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Preempting patient safety
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Although generally an anathema to physicians, patient medical lawsuits can serve a useful societal function when brought against drug companies that obscure the harmful effects of their products. There are many instances where the tort process uncovers a drug company’s cover-up of adverse drug effects.
Tort actions by patients against drug companies are far outweighed by the number of lawsuits initiated against physicians, even though lawsuits against drug companies are robustly reported in the media. This disparity between lawsuits against drug companies and physicians could be further exaggerated, with consumer lawsuits against drug companies becoming even rarer, when the U.S. Supreme Court renders its decision in the case of Levine v. Wyeth, currently before the court.
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The case before the court
Levine v. Wyeth involves Diana Levine, a guitar-, bass- and piano-playing musician who was given Wyeth’s antinausea drug, Phenergan, by intravenous “push” for migraine-related nausea. Gangrene ensued, and her right arm was amputated below the elbow, essentially ending her career as a musician.
She sued Wyeth, arguing that the labeling did not provide adequate warning against this effect, even though it complied with FDA labeling requirements. Wyeth, she argued, had a duty to better warn about the risk of gangrene. As this case has proceeded through the Vermont Supreme Court to the U.S. Supreme Court, Wyeth has argued that its product warning was adequate. More importantly, Wyeth has asserted that the FDA-approved warning for Phenergan should preempt Levine’s suit in state court.
Preemption in the law
This legal concept of preemption has its roots in the Supremacy Clause of the Constitution, which reads that federal law, the “supreme law of the land,” trumps conflicting or competing laws of states, where most product liability and medical malpractice suits are brought. The legal theory of preemption is based on the view that some activities of national importance, like airline safety, require uniform federal regulation, which cannot be provided by states.
If the U.S. Supreme Court agrees with Wyeth, as it recently agreed with the medical device company Medtronic in a corresponding case regarding FDA-approved medical devices, an important door for injured patients to access the legal system will be closed. This legal passageway is already narrowed by the learned intermediary doctrine.
The learned intermediary doctrine
The learned intermediary doctrine, as I discussed in a previous article in Endocrine Today, places physicians as intermediaries between their patients and drug companies and assigns to physicians, not to drug companies, the duty to disclose the adverse effects of drugs that are prescribed to patients. So this doctrine can actually shield drug companies against liability for the harm that their products cause and place the liability on the prescribing physician.
The learned intermediary doctrine can thus exempt drug manufacturers from the general rule of law that requires product manufacturers to adequately warn consumers of their products’ potential harm. The doctrine does not protect drug companies when they fail to adequately warn the physician about a drug’s adverse effects. When this happens, the patient can directly sue the drug company.
Direct-to-consumer advertising
This drug company armor against patient lawsuits prevails today, even though it was dented in 1999 by the New Jersey Supreme Court in the Norplant litigation, in which Wyeth was found liable for patient harm caused by this implanted contraceptive. Wyeth’s direct-to-consumer advertising, a now-common practice by many drug companies for their products, pierced the learned intermediary shield.
In recognizing a direct-to-consumer exception to the learned intermediary doctrine, the Court reasoned that “our medico-legal jurisprudence is based on images of health care that no longer exist,” because the concern that drug company warnings interfere with the doctor-patient relationship are no longer valid because that relationship is less paternalistic than when the doctrine was developed in the 1960s. Secondly, patients play a more active role in deciding which drugs to take, especially because managed care forces physicians to spend less time with each patient. Thirdly, the billions of dollars that drug companies spend to communicate with consumers through advertising undermines the premise that manufacturers lack effective means to warn consumers. Lastly, the FDA requirement that prescription drug advertising carry warnings presumes that lay people are capable of understanding complex drug warnings.
FDA approval and preemption
Although these judicial arguments seem compelling, exception to the learned intermediary defense by drug companies continues to be rejected by most courts. However, it was recently invoked against Johnson & Johnson in a 2007 decision by a West Virginia court in a case regarding harm caused by Propulsid. Furthermore, the drug companies try to escape liability by arguing that their compliance with FDA regulations equates to adequate warning and preempts any state court action by the patient. This is Wyeth’s core argument against Diana Levine. The corresponding argument regarding medical devices prevailed in the U.S. Supreme Court’s recent 8-1 decision in Reigel v. Medtronic. There are some legal arguments that distinguish between the express preemption in the law applicable to medical devices compared with only implied preemption for drugs, but such preemption seems likely to prevail in the disappointing 8-1 Court decision when applied to consumer drug lawsuits.
Bad news for physicians, patients
If so thwarted by the Supreme Court for legal redress against drug companies, patients may be more likely to turn their perceived harm to malpractice suits against their physicians and thus cause even further imbalance in the number of lawsuits brought against physicians compared with those brought against drug companies. Such legal actions can have great personal but minimal societal benefit. It should not be surprising that the current administration supports Wyeth in this case, another assault on reasonable regulation that continues in many areas — medical, economic, environmental, civil — even as the administration leaves the scene of its political malpractice.
L.J. Deftos, MD, JD, LLM, is a Professor of Medicine at the University of California, San Diego, Professor of Law at California Western School of Law, San Diego, and is an Endocrine Today Editorial Board member.
For more information:
- Deftos LJ. The physician as a learned intermediary — don’t be flattered. Endocrine Today. 2004; May.
- Glantz LH, Annas GA. The FDA, preemption and the Supreme Court. N Engl J Med. 2008; 358:1883-1885.