The Legal Intelligencer reported Tuesday that drug manufacturer Pfizer is seeking reconsideration or en banc review of an August 2 Pennsylvania appeals court ruling (Lance v. Wyeth) which permits a plaintiff to argue that Wyeth (now owned by Pfizer) negligently designed the FDA-approved drug Redux.  The appellate judges’ embrace of a negligent design claim, an issue neither considered by the lower court nor fully briefed by the parties on appeal, is deeply troubling to pharmaceutical companies (and should be equally so for consumers), but cause for celebration among plaintiffs’ lawyers.

The comments of several such attorneys in the Intelligencer story reflect a concerted public relations effort by the plaintiffs’ bar to vilify their business opponents and craft an image for themselves as self-appointed regulators.

One plaintiffs’ attorney remarked that Lance is

probably a good case for the Supreme Court to rethink liability for unsafe drugs. When the drug companies have spent so much time and money marketing their drugs to the consumer on television, in periodicals, on the Internet, I’m not sure the learned intermediary is appropriate in the context of all this mass marketing where you as the patient go to your doctor and say, ‘I want Vioxx. I saw this on TV. Can you prescribe it to me?’

Another (partially paraphrased by the Intelligencer reporter) stated that the negligent design theory is important because

 it would increase the costs of what is continual misbehavior of several drug companies.  The best way to do it is through the justice system.

The first quote creatively juxtaposes the terms “liability” and “unsafe drugs,” leaving the impression that drugs are dangerous and more litigation is needed to make them safer. It then goes on to further demonize drug companies’ (entirely lawful) communications about their products, which in the lawyer’s opinion essentially eliminates the protective “learned intermediary” (your doctor) and leaves you, the consumer, vulnerable.  The other lawyer’s quote follows up these points by emphasizing the “continual misbehavior” of companies and how liability litigation is the “best” way to police it.

This “negligent design” theory would allow lawyers, judges, and juries to step into FDA’s shoes and determine whether a pharmaceutical company’s “design” of its drug was “reasonable” and thus safe.  But is such a subjective standard, interpreted and applied by laypersons and self-interested attorneys, the “best” way to protect consumers?  As the ever-insightful authors of the Drug & Device Law Blog asked about this theory’s application to pharmaceuticals, “How does one change the ‘design’ of a drug?”  They also wondered, “So what’s the ‘standard of care’ that was violated?  We don’t know that either.”  What we do know is that more litigation will generate greater profits for plaintiffs’ lawyers.

We also know, as the second quote above notes, that negligent design suits would impose “costs.”  Negligence lawsuits cannot, however, impose an economic incentive on drug makers to create safer products. If the standard of what is “safe” or “reasonable” is ever-shifting and based on the whims of non-experts, drug companies won’t take the enormous financial risk of developing new treatments, and ultimately, medical consumers will be the ones bearing the costs of novel lawsuits.

Trial lawyers consistently hammer home a mantra that bringing businesses to heel through litigation is always in the public interest.  Defenders of free enterprise can do a better job countering this media-friendly message. On Friday, September 17 at 10:00 a.m. EST, Washington Legal Foundation will be hosting a Web Seminar program where Cato Institute scholar and creator Walter Olson, along with McGuire Woods LLP counsel and Class Action Countermeasures author Andrew J. Trask examine the PR activities of plaintiffs’ lawyers and discuss counter-strategies.  More information will soon be available at