Schachtman gives an interesting legal update today on his blog concerning the issue in my post Generic Drugs Resistant to Lawsuits” (Mar. 22, 2012). I post it here:
By: Nathan Schachtman, Esq., PC*
Last week marked the launch of a New York Times a rhetorically fevered, legally sophomoric campaign against generic drug preemption. Saturday saw an editorial, “A Bizarre Outcome on Generic Drugs,” New York Times (March 24, 2012), which screamed, “Bizarre”! “Outrageous”!
The New York Times editorialists have their knickers in a knot over the inability of people, who are allegedly harmed by adverse drug reactions from generic medications, to sue the generic manufacturers. The editorial follows a front-page article, from earlier last week, which decried the inability to sue generic drug sellers. See Katie Thomas, “Generic Drugs Proving Resistant to Damage Suits,” New York Times (Mar. 21, 2012).
The Times‘ writers think that it is “bizarre” and “outrageous” that these people are out of court due to federal preemption of state court tort laws that might have provided a remedy.
In particular, the Times suggests that the law is irrational for allowing Ms. Diana Levine to recover against Wyeth for the loss of her arm to gangrene after receiving Phenergan by intravenous push, while another plaintiff, Ms. Schork, cannot recover for a similar injury, from a generic manufacturer of promethazine, the same medication. Wyeth v. Levine, 555 U.S. 555 (2009). See also Brief of Petitioner Wyeth, in Wyeth v. Levine (May 2008).
Of course, both Ms. Levine and Ms. Schork received compensation from their healthcare providers, who deviated from their standard of care when they carelessly injected the medication into arteries, contrary to clear instructions. At the time that Levine received her treatment, the Phenergan package insert contained four separate warnings about the risk of gangrene from improper injection of the medication into an artery. For instance, the “Adverse Reactions” section of the Phenergan label indicated: “INTRA-ARTERIAL INJECTION [CAN] RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.”
As any tort practitioner knows, a plaintiff can almost always second guess the adequacy of a warning, but the Levine case did not involve any real failure to warn, or failure to warn adequately. Healthcare providers and the FDA are well aware of the dangers of intra-arterial injection of Phenergan, but plaintiffs’ counsel can always play the hindsight bias game, and ask for something more.
What distorts tort law and creates irrational, disparate outcomes often has more to do with who has the deep pocket. The Physician’s Assistant who screwed up and caused Ms. Levine’s gangrene settled, but Ms. Levine was left free to pursue the manufacturer despite the negligence of the P.A. According to the Times article, Ms. Schork, who was injured from a careless injection of the generic version, pursued a similar strategy, and obtained a “limited settlement” from her healthcare provider (amount not specified).
Many states have caps on medical malpractice awards, and often plaintiffs’ counsel are reluctant to push hard against healthcare providers who will be viewed as sympathetic by juries. Punitive damages are virtually impossible to obtain against physicians, physician assistants, and nurses, but are commonplace against large pharmaceutical companies. So tort law creates a perverse set of incentives to ignore the truly culpable parties, or “to go lightly” on them, and to pursue the manufacturing defendant on the vagaries of “adequacy” of warning. The incentives are so corrupting that in some states, the healthcare providers, afraid of insurance premium hikes, turn to plaintiffs’ counsel to offer support against the manufacturing defendant.
What is bizarre and outrageous is that anyone would have a remedy against the manufacturer in the facts of the Levine case, or in similar cases.
The Times notes that federal preemption of state tort law in lawsuits against generics follows from the generic manufacturers’ lack of control over package insert labels. Shilling for the lawsuit industry, the Times fails to mention that it is the original sponsor of the medication, the proprietary pharmaceutical manufacturer, which prepared the new drug application, and which has had the longest experience with post-marketing surveillance of the medication.
Professor Deborah Mayo asks whether anyone is responsible for updating the label after a medication has lost its patent protection. See “Generic Drugs Resistant to Lawsuits” (Mar. 22, 2012)
If the question is raised in the context of the sponsor’s continued sale of the medication, then the sponsor still must fulfill its product stewardship. The FDA has a considerable interest in maintaining consistency across labels, and the agency has generally been reluctant to permit one manufacturer of a drug, or in a class of drugs, to deviate substantially from what the agency believes is the appropriate level of warning in the context of the indicated use. Of course, in the case of Phenergan, none of these considerations was really involved, because the FDA was well aware of the danger of gangrene from arterial injection, and the FDA-approved label contained multiple references to the hazard.
Tort law is the wrong hobby horse to ride into battle for an equality of results. Two patients may have equally careless healthcare providers, but one of them gets lucky and accidentally manages to inject the IV into a vein. The other is unfortunate, and suffers grievous injury because her physician negligently injected the medication into an artery. Tort law provides a remedy only against the careless provider whose negligence causes harm. The other negligent provider goes free, to inflict malpractice on another victim.
Or consider two equally meritorious plaintiffs who sue two companies under almost identical facts. One of the companies is insolvent. One of the plaintiffs will thus go uncompensated.
Or suppose we have two plaintiffs, each of whom receives a particular medication from his physician and is harmed by a well-recognized adverse drug reaction. Although well understood by the medical professional, further assume that the harm is not adequately addressed in the package insert. One plaintiff’s physician acknowledges that he was well aware of the reaction; the other plaintiff’s physician is incompetent and says he never heard of the problem. The learned intermediary doctrine will properly cut off the claim of the knowledgeable physician; the plaintiff whose physician was incompetent may still have a claim against the manufacturer. Lucky plaintiff to have had such an ill-trained physician.
Similarly, if a plaintiff’s physician testifies that he never reads package inserts, then the plaintiff may lose any remedy because regardless whether the warning label was adequate or not, the prescribing physician’s carelessness prevented the actual labeling, and any hypothetical proposed labeling, from influencing his prescribing practice.
The Times quotes Michael Johnson, a lawyer who represented Gladys Mensing, whose case gave rise to the Supreme Court’s ruling on generic preemption: “Your pharmacists aren’t telling you, hey, when we fill this with your generic, you are giving up all or your legal remedies.” Well, if you have a well-trained physician, who is aware of the risks of a medication, as he or she should be, you may have given up the rights you had if your physician was an ignoramus, willfully ignorant of the medication’s unavoidable risks. Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011).
The point is that tort law is not, and has never been, a system of generating equal outcomes; nor is tort law a system of insuring people against bad results. Generic medications cost less. People who are looking to buy lawsuits may choose to buy proprietary pharmaceutical manufacturers’ drugs. People who are looking to buy good healthcare may choose to select their healthcare providers more carefully, and look to a system that better places the cost of harm on those parties that can best avoid the bad outcome. In the Levine and Schork cases, the most efficient, and the fairest, cost and risk avoiders were the women’s healthcare providers.
Is it absurd for recovery to be limited against generics when allowed against proprietary pharmaceutical manufacturers? Yes, because the proprietary manufacturers should have similar protection from the welter of state tort laws. The irrational result in Levine is not to be imitated.
*Schactman’s legal practice focuses on the defense of product liability suits, with an emphasis on the scientific and medico-legal issues. He teaches a course in statistics in the law, at the Columbia Law School, NYC.