Supreme Court says companies responsible for their actions
Leila Watson March 30th, 2009
Opinion essay published in The Birmingham News
Sunday, March 29, 2009 ERNEST CORY and LEILA H. WATSON
Accountability. If a company manufactures what it knows to be a potentially dangerous drug and sells it without adequate instruction of how to use it safely, the manufacturer should be held accountable when a patient is harmed because the instructions were deficient.
Earlier this month, the U.S. Supreme Court held in a 6-3 decision of Wyeth v. Levine, that this basic rule of accountability, which we were all taught, and which we have all passed on to our own children, also applies to corporate drug manufacturers: You are responsible for your own actions.
Diana Levine, suffering a migraine headache, went to a Vermont medical clinic for a treatment she had received many times: Demerol for pain and Phenergan for nausea. On this occasion, however, the medications were administered by “IV push.” The Phenergan was exposed to arterial blood, and caused swift and irreversible gangrene. Levine’s right hand and forearm had to be amputated. Wyeth, the manufacturer, knew that Phenergan should not be administered by IV push because of this very risk, yet failed to warn doctors against it.
Wyeth argued that the Food and Drug Administration is responsible for the labeling on Phenergan and all other pharmaceuticals sold in the United States, and therefore no drug company can ever be sued for mistakes and failures in the labels and warnings. Wyeth wanted legal immunity for any harm caused by its products, even in cases like Levine’s lawsuit, where the patient could prove Wyeth knew of the undisclosed risks.
The Supreme Court disagreed. Recognizing that the FDA is underfunded and overworked, the Supreme Court said “the FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their (own) drugs.” The court specifically said drug manufacturers, not the FDA, bear the primary responsibility at all times to ensure that instructions and warnings are complete and accurate. Drug companies – corporate America – must live by the same rules we do: Each of us is responsible – and accountable – for our own actions.
By sweeping aside legal immunity and federal pre-emption, the Levine decision restored the important role of jury trials. Filing a lawsuit and trying your case to a jury has been the foundation of our civil justice system since the drafting of the Constitution. But over the past decade, there has been a concerted effort, mostly by insurance companies, big tobacco, oil companies, multinational corporations and the George W. Bush administration, to discredit juries and the verdicts they reach.
Wyeth argued to the Supreme Court that a civil jury should not undermine the work of the FDA to approve drug warnings, and that the FDA was an agency of experts and no civil jury of lay people should be allowed to second-guess the agency decisions to approve drug labels. In fact, as pointed out by the Supreme Court, the FDA relies on the civil justice system to provide “an additional, and important, layer of consumer protection that complements FDA regulation.”
Lawsuits and jury trials have produced evidence for public review of drug hazards even after the particular product has been approved by the FDA. Vioxx, the blockbuster pain reliever manufactured by Merck & Co. Inc. is just one such example of a drug whose dangers were uncovered after injured patients hired attorneys. The lawyers opened up millions of pages of studies, documents and memos to experts and discovered that Vioxx caused an increased risk of heart attack and stroke, all of which led to the removal of Vioxx from the market, and the addition of strong warnings on other drugs in the same class.
No one should be able to act irresponsibly, cause harm and never face a jury to answer for his conduct. The Levine decision puts drug companies on the same level as the people who are harmed by their products and as those who sit on the juries.