Product News and Recalls

Why Lance decision is not novel nor judicial over-reach

If you practice in mass torts or the area of dangerous drugs, you’ve probably heard about the recent Pennsylvania Supreme Court decision Lance v. Wyeth. The decision has generated a lot of commentary from lawyers, and even some popular media attention, but the decision is not as novel or far-reaching as some have claimed.

The reason we make this claim stems from the factual premise relied on by the Court, and concessions made by the Defendant. Before we dive into why, we provide some background. The case centered on allegations that a woman took Redux, which was marketed in the United States for weight-loss, in 1996 and 1997. It was withdrawn from the market in September 1997 because it appeared to cause pulmonary hypertension and the FDA determined that it was not safe for use.

Indeed, the plaintiff developed pulmonary hypertension and died, and her survivors brought suit, arguing that the Defendant should never have sold Redux because it was unsafe for anyone to use, despite the FDA approval.

The Defendant then argued, essentially, that the case should be thrown out because it warned doctors and patients that Redux could cause pulmonary hypertension. While the Defendant could be sued for inadequate warnings, it argued that it could not be sued for selling a drug that was unsafe.

And it is that last argument (which, to be fair, the Defendant did not say in so many words) that is the factual premise underlying the decision: Because of the timing of when the Defendant asked the court to dismiss the lawsuit, the Pennsylvania Supreme Court assumed, for purposes of argument, that 1) Redux was not safe for anyone, 2) the company knew this, or should have known it, and 3) it did not inform the FDA of this fact (at least not right away).

When this premise is combined with the concession made by the Defendant, we can see why the decision is not as novel as it might appear. The Defendant conceded that Pennsylvania law allows it to be held liable if it is negligent in warning about known risks.

What the case, then, boils down to, is one where we assume that the Defendant knew that Redux was not safe for anyone, and didn’t tell the FDA (or anyone else) that fact, until Redux was withdrawn from the market in September, 1997. This sounds a lot like a failure to warn, which the Defendant conceded it would be liable for, if proven.

The question in a failure to warn case is always whether the warning would have made a difference. In other words, since every drug involves a risk/benefit analysis, would it change a doctor’s prescribing habits? For example, if doctors were told that Tylenol caused liver failure, would they still prescribe it? It probably depends on the risk and the patient’s health. If the risk for a healthy adult is 1 out of 1 million, then the doctor and patient would probably accept the risk relative to the benefits. But someone with liver failure would probably avoid Tylenol because the risk is higher in that case, and there are safer alternatives (albeit with different risks and benefits). Similarly, doctors and patients are generally willing to accept higher risk of severe side-effects for HIV and cancer treatments when treatment is likely to delay premature death.

As with any drug, the issues in the Lance case can be viewed through this risk/benefit balancing and a failure-to-warn analysis. Under this view, the lawsuit should not be dismissed: If doctors were told that the Redux was not safe (remember, this is the factual premise), would doctors prescribe the drug? Probably not: the risk/benefit analysis has already been calculated, and the risks outweigh the benefits, but doctors were not told this. Doctors and patients are entitled to all relevant information to determine the risks and benefits of a drug, and the Defendant’s failure to provide the information in this case amounts to a failure to warn.

This brings us back to the Defendant’s concession: It agreed that Pennsylvania law allows it to be held liable for failure to warn. Why the Plaintiff didn’t press this argument is unknown, but perhaps it is not surprising that Pennsylvania Supreme Court refused to throw out the case, given that the defendant did exactly what it agreed could cause liability: fail to warn about a known, serious risk.