Law - October 2008
Tex Med . 2008;104(10):32.
By Crystal Conde
The quality of patient care could be compromised and physicians would risk more liability lawsuits if the U.S. Supreme Court sides with the drug manufacturer Wyeth in a Vermont case.
That is the conclusion reached in a brief [ PDF ] filed with the court by the Texas Medical Association, the Texas Medical Liability Trust (TMLT), and the North Carolina Medical Society. They urge the justices to uphold the Vermont Supreme Court's decision ordering Wyeth to pay damages to a patient whose arm was amputated after complications from intravenous push administration of the antinausea drug Phenergan. The California Medical Association, editors of the New England Journal of Medicine , and two former U.S. Food and Drug Administration (FDA) commissioners also filed a brief supporting the Vermont court's ruling.
Wyeth is asking the Supreme Court to overturn the decision and declare that the federal Food, Drug, and Cosmetic Act preempts state tort actions against drug manufacturers. Preemption may also negate state tort reform measures if these statutes are viewed as infringing on the FDA's regulatory authority, Wyeth says.
TMA, TMLT, and North Carolina disagree, arguing that federal preemption of pharmaceutical manufacturers' liability for labeling would be "unwarranted." The FDA "arguably does not have the manpower, financial resources, or statutory authority to adequately police the drug and device industry," they said.
Furthermore, the brief contends, preempting the drugmakers' liability could impose significant liability on physicians.
"It has long been accepted that physicians 'may prescribe [drugs] for uses or in treatment regimens or patient populations that are not in approved labeling,'" it says. "The result is that a significant percentage of prescriptions are prescribed for 'unlabeled' uses. A concern for patient health arises when physicians are encouraged to prescribe drugs for unlabeled uses by being exposed to scientific and medical literature, the integrity of which is subject to question."
The brief adds, "It is unlikely that judicial adoption of preemption in favor of pharmaceutical manufacturers will result in the wholesale discontinuation of all lawsuits arising from the use of FDA-approved prescription medications." If pharmaceutical companies are insulated from liability, it says, patients would have no option but to sue their doctor.
The brief also says neither peer-reviewed medical journals nor actual practice support the argument that over-warning attributable to claims would lead to underuse of medications. Rather, it contends, "inadequate use of drugs is more likely due to patient misperceptions and physicians' lack of knowledge about available drug treatments."
TMA, TMLT, and North Carolina say shielding only one segment of the health care industry from liability is not equitable, just, or right. "By any application of principles of fairness and justice, health care providers should receive the same measure of protection as drug companies if the physicians utilize or prescribe FDA-approved drugs in a reasonable and prudent manner."
The brief concludes, "The welfare of patients and healthcare reform should be the primary goal of physicians, the pharmaceutical industry, and the FDA."
Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail at Crystal Conde .
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