Products Liability Law Daily Aside from package inserts, generic drug maker had no duty to warn doctors of potential side effects
Wednesday, May 1, 2019

Aside from package inserts, generic drug maker had no duty to warn doctors of potential side effects

By Jeffrey H. Brochin, J.D.

A lack of warnings was not the cause of the patient’s injuries given the doctor’s testimony he had not read the drug package inserts.

A state appeals court in Washington reversed a trial court’s denial of summary judgment favoring generic drug manufacturers after it became clear that the manufacturers’ alleged failure to warn could not have been the proximate cause of a patient’s injuries related to side effects of the drug she had taken for digestive disorders. Her physician testified that he never read package inserts, the court said, concluding that the patient’s injuries would not have been prevented even if the warnings were strengthened (Sherman v. Pfizer, Inc., April 30, 2019, Maxa, C.).

Short-duration drug prescribed for six years. A woman who was suffering from severe digestive disorders was prescribed the drug metoclopramide—the generic version of the brand-name drug Reglan®. Her digestive symptoms improved significantly, and she stayed on metoclopramide from September 2004 until December 2010. Her doctor evaluated her regularly while she was on the drug and did not see any indication that she was experiencing any side effects such as involuntary movements until June 2010. In August 2011, she was diagnosed with tardive dyskinesia, which had been found to be a rather prevalent side effect of the drug in 2004.

Reglan package warnings. Beginning in 1985, the package insert for Reglan contained a warning stating that tardive dyskinesia may develop in patients treated with the medication. The warning stated that the risk of developing the syndrome was believed to increase with the duration of treatment and the total cumulative dose, and the warning also stated that certain symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with metoclopramide.

In 2004, and again in 2009, the U.S. Food and Drug Administration required the brand-name manufacturer to significantly strengthen the Reglan warnings. Thereafter, the new package insert specifically warned of the risk of tardive dyskinesia, and warned that the risk of developing the condition increases with duration of treatment and total cumulative dose. Furthermore, the insert warned that metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia, that there is no known treatment for tardive dyskinesia, and that treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.

Generic warnings not strengthened. The patient filed suit in 2013 against the generic manufacturers, alleging that they had violated the Washington Product Liability Act (WPLA) by having failed to provide adequate warnings about the risk of developing tardive dyskinesia. She cited the federally-approved changes to the Reglan label (package insert), and claimed that the generic manufacturers had violated their duty to warn in two ways: (1) they failed to update their package inserts for generic metoclopramide to reflect the strengthened warnings on the revised Reglan labels; and (2) they failed to communicate the strengthened warnings to her doctor through means other than the package insert.

After the doctor testified that he had never read the package inserts, the generic manufacturers moved for summary judgment, arguing that even if they had failed to warn, that failure could not have been the proximate cause of the patient’s injuries because her doctor never read warnings anyway. The trial court denied the motion, and the instant appeal followed.

Inadequacy of warnings not relevant. The appellate court noted that pursuant to the learned intermediary doctrine, the generic manufacturers were under no obligation to warn the patient directly of risks involving the drug. Their duty was only to provide adequate warnings directed to physicians through the package inserts required under federal law. The patient argued that the generic manufacturers’ duty was breached by the companies’ failure to update the package inserts to reflect the strengthened warnings included in the 2004 and 2009 revisions to the Reglan package inserts.

The generic manufacturers argued that even if their package inserts were inadequate, the trial court erred in denying their summary judgment motion regarding the failure-to-update claim based on proximate cause because the doctor testified that he did not read any package inserts and did not consider package inserts in prescribing metoclopramide for the patient.

The court agreed with this argument and ruled that a prescription drug manufacturer’s duty under Washington regulations is to provide adequate warnings with the product and that there was no duty under the WPLA to communicate such warnings to doctors in ways other than through package inserts. Furthermore, under the facts of this case, the duty to warn was inapplicable because the doctor did not read them. Accordingly, the court held that the trial court erred in denying summary judgment favoring the generic manufacturers, and the case was reversed and remanded for the trial court to dismiss the claims against the generic drug manufacturers.

The case is No. 50914-8-II.

Attorneys: Lisa Taylor (Durham Taylor LLC) for Diana Sherman and Mark Sherman. Robert William Novasky (Forsberg & Umlauf, PS) and Aaron Paul Riensche (Ogden Murphy Wallace PLLC) for Teva Pharmaceuticals, Inc., Pliva, Inc. and Barr Laboratories, Inc. Eric Allen Norman (Fain Anderson VanDerhoef Rosendahl O’Halloran Spillane, PLLC) for Pfizer, Inc., Wyeth LLC f/k/a Wyeth, Inc. and Wyeth Holdings Corp.

Companies: Teva Pharmaceuticals, Inc.; Pliva, Inc.; Barr Laboratories, Inc.; Pfizer, Inc.; Wyeth LLC f/k/a Wyeth, Inc.; Wyeth Holdings Corp.

MainStory: TopStory WarningsNews CausationNews DrugsNews WashingtonNews

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