Bilbray: Who Can I Sue? Litigation Denies Access to Needed Drugs

During the two days of committee discussion last week on the House’s medical liability reform bill,
H.R. 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011, Rep. Henry Waxman (D-CA) and several fellow committee members defended litigation and trial lawyers from the (well-founded) accusations that lawsuits increase health care costs and detract from medical treatment.

Litigation actually works to improve quality, supplementing the work of the Food and Drug Administration in the regulatory approval of drugs, they argued. Uh huh. The term is “regulation through litigation,” and it’s an inefficient, expensive and counterproductive system of dual regulation, in which trial lawyers and juries of laymen replace scientific experts and testing in determining which drugs are allowable.

At one point, an apparently frustrated Rep. Brian Bilbray (R-CA) reminded the committee members of the real-world consequences of this kind of litigation: Lawsuits force drugs off the market that help people. People really suffer because of the cash-seeking litigation by trial lawyers.

Bilbray spoke passionately about the loss of Benedictin, an anti-morning sickness medication, taken off the market after The National Enquirer published an alarmist article, “New Thalidomide Scandal-Experts Reveal,” and thousands of lawsuits followed. As a consequence, his wife was deprived of a safe and widely prescribed drug she had used in previous pregnancies. She wound up in intensive care.

Rep. Bilbray:

This is one issue you don’t talk about. You had a treatment, Benedictin, that was used all over the country. There was a National Enquirer story in ’79. It ended up being lawsuit after lawsuit after lawsuit, with no scientific data, according to the FDA, to take it off the market. But sheerly by the harassment of litigation this product is no longer available to women across this country.

And my wife was one of those that went into intensive care, while she was in the first trimester of pregnancy, because the litigation drove that product off the market and denied her access to that product. And you know what physicians do now? … They prescribe the chief components of Benedictin separately, because the private sector cannot provide it because it was driven off the market through litigation, not through science.

So this does have an effect. It has an effect on what’s available for consumers. And I say this…Who do I get to sue? Who do I get to take to trial for those who drove this product off the market. Who do I get to point the finger at? Which lawyers do I get to litigate with who drove it off the market, because my wife didn’t a product that she had in her previous pregnancies, she didn’t have the ability to get the medication that is essential to not only her, but to her unborn baby. Who do I get to have justice with because this product was driven off?

That baby died of crib death three months after her birth, and everybody who knows crib death knows one of the most important components is the development in the first trimester of the central nervous system. And I don’t get the right to be able to sue, the men and women that want their babies born healthy, and do not want their wives to go through the morning sickness that my wife went through, we do not have the right to buy that product today. And it wasn’t the FDA that took it off the market, it was lawyers that saw deep pockets, litigation, a lot of money….

This works both ways, Bilbray concluded: “There is a price for this litigation.”

The committee ultimately voted 30-20 to report out the bill. (News release, more background)

More background …

At one point during Rep. Bilbray’s remarks, Rep. Waxman expresses unfamiliarity with the issue and asks about Thalidomide — apparently National Enquirer’s bogus comparison stuck — and Rep. Michael Burgess (R-TX), a physician, explains more about the anti-Benedictin campaign.

Bilbray’s comments followed a member’s mention of Dennis Quaid, the actor, whose children were sickened when a nurse gave them an overdose of the blood thinner, Heparin. Quaid sued the manufacturer in 2007 despite the product being safe and widely used; the mistake was in the actual administration of the drug. Quaid testified at a House Oversight Committee hearing in 2008 (transcript). During that hearing, Bilbray related his and his wife’s experience with Benedictin.

Rep. Bilbray also recalled these events during a House Oversight Committee hearing on FDA drug approval on March 14, 2008. (Committee transcript)

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