On Wednesday, actor Dennis Quaid urged the U.S. Congress to preserve patients’ rights to sue manufacturers for injuries from defective drugs as he related how his newborn twins nearly died from an accidental Heparin overdose. In late 2007, the babies were given a massive, accidental overdose of the blood thinner, Heparin, at California’s Cedar-Sinai hospital and were dosed with vials of Heparin 1,000 times stronger than what should have been prescribed.
Dennis Quaid has sued Baxter International Inc., maker of Heparin, for negligence in packaging different doses in similar vials—which contributed to the overdose—and not issuing a recall after three other infants died from a similar mix-up wherein six newborns were mistakenly overdosed.
Quaid said his twins were two weeks old when they were twice given 1,000 times the recommended dose of Baxter’s Heparin 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.
Quaid 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 (FDA) approval should preempt state liability suits in many instances; 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 as he urged Congress to pass legislation to protect patients’ ability to sue drugmakers if the Supreme Court further restricts the suits.
Pharmacy technicians stock Heparin for use in preventing clots and for flushing IVs. Hospital protocol is to keep the different units separated, but a technician accidentally put the 10,000 unit vials in the drawer where the 10 unit vials were stored. Baxter said the overdose resulted from human error at the hospital and was “unrelated to the safety and efficacy of Baxter’s product.” Baxter had revised Heparin labels before the Quaid twins were treated, but 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.
Under the current administration, the FDA advocates preemption. “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, he added.
Representative Henry Waxman—Democrat-California and House Oversight and Government Reform Committee chair—called the FDA’s view a “radical legal doctrine” that was not in keeping with previous FDA positions and would be harmful if allowed. “One of the most powerful incentives for safety—the threat of liability—would vanish,” added Waxman who 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.
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