The Weakness of Weeks—Blazing the Wrong Trail in Pharmaceutical Liability

The Alabama Supreme Court’s recent decision in Wyeth v. Weeks, 2014 BL 227432, Ala., 1101397, 8/15/14, holding that pioneer/branded drug manufacturers may be held liable for injuries caused by generic imitations of their products adds another strand of complexity and irrationality to the already tangled web of liability rules for prescription pharmaceutical injuries.

The pursuit of legal remedies for pharmaceutical injuries is complicated by the interplay of Food and Drug Administration (FDA) regulation and state law and the incremental ad hoc accretion of judge-made remedial doctrines that have created needless inequities and expenses without making any significant contribution to patient safety.

It is high time to rethink the basic elements of the pharmaceutical liability regime and move toward a comprehensive national liability system in which injury minimization and prompt relief for those bearing the often crippling expenses of injury remediation are efficiently and rationally pursued.

Prescription pharmaceuticals are powerful agents that inescapably generate both beneficial and potentially harmful effects. In general, when the anticipated therapeutic benefit of a drug outweighs its risk of harm, making it available serves the public health interest.

Where the opposite is true, a strong case can be made for foreclosing product distribution nationwide. Since 1938, threshold screening of new pharmaceuticals has been entrusted to the FDA whose approval is a pre-requisite to the distribution of a pharmaceutical in interstate commerce.

Since 1962, the FDA’s threshold evaluation of new drugs has expressly been predicated on balancing benefit (efficacy) and harm (adverse effects).

The scientific review conducted by FDA is frequently criticized for expense and delay but has contributed importantly to patient safety by screening out insufficiently tested and unreasonably high risk products.

FDA’s review also seeks to ensure that pharmaceutical labeling assists prescribers in minimizing harm by warning/cautioning of potential known adverse effects and, when possible, contra-indicating use in patient populations for whom risk is excessive. Unfortunately, while acknowledging that some injuries, including serious injuries, will inevitably arise from approved pharmaceuticals, neither the FDA regime nor any other federal law provides a remedy for those injured or any guidance on when a litigation remedy would be appropriate.

State, Federal Interplay

Prodded by sympathetic injury claims, state law liability remedies have been overlaid on the federal regime. State law has not extended the strict, no fault, liability sometimes applied to inherently dangerous activities to the sale of federally-approved pharmaceuticals that, on balance, are beneficial products.

Thus, absent a manufacturing defect, state law liability typically turns on a showing that inherent risk could have been avoided in a particular case by enhanced warnings that would have caused the prescriber or patient not to use or to cease using the injurious drug. State liability theories can be premised on the theory that inadequate warnings, however caused, rendered the product itself unreasonably dangerous, or on negligent failures to enhance labeling warnings of risks coming to manufacturer attention post-FDA approval.

State law liability actions purport to address a post-approval monitoring gap. With limited resources to oversee 11,000 or more approved drugs, FDA largely depends on manufacturers to monitor and react to new post-approval safety data, and FDA permits pioneer holders of approved new drug applications to make most safety-related changes in their approved labeling subject only to after-the-fact review.

Also, FDA’s authority to withdraw existing approvals or to require changes in labels once approved is heavily circumscribed. State liability actions purport to address the post-approval monitoring gap in the federal safety regime by imposing fault-based liability on all pharmaceutical manufacturers who allegedly fail to properly update their labels.

Flaws in Current Scheme

While thus supportive of federal regulation in theory, state liability regimes are far from a perfect complement to the federal regime. First, imposing tort-based labeling liability does nothing to remedy the injuries suffered by those patients injured by the disclosed risks society chooses to accept as the price of benefitting the majority of a drug’s users.

Moreover, by incentivizing manufacturers to protect themselves by making expansive risk disclosure on limited evidence, fault-based liability may overdeter careful, cautious prescribers while drowning less risk averse prescribers in a sea of warnings that are largely ignored if they are read at all. Because the parameters of necessary risk disclosure are set ultimately by lay jurors in state liability actions after injuries occur, a defensive over-warning strategy by manufacturers is a virtually certain by-product of the existing liability regime.

