Actor Quaid Testifies Before House Committee Over Need For Legislation Blocking Pre-Emption Of Drug Lawsuits

Main Category: Medical Malpractice / Litigation
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 16 May 2008 - 5:00 PDT

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Actor Dennis Quaid on Wednesday testified before the House Oversight and Government Reform Committee, asking lawmakers to support legislation that would allow consumers to file product liability lawsuits in state courts if the Supreme Court rules in favor of so-called pre-emption, CongressDaily reports (Edney, CongressDaily, 5/15). Quaid and his wife filed a lawsuit against Baxter Healthcare after the couples' newborn twins in November 2007 were given 1,000 times the intended dosage of Baxter's blood-thinner heparin. The Quaids claimed that the company knew the product had confusing labeling because it began using new labeling but did not recall heparin with the old labeling (Rockoff, Baltimore Sun, 5/15).

Drug and medical device makers, with backing from FDA, have argued in product liability lawsuits that prior agency approval of their products pre-empts them from liability in state-level lawsuits. They have said that such lawsuits undermine FDA decisions (Cohen, Newark Star-Ledger, 5/15).

The U.S. Supreme Court in February ruled 8-1 that FDA approval of certain medical devices protects manufacturers from product liability lawsuits filed in state courts.
In the case, Riegel v. Medtronic, Charles Riegel, a New York man who allegedly experienced severe complications in 1996 when a balloon in a catheter manufactured by Medtronic burst in his severely blocked right coronary artery, alleged that the catheter had design flaws and a misleading label. Medtronic had received FDA approval to market the catheter in 1994. Two lower federal courts dismissed the lawsuit, based on the argument that the 1976 Food, Drug and Cosmetic Act protects manufacturers of medical devices approved by FDA from product liability lawsuits filed in state courts (Kaiser Daily Health Policy Report, 2/21).

Committee Chair Henry Waxman (D-Calif.) during the hearing said he supports legislation that would overturn the Riegel v. Medtronic ruling. Republicans countered that an increasing number of product liability lawsuits discourage companies from bringing products to market and increases costs, CQ HealthBeat reports (CQ HealthBeat, 5/14).

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Waxman said, "Some drug and device companies have hidden and manipulated important safety data. Some have failed to report serious adverse events. And some have failed to disclose known defects. If manufacturers face no liability, all the financial incentives will point them in the wrong direction, and these abusing practices will multiply" (Newark Star-Ledger, 5/15).

Quaid said, "I believe that if pre-emption of lawsuits is allowed to prevail, it will make all of us -- the public -- uninformed and uncompensated lab rats" (Baltimore Sun, 5/15).

Committee ranking member Tom Davis (R-Va.) during the hearing said, "When a regulated company is in compliance with all key federal requirements, allowing state judges and juries to second-guess FDA experts and scientific advisory panels adds instability, not protection, to a system the nation relies [on] for vital medical advances" (Newark Star-Ledger, 5/15).

ABC's "World News" on Wednesday reported on the hearing. Additional ABC News video of Quaid's testimony also is available online (ABCNews.com, 5/15).

AP/Chicago Sun-Times Examines Pre-emption Issue
The AP/Chicago Sun-Times on Wednesday examined how government agencies' "use of the government's rule-making authority represents the [Bush] administration's final act in a long-standing drive to shield" industries, including drug makers, from lawsuits. Restrictions concerning liability lawsuits filed in state courts have been included in 51 rules proposed or adopted by "agency bureaucrats governing just about everything Americans use: drugs, cars, railroads, medical devices and foods," according to the AP/Sun-Times, including 41 filed by FDA and the National Highway Traffic Safety Administration.

The AP/Sun-Times reports that lawsuit limits have been ordered or proposed on drug labeling and packaging. The limits are based on "the concept of federal pre-emption" -- under which federal laws and regulations are given favor over state laws -- which state that once a product has been approved by a federal agency, such as FDA, the manufacturer cannot be held liable in state courts for injuries related to the product, the AP/Sun-Times reports. The pre-emption language exist in the agencies' preambles, and an "expansive interpretation of pre-emption leaves little room for consumers to sue," according to the AP/Sun-Times.

The U.S. Supreme Court later this year will hear a case focusing on the issue of pre-emption, the AP/Sun-Times reports. The defendant, a pharmaceutical company, claims FDA approval of its drug's warning labels preempts any lawsuits brought by consumers. The plaintiff, a woman whose arm was amputated after anti-nausea medication was inadvertently injected into an artery, was awarded $6.8 million by a lower court (AP/Chicago Sun-Times, 5/14).

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