Drug Decision Discusses Learned Intermediary Doctrine and Failure to Warn Claims

On July 28, 2014, Judge Mark R. Hornak of the Western District of Pennsylvania granted Novartis partial summary judgment on product liability claims for Zometa in Rowland v. Novartis Pharmaceuticals Corp., 12-cv-1474.  These plaintiffs brought claims in strict liability, negligence and breach of warranty arising out of their use of Zometa, a prescription bisphosphonate medication for metastatic bone cancer. The plaintiffs claimed that the use of Zometa caused osteonecrosis of the jaw bone. Novartis moved for summary judgment arguing that the plaintiffs’ claims were not viable under Pennsylvania law.

The FDA approved Zometa treatment for metastatic bone cancer in February 2002, and Novartis received the first adverse event for osteonecrosis in December of 2002. In September 2003, the first published case report linked osteonecrosis to Zometa.  From September of 2003 to May of 2005, Novartis made several labeling changes as to osteonecrosis. The first “adverse events” change included language advising that cases of osteonecrosis had been reported but had other well documented risk factors.  The label was amended several times, and by 2005 the label stated that osteonecrosis has been reported in patients with cancer receiving bisphosphonates and that preventative dentistry should be completed prior to starting the prescription. The label warned against invasive dental procedures while taking the medication.  In May 2005, “Dear Doctor” letters were sent to dentists with the same information.

The court granted summary judgment on the strict liability claims in keeping with the  Pennsylvania Supreme Court’s rulings in Hahn v. Richter and Lance v. Wyeth, which adopted the Restatement (Second) of Torts §402A that precludes strict liability claims against prescription drug manufacturers.  The court observed that all non-negligence based product liability claims as to a pharmaceutical product are barred under Pennsylvania law. Thus, claims of strict warranty for design defect, manufacturing defect, failure to warn and breach of warranty were dismissed.

In reaching its conclusions on the strict liability claims, the court declined to adopt the Doughtery court’s finding that Restatement (Second) of Torts §402A cmt. k does not preclude the express warranty claims on prescription drugs. The Doughtery court had ruled that §402A should only apply to warranties implied by law, not a breach of express warranty claim which was akin to a breach of contract claim. The court found Doughtery’s conclusions to be dicta and further distinguished its findings by pointing out that Doughtery was a medical device case, not a prescription drug case such as the one at hand.

The court then turned its analysis to plaintiff’s product claims focused on a claimed failure to warn and analyzed Hahn’s holding that: “where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability.” Pennsylvania law uses the learned intermediary doctrine which requires the manufacturer to provide appropriate information to the prescribing physician.  Plaintiffs argued that the doctrine also requires warning other treating (but non-prescribing) doctors such as dentists. The plaintiffs based their argument on the Restatement (Third) of Torts.  The Pennsylvania Supreme Court has not yet decided this issue so this court “predicted” how that court would rule. Because Pennsylvania’s learned intermediary law runs only to the prescribing doctor, the court did not extend the duty to warn to non-prescribing doctors.

Novartis also sought summary judgment on the grounds that the warnings were adequate as a matter of law. Adequacy is assessed by looking at what the manufacturer knew, or should have known, and whether the labeling warned of that risk.  As the court felt that adequacy of a warning is generally a jury question, it declined to grant summary judgment to Novartis.  The court also applied the law of the case doctrine because the MDL court had previously denied summary judgment.

Summary judgment was also sought based on the absence of proximate cause with Novartis arguing that the prescribers would have prescribed the drug anyway. Under Pennsylvania law, the plaintiff must prove that a different warning would have prevented the prescription. As this is a fact intensive inquiry, the court analyzed each of the three plaintiffs separately granting summary judgment in one case but not the other two.

Rowland’s import is several fold. It recognizes that there is not a consensus amongst the Pennsylvania federal courts with respect to whether or not breach of implied warranty and/or express warranty claims are precluded against prescription drug manufacturers.  While there is only one dissenting opinion, Doughtery, the lack of a consensus leaves this issue ripe for a decision by the Third Circuit. The Doughtery opinion also gives plaintiffs a platform upon which to continue to seek damages for these types of claims. This issue has not been conclusively decided and pharmaceutical manufacturers will have to continue defend against and argue for summary judgment on breach of express and implied warranty claims in Pennsylvania.

The court permitted the learned intermediary defense to be asserted where the prescriber testified that even though he would have prescribed the drug anyway, if he had more information about the risks, he would have advised the patient. The plaintiff testified that had these facts been presented, she would not have taken the drug. This tactic presents an opportunity for plaintiff to avoid the learned intermediary doctrine.

The reluctance of the court to revisit the MDL court’s denial of summary judgment as to the adequacy of the warning is not unexpected and highlights the critical importance of such motions before the MDL court.

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