Photo of Michelle Yeary

Normally we embrace cases that find that plaintiff has failed to meet the pleading requirements of Twombly  and Iqbal.  We like when courts ferret out the claims that can’t even get out of the starting gate.  And while there is a little bit of that to celebrate in Bergstresser v. Bristol-Myers Squibb Company, 2013 U.S. Dist. LEXIS 58482 (M.D. Pa. Apr. 24, 2013), we are more concerned with what it gets wrong (in our opinion).

Bergstresser involves the prescription drug Abilify which plaintiff alleges caused him to develop a movement disorder.  Id. at *4-5.  Plaintiff alleges three causes of action against the drug’s manufacturer:  negligence, strict liability and breach of implied warranty.  Let’s start, as the court did, with strict liability. Anyone who is even a causal reader of this blog is probably familiar with Hahn v. Richter, 673 A.2d 888 (Pa. 1996) in which the Pennsylvania Supreme Court rejected strict liability failure to warn claims against prescription drug manufacturers, determining that such claims sound only in negligence in Pennsylvania.  There is a healthy body of case law (we’ve discussed many examples, i.e. here , here , here, and here) that extends the reasoning of Hahn to prohibit all strict liability claims in prescription drug cases.  But, Bergstresser, relying on Doughtery v. C.R. Bard, Inc., 2012 U.S. Dist. LEXIS 100374 (E.D. Pa. Jul. 18, 2012) (see post) which in turn relies on Lance v. Wyeth, 4 A.3d 160, 165 (Pa. Super. 2010), appeal pending, holds differently.  This is where the muddling begins.

Because Lance specifically rejected strict liability for design defect claims and reiterated that failure to warn claims sound only in negligence, the Doughtery court interpreted its silence on manufacturing defect claims to mean that such claims could still sound in strict liability.  Doughtery, 2012 U.S. Dist. LEXIS 100374 at *15-16.  Doughtery pauses slightly to acknowledge that Lance didn’t actually involve a manufacturing defect claim and hence the court had no reason to address it.  Id. at n.8.  But nonetheless Doughtery finds strict liability manufacturing defects claim viable in Pennsylvania.

Bergstresser follows in Doughtery’s footsteps – dismissing plaintiff’s strict liability failure to warn and design defect claims, but finding a claim for strict liability manufacturing defect.  Id. at *8-9.   Now, the truth is that manufacturing defect claims in prescription drug cases are exceedingly rare because they require plaintiff to demonstrate that the particular drug that they took somehow deviated from the manufacturer’s specifications (although slightly more common in device cases, they still aren’t the meat of plaintiffs’ claims).  So, the lingering manufacturing defect claim hasn’t revved our engines like some other topics.  But, the muddling continues because both Bergstresser and Doughtery use the strict liability manufacturing claim to revive breach of implied warranty claims in prescription drug cases in Pennsylvania.  We say revive because several courts to have considered the issue have found that Pennsylvania doesn’t recognize breach of implied warranty in prescription drug cases based on Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374 (Pa. Super. Ct. 1987):

[D]rugs are not available to the general public but may be obtained only upon the prescription of a licensed physician. This restriction upon the availability of such drugs has been imposed because of the inherently dangerous properties of such drugs. . . . Thus, we find that the very nature of prescription drugs themselves precludes the imposition of a warranty of fitness for “ordinary purposes”, as each individual for whom they are prescribed is a unique organism who must be examined by a physician who is aware of the nature of the patient’s condition as well as the medical history of the patient.

Id. at 376-77 (rejecting applicability of implied warranty of merchantability) (emphasis added).

Much like Bergstresser and Doughtery don’t read Hahn as an across-the-board rejection of strict liability, they don’t read Makripodis as an across-the-board rejection of breach of implied warranty.  In fact, the latter is because of the former:>

[T]he theories of  strict liability and breach of the implied warranty of merchantability are parallel theories of recovery, one in contract and the other in tort.  As such, any claim by the plaintiff under a theory of breach of the implied warranty of merchantability or breach of the implied warranty of fitness for a particular purpose would be barred under Pennsylvania law to the extent that they are based on a design defect or failure to warn, but would be allowed if based on a manufacturing defect.

Bergstresser, at *10-11.  But, with that Bergstresser muddles things even more than Doughtery did.  Doughtery only permitted a claim for breach of implied warranty of merchantability.  As to implied warranty of fitness for a particular purpose, Doughtery found it was not viable under Pennsylvania law:

But where, as here, a product is considered “unavoidably unsafe,” it would be inconsistent with the policy underlying comment k to find an implied promise by the manufacturer that the product is suitable for a particular purpose and to subject the manufacturer to strict liability for a personal injury resulting from a breach of that implied promise. The same policy considerations that except manufacturers of prescription drugs and devices from strict liability for design and warning defects apply here as well and counsel against imposing liability under an implied-warranty theory.

Doughtery, 2012 U.S. Dist. LEXIS 100374 at *33.  Now we would argue that similar reasoning should hold for breach implied warranty of merchantability, but at least Doughtery got one out of two.  We are hopeful that the Bergstresser court simply conflated the two types of warranties because plaintiff’s complaint was devoid of any facts to support either claim.  Bergstresser,  2013 U.S. Dist. LEXIS 58482 at *11-12.   Plaintiff is being given an opportunity to cure this and other pleading deficiencies as to her surviving claims.  Maybe a tad more substance will help the court see that even with strict adherence to the reasoning of its sister court in Doughtery, plaintiff’s implied warranty of fitness for a particular purpose claim is not sustainable.

With all of that muddling, we did find a positive in Bergstresser.  Based on the briefing, the court assumed plaintiff’s only negligence claim was for failure to warn.  As to this claim, the court found plaintiff’s allegations wanting.  Specifically, TwIqbal requires plaintiff to the actual warning deficiency and specific causation:

The plaintiff does not address the warnings provided on the Abilify label, nor does he point to any deficiencies in the labeling. Further, the plaintiff fails to indicate what warning should have been given or that any alternative warning would have prevented his physician from prescribing him Abilify.

Bergstresser, 2013 U.S. Dist. LEXIS 58482 at *16.  A small silver lining, but we’ll take what we can get.  We’ll also take that plaintiff has to bring his complaint up to federal pleading standards to survive.  The legal analysis may be muddled, but at least the facts have to be clear.