HARRISBURG – A trio of judges from the Superior Court of Pennsylvania have upheld a state court ruling that the makers of Reglan’s generic version properly warned of its use leading to increased risk for conditions such as tardive dyskinesia.
Superior Court judges Anne E. Lazarus, Alice Beck Dubow and Kate Ford Elliott issued the Oct. 19 ruling, with Dubow having authored the Court’s decision in this case putting Jannine and Steve Zitney against more than four dozen pharmaceutical companies.
Wyeth, LLC manufactures the drug Reglan, while Teva and PLIVA manufacture Reglan’s generic equivalent, metoclopramide. In the 1980s, the Food and Drug Administration 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. In June 2005, Teva sought FDA approval to update its metoclopramide label to mirror the Reglan label. On Jan. 17, 2017, the FDA approved Teva’s label update.
“Mrs. Zitney has suffered from debilitating migraine headaches for more than forty years. Between 2004 and 2009, Dr. Karen Tobin, Mrs. Zitney’s neurologist, prescribed metoclopramide to treat the nausea associated with Mrs. Zitney’s migraines,” Dubow said.
“Dr. Tobin instructed Mrs. Zitney to take metoclopramide on an as-needed basis. Mrs. Zitney’s pharmacist dispensed metoclopramide manufactured by PLIVA on four occasions from Oct. 31, 2004, to Dec. 4, 2006. The pharmacist also dispensed metoclopramide manufactured by Teva on four occasions between Dec. 28, 2007, and Nov. 21, 2008.”
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. Vernon Neppe, a neuropsychiatrist, opined that appellant suffers from tardive dyskinesia caused by her metoclopramide use.
In early 2010, the Philadelphia County Court of Common Pleas formed the Reglan/metoclopramide mass tort litigation. On Feb. 28, 2011, appellants commenced this action by filing a 14-count short-form complaint against 50 separate pharmaceutical defendants in that court.
The Zitneys’ claims included: (1) Strict liability failure to warn; (2) Strict liability design defect; (3) Negligence; (4) Negligence per se; (5) Fraud and intentional misrepresentation; (6) Constructive fraud; (7) Breach of implied warranty; (8) Unfair trade practices; (9) Unjust enrichment; (10) Negligent misrepresentation; (11) Civil conspiracy; (12) Loss of consortium; (13) Gross negligence/malice; and (14) Punitive damages.
By January 2019, all defendants other than PLIVA and Teva had settled with appellants or had been dismissed from the case. In June 2019, both PLIVA and Teva filed motions for summary judgment.
After considering the motions filed by the parties, the trial court concluded that Pennsylvania law does 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 that because PLIVA and Teva had undisputedly complied with that mandate, they had not breached their duty to warn appellant by not providing Dr. Tobin with a DHCP letter. Therefore, on Oct. 16, 2019, the trial court entered orders granting PLIVA’s and Teva’s motions for summary judgment and dismissing appellants’ claims against them with prejudice.
The Zitneys then appealed the case to the Superior Court.
Under the learned intermediary doctrine, drug manufacturers must direct required drug safety warnings to physicians, and not to patients – and 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.
Though citing the learned intermediary doctrine’s requirement that pharmaceutical companies direct drug warnings to physicians and not to the general public, Dubow said the Zitneys challenged the trial court’s conclusion that by merely including warning labels containing warnings about metoclopramide’s safety in the drugs’ packaging, the companies had satisfied their legal duty to warn.
However, Dubow noted the Court’s disagreement.
“In explaining its conclusion that appellees were entitled to judgment as a matter of law, the trial court noted as follows: Here, [appellants] do not argue Teva or PLIVA distributed their metoclopramide without the FDA approved label. Similarly, [appellants] conceded the contents of [appellees’] warnings was proper and adequate. Accordingly, since Teva and PLIVA distributed their metoclopramide with labels containing warnings that [appellants] concede are sufficient, [appellees] have fulfilled their duty to warn under Pennsylvania law,” Dubow said.
“We agree with the trial court. Moreover, and contrary to appellants’ claim, Pennsylvania law does not impose on drug manufacturers a duty to send DHCP letters to prescribing physicians like Dr. Tobin. Because Pennsylvania law does not impose upon appellees the heightened duty advocated by appellants, and because appellants conceded that appellees fulfilled their duty to provide content-appropriate warning labels in their metoclopramide packaging, the trial court properly found that appellees had not breached their duty to appellants.”
Therefore, Dubow said the appellees were entitled to judgment as a matter of law and the trial court did not err in entering summary judgment in favor of appellees.
Superior Court of Pennsylvania case 3369 EDA 2019
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com