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From Health Law Daily, April 10, 2015

Doctor’s orders, ‘uninfluenced’ decision stops off-label suit

By Anthony H. Nguyen, J.D.

A Fifth Circuit panel upheld a lower court’s decision that a pregnant patient and her child failed to show that the child’s injuries were caused by any alleged off-label promotional activities engaged in by pharmaceutical manufacturers of metoclopramide. The injured patient was unable to demonstrate causation, specifically that the off-label promotional activities influenced her physician’s decision to prescribe generic versions of the drug alleged to cause her injuries (Whitener v. PLIVA, Inc., April 9, 2015, per curiam).

Background. Lindsey Whitener’s son was born prematurely with birth defects after Whitener was prescribed metoclopramide to treat the nausea and morning sickness she experienced during her pregnancy. Whitener sued various pharmaceutical manufacturers, alleging that the manufacturers had promoted the prescription of metoclopramide as an “off-label” use for morning sickness.

Three of the pharmaceuticals—PLIVA, Inc., Barr Laboratories, Inc., and Teva Pharmaceutical Industries, Ltd.—manufactured generic metoclopramide, the product that Whitener used. Three of them—Alaven Pharmaceutical L.L.C., Meda Pharmaceuticals, Inc., and Schwarz Pharma, Inc.—manufactured brand-name Reglan®, a product that Whitener did not use.

District court decision. In 2011, the Supreme Court held in PLIVA, Inc. v. Mensing (U.S., June 23, 2011) that, because federal law requires generic drug labels to be the same at all times as corresponding brand-name drug labels, state-law inadequate-warning claims based on a generic pharmaceutical manufacturer’s failure to provide a more adequate label are preempted. Subsequently, the pharmaceutical manufacturers filed a motion for summary judgment asserting Whitener’s claims were preempted.

The district court agreed that, to the extent the Whiteners’ claims were based on the generic pharmaceutical manufacturers’ failure to change metoclopramide’s label to warn of the danger of taking it during pregnancy, they were preempted. However, the district court was not willing to conclude that the Whiteners’ claims based on the pharmaceutical manufacturers’ affirmative promotion of metoclopramide for use during pregnancy failed as a matter of law (see Companies not responsible for patient’s injuries, despite promotion of off-label use, March 31, 2014).

After Teva was dismissed for jurisdictional issues, because it was an Israeli corporation with a principal place of business in Israel, the remaining pharmaceutical manufacturers moved for summary judgment, arguing that the Whiteners’ off-label-promotion claim was not a viable, non-preempted one under state law; and that, even if it were, the Whiteners could not establish that any promotional activities engaged in by the defendants had caused their injuries. Although the district court assumed for the argument that the off-label promotion claim was viable, it granted summary judgment because the prescribing physician had testified that it was his decision to prescribe the drug, independent of any alleged off-label conduct made by the pharmaceutical manufacturers.

Affirming. The Fifth Circuit panel affirmed the dismissal of Teva as a party to the suit for jurisdictional issues. The Fifth Circuit stated that nothing in the record demonstrated that Teva’s contacts with the state of Louisiana (where Whitener brought her suit) was “continuous and systematic’ enough” to make this such an “exceptional case” to render Teva subject to the general jurisdiction of Louisiana.

As for the remaining pharmaceutical manufacturers, the Fifth Circuit noted that various reasons were offered as to why the Whiteners’ off-label promotion claim was not viable claim under Louisiana law. The generic pharmaceutical manufacturers PLIVA and Barr Laboratories argued that the off-label promotion claim was a failure-to-warn claim in a different form, and thus, preempted by Mensing. The brand name pharmaceutical manufacturers Alaven Pharmaceutical, Meda Pharmaceuticals, and Schwarz Pharma argued that the only claims the Whiteners could assert were those arising under Louisiana products liability laws, which in turn removed their liability because Whitener did not use their products.

Despite the various arguments, the Fifth Circuit noted that the Whiteners could recover only if they proved causation—that is, the Whiteners were required to show that, but for the defendants’ off-label promotion of metoclopramide for use by pregnant women, Whitener would not have ingested it. The district court held that the Whiteners could not show causation because the prescribing physician’s testimony indicated that it was his decision to prescribe metoclopramide to Whitener. The physician testified that he did not have any contact with either PLIVA or Barr Laboratories’ representatives in regards to metoclopramide. As such, the record was clear that the physician was not influenced by any alleged off-labeling promotion in his prescribing decision. The Fifth Circuit held that the district court’s holding was not in error and affirmed.

The case is No. 14-30468.

Attorneys: Joseph Arthur Smith, III (Smith Law Firm) for Joshua A. Whitener, Sr. Jeffrey Francis Peck (Ulmer & Berne, LLP), and Richard E. Sarver (Barrasso, Usdin, Kupperman, Freeman & Sarver, LLC) for PLIVA, Inc., Barr Laboratories, Inc., Barr Pharmaceuticals, LLC, and Watson Pharmaceuticals, Inc. Henninger Simons Bullock (Mayer Brown, LLP), and Gregory Fortier Rouchell (Adams & Reese, LLP) for Schwarz Pharma, Inc.

Companies: PLIVA, Inc.; Barr Laboratories, Inc.; Barr Pharmaceuticals, LLC; Watson Pharmaceuticals, Inc.; Schwarz Pharma, Inc.; Teva Pharmaceutical Industries, Ltd.; Alaven Pharmaceutical L.L.C.; Meda Pharmaceuticals, Inc.

MainStory: TopStory PLDrugNews AdvertisingNews DrugBiologicNews GenericDrugNews LabelingNews PrescriptionDrugNews LouisianaNews MississippiNews TexasNews

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