Second, the idiosyncrasies of federal labeling law create an increasingly serious “generic gap” in state tort liability. Generic drug manufacturers are precluded by federal law from changing their drug labeling so long as the innovator manufacturer labeling they are required to imitate does not change. Generic manufacturers also are permitted to rely on continuing innovator authorization to keep their generic imitations on the market. In Pliva, Inc. v. Mensing, 131 S. Ct. 2567, U.S., and Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, U.S., the Supreme Court focused on these constraints to preclude state law liability from being imposed on generic manufacturers for labeling deemed inadequate under state law, or for continuing to sell while recognizing the inadequacy of the labeling that federal law required them to use. Accordingly, most patient claims against generic manufacturers are now routinely dismissed at the threshold so long as a generic operates in compliance with federal law. Generic manufacturers, often the dominant sellers, thus have little incentive to monitor and identify emerging safety risks.

The FDA made an initial foray into closing the “generic gap” by proposing a regulatory change that would have permitted generic manufacturers to independently initiate safety-related labeling changes, thus opening them to state law liability 11 PLIR 1369, 11/15/13. FDA’s proposal raised a storm of generic objections including a telling legal argument that FDA’s governing legislation—as well as the need to avoid prescriber confusion—required identical labeling for identical drug products. There is little reason to believe that FDA’s proposal will be adopted and an identical legislative effort appears to be gaining little traction.

Weeks in Review

The Weeks court now has stepped into the generic gap by endorsing what it proclaims as a universal innovator liability theory limited to pharmaceutical injuries. Weeks focuses on the fact that prescribers often rely on innovator labeling to choose pharmaceutical treatments even when they permit prescriptions to be filled by generic imitations.

The Weeks majority reasoned that, absent any other relationship between the innovator and the patient or prescriber, innovator labeling inadequacies still could be a cause of prescription pharmaceutical injuries from generic drug use thus creating a basis for innovator liability.

While the Weeks majority acknowledges that its result is inconsistent with the great weight of precedent, its espousal of innovator liability will undoubtedly lead to efforts to extend the innovator liability doctrine to other states that have not yet addressed the issue at their highest judicial level.

Unanswered Questions

Even apart from the glaring inequity of forcing innovators to remedy injuries to patients with whom they have no business relationship, and whose purchase of a competing generic product is commercially detrimental to the innovator, the Weeks court’s effort to close the “generic gap” raises a host of troublesome questions.

Can a state, acting through its courts constitutionally effect an uncompensated taking of innovator property (i.e., money) to serve the public purpose of compensating those injured by using a generic drug?

Alternatively, can an innovator facing Weeks liability cross-claim against a selling generic to remedy the unjust enrichment of having to pay a judgment that, absent federal preemption, would have been lodged against the generic manufacturer under state law?

Can the speech-based theory of innovator liability law be confined to drug manufacturers or will it spread to publishers and others who provide information about prescription pharmaceuticals on which prescribers may rely? If other influential speakers are not reached, would a Weeks theory violate the Fourteenth Amendment safeguard of equal protection? Could an innovator avoid Weeks liability by voluntarily surrendering its new drug authorization for commercial reasons thus ceasing to be obligated to monitor new safety information and leaving generic labeling frozen at the date of surrender? And, if so, how could such withdrawal advance patient interests in competitive markets and post-approval surveillance?

In short, Weeks may raise more questions than it answers and make today’s imperfect pharmaceutical liability regime even more complex, controversial and expensive. The inadequacies and inequities of the existing regime make it well past time to rethink safety and remedy first principles, and for Congress to enact a federal regime that would properly empower and fund lifetime FDA pharmaceutical oversight, and also determine how to remedy injuries that, even with the best of supervision, cannot be eliminated.

It is virtually indisputable that while existing ad hoc approaches may provide comfort in some injury cases and generate novel legal theories that enrich the legal profession, they do little to advance public health and welfare.