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From Products Liability Law Daily, July 22, 2013

Patient’s products liability claims against maker of prescription blood thinner survive dismissal motion

By Pamela C. Maloney, J.D.

A patient who was injured allegedly as a result of ingesting a prescription blood thinner stated sufficient allegations to support his claims that the drug was defectively designed and manufactured and that the warnings were inadequate to overcome the manufacturer’s motion for summary judgment, a federal district court in Illinois determined (In re: Pradaxa (Dabigatran Etexilate) Products Liability Litigation (Jackson v. Boehringer Ingelheim Pharmaceuticals, Inc.), July 18, 2013, Herndon, D.). However, because the Louisiana Products Liability Act (LPLA) sets forth the “exclusive theories of liability for manufacturers for damage caused by their products,” the patient’s remaining claims based on negligence, warranty, fraud/misrepresentation, and deceptive trade practices were dismissed, with leave to amend should discovery reveal that the named defendants were non-manufacturing sellers.

Background. The patient, who was prescribed the blood thinner Pradaxa, brought negligence, strict liability, and warning claims under the LPLA against several defendants that allegedly designed, manufactured, marketed, advertised, distributed, promoted, labeled, tested, and sold the drug. The complaint alleged that the drug was defective and unreasonably dangerous in design, and was unreasonably dangerous because its warnings were inadequate. The patient’s complaint also included counts alleging redhibition, negligence, fraud/misrepresentation, and deceptive trade practices. Of the named defendants, three were foreign entities that had not been served. The remaining defendant, Boehringer Ingelheim Pharmaceuticals, Inc., moved for dismissal, arguing that the non-LPLA claims were precluded by that Act and that the patient failed to sufficiently allege any claims under the LPLA.

Scope of LPLA. By its terms, the LPLA provides the exclusive theory of liability against manufacturers for damages caused by their products. However, the LPLA applies only to manufacturers and does not govern claims against non-manufacturing sellers unless the seller also qualified as a manufacturer under the Act. Because the patient alleged that the named defendants designed and manufactured the drug and that his injuries were the “fault” of the named defendants as manufacturers, the LPLA controlled and only the patient’s claims brought under that Act survived the motion for summary judgment. Thus, the court granted the manufacturer’s motion to dismiss the patient’s negligence, fraud/misrepresentation, and deceptive trade practices claims, but granted the patient leave to amend should discovery reveal that any of the named defendants were determined to be non-manufacturing sellers that would be subject to non-LPLA claims.

Products liability allegations. Turning to the manufacturer’s claim that the patient failed to state a claim under the LPLA, the court determined that the patient’s allegations were sufficient under federal pleading requirements. Specifically, the patient alleged that the drug was defective and unreasonably dangerous in design because its levels in the blood were difficult or impossible to assess and bleeds could not be stopped because there was no known reversal agent. These defects place patients at an increased risk for developing life-threatening bleeds. The patient also alleged that the benefits of taking the drug did not outweigh the serious and “undisclosed” risks of its use, that the “one size fits all” dosage was unreasonably dangerous, and that there were safer alternatives which did not carry the same risks. With regard to the inadequate warnings claims, the patient alleged that the manufacturer did not provide timely and adequate warnings and/or adequate clinical data regarding the risk of irreversible and/or uncontrollable bleeds, the lack of a reversal agent, and how to intervene and stabilize a patient should a bleed occur. Finally, the patient alleged that as a direct result of the design marketing and manufacturing defects, he sustained serious and permanent injury. These allegations, combined with others in the complaint were sufficient to survive the motion to dismiss.

Breach of express warranty. The court dismissed the breach of warranty claim under the LPLA because the patient failed to identify any representation or statement of alleged fact or promise about the drug made by the manufacturer that could have formed the basis for an express warranty.

Redhibition claim. Explaining that the LPLA allows for a redhibition claim to the extent a plaintiff sought recovery for economic losses, the court found that the patient’s complaint was sufficient to state a claim for redhibition. The patient claimed that he was entitled to a rescission of the sale of the drug or a reduction in the purchase price, as well as attorneys’ fees because the drug contained a defect that rendered the product useless or unreasonably dangerous. While these allegations were sufficient to preserve the claim for further proceedings, the court dismissed the patient’s claims for attorneys’ fees as well as his claim for punitive damages.

The case number is: MDL No. 2385 (Case No. 3:12-cv-60004-DRH-SCW).

Attorneys: Mark R. Niemeyer (Onder, Shelton, O'Leary & Peterson), Michael A. London (Douglas & London. P.C.), Mikal C. Watts (Watts, Guerra, Craft, LLP), Roger C. Denton (Schlichter, Bogard & Denton), Seth A. Katz (Hersh & Jardine, P.C.), and Steven D. Davis (TorHoerman Law) for Jackson. Dan H. Ball (Bryan, Cave), Eric E. Hudson (Butler, Snow, O'Mara, Stevens & Cannada), Paul W Schmidt (Covington & Burling LLP) for Boehringer Ingelheim Pharmaceuticals, Inc. Beth S. Rose (Sills Cummis & Gross P.C.) for Boehringer Ingelheim Pharma GMBH & Co. KG.

Companies: Boehringer Ingelheim Pharmaceuticals, Inc.

MainStory: TopStory JurisdictionNews SCLIssuesNews WarningsNews DesignManufacturingNews DrugsNews IllinoisNews

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