennis Quaid testified before the U.S. Congress Wednesday, urging them to maintain the rights of patients to sue drugmakers for injuries.

The Quaid twins were injured while in the hospital last year and mistakenly received an overdose of the blood-thinning drug Heparin, made by Baxter International Inc. Quaid and his wife have since sued the company, arguing that the drug is kept in bottles that are not clearly labeled, and that this contributed to the overdose. They believe the drug should have been recalled after three other infants died from a mix-up.

During his testimony, the actor said victims who had been harmed by drugs should be able to seek damages in state court from the manufacturers of those drugs.  However, drug and medical-device makers argue that U.S. Food and Drug Administration (FDA) approval should preempt state liability suits, a view supported by the Supreme Court 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 during the hearing.  He urged Congress to pass legislation to preserve patients' ability to sue drugmakers if the Supreme Court further restricts these actions.

Quaid recalled how his twins, two weeks old at the time, were twice given 1,000 times the suggested dose of heparin while being treated for an infection.  Their blood had "basically turned to the consistency of water“, he said, something that had caused massive bleeding.  About 40 hours later, clotting began returning to normal and the twins recovered, he explained.  But the long-term effects are unknown.

In a statement released Wednesday, Baxter said 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 updated its heparin labels before the twins were treated.  However, it did not recall older bottles because it "may have disrupted the supply of a safe and critical medication."  

The company filed a motion to dismiss the Quaid’s lawsuit, citing preemption, a position also advocated by the FDA.   At the hearing, a senior FDA official said the position had also 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," FDA Deputy Commissioner Randall Lutter told Reuters.

Lutter said patients still could sue if companies sold products that did not meet FDA conditions of approval.

But Rep . Henry Waxman (D-CA) called the FDA's current stance a "radical legal doctrine" that deviated from the agency's prior views, and said it would be damaging if allowed to stand.

"One of the most powerful incentives for safety -- the threat of liability -- would vanish," said Waxman, chairman of the House Oversight and Government Reform Committee.

Waxman had previously said he would support legislation to overturn the Supreme Court's February ruling.  That ruling involved a New York man who was injured during an artery-clearing procedure when a doctor inflated a balloon catheter made by Medtronic Inc.   A similar case involving drugmaker Wyeth is expected to go before the Supreme Court in October.

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Source: redOrbit Staff and Wire Reports

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