In Lance v. Wyeth the plaintiff alleged, among other things, that defendant had somehow negligently designed the molecule dexfenfluramine and that such negligent design was the proximate cause of her daughter's death. The defendant however prevailed on its motion for summary judgment having demonstrated to the trial court that plaintiff did not have any cognizable product liability claims under Pennsylvania product liability law as it applies to prescription drug cases. On appeal the trial court's rulings were affirmed one by one until the appellate court came to the negligent design claim.
The court held "that notwithstanding comment k in section 402A Restatement (Second) of Torts, this claim is actionable under Pennsylvania law." Noting that "a strict liability design defect claim is distinct from a negligence design defect claim" the court examined section 395 (negligent design of products) and found no exemption for unavoidably unsafe products like the one for things like pharmaceuticals found in comment k of 402A. Accordingly, the appellate court determined that "Appellant's negligent design claim is not precluded by comment k, and is a valid cause of action upon which relief may be granted. The trial court thus erred in entering summary judgment in favor of Wyeth on Appellant's negligent design defect claim."
In arriving at its conclusion the court relied on just three cases. For the proposition that plaintiff can lose on a strict liability design defect claim yet prevail on a negligent design defect claim the court cites Phillips v. Cricket Lighters. In that case though the court held that on the strict liability side the question went to whether the lighter was safe for the intended user, in that case an adult, whereas on the negligence side the question was whether the lighter's lack of a safety feature was a design defect given the fact that an unintended but foreseeable user, a child, started the fatal fire. In Lance, of course, the person for whom the drug was intended and its user were one and the same so I don't see the point.
For the proposition that their reasoning applies to pharmaceuticals the court pointed to Toner v. Lederle Labs. In Toner though the question wasn't whether a molecule like dexfenfluramine was defectively designed; the question was whether making a vaccine out of a whole library of bacterial molecules, most, necessarily, of unknown nature and function could have been done more safely by using just a few bits of B. pertussis rather than the whole cell. Ok, but that's mixing apples and sangria.
Finally, for further support for the proposition that you can lose a strict liability design defect claim and yet win on a negligent design defect claim for the same product the court points to Artiglio v. Superior Court. Artiglio was a petition for writ action seeking a reversal of a summary judgment in favor of defendant on plaintiff's strict liability claim in a breast implant case. Plaintiff's petition for writ was denied; the appellate court finding that "the entire category of medical implants available only by resort to the services of a physician are immune from design defect strict liability." The problem with Artiglio and of the case to which it points, Brown v. Superior Court, is that they appear to stand for the proposition that in a prescription drug case there's really no such thing, at least under California law as strict liability defective design case - not that it's somehow different and so equally actionable.
Putting all that aside for the moment, what would it mean to defectively design the small organic molecule that is the essence of any modern medicine?
Surely it doesn't mean that the molecule ought to have been made up of different atoms. If that were the case then it necessarily wouldn't have been the same drug - we're not talking alternate design; we're talking alternate universe. Even in Beaumont twenty years ago the judges tossed out plaintiffs' claim that benzene ought to have been designed with all of its useful properties but with a methyl group in place of one of its hydrogens.
Maybe the claim could have to do with how the atoms are arranged in the molecule. It's true that some organic molecules can be made in two forms akin to our right and left hands and that each form may have different biological properties. Thus if say, to use a trivial example, D-glucose (right handed) was safe and effective and L-glucose (left handed) was unsafe though effective you might have something to talk about if you'd taken the L- variety. Such a circumstance is mainly hypothetical and the typical finding is that one form is ineffective so that it's never consciously made in the first place leaving at best a manufacturing defect claim, if anything.
Perhaps the claim goes to the design process itself. Drug design has gone from trial-and-error to a find it and bind it approach to mindbogglingly complex efforts involving huge numbers of simulations run on supercomputers. But if something's wrong with the approach then the complaint, again, is not with the product consumed but with the failure to discover a different and better product. Something akin to a loss of chance claim perhaps. Surely the courts won't impose a duty of scientific discovery on companies. If they do they could at least solve the problem of induction first.
All in all it's hard to see how this new negligent design defect claim changes things. Really, what can it possibly mean to say that someone defectively designed something she didn't design, or to say that she defectively designed one thing because she didn't design it like something completely different? Can a car be found defectively designed because it's not an airplane? I hope not.
