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A Supreme Court top list for medical impact
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The law has an ever-increasing effect on the practice of medicine, but legal controversies with medical impact rarely reach the US Supreme Court because such cases must go through several levels of hearings and appeals before even being considered by the Supreme Court.
Furthermore, the issues must involve interpretation of the US Constitution or federal law, and at least four of the nine justices must agree to accept a case. Thus, the Supreme Court reviews only a small percentage of the several thousand cases submitted each year. Consequently, most medical controversies at law take place in state courts. So, it has been unusual that the Supreme Court has lately reviewed several medical cases.
Because the Supreme Court has the final case-law word, five recent cases will shape the practice of medicine; two pending cases will be of special interest to endocrinologists, with a third of greatest interest to all; and review of Medicaid payments and the 2010 federal health care plan loom on the Supreme Court’s horizon.
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The decided cases
Two cases have established different outcomes for patient torts, depending on whether they are injured by a drug or by a medical device. The 2008 case of Riegel v Medtronic was about the rupture of Medtronics’ FDA-approved catheter during surgery. Riegel alleged that the device was produced in a manner violating New York law about medical safety. But the US Supreme Court ruled with near unanimity that FDA approval blocked the Riegel’s state tort claim because of the federal Medical Device and Safety Act’s pre-emption clause, articulating the supremacy of federal law over state law.
This case stands in contrast to the 2009 case of Wyeth v Levine, in which a lawsuit about a drug was not precluded by federal law. In this 6-3 decision for patient Levine, a musician whose arm needed amputation after an ischemic reaction to promethazine hydrochloride (Phenergan), the Supreme Court ruled that FDA-approved warning labels do not pre-empt state court lawsuits claiming inadequate warnings of a drug’s health risk. So in a seeming inconsistency, injured patients can sue drug makers for harm by their products but cannot sue device makers for harm by their products. The frustrated patient injured by a device may thus be more likely to go after the physician.
Harm to patients by drugs was also addressed in Pliva v Mensing (2011), involving generic metoclopramide, branded as Reglan, and its neurological adverse effects. A 5-4 Supreme Court reversal held that generic drug makers such as Pliva cannot be sued under state law for failing to warn consumers such as Mensing of possible adverse effects of their products if they disclose the exact warnings of the brand-name drug, even when state laws require updates of safety warnings. So a patient’s right to compensation for inadequate warnings can depend on whether the pharmacist fills the prescription with a brand name or generic drug. Both the patient and physician are now in this bind of cost vs. apparent safety regarding generic drugs.
Stanford v Roche is a 2011 Supreme Court case of special relevance to the academic physician. The complex events leading to this case began in 1988 when Cetus [company] began collaborating with Stanford University in the development of a clinical test for HIV. Stanford arranged for its fellow to learn the procedure at Cetus, where he was required to sign a confidentiality agreement with the terms that he “will assign and do[es] hereby assign” to Cetus his “right, title, and interest in each of the ideas, inventions, and improvements made.” Of course, the fellow had previously signed a similar agreement with Stanford University, stating that he “agrees to assign” to Stanford University his “right, title, and interest” in inventions resulting from his university employment. So, the fellow acquired two landlords for his intellectual property. The conflicting agreements notwithstanding, both Stanford University and Cetus/Roche patented and commercialized the HIV procedure. After apparently unsuccessful attempts at licensing agreements, Stanford University in 2005 filed a suit contending that Roche’s HIV test infringed on the university’s patents. When the case reached the Supreme Court, a majority let stand the Circuit Court’s reversal of the District Court and concluded that the fellows agreement with Stanford University (“agrees to assign”) was a mere promise, whereas his Roche/Cetus agreement (“does hereby assign”) was an actual assignment and superseded the Stanford University agreement as a matter of contract law.
This decision against Stanford University could cause further disputes because many academic institutions have the future tense in their large numbers of employment contracts. Modifying such existing contracts retrospectively to the present tense presents a formidable legal and practical hurdle. Some faculty might not agree to such modifications, especially if they have a substantial interest in a commercial entity, a not-uncommon situation. And many outside agreements of faculty are contained in confidentiality agreements, which administrators may not see; requiring disclosure here may be particularly challenging. Additionally, challenges to intellectual property rights of academic institutions could be similarly made by companies that want to shed licensing and royalty arrangements with academia, again, not uncommon.
Lastly, most physicians will not like the 2011 Supreme Court decision in Sorrell v IMS Health, in which a six-justice majority struck down a Vermont law that banned some of the uses of prescription information collected by pharmacies. The law banned data mining of prescriber-identified, patient de-identified prescription records of physicians that pharmacies sold to information companies such as IMS Health for marketing purposes. The court blocked this ban, finding the prohibition inconsistent with the First Amendment’s protection of free speech. This decision elevated the protected status of commercial-free speech, a ruling that could threaten other aspects of health care regulation, including consumer protections and FDA regulations.
Two pending cases
Endocrinologists, who increasingly use genetic and complex testing, will be most interested in two cases on their way to the Supreme Court, Molecular Pathology v Myriad Genetics, challenging gene patenting, and Prometheus v Mayo, challenging the patent to a diagnostic test procedure. The patents of Myriad Genetics for breast (and ovarian and prostate) cancer genes were challenged by several institutions. In a surprising decision, a District Court ruled that the patents were invalid on several grounds, even though thousands of such patents had been awarded for decades and much of the human genome has been patented. The most riveting of reasons for not allowing the gene patents was that they were products of nature and thus not patentable subject matter under US patent law. Here is the pivotal question posed by the case: Are isolated human genes unpatentable as “products of nature” because they are not “markedly different” from their natural counterparts? After the District Court answered unpatentable, the Appeals Court countered patentable, and the Supreme Court is left to decide.
Because endocrinologists can commonly use genetic testing in their practice, this case holds special interest to them. As does the Mayo challenge, accepted by the Supreme Court for the next term. This case addresses Patent Law’s proscription of patenting abstract ideas through Mayo’s contesting Prometheus’ patent on a diagnostic test based on the “abstract mental steps” of using correlations of blood measurements for determining drug dosage. Either way, the Myriad and Mayo cases will influence endocrine practice.
The court’s impact
These recent Supreme Court decisions can affect physicians and patients in both practice and academic settings in a manner that can be reasonably gauged. Besides reflecting the pro-business bent of today’s Supreme Court, the decided cases reveal the naiveté that often accompanies court decisions about medical issues. The effect of the pending cases on practice and society can be great, as they will address fundamental issues of law and medicine — can genes and abstract medical information be patented? And, of course, Medicaid payment to physicians and the new federal health care legislation (“Obamacare”) are on track to the Supreme Court, perhaps bearing the greatest effect of all.
L.J. Deftos, MD, JD, LLM, is professor of medicine at University of California, San Diego, and professor of law at the California School of Law. He is also an Endocrine Today Editorial Board member.
Disclosure: Dr. Deftos reports no relevant financial disclosures.