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Loomis v. Boehringer Ingelheim Pharmaceuticals, Inc.

Superior Court of Delaware

June 29, 2017

BETTY LOOMIS, as Personal Representative of the Estate of JAMES R. LOOMIS, SR., and individually Plaintiff,
v.
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.; BOEHRINGER INGELHEIM INTERNATIONAL GMBH; BOEHRINGER INGELHEIM VETMEDICA, INC.;andBOEHRINGER INGELHEIM USA CORPORATION, Defendants.

          Submitted: April 13, 2017

         Upon Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.'s Motion to Dismiss Plaintiff's Complaint DENIED

          James D. Heisman, Esquire, Napoli Shkolnik, LLC, Wilmington, DE, Attorney for Plaintiff Betty Loomis.

          Michael P. Kelly, Esquire, Daniel J. Brown, Esquire, McCarter & English, LLP, Wilmington, DE, Eric E. Hudson, Esquire, Butler Snow, LLP, Memphis, TN, Attorneys for Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.

          Eric M. Davis, Judge.

         I. INTRODUCTION

         This is a products liability case arising out of the use of the drug Pradaxa. Plaintiff Betty Loomis, as a personal representative of the estate of James Loomis, filed a Complaint (the "Complaint") against Defendants Boehringer Ingelheim Pharmaceuticals, Inc. ("Boehringer Pharmaceuticals"), Boehringer Ingelheim International GmBH ("Boehringer International"), Boehringer Ingelheim Vetmedica, Inc. ("Boehringer Vetmedica"), and Boehringer Ingelheim USA Corp. ("Boehringer USA") (collectively, the "Defendants"). The Complaint asserts causes of action for: (i) Strict Liability, (ii) Strict Liability - Design Defect, Marketing Defect and Manufacturing Defect, (iii) Negligence, (iv) Breach of Express Warranty, (v) Breach of Implied Warranty, (vi) Wrongful Death, and (vii) Loss of Consortium.

         On February 16, 2017, Defendants Boehringer Pharmaceuticals and Boehringer USA (together, "the Boehringer Defendants") moved to dismiss the Complaint and filed Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.'s Motion to Dismiss Plaintiff's Complaint (the "Motion to Dismiss").[1] The Boehringer Defendants contend that the allegations in the Complaint about the lack of a reversal agent fail to state a claim for relief because the Food and Drug Administration ("FDA") approved a reversal agent before the date of Mr. Loomis' injuries. Mrs. Loomis opposes the Motion to Dismiss, responding to the Motion to Dismiss with Plaintiff's Opposition to Defendants' Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.'s Motion to Dismiss Plaintiff's Complaint (the "Response") on March 31, 2016.

         The Court held a hearing and heard oral argument on the Motion to Dismiss on April 7, 2017. At the conclusion of the hearing, the Court asked the parties to submit additional briefing on the learned intermediary doctrine, which the Boehringer Defendants raised for the first time at the hearing. On April 13, 2017, the Boehringer Defendants filed Defendants Boehringer Ingelheim Pharmaceuticals, Inc. and Boehringer Ingelheim USA Corp.'s Supplemental Brief in Support of its Motion to Dismiss Plaintiffs' Complaints Pursuant to Rule 12(b)(6) (the "Supplemental Motion")[2] and Ms. Loomis' counsel filed Plaintiff's Letter Brief in Further Opposition to Defendants' Motion to Dismiss Plaintiff's Complaint (the "Supplemental Response"). After receiving the Supplemental Motion and the Supplemental Response, the Court took the Motion to Dismiss under advisement.

         This is the Court's decision on the Motion to Dismiss. For the reasons set forth below, the Court DENIES the Motion to Dismiss.

         II. FACTUAL BACKGROUND[3]

         Mrs. Loomis, personal representative of the estate of decedent Mr. Loomis, is an individual and resident of the State of California and is the spouse of decedent Mr. Loomis.[4]Boehringer Pharmaceuticals, Boehringer USA, and Boehringer Vetmedica are Delaware corporations doing business in Delaware.[5] Boehringer International is a foreign corporation with a principal place of business in Rhein, Germany.[6]

         Defendants were involved in the manufacturing, marketing, advertising, and distribution of the drug Pradaxa.[7] Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in certain individuals.[8] Pradaxa was approved by the FDA on October 19, 2010, making it the first new treatment alternative to Coumadin.[9] Prior to FDA approval, Coumadin was the only oral anticoagulation available in the U.S. for reducing stroke and systemic embolism in patients with atrial fibrillation.[10]

         After FDA approval, Defendants promoted Pradaxa as a viable alternative to Coumadin in patients with atrial fibrillation.[11] Defendants' marketing campaign emphasized that Pradaxa, unlike Coumadin, did not require blood monitoring, dose adjustment, or changes to diet.[12]Pursuant to this marketing campaign, Mr. Loomis' doctors received promotional materials from Defendants, and Mr. Loomis also received direct-to-consumer advertisements.[13] Based on the information contained in these promotional materials, Mr. Loomis began taking Pradaxa for atrial fibrillation and heart problems on April 21, 2011.[14] Subsequently, Mr. Loomis suffered subarachnoid hemorrhage on December 5, 2015 and was admitted to the hospital in Nashville, Tennessee.[15] Mr. Loomis died on December 23, 2015.[16]

         On December 21, 2016, Mrs. Loomis filed the Complaint against Defendants. In short, the Complaint alleges that through their marketing campaign, Defendants' overstated the efficacy of Pradaxa with respect to preventing stroke and systemic embolism, failed to adequately disclose to or warn patients that there is no drug or means to reverse the anticoagulation effects of Pradaxa, and that such irreversibility could have permanently disabling, life-threatening and fatal consequences" such as increased risk of bleeding.[17] The Complaint further alleges that the Defendants' actions directly and proximately caused Mr. Loomis' injuries.[18]

         III. PARTIES' CONTENTIONS

         A. The Boehringer Defendants

         The Boehringer Defendants contend that the main claim in the Complaint-that Pradaxa was defective because it contained no reversal agent-does not state a claim for relief because the FDA approved a reversal agent for Pradaxa on October 23, 2015, two months before Mr. Loomis' hemorrhage on December 5, 2015. The Boehringer Defendants further argue that whether Mr. Loomis knew about the reversal agent is irrelevant because the Boehringer Defendants had no duty to warn Mr. Loomis about the reversal agent based on Tennessee's learned intermediary doctrine.

         B. Mrs. Loomis

         Mrs. Loomis claims that the Complaint is properly pleaded because it is not based exclusively on the lack of a reversal agent as argued by the Boehringer Defendants. Rather, the Complaint also includes allegations related to the efficacy of Pradaxa and the Boehringer Defendants' failure to warn of the risks associated with the use of Pradaxa. Mrs. Loomis further argues that it is a question of fact whether the Boehringer Defendants had a duty to warn under the learned intermediary doctrine. In the alternative, Mrs. Loomis also asks for leave to amend under Civil Rule 15(a) the Complaint if the Court does not find Mrs. Loomis' arguments to be persuasive.[19]

         IV. LEGAL STANDARD

         Upon a motion to dismiss under Civil Rule 12(b)(6), the Court (i) accepts all well-pleaded factual allegations as true, (ii) accepts even vague allegations as well-pleaded if they give the opposing party notice of the claim, (iii) draws all reasonable inferences in favor of the non-moving party, and (iv) only dismisses a case where the plaintiff would not be entitled to recover under any reasonably conceivable set of circumstances.[20] ...


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