Medication Risks

Medication Risks

Medication Risks

In Zitney v. Wyeth, et al., No. 3369 EDA 2019, 2020 PA Super, 278, the Superior Court addressed Pennsylvania’s “learned intermediary” doctrine and whether it imposed a duty on pharmaceutical companies to provide written notice to doctors concerning a medication’s risks.

Wyeth, LLC, manufactures the drug Reglan. Teva and PLIVA manufacture Reglan’s generic equivalent, metoclopramide. In the 1980s, the Food and Drug Administration (“FDA”) approved Reglan and metoclopramide for the treatment of chronic digestive disorders. Physicians also used metoclopramide “off-label” to treat nausea associated with a range of illnesses, including migraines. Since the 1980s, Reglan’s label contained a warning that its use was associated with an increased risk of tardive dyskinesia, a neurological disorder characterized by involuntary movements of the face and jaw. In July 2004, Wyeth updated the Reglan label to include language indicating that metoclopramide should not be used for longer than 12 weeks. Sometime later, both Teva and PLIVA updated their warnings consistent with Wyeth’s label.

Mrs. Zitney suffered from migraine headaches for over 40 years. Between 2004 and 2009, Dr. Tobin, Mrs. Zitney’s neurologist, prescribed metoclopramide to treat the nausea associated with Mrs. Zitney’s migraines. Dr. Tobin instructed Mrs. Zitney to take metoclopramide on an as-needed basis. During that period of time, Mrs. Zitney’s pharmacist dispensed metoclopramide manufactured by PLIVA on four occasions and also dispensed metoclopramide manufactured by Teva on four occasions. In December 2009, Mrs. Zitney complained of an eye twitch to Dr. Tobin. Additionally, on multiple occasions starting in 2009, Mrs. Zitney complained of muscle spasms in her back and neck. Dr. Neppe, a neuropsychiatrist, opined Mrs. Zitney suffered from tardive dyskinesia caused by her metoclopramide use.

Mrs. Zitney sued PLIVA and Teva, among other pharmaceutical companies, which set forth claims for: strict liability failure to warn; strict liability design defect; fraud and intentional misrepresentation; constructive fraud; breach of implied warranty; unfair trade practices, negligent misrepresentation, and negligence. After discovery concluded, Mrs. Zitney filed a Motion for Partial Summary Judgment asserting she was entitled to judgment as a matter of law against Teva on her failure to warn claim. More specifically, Mrs. Zitney argued Teva was negligent because it failed to inform Dr. Tobin about the July 2004 updates to the Reglan label and the corresponding updates to its metoclopramide label through a “Dear Health Care Provider” (“DHCP”) letter. Stated differently, Mrs. Zitney based her failure to warn claim on the manner in which Teva notified Dr. Tobin of the warnings, not on the warnings themselves. Teva and PLIVA filed a Motions for Summary Judgment in which it argued they were entitled to judgment as a matter of law on all of Mrs. Zitney’s claims.

After considering the Motions filed by the parties, the trial court concluded that Pennsylvania law did not impose a duty on drug manufacturers to convey safety warnings in any manner other than by including them in a product’s package insert shipped with the product. Consequently, it found because PLIVA and Teva had undisputedly complied with that mandate, they had not breached their duty to warn Mrs. Zitney by not providing Dr. Tobin with a DHCP letter. Therefore, the trial court entered Orders granting PLIVA’s and Teva’s Motions for Summary Judgment and dismissing Appellants’ claims against them with prejudice.

According to Pennsylvania law, “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.” Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996). With respect to negligence, a plaintiff in a products liability case must show that: (1) the product was defective; (2) the defect caused the plaintiff’s injury; and (3) the defect existed at the time the product left the manufacturer. Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1153-54 (Pa. Super. 1996). “A product may be deemed defective if it lacks adequate warnings or instructions necessary for safe use of the product.” Id. at 1154. However, a pharmaceutical product, when “accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.” Id. (citing Restatement (Second) of Torts, § 402A, Comment k).

Moreover, “Pennsylvania applies the learned intermediary doctrine to claims for failure to warn involving pharmaceutical drugs.” Simon v. Wyeth Pharmaceuticals, Inc., 989 A.2d 356, 368 (Pa. Super. 2009). Under the learned intermediary doctrine, drug manufacturers must direct required drug safety warnings to physicians, and not to patients. Id. See also Dion v. Graduate Hosp. of Univ. of. Penna. 520 A.2d 876, 879 (Pa. Super. 1987) (noting that “where the drug is available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor.”) “Thus, in an action against a drug manufacturer based upon inadequate warnings, the issue to be determined is whether the warning, if any, that was given to the prescribing physicians was proper and adequate.” Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909, 924 (Pa. Super. 2011).

Here, Teva and PLIVA distributed their metoclopramide with the FDA approved label. Moreover, Mrs. Zitney conceded the contents of Teva’s and PLIVA’s warnings were proper and adequate. Accordingly, since Teva and PLIVA distributed their metoclopramide with labels containing warnings Mrs. Zitney conceded was sufficient, the Superior Court determined Teva and PLIVA fulfilled their duty to warn under Pennsylvania law. Furthermore, the Superior Court held Pennsylvania law does not impose on drug manufacturers a duty to send DHCP letters to prescribing physicians.