Knight v. Boehringer Ingelheim Pharm., Inc.
| Decision Date | 31 May 2018 |
| Docket Number | CIVIL ACTION NO. 3:15–6424 |
| Citation | 323 F.Supp.3d 809 |
| Parties | Claude R. KNIGHT and Claudia Stevens, individually and as Personal Representatives of the Estate of Betty Erelene Knight, deceased, Plaintiffs, v. BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., Defendant. |
| Court | U.S. District Court — Southern District of West Virginia |
C. Andrew Childers, Pro Hac Vice, Emily Tweed Acosta, Childers Schleuter & Smith, Russell Abney, Pro Hac Vice, Ferrer Poroit & Wansbrough, Atlanta, GA, Harry F. Bell, Jr., The Bell Law Firm, Charleston, WV, Lisa L. Causey, Pro Hac Vice, Salim–Beasley, Robert L. Salim, Pro Hac Vice, Law Offices of Robert L. Salim, Natchitoches, LA, Neal L. Moskow, Pro Hac Vice, Ury & Moskow, Fairfield, CT, for Plaintiff.
Ben J. Scott, Pro Hac Vice, Eric E. Hudson, Butler Snow, Memphis, TN 38119, Gretchen M. Callas, Thomas J. Hurney, Jr., Jackson Kelly, Charleston, WV 25322–0553, John Q. Lewis, Pro Hac Vice, Madeline B. Dennis, Pro Hac Vice, Tucker Ellis, Cleveland, OH 44113, Mark A. Dreher, Pro Hac Vice, Orlando R. Richmond, Sr., Pro Hac Vice, Butler Snow O'Mara Stevens & Cannada, Ridgeland, MS, Michael X. Imbroscio, Covington & Burling, Washington, DC, for Defendant
Pending before the Court are a litany of motions, including Defendant's Motion for Summary Judgment (ECF No. 42) and Plaintiffs' Motion for Partial Summary Judgment (ECF No. 44). Importantly, four of Defendant's other still-pending motions are relevant to its summary judgment motion: Motion to Exclude Case–Specific Testimony of Dr. Hazem Ashhab (ECF No. 45). ("Motion to Exclude Dr. Ashhab"); Motion in Limine No. 3 to Exclude Evidence, Testimony, or Argument Related to Foreign Regulatory Actions, Foreign Labeling Materials and Company Core Data Sheet (ECF No. 65) ("Foreign Label Motion"); Motion in Limine No. 4 to Exclude Evidence and Argument Regarding Lack of a Reversal Agent (ECF No. 66) ("Reversal Agent Motion"); Motion in Limine No. 6 to Exclude Evidence and Argument Regarding Plasma Concentration Levels (ECF No. 68) ("Plasma Levels Motion"). In addition to fully briefing the motions, the parties provided oral argument before the Court at the Pretrial Motions Hearing on May 15, 2017. As explained below, the Court GRANTS, IN PART, AND DENIES, IN PART Defendant's Motion for Summary Judgment (ECF No. 42), DENIES Plaintiffs' Motion for Partial Summary Judgment, DENIES Defendant's Motion to Exclude Dr. Ashhab (ECF No. 45), DENIES Defendant's Foreign Label Motion (ECF No. 65), DENIES Defendant's Reversal Agent Motion (ECF No. 66), and DENIES Defendant's Plasma Levels Motion (ECF No. 68).
