A sharp-eyed reader (who wishes to remain nameless) yesterday put together our Bruesewitz user’s guide with our post last Tuesday about the Superior Court affirming (and confirming) in the Lance case that strict liability design defect claims don’t don’t lie against the manufacturers of prescription medical products in Pennsylvania.

The reader’s comment was:  “Do you wonder–as i do–how they got to preemption in Bruesewitz when there is no design defect claim under the relevant state law??”

We thought it was a good question, so we thought we’d try to find the answer.  Wyeth hires good lawyers (like us, but not in Bruesewitz) so we didn’t figure it was inadvertent.  We were right.  It turns out that Wyeth did indeed make the argument – based upon the Pennsylvania Supreme Court’s decision in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), that Pennsylvania law did not recognize design defect cases at all.

In an ironic turnaround, the plaintiffs argued that Pennsylvania law refusing to recognize such a cause of action was preempted.  The district court – in a footnote – more or less bought the argument:

Wyeth alternatively argues that Pennsylvania state law does not allow for a finding of strict liability for design defect or manufacturing defects in this case.  Plaintiffs counter that the Vaccine Act preempts any bar to their claim. Pennsylvania has adopted Section 402A of the Restatement (Second) of Torts.  Therefore, Pennsylvania also provides immunity to the manufacturers of prescription drugs pursuant to comment k.  See Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 891 (1996) (“the manufacturer’s negligence, is the only recognized basis of liability.”)  However, not only does the Vaccine Act preempt state law allowing claims arising out of defectively designed vaccines, it also explicitly prohibits states from “establish[ing] or enforc[ing] a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this subtitle.”  42 U.S.C. §300aa-22(e).  The Vaccine Act clearly permits manufacturing defect claims under §22(b)(1), without reference to the theory of liability.  Therefore, strict liability claims for manufacturing defect are not barred by the Vaccine Act.   As such, the preemption provision in §22(e) applies, and Pennsylvania’s bar to strict liability claims for manufacturing defects, enunciated in Hahn, is preempted.  As the Court will grant summary judgment as to Count III based on Vaccine Act preemption and Count IV on the merits, preemption of the Hahn rule does not impact the outcome of this case.

Bruesewitz v. Wyeth, Inc., 508 F. Supp.2d 430, 451 n.15 (E.D. Pa. 2007) (emphasis added, irrelevant citations omitted).

The district court in Bruesewitz bought the plaintiffs’ identical preemption arguments as to manufacturing defects, and avoided any decision on design defects by holding them preempted.

What to make of this?  Well, we’d have to say that, if the plaintiffs were somehow to succeed on their presumption against preemption-based arguments in overturning the preemption of design defect claims under §22(b)(2) of the Vaccine Act, then they’d still lose – because application of the very same (we would say incorrectly applied) presumption would conversely prevent operation of §22(e) to preempt Pennsylvania’s general common-law rule, expressed in Hahn that comment k precludes design defect claims.  The wording of this part of the Vaccine Act strongly suggests that Congress was looking to preempt only statutes aimed at protecting vaccines (there are a number of them) and not common-law principles like comment k (which the Act actually sought to follow) that apply globally to all product liability claims.

Heads, Wyeth wins; tails, plaintiffs still lose.