Shift in the law
A recent trend in the law has greatly weakened the impact of Comment K and shifted the focus away from pharmaceutical companies'
warning labels. In more and more jurisdictions, plaintiffs are now able to prove liability by the more liberal and jury-friendly
strict liability standards previously applied to non-prescription products. Under these traditional strict liability standards,
the jury is allowed to determine whether a product is defectively designed under a risk-utility test—whether a product's risks
outweigh the intended benefits, a decision ostensibly made already by regulators—or even worse, a consumer-expectation test
which, in essence, asks the jury to determine if a consumer would have expected to be injured by the product in the manner
in which she was injured.
In some of these jurisdictions, Comment K has been reduced to an affirmative defense which only offers a defendant a Hobson's
Choice of either defending the product under the more liberal and jury-friendly strict liability standards or taking on the
affirmative burden of first convincing the jury that its prescription drug is "unavoidably unsafe" in order to rely on its
warning label as an affirmative defense (i.e. that the drug was labeled adequately despite the risks outweighing the benefits).
No pharmaceutical company can be pleased with the proposition of having its media relations team explaining why its trial
lawyer just stated in open court that its most successful medication on the market is "unavoidably unsafe."
How to fix the problem
First, in jurisdictions where the appellate courts have not already shifted the law to this more liberal approach, the best
chance to convince a trial judge to follow the original interpretation of Comment K, which focused on the company's prescription
drug's warnings, may be to revisit and update the public policy arguments that first formed the basis of Comment K. Pharmaceutical
companies and their counsel should draw the court's attention to the repercussions of permitting a jury to declare a drug—which
is FDA-approved as "safe and effective" and still on the market—categorically defective based on the jury's determination
that the drug's risks outweigh the benefits for a particular plaintiff. A jury should not be empowered to cast aside the rigorous
drug approval process, which requires years of research and development, clinical trials, and FDA approval before a drug can
enter the market.
Courts should also be focused on the practical implications of the jury's task. For example, is a jury to weigh the entire
range of the medication's therapeutic values or simply find that a drug is defective for the plaintiff's prescribed dosage
and duration given the symptoms she was prescribed the drug to treat? If the latter, how can a drug be declared "defectively
designed," even though the same jury may have decided that the drug was not defective if it was prescribed in a lower dosage,
for a shorter duration, or to treat a different symptom? Likewise, how does a determination of "defective design" account
for the thousands (or millions) of users who benefit from the drug without any adverse side effect? Such an inquiry demonstrates
why prescription medications must be judged on their warnings, which account for proper dosage and usage. After all, warning
labels can be revised and updated as science evolves, but a "defectively designed" drug cannot be reformulated without spending
untold millions of dollars on research and development.
Second, pharmaceutical companies and their attorneys should alert the court that this shift in product liability law creates
the potential for inconsistent verdicts and irrational judicial outcomes. As one Connecticut federal court judge recognized
earlier this year in Moss v. Wyeth Inc., there is a risk of inconsistent verdicts because the "defendant's burden to prove
the adequacy of the warning [in a strict liability design defect claim] is the mirror image of the plaintiff's burden to prove
the inadequacy of the warning in a warning defect claim." Similarly, Bartlett v. Mutual Pharm. Co., a case from the First
Circuit—the appellate court for federal trial courts in Maine, Massachusetts, New Hampshire, Puerto Rico, and Rhode Island—teaches
us that the new trend can result in a situation where the court dismisses a failure to warn claim, yet a jury (or court) finds
the defendant strictly liable for selling a defective product. Both of these outcomes are avoided by focusing litigation on
a prescription drug's warnings.
Finally, pharmaceutical companies and their counsel must engage in a strategic, big picture approach in the appellate courts.
As the old adage goes, "bad facts make bad law." As such, one must carefully weigh the desire to appeal any adverse ruling
with the need to appeal the "right" adverse ruling. Simply put, pharmaceutical companies do not want the wrong case to end
up in front of appellate courts—or even worse, the United States Supreme Court. With this in mind, pharmaceutical companies
should work with their counsel to select at least one strong case to get on an appellate court's docket for 2013. Convincing
one appellate court to adhere to what may now be the minority's interpretation of Comment K could be all it takes to shift
the current tide in product liability law.
Andrew Solow is a Partner at Kaye Scholer LLP. He can be reached at Andrew.firstname.lastname@example.org
Daniel Meyers is an Associate at Kaye Scholer LLP. He can be reached at Daniel.email@example.com