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Sherman v. Pfizer, Inc.

Court of Appeals of Washington, Division 2

April 30, 2019

DIANA SHERMAN and MARK SHERMAN, Respondents,
v.
PFIZER, INC., WYETH LLC (formerly known as WYETH, INC); WYETH HOLDINGS CORPORATION; WYETH PHARMACEUTICALS INC., SCHWARZ PHARMA, INC.; UCB, INC; ALAVEN PHARMACEUTICAL LLC, QUALITEST PHARMACEUTICALS, INC., GENERICS BIDCO I, LLC, RANBAXY PHARMACEUTICALS, INC.; GASTROENTEROLOGY ASSOCIATES, PLLC., GRACE KIM, RPh, ROBERTA MATTHEWS, RPh, RITE AID CORPORATION, Defendants, BRUCE A. SILVERMAN, M.D., Respondent, TEVA PHARMACEUTICALS, INC., PLIVA, INC., BARR LABORATORIES, INC., Appellants.

          MAXA, C.J.

         PLIVA, Inc., Teva Pharmaceuticals USA, Inc., and Barr Laboratories, Inc. (collectively Generic Defendants) appeal the trial court's denial of their summary judgment motion in a products liability lawsuit filed by Diana Sherman.

         The Generic Defendants are manufacturers of metoclopramide, the generic version of the prescription drug Reglan. Sherman developed a movement disorder called tardive dyskinesia after taking metoclopramide for six years as prescribed by Dr. Bruce Silverman. She filed a lawsuit against the Generic Defendants, alleging that they had violated the Washington Product Liability Act (WPLA), chapter 7.72 RCW, by failing to provide adequate warnings about the risk of developing tardive dyskinesia associated with using metoclopramide.

         Sherman's duty to warn claim against the Generic Defendants derives from federally approved changes to the Reglan label, also known as the "package insert," that in 2004 and 2009 strengthened the warnings about using metoclopramide. Sherman claims that the Generic Defendants violated their duty to warn in two ways. First, they failed to update their package inserts for generic metoclopramide to reflect the strengthened warnings on the revised Reglan labels. Second, they failed to communicate the strengthened warnings to Dr. Silverman and the physician community in general in other ways besides in their package inserts.

         We hold that the trial court erred in denying the Generic Defendants' summary judgment motion regarding (1) Sherman's "failure to update" claim because Dr. Silverman's testimony that he did not read any package inserts precluded any genuine issue of fact as to whether the Generic Defendants' failure to update their metoclopramide warnings proximately caused her tardive dyskinesia; and (2) Sherman's "failure to communicate" claim because, under the facts of this case, the Generic Defendants had no duty under the WPLA to communicate warnings by means other than the package insert.[1]

         Accordingly, we reverse the trial court's order denying the Generic Defendants' summary judgment motion and remand for the trial court to dismiss Sherman's claims against the Generic Defendants.

         FACTS

         Prescription for Metoclopramide

         Metoclopramide is a prescription medication that is used for the treatment of gastroesophageal reflux. A known risk of using metoclopramide includes the development of tardive dyskinesia, a neurological disorder characterized by abnormal involuntary movements.

         Sherman first saw Dr. Silverman in 2003 for severe digestive issues. After other treatments failed to relieve Sherman's symptoms, Dr. Silverman prescribed metoclopramide. While on metoclopramide, Sherman's digestive symptoms improved significantly. She stayed on metoclopramide from September 2004 to December 2010.

         Dr. Silverman evaluated Sherman regularly while she was on metoclopramide and before 2010 did not see any indication that she was experiencing involuntary movements. However, in June 2010, Sherman began experiencing involuntary movements. In August 2011, she was diagnosed with tardive dyskinesia.

         Package Insert Warnings

         Beginning in 1985, the package insert for Reglan contained a warning stating that tardive dyskinesia may develop in patients treated with metoclopramide. The warning stated that the risk of developing the syndrome was "believed to increase with the duration of treatment and the total cumulative dose." Clerk's Papers (CP) at 715. The warning also stated that "[e]xtrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients" treated with metoclopramide. CP at 715. Under the dosage and administration section, the package insert stated that "[t]herapy longer than 12 weeks has not been evaluated and cannot be recommended." CP at 716.

         In 2004, the brand-name manufacturer revised the Reglan package insert. Both the indications and usage section and the dosage and administration section of the revised package insert contained a statement that therapy with metoclopramide "should not exceed 12 weeks in duration." CP at 766. There was no change to the reference to tardive dyskinesia in the warnings section.

         In 2009, the Food and Drug Administration (FDA) required the brand-name manufacturer to add a "black box warning" to the Reglan package insert. CP at 84. The warning was placed at the top of the package insert and stated:

WARNING
TARDIVE DYSKINESIA
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
See WARNINGS.

         CP at 503.

         The warnings section of the revised package insert contained additional information about tardive dyskinesia, including that "one published study reported a TD [tardive dyskinesia] prevalence of 20% among patients treated for at least 12 weeks." CP at 507. The warning concluded, "Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD." CP at 507.

         Complaint

         In 2013, Sherman filed a complaint against the Generic Defendants and others.[2] In her amended complaint, she asserted a WPLA claim against the Generic Defendants for failing to provide adequate warnings to doctors regarding the use of metoclopramide. Specifically, Sherman alleged that the Generic Defendants had breached their duty to provide adequate warnings by failing (1) to update their package inserts for metoclopramide to match the strengthened warnings added to the Reglan label in 2004 and 2009, and (2) to communicate the new warning information in the revised Reglan labels to doctors through other means.

         In his deposition, Dr. Silverman stated that he was aware when he prescribed metoclopramide for Sherman that one of the potential risks was development of some sort of movement disorder. For any patient on metoclopramide, including Sherman, he would always watch for movement disorders. Dr. Silverman stated that he was not aware of any clinician who had actually observed tardive dyskinesia associated with using metoclopramide, but that at some point "word got around" that tardive dyskinesia was something for which doctors should be looking. CP at 192.

         However, Dr. Silverman testified that he did not read package inserts and did not recall ever reading a package insert. He did not use package inserts to learn about medications. Specifically, Dr. Silverman testified that he had never read a package insert for Reglan or metoclopramide. He also did not recall ever seeing a "Dear Doctor" letter[3] from a drug manufacturer. CP at 178. He said that such letters might have been in a stack of mail he received every day that he never opened. But he generally did not learn new information about medications through the mail.

         Regarding his treatment of Sherman, Dr. Silverman testified that he did not rely on any package insert for Reglan or for generic metoclopramide when deciding whether to initially prescribe metoclopramide and whether to continue prescribing metoclopramide. Similarly, he stated that any changes to the package inserts for metoclopramide did not impact his prescription decision because he did not look at them. Instead, he relied on his clinical training and experience, the experience of his colleagues and associates, and his mentors and people in the academic world who he respected.

         The Generic Defendants filed a motion for summary judgment. In support, they relied on Dr. Silverman's deposition testimony to argue that any failure to warn could not be the proximate cause of Sherman's condition as a matter of law. The trial court denied the summary judgment motion.

         The Generic Defendants filed a motion for discretionary review of the trial court's ruling. A commissioner of this court granted the motion. Ruling Granting Review, Sherman v. ...


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