This case is one in a series of product liability suits brought around the country, in which plaintiffs have claimed that they were harmed due to allegedly defective aspects of Pradaxa, a drug created and sold by Defendant Boehringer Ingelheim Pharamaceuticals, Inc. ("BI"). See generally Chambers v. Boehringer Ingelheim Pharmaceuticals, Inc. , No. 4:15-CV-00068 (CDL), 2018 WL 849081 (M.D. Ga. Jan. 2, 2018) ; Warren v. Boehringer Ingleheim Pharmaceuticals Inc. , No. 1:16-cv-01326-SEB-DML, 2017 WL 3970666 (S.D. Ind. Sept. 8, 2017). In this variation of the nation-wide cases, Ms. Betty Knight had been taking Pradaxa for roughly 18 months before she suffered a serious gastrointestinal bleed
in May 2013. Ex. 1 to Pls.' Resp. to Summ. J. , ECF No. 51–1, at 2–3. Although doctors eventually stopped the bleed, Ms. Knight remained largely debilitated, being moved in and out of in-patient care facilities, hospitals, and her home. Id. A few months later, in September 2013, Ms. Knight passed away at the age of 84. Id. at 4; Ex. 3 to Def.'s Mot. for Summ. J. , ECF No 41–3, at 2.
Among other conditions1 , Ms. Betty Knight suffered from atrial fibrillation
("A–Fib"), a condition in which the heart beats irregularly. Ex. 1 to Def.'s Mot. for Summ. J. , ECF No. 42–1, at 3–4; Ex. 3 to Def.'s Mot. for Summ. J. , at 2. This irregular heart beat can cause a pooling of blood in areas of the heart, and can lead to the development of blood clots. Ex. 1 to Def.'s Mot. for Summ. J. , at 3–4. Significantly, if these clots break away and travel to the brain, the suffering patient can have a stroke. Id.
Ms. Knight's A–Fib, in addition to her being over 75 years-old, increased her stroke
risk. Ex. 1 to Def.'s Mot. for Summ. J. , at 4. In fact, largely because of these two factors, Ms. Knight's primary care physician, Dr. Dawn MacFarland, characterized Ms. Knight has having a high risk of stroke. Id.
As early as 2005, doctors had prescribed medicine to Ms. Knight in order to lessen her atrial fibrillation-related stroke
risk. Ex. 1 to Pls.' Resp. to Summ. J. , at 2. The first drug Ms. Knight received was warfarin, which is marketed under the brand name Coumadin. Like Pradaxa, warfarin works as an anticoagulant that helps to prevent the development of blood clots, thereby reducing the risk of stroke. Ex. 4 to Pls.'s Resp. to Summ. J. , ECF No. 51–4, at 22–23. And as with the use of any anticoagulant drug, warfarin increases the risk of a patient experiencing bleeding. Id. at 20.
In order to address and mitigate the bleed risk associated with warfarin
use, patients must submit to stringent dietary restrictions and a regular and frequent monitoring regime. Id. at 22–24; Ex. 8 to Pls.' Resp. to Summ. J. , ECF No. 51–8, at 6–8; Ex. 1 to Def.'s Mot. to Summ. J. , at 5–6; Ex. 9 to Pls.' Resp. to Summ. J. , ECF No. 51–9, at 3. Warfarin has a narrow therapeutic range, which is a range of anticoagulant effect that decreases the risk of stroke without unnecessarily increasing the risk of a bleed. Ex 4 to Pls.' Resp. to Summ. J. , at 22–23. Based upon the measurement levels reflected during the monitoring tests, doctors adjust a patient's warfarin dose in an effort to keep the patient in the therapeutic range. Id.
During her time on warfarin
, Ms. Knight regularly submitted to this monitoring. Despite the inconvenience it posed to Ms. Knight, the regular testing was critical to her warfarin treatment. According to her doctors, they had a difficult time managing Ms. Knight's warfarin levels. Ex. 1 to Def.'s Mot. for Summ. J. , at 6. In fact, Ms. Knight's warfarin levels regularly fell outside of the therapeutic range. Id. Indeed, even while on warfarin, Ms. Knight's monitoring reflected that at times she was over-anticoagulated. Id. at 7. Despite this intermittent over-anticoagulation on warfarin, Ms. Knight did not experience a major bleed while on the medicine.
