Photo of Michelle Yeary
            The Sixers lost Game 5 to the Celtics last night while the Nationals beat the Phillies 2-1.  The Flyers have been eliminated, and it’s not football season yet.  Philadelphians can’t even look to soccer right now: the Union have only won 2 games this season.  So, we thought a good decision from the Eastern District of Pennsylvania might just lift all our Philly fans’ moods.  It’s not ground-breaking or earth-shattering – but it is another solid win in a prescription medical device case and a win is a win, so here you go.
            Even the facts are fairly routine.  Plaintiff undergoes knee replacement surgery.  A few years later, she experiences pain and is told one of the implants has loosened.  She has revision surgery and then sues the manufacturer of the artificial knee.  Kee v. Zimmer, Inc., 2012 U.S. Dist. LEXIS 68862 (E.D. Pa. May 17, 2012).  Plaintiff asserted all the standard product liability claims:  strict liability design defect and failure to warn; violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”) and fraud; breach of implied warranties; breach of express warranty; negligence; and punitive damages.  Id. at *2-3.  Defendant moved to dismiss all but the negligence claim and ultimately, that’s all that survived.
            The opinion reads like a checklist of Pennsylvania claims that cannot be brought and/or how not to plead them:

ü  As a matter of Pennsylvania law, strict liability and breach of implied warranty claims are barred against manufacturers of prescription medical devices. 

Is this really still open for debate?  The Pennsylvania Supreme Court adopted this hard line rule for prescription drugs in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), sixteen years ago.  And the Pennsylvania Superior Court extended it to prescription medical devices six years ago.  See Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006).  The reasoning of these courts also has been extended to implied warranty claims.  See Kee, 2012 U.S. Dist. LEXIS 68862 at *7-8, n.3.  So, why do Pennsylvania plaintiffs continue to file these claims?  Well, this plaintiff argued the Hahn line was actually quite soft.  Plaintiff claimed Hahn did not impose a “blanket exemption on medical device manufacturers” but rather required a “case-by-case, product-by-product analysis.”  Kee at *9.  But the court was quick to point out that plaintiff had no authority whatsoever for her interpretation of Pennsylvania law, which was at odds with the overwhelming majority of courts to consider the issue.  Id.   No strict liability and no implied warranty.  Check.

ü  For breach of warranty of claims, plaintiff is a buyer and must plead notice.

In order to maintain a breach of warranty claim, Pennsylvania law requires the buyer “within a reasonable time after he discovers or should have discovered any breach [to] notify the seller of the breach or be barred from any remedy.”  13 Pa. Cons. Stat. Ann. §2607(c)(1).  Plaintiff bears the burden of proving compliance with the statute.  Since plaintiff here failed to plead notice, she tried to get around the requirement by arguing that she was not a buyer, but rather a “third-party beneficiary of the relationship which existed between the plaintiff’s treating orthopedic surgeon . . . and the defendant enjoying standing to advance the instant theory of recovery.”  Kee at *12.  Wrong again.  The third-party payer case plaintiff attempted to rely on, in fact, held that third-party payers are buyers under the UCC.  Id.  No express warranty.  Check.

ü  Consumer fraud claims are barred by the learned intermediary doctrine.

We are going to give it to you straight from the decision – we don’t think we could sum it up any better:

     Under Pennsylvania law, a consumer does not have a cause of action under the UTPCPL against the manufacturer of prescription drugs because prescription drug manufacturers do not have a duty to disclose information directly to consumers. Permitting a cause of action under UTPCPL would result in effectively making prescription drug manufacturers absolute guarantors of any anticipated effects of the drug.  This is so because a claim under the UTPCPL requires proof of causation and reliance, and the learned intermediary doctrine breaks the chain in terms of reliance, [because] the patient cannot obtain prescription drugs without the physician no matter what [the patient] believe[s] about them. In other words, a private right of action under the UTPCPL requires proof of justifiable reliance and causation, and such requirements cannot be present when the defendant is a pharmaceutical company that did not sell its product directly to the patient.  The same reasoning extends to manufacturers of prescription medical devices.

Id. at *13-14 (citations and quotation marks omitted).  No consumer fraud violation.  Check.

ü  Fraud and UTPCPL claims must be pled with particularity.

As if the learned intermediary doctrine wasn’t enough to get rid of the fraud claims, plaintiff also failed to meet the requisite standard of particularity under Rule 9(b).  Plaintiff’s claims of fraud were vague and general at best:   defendant knew of “risks” and “complications” that they failed to disclose; defendant misled customers by failing to notify them of an increased risk; defendant failed to disclose that the product did not perform safely.  Id. at *17-18.  The court found these allegations lacking:

     Plaintiff fails to allege facts supporting the nature of her reliance or specific representations Defendant made relating to the reliance. Plaintiff fails to allege facts indicating the date, time, and place of the alleged fraud, or, alternatively, inject any precision or measure of substantiation into her fraud allegations that would place the defendant on notice of the precise misconduct with which it is charged.

Id. at *18.  No fraud.  Check.

ü  No outrageous conduct equals no punitive damages.

This one is also very straightforward.  Plaintiff alleged she was injured from the malfunction of a prescription medical device.  That’s it.  She “failed to muster any facts indicating that Defendant acted with reckless indifference to Plaintiff’s rights.”  Id. at *19-20.  No allegations of intentional, willful, wanton or reckless conduct; no punitive damages.  Check.
So, under Pennsylvania law, plaintiff’s case was stripped of all but her negligence claim, which is all she should have pled from the beginning.  So, if Philadelphia’s sports scene doesn’t improve, maybe we can take our foam fingers and rally caps to the courthouse where, at least for today, we have something to cheer about.
 

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn More About This Book