While watching the U.S. House of Representatives’ Committee on Oversight and Government Reform’s hearing today on drug preemption, the first thing that struck me was that Dennis Quaid’s lawsuit against Baxter Healthcare over his twin’s overdoses on the blood-thinning drug Heparin was that how can a person stand opposed to preemption when his case isn’t even based on a failure-to-warn claim? Pardon my ignorance for a second with regard to not knowing the facts of his case until now, but he and his wife’s claims against the company literally involve the color of drug’s label, which was similar to Hep-Lock.

I think the anti-preemption party needs to find a better spokesperson. Quaid, who at one point said that until now thought of himself as a Republican who detests frivolous lawsuits, talked more about his desire to have medications bar coded than the issue of product liability and the Food and Drug Administration’s review of Heparin’s safety label.

The hearing itself, which was headed by Chairman Henry Waxman (D-Calif.), heard testimony from former head of the FDA David A. Kessler, who is now a professor of pediatrics and epidemiology and biostatistics at the University of California, San Francisco School of Medicine, William H. Maisel, M.D., M.P.H., the director of the Medical Device Safety Institute at the  Department of Medicine, Beth Israel Deaconess Medical Center in Boston, and Aaron  Kesselheim, M.D., J.D., from the division of pharmacoepidemiology at Harvard Medical School.

For the most part, each member of the panel opposed the idea of preemption.  From the opening strike of the gavel, Waxman attacked the idea of preemption, calling it a “radical legal doctrine” and explaining that the FDA’s ability to protect the public is plummeting due to a lack of funds and people-power. After the remaining opening statements from the Oversight Committee, Maisel followed up with a brief discussion of medical device claims. Kesselhiem then discussed how product liability lawsuits are beneficial because they require drug companies to monitor the data. Kessler  explained that the FDA can only be classified as an expert during the approval stage of a drug because that is the time when the agency has all of the clinical data in front of it. After a drug is approved, though, the company becomes the proprietor of the data and it is up to the company to alert the FDA when data signals an increased risk of an adverse event.

Although the first panel was overtly anti-preemption, each member, except Quaid, of course, stressed that a balance must be reached because blanket preemption takes away a company’s desire and/or willingness to act responsibly with regard to how it handles adverse data. In addition, the panel discussed how lawsuits positively and adversely affect public health.

Following a short recess, Congressman Darrell Issa (R.-Calif.), Chris Shays (R.-Conn.) and Brian Bilbray (R-Calif.) peppered the first panel about the dangers of litigation with regard to its ability to deprive patients from useful medications. Specifically, Bilbray told the story of Bendectin, a morning sickness drug that was withdrawn due to litigation, not data reflecting a dangerous side effect, and how his wife, who experienced severe morning sickness while pregnant with their first child, was unable to get the drug. Three months after the birth of their son, the baby died, allegedly due to trauma it may have experienced during the first trimester.

Dennis Quaid, you're fired.