The Supreme Court ruling in the case of Mutual Pharmaceutics Co. Inc v. Bartlett shows the legal mind, or at least the legal mind at its highest level, at work. The details of the case had evolved on the way to the Supreme Court, but the New York Times reduced the headline to “In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs.” Very roughly, the patient received a prescription for sulindac, a non-steroidal anti-inflammatory drug, as a result of which she developed toxic epidermal necrolysis (TEN). This is a terrible condition, and although the patient survived, she is now disfigured and legally blind. The underlying cause is unknown, but 95% of cases are linked to common medications, most often antibiotics, but also non-steroidal anti-inflammatories. The risk of TEN caused by drugs similar to sulindac had been known, but at the time of the event, the package insert did not contain a warning about the risk and lawyers for Ms. Bartlett argued that this failure to either reformulate the drug or provide adequate warning made the company liable for damages.
The original suit had been brought under a New Hampshire law that requires that unsafe drugs be changed to make them safe. Without knowing the history of the law, it sounds as if it was passed in response to the 1937 Elixir Sulfonilamides tragedy where over 100 people died as a result of a drug made with a poisonous solvent. Toxicology has advanced since then, although there still may be some unintended risk from counterfeit drugs. The overwhelming majority of drugs in current use have some risk of toxicity, but it’s due to the active drug, not the fillers and binders. There are almost never easy reformulations to increase safety.
From there, the Court discussed whether the company should have changed the labeling to indicate the risk of such severe reactions. The majority, written by Justice Alito with Justices Roberts, Scalia, Kennedy and Thomas concurring, argued that since federal law said that only the originator of a drug product could change the labeling, the generic manufacturer couldn’t legally make changes, and so couldn’t be held responsible for adverse effects. Justice Alito wrote “... sympathy for respondent does not relieve us of the responsibility of following the law.”
Justices Breyer and Kagan filed a dissent arguing that the supremacy of the Federal regulations had not been established by law or formal regulation, only though trial briefs. These justices quoted a brief from an earlier case: “In keeping with Congresses’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complimentary form of drug regulation.”
Justices Sotomayor and Ginsberg also dissented in a lengthy and well documented response. At least one critical point, which appears in a footnote, is that Congress left the preemption of federal law unclear regarding drug labeling, and when Congress has been unclear; there should be a presumption towards the states. Justices Sotomayor and Ginsberg feel that the majority opinion oversimplifies the role of the FDA and ignores the fact that drugs, and their labeling should be and are subject to post-marketing surveillance.
In passing, the opinions raised the question of whether the company should simply have discontinued making this drug, but the answer is that sulindac, a non-steroidal anti-inflammatory, is essential. The risk of TEN applies to all drugs in this class, and although any single non-steroidal anti-inflammatory drug (NSAID) can be dropped, the class as a whole serves a valuable purpose. There are few enough drugs to relieve pain, and each class has serious risks. Aspirin carries the risk a Reye’s Syndrome in children, and an elevated risk or bleeding ulcers in the elderly. Acetaminophen may cause kidney failure. Narcotics, even ignoring their potential for misuse, cause respiratory depression. There is no completely safe drug – it’s simply a matter of determining which has the best risk/benefit ratio for any single patient. In most cases, the NSAIDs are a good choice.
Instead of worrying about the wording of the package insert, states could mandate and enforce a requirement that both physicians and pharmacists cousel patients about the use and risks of prescription drugs. In 1990 the Omnibus Budget Reconciliation Act required that pharmacists offer this type of counseling to all Medicaid patients, and many states have extended the requirement to all patients, but in practice counseling isn’t even offered, and patients are simply asked to sign a form waiving the right to counseling.
Even if Ms. Bartlett had been warned, it might not have altered her willingness to take the drug. The chance of developing TEN from a non-steroidal anti-inflammatory may be as low as 1 in 2,000,000. With those odds, knowing the risk might not matter.
The National Vaccine Injury Compensation Program was created in 1988 to compensate people who were injured by vaccines, or, more honestly, to protect vaccine manufacturers from having their pants sued off. Actually, the vaccine makers threatened to close up shop unless they were protected from lawsuits. It may not be the best solution, but it’s something. Perhaps a comparable fund to assist people injured by drugs that were properly used may be a better solution than Justice Alito’s expressions of sympathy.
Sam Uretsky is a writer and pharmacist living on Long Island, N.Y. Email firstname.lastname@example.org.
From The Progressive Populist, August 1, 2013
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