With the numerous restrictions of warfarin
, Ms. Knight and her family were interested in getting her on a different anticoagulant that would intrude less upon Ms. Knight's everyday activities. Ex. 1 to Def.'s Mot. for Summ. J. , at 7–8. And, prompted by a commercial they saw which touted the benefits of Pradaxa, Ms. Knight and her children made an appointment to speak with Dr. MacFarland about switching Ms. Knight to Pradaxa. Id. ; Ex. 9 to Pls.' Resp. to Summ. J. , at 2; Ex. 1 to Pls.' Resp. to Summ. J. , at 2.
Ms. Knight and her children visited Dr. MacFarland's office on October 17, 2011, at which point Ms. Knight first received a prescription for Pradaxa. Ex. 1 to Def.'s Mot. for Summ. J. , at 12–13; Ex. 1 to Pls.' Resp. to Summ. J. , at 2. Freed from the warfarin
related constraints, Ms. Knight enjoyed not having to regularly submit to the monitoring and testing of her anticoagulant levels. Ex. 9 to Pls.' Resp. to Summ. J. , at 9. Instead of the frequent dose adjustment involved with warfarin, Dr. MacFarland's office prescribed a set dose for Ms. Knight's Pradaxa, 75 mg B.I.D. Ex. 1 to Pls.' Resp. to Summ. J. , at 2. For sales in the United States, Pradaxa's package insert, often referred to as the "label," recommended that doctors prescribe either a dose of 75 mg or 150 mg, dependent upon the patient's renal function. Id. ; Ex. 2 to Pls.' Resp. to Summ. J. , ECF No. 51–2, at 2. Based upon Ms. Knight's severe kidney impairment, the Pradaxa label recommended the 75 mg dose, twice a day. Id. Dr. MacFarland's prescription followed the label's dosing recommendation. Id. ; Ex. 8 to Pls.' Resp. to Summ. J. , at 8–9. At the time of her initial prescription, Ms. Knight was 82 years old, and took two P-gp inhibitor drugs, as well as Iburprofen three times a day. Ex. 1 to Pls.' Resp. to Summ. J. , at 2.
In April 2013, Ms. Knight went to the hospital after suffering from a heart attack
. Ex. 3 to Def.'s Mot. for Summ. J. , at 3. At the hospital, Ms. Knight underwent a left heart catheterization, with stint placement. Id. After the procedure, doctors continued to give Ms. Knight her Pradaxa, and required her to take two other drugs: Plavix and aspirin. Id. ; Ex. 1 to Pls.' Resp. to Summ. J. , at 2. Plavix is an anti-platelet drug that affects the blood's clotting, and was prescribed to Ms. Knight to address her cardiac risk after the placement of two stints. Id. So too, taking aspirin also helps to prevent heart attacks. Doctors refer to the prescription of Pradaxa, Plavix, and aspirin together as "triple therapy." Ex. 3 to Def.'s Mot. for Summ. J. , at 2; Ex. 4 to Def.'s Mot. for Summ. J. , ECF No. 42–4, 8–10. Like Pradaxa, both Plavix and aspirin increase the risk of bleeding. Ex. 3 to Def.'s Mot. for Summ. J. , at 2; Ex. 4 to Def.'s Mot. for Summ. J. , at 9; Ex. 5 to Def.'s Mot. for Summ. J. , ECF No 42–5, at 5; Ex. 7 to Pls.' Resp. to Summ. J. , ECF No. 51–7, at 2.
On May 20, 2013, almost a month after she had started the triple therapy, Ms. Knight reported to her doctors that she was experiencing symptoms indicative of gastrointestinal bleeding
. Ex. 4 to Def.'s Mot. for Summ. J. , at 10–11; Ex. 1 to Pls.' Resp. to Summ. J. , at 3. According to her medical records, Ms. Knight had been experiencing those symptoms for roughly a week by the time she visited her doctor. Ex. 1 to Pls.' Resp. to Summ. J. ,...
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