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From Products Liability Law Daily, November 1, 2013

U.S. Patient questions refusal to admit previous drug warning labels

By Pamela C. Maloney, J.D.

A patient who was injured allegedly as a result of taking injections of a leuprolide acetate drug to treat endometriosis has asked the U.S. Supreme Court to review an unpublished decision by the U.S. Court of Appeals for the Ninth Circuit which affirmed a Nevada district court’s decision to exclude evidence of the drug’s former packaging labels as well as other adverse event reports about the drug (Klein v. TAP Pharmaceutical Products, Inc., petition filed October 28, 2013.).

Background. The 17-year-old patient, Karin Klein, was prescribed the drug Lupron Depot, which was manufactured and marketed by TAP Pharmaceutical Products, Inc., in a joint venture with Abbott Laboratories and Takeda Chemical Industries, Ltd., for the temporary management of pain associated with endometriosis. After receiving the prescribed six injections of the drug, the patient developed significant thyroid diseases, extreme and permanent bone density loss, a permanent inhibition to bone mass development, as well as chronic neck and back pain, all of which have left her totally and permanently disabled.

Failure-to-warn claim. According to the patient, she had read the packaging label provided by the drug companies after her first injection but, according to the complaint, the package label provided no warning that she risked any of the adverse events which she experienced. The patient filed state claims for strict liability failure-to-warn, negligence, and breach of warranty claims against the drug companies (although Takeda Chemical was never served and was no longer a party to the action). The action was removed to federal court. Prior to trial, the district court denied the patient’s motion seeking to admit into evidence certain Lupron labels used by the drug companies in the United States before 2005, along with evidence of the drug companies’ knowledge of the risks. According to the memorandum in support of the motion, the pre-2005 packaging labels; the drug companies’ foreign Lupron labels after 2005; various 1995 and 1996 Physician Desk References to Lupron; a children’s label; and a men’s Lupron label were relevant to show that the drug companies knew of the association between Lupron and bone mass density loss and thyroid disease yet failed to warn the patient of this risk in the 2005 packaging label.

District court’s ruling. The patient’s motion was denied by the district court because any information with respect to any other label, particularly of products that were not used by the patient, were totally irrelevant to the case, and would be highly prejudicial and confusing. The court believed that any of the labels issued after 2005 were also irrelevant and would discourage drug companies from correcting their labels. The trial court instructed that the only issue at trial was whether the warnings on the patient’s medication were sufficient and warnings or reports that involve other renditions of the drug were irrelevant. The court also found the foreign labels irrelevant because the drugs involved different formulations.

Questions presented. The petitioner presented the following questions for resolution: (1) Where the petitioner claims that in 2005 the drug companies failed to warn her in their packaging label that she risked thyroid damage and severe bone density loss if she took their drug, does a jury deserve to know that the drug companies warned of this very association in their prior labeling of the drug but then removed those warnings from the 2005 packaging label for the drug they sold the petitioner; and (2) Did the petitioner receive a fair trial where the trial judge excluded from evidence the drug companies’ labeling prior to 2005 and its awareness of Medwatch and other adverse event reports all showing that the drug companies knew there was a nexus between the drug and the thyroid damage and severe bone density loss which the petitioner sustained, but removed those warnings from the 2005 packaging label for the drug they sold the petitioner.

The case number is: 13-542.

Attorneys: Joseph J. Huggins (Huggins & Maxwell Law Offices) and Beau Sterling (Sterling Law LLC) for Karin Klein.

Companies: TAP Pharmaceutical Products, Inc.; Abbott Laboratories

MainStory: TopStory WarningsNews DrugsNews

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