Products Liability Law Daily Pradaxa® verdict for manufacturer upheld on appeal
Tuesday, May 5, 2020

Pradaxa® verdict for manufacturer upheld on appeal

By David Yucht, J.D.

A design defect claim based on the drug manufacturer's lack of a reversal agent for the anticoagulant was preempted.

The state supreme court of Connecticut refused to reopen a Pradaxa® inadequate labeling case filed by the estate of a woman who had died from kidney failure. The court ruled that the lower court correctly precluded evidence and arguments related to spoliation, and properly prevented the use of an excerpt from a deposition on rebuttal. Moreover, the trial court correctly granted the manufacturer’s motion for summary judgment on a design defect claim based on impossibility preemption, and its curative instruction to the jury after closing arguments was not an abuse of discretion (Boone v. Boehringer Ingelheim Pharmaceuticals, Inc., May 4, 2020, Kahn, M.).

A patient who was at risk for strokes due to blood clots was initially prescribed warfarin, an anticoagulant drug which required dietary restrictions and increased the risk of bleeding. In 2010, the Food and Drug Administration (FDA) approved the sale of dabigatran etexilate, an anticoagulant marketed by Boehringer Ingelheim Pharmaceuticals, Inc. (BIP) as Pradaxa®. The patient was switched to this drug, which required no dietary restrictions and was approved for use without blood monitoring. After taking Pradaxa for several years, the patient suffered a severe gastrointestinal bleed and was hospitalized. She underwent dialysis to remove Pradaxa from her blood and was administered multiple transfusions. Although the bleeding stopped, she died from kidney failure a few days after being admitted. Consequently, her estate sued BIP alleging that it negligently failed to give adequate warnings, negligently failed to investigate the benefits of establishing a therapeutic range for Pradaxa, and defectively designed Pradaxa due to the absence of a reversal agent.

The trial court granted summary judgment to BIP on the estate’s design defect claim based on federal preemption. Prior to trial, the court ruled in favor of the estate and agreed to provide the jury with a spoliation charge because BIP had lost certain relevant files. At the conclusion of trial, a jury returned a verdict finding that, although BIP had negligently failed to give adequate warnings, directions, and instructions to guard against the risk of bleeding, the estate had failed to prove that BIP’s wrongful conduct caused the decedent’s death. The estate appealed.

Evidence—spoliation. The Connecticut high court was not persuaded by the estate’s argument concerning spoliation. The trial court issued an instruction to the jury relating to spoliation concerning evidence from a BIP scientist who researched Pradaxa that was not available to the estate because BIP had failed to preserve it, when it had a duty to do so. The jury was instructed that they may, but were not required to, draw an adverse inference that the destroyed evidence would have been unfavorable to BIP. Prior to trial, it was agreed that if the court gave this charge, the estate would not present evidence concerning the circumstances surrounding this lost file. Thereafter, the estate sought permission to "inform the jury during opening, at trial, and during closing argument of [BIP’s] unlawful destruction of critically important evidence " The trial court ruled that references to spoliation during opening statements risked unfair prejudice to BIP and, consequently, precluded such references. The supreme court noted that during the trial, the lower court only once excluded testimony relating to the destruction of these files. After the verdict in BIP’s favor, the estate moved for a new trial claiming that the court should have allowed freer comment on the destruction of evidence. The supreme court agreed with the trial court’s finding that this claim was "wholly without merit" because the estate, in seeking an instruction, expressly represented that evidence relating to spoliation would not be presented at trial. The estate was arguing that there was an error in the approach it had successfully advocated for, implicating the "induced" error doctrine.

Expert evidence. The supreme court did not agree with the estate that the trial court erred by preventing the estate from using an excerpt from the deposition of an expert witness on rebuttal. The estate claimed that the trial court improperly excluded portions of a video-recorded deposition of BIP’s Senior Vice President for Clinical Development, from its case on rebuttal. However, the supreme court agreed that the proffered testimony did not contradict testimony presented by BIP’s expert witnesses. The proffered question and answer from this deposition was not proper rebuttal because it did not involve a situation in which a person’s gastrointestinal bleed had resolved prior to death. The colloquy established only that a gastrointestinal bleed can lead indirectly to death. Such a broad statement did not contradict BIP’s expert testimony that, in this case, the decedent’s death was not caused by gastrointestinal bleeding.

Design defect—preemption. The supreme court affirmed the trial court’s grant of BIP’s motion for summary judgment on a design defect claim relating to the absence of a reversal agent pursuant to the impossibility preemption doctrine. The FDA approved Pradaxa in 2010. Five years later, after the decedent’s death, BIP obtained approval to sell a chemical reversal agent for Pradaxa. Because this agent was not available at the time of the decedent’s gastrointestinal bleed, kidney dialysis was required to remove Pradaxa from her bloodstream. As a result, the decedent’s gastrointestinal bleed took three days to stop. The estate argued that BIP could have brought this agent to market earlier and that because it did not, the decedent’s gastrointestinal bleed was prolonged. The estate asserted that BIP had defectively designed Pradaxa by failing to seek concurrent approval for the reversal agent.

The Connecticut high court concluded that the trial court properly granted BIP’s motion for summary judgment as to the design defect claim. To cure the alleged design defect, BIP would have had to have brought the reversal agent to market before the decedent’s gastrointestinal bleed in 2014. Because this agent was not approved by the FDA until 2015, BIP could not have satisfied its alleged state law duty to the decedent without marketing an unapproved drug in violation of federal law. Because of this conflict, the trial court correctly concluded that the design defect claim based on the absence of a reversal agent for Pradaxa was preempted.

Jury instructions. Finally, the supreme court was not swayed by the estate’s argument concerning jury instructions. The estate claimed that the trial court abused its discretion by instructing the jury that it could not hold BIP liable for failing to conduct tests of a 110 mg dose of Pradaxa. Before trial, the court excluded most uses of evidence concerning Pradaxa in its 110 mg dose, which was smaller than the 150 mg dose that the decedent had used. The trial court concluded that such evidence could not be used to prove that BIP negligently failed to investigate the various action items identified by the FDA when securing approval of the 110 mg dose. Such a failure-to-test claim was preempted by federal law. However, the trial court acknowledged that evidence concerning the 110 mg dose might be relevant to the claim that BIP had failed to adequately warn physicians about a risk of bleeding. Accordingly, the trial court deferred ruling on the admissibility of this evidence until trial.

During summation, the estate’s counsel referred to a document, admitted into evidence, which discussed a "potential path forward" for the 110 mg dose previously proposed by the FDA. The trial court concluded that counsel had improperly suggested to the jury that BIP should be liable for failing to pursue a smaller dose. The trial court gave a curative instruction telling the jury not to hold BIP liable for a failure to conduct the testing outlined in this document. The supreme court upheld this curative instruction, noting that the "potential path forward" described in the subject document discussed the prospect of FDA approval for a smaller dose, which was not properly before the jury.

The case is No. SC 20200.

Attorneys: Brenden P. Leydon (Wocl Leydon, LLC) for Geralynn Boone. Paul W. Schmid (Covington & Burling LLP) for Boehringer Ingelheim Pharmaceuticals, Inc.

Companies: Boehringer Ingelheim Pharmaceuticals, Inc.

MainStory: TopStory DesignManufacturingNews WarningsNews EvidentiaryNews JuryVerdictsNewsStory DrugsNews PreemptionNews GCNNews ConnecticutNews

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