Photo of Michelle Yeary
            It’s a beautiful day in the Philadelphia area.  The humidity is down, the sun is out, the breeze is delightful.  If we were morning radio jocks, we’d be telling you to drop your briefcases and laptops and pick up your Frisbees, suntan lotion and beach chairs and head for the nearest park, lake or beach.  And so we hope that at least some of you are reading this on a portable device from one of those locations (or even reading it tomorrow when the heat gets dialed back up to sauna-like levels).   On a day like this, we don’t need much more to make us smile. And that’s why we are choosing to view the case of Doughtery v. C.R. Bard, Inc., 2012 U.S. Dist. LEXIS 100374 (E.D Pa. Jul. 18, 2012) as the glass half-full.  Actually, it is probably more like three-quarters full.  So, on this atypically pleasant day in July in the Mid-Atlantic, we envision enjoying an almost full glass of our favorite ice-cold summertime beverage (we’re envisioning an Arnold Palmer since we’re writing this before noon, but the choice is yours).
            The reason Doughtery, is an “almost” for us, is that, like so many cases that look at Pennsylvania medical device/prescription drug product liability law, it strips plaintiff of “almost” all of her claims.  For instance, we don’t think any of our readers would be surprised to learn that plaintiff will be permitted to plead a negligent failure to warn claim.  In fact, this is often the only claim left standing at the motion to dismiss stage under Pennsylvania law.  See post on Kee v. Zimmer, Inc., 2012 U.S. Dist. LEXIS 68862 (E.D. Pa. May 17, 2012).  We say permitted because plaintiff is being given a chance to amend her complaint to see if she can plead facts sufficient to withstand TwIqbal scrutiny.  Doughtery, 2012 U.S. Dist. LEXIS 100374 at *5.  Plaintiff actually included a proposed second amended complaint with her response to the motion to dismiss, but because it still included several claims that the court was dismissing with prejudice, plaintiff was sent back to the drawing board. 
            Nor do we think it comes as any surprise that plaintiff’s breach of implied warranty for fitness for a particular purpose claim and claim under Pennsylvania’s Unfair Trade Practices and Consumer Protection Law were dismissed with prejudice.  Id. at *4, 31-33.  But where this case doesn’t quite reach the point of overflowing our cup is in its discussion of strict liability.  We’ve reported on numerous cases – too many to count – that hold that Pennsylvania’s across-the-board application of Restatement §401A, comment k to drugs and medical devices bars strict liability claims.  See here , here , here, and here.  In fact, some of the cases discussed in these posts are cited in Doughtery recognizing that many courts have read Pennsylvania law “broadly to preclude all strict liability claims.”  Id. at *14.  What Doughtery, however, further recognizes is that that those courts didn’t specifically address a strict liability manufacturing defect claim and therefore weren’t controlling on that issue.  Id.   To our dismay, the court also cited to Schiff v. Hurwitz, 2012 WL 1828035 (E.D. Pa. May 18, 2012) to support the argument that Pennsylvania law recognizes strict liability in drug and device cases for something “more than a failure to warn.”  Doughtery, at *14.  We’ve made our feelings about Schiff well known here.  
            To be honest, we’ve contemplated that strict liability manufacturing defect was a door left open in Pennsylvania.  It is just so rarely pursued by plaintiffs, that it is a really tiny door.  Picture Alice standing before the 15 inch door to Wonderland and pondering how she was going to get through.  Except plaintiff’s don’t often get a magic vial that says “Drink Me” that grants them easy access to a manufacturing defect claim.  Hence, when strict liability failure to warn and design defect claims are tossed out in Pennsylvania, that usually does away with strict liability in its entirety.  Plaintiff Doughtery having expressed the desire to attempt to squeeze through that little door, the court decided Pennsylvania law permitted that opportunity.  The court’s reasoning was twofold:  (1) nothing in the lead Pennsylvania cases “unambiguously precludes all strict-liability claims against a [drug/device] manufacturer, id. at *16-17 (see discussion of cases in footnote 9); and (2) “the fact that the Pennsylvania Supreme Court decided to apply a negligence standard to failure-to-warn claims does not necessarily mean that the court would similarly adopt a negligence standard for manufacturing-defect claims.” Id. at *20.  As to point two, the court noted that the concern behind applying strict liability to drugs/medical devices in the context of failure to warn and design defect is that

if a manufacturer could not count on limiting its liability to risks that were known or knowable at the time of manufacture or distribution, it would be discouraged from developing new and improved products for fear that later significant advances in scientific knowledge would increase its liability.

Id. at *21 (citation and quotation marks omitted).   The court then reasoned that that concern is not an issue for alleged manufacturing defects.  Id. at *23 (strict liability creates proper incentives for manufacturers to adhere to good quality control practices). 
Having decided that Pennsylvania law does not bar a strict liability manufacturing defect claim, the court’s ruling on breach of implied warranty of merchantability should come as no surprise.  The Doughtery court, like many others, took the position that “the 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.”  Id. at *29 (citation and quotation marks omitted).  As such, “comment k precludes implied-warranty claims against manufacturers of prescription drugs and devices to the same extent that it precludes strict-liability claims against such manufacturers.”  Id. at *28-29.  If strict liability manufacturing defect claims survive, so too do implied warranty claims based on manufacturing defects – or so says DoughteryId. at *30. 
What’s left?  Negligence, strict liability manufacturing defect, breach of implied warranty of merchantability but only to the extent based on a manufacturing defect, and breach of express warranty.  And we have a plaintiff who has submitted at least three complaints to the court and hasn’t gotten it right yet.   So, to return to where we started, enjoying a sunny day on the East Coast, we leave you with the court’s words of caution to plaintiff and her counsel:

I caution Doughtery that she must allege sufficient facts to support an inference that an express warranty was created, including the specific source of the alleged warranty (e.g., a publication or package insert) and the specific statements made, something that she has not done in either her first amended complaint or her proposed second amended complaint.

Id. at *37, n.15.  And:

The infirmities in Doughtery’s first two complaints were due, at least in part, to her counsel’s apparent unfamiliarity with the applicable law. I caution Doughtery and her counsel to carefully review the relevant law before drafting and filing her second amended complaint. I am unlikely to allow a third amended complaint should her second amended complaint fail to plead adequate factual allegations or legally proper claims for relief.

Id. at *38.  We like to think of these as the prologue to Doughtery part II — at which point our cup could well be filled to the brim.