Encouraging News? Congress Prepares to Undo Anticipated Supreme Court Decision Precluding Lawsuits Over Dangerous Drugs

In the event that the Supreme Court applies the federal doctrine of preemption to permit the pharmaceutical industry to avoid accountability for the harm dangerous drugs cause, the only remedy would be for Congress to pass a law expressly stating that preemption does not preclude state court lawsuits for compensation.

And that, hopefully, is the goal of the process engaged in by Chairman Rep. Henry A. Waxman of the Committee on Oversight and Government Reform of the U.S. House of Representatives this past Wednesday, May 14, 2008. Similarly, Reps. Frank Pallone (D-N.J.) and Waxman (D-Calif.) have drafted legislation, the Medical Device Safety Act of 2008, to ensure federal law does not preempt state law when people harmed by medical devices sue.

The new law would amend the federal Food, Drug, and Cosmetic Act (FDCA) by adding the subsection No Effect on Liability Under State Law, which states, Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State. On May 14, the Committee on Oversight and Government Reform of the U.S. House of Representatives held a hearing titled, Should FDA Drug and Medical Device Regulation Bar State Liability Claims? concerning the legal liability of manufacturers that produce dangerous drugs and medical devices.

As framed by Chairman Waxman, the question to answer is, “Should the companies that produce these products be absolved of their legal obligation to ensure the safety of their products?” In Chairman Waxman’s Opening Statement, he specifically lashed out at preemption, calling it a radical legal doctrine because patients hurt by defective drugs and medical devices would no longer have the ability to seek compensation for their injuries. As he aptly points out, with preemption, one of the most powerful incentives for safety the threat of liability would vanish.

Yet that is precisely what will occur should the Supreme Court hold, like it already has in many cases of medical devices, that FDA approval of a drug precludes a person harmed by the drug from suing the drug manufacturer, even if the manufacturer mislead the FDA about the safety of the drug.

Imagine – the withholding of information about potentially fatal defects from physicians, patients or the FDA being rewarded with legal immunity from liability. Its a beautiful thing, if you’re a pharmaceutical giant profiting by the millions.

The pharmaceutical industry (and the Justices of the Supreme Court as well) knows full well that the FDA lacks the funding and manpower to properly evaluate the safety of drugs. The FDA’s own Science Board said American lives are at risk.

It is outrageous that the industry peddles its nonsense while American lives are at risk and people are seriously injured or killed. But it’s also shrewd; lawsuits under state law are the only way for victims to seek compensation for pain, permanent disabilities, inability to work and expensive medical procedures.

The combination of an ineffective FDA giving its blessing to insufficiently (or deceptively) tested drugs coupled with an inability of victims injured or killed from these drugs to sue to hold the drug manufacturers accountable can only result in exposing Americans to more harm.

One witness who testified at the Congressional hearing described the case of a 21-year-old who died when his cardiac defibrillator malfunctioned. The malfunction was due to a design flaw that was known to the manufacturer at the time of his death, but was not known to the patient or his doctor. It took three years for the manufacturer to withdraw the defibrillator from the market after it first learned of the defect, during which time doctors continued to implant the device. And for this it is right to give the manufacturer a free pass? Yes, would say the Supreme Court.

Another witness before the Committee was Dennis Quaid, whose twins almost died from a mistakenly given dosage of heparin.

The lawyers at Levine & Slavit have decades of experience handling personal injury claims including those involving dangerous and defective products . For 50 years spanning 3 generations, we have obtained results for satisfied clients. We have offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas. If you or someone close to you has been injured by a product that was not properly manufactured, designed or labeled, contact the personal injury lawyers at Levine & Slavit for their help. To learn more, watch our videos.

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