West v. Bayer Healthcare Pharm. Inc.

293 F. Supp. 3d 82
CourtCourt of Appeals for the D.C. Circuit
DecidedFebruary 1, 2018
DocketCivil No. 15–1053 (CKK)
StatusPublished
Cited by7 cases

This text of 293 F. Supp. 3d 82 (West v. Bayer Healthcare Pharm. Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
West v. Bayer Healthcare Pharm. Inc., 293 F. Supp. 3d 82 (D.C. Cir. 2018).

Opinion

COLLEEN KOLLAR-KOTELLY, United States District Judge

Plaintiff William Preston West, Jr. alleges that he contracted a severe bacterial infection after using a contaminated alcohol prep pad that was packaged with an injectable medicine produced by Defendant Bayer HealthCare Pharmaceuticals, Inc. ("Bayer"). Plaintiff and his wife, Carolyn Gleason, have filed this lawsuit against Bayer, asserting causes of action for negligence, gross negligence, failure to recall, failure to warn or instruct, strict liability, breach of implied warranty, negligence per se , punitive damages and loss of consortium.1 Presently pending before the Court are Defendant Bayer's [124] Motion to Exclude the Expert Opinions of Paul Auwaerter, M.D. and Mark Abbruzzese, M.D., and [125] Motion for Summary Judgment. Upon consideration of the pleadings,2 the relevant legal authorities, and the record *86for the purposes of these motions, the Court will DENY Defendant's Motion to Exclude, and GRANT-IN-PART and DENY-IN-PART Defendant's Motion for Summary Judgment.

Specifically, the Court concludes that the opinions of Plaintiffs' experts are admissible because they have an adequate factual basis and are sufficiently reliable. Defendant's critiques of those opinions bear on their weight, and can be explored through cross-examination, but they do not render those opinions inadmissible. Largely because the Court will allow Plaintiffs to present this expert testimony, summary judgment for Defendant is not appropriate on Plaintiff West's substantive claims. Summary judgment is also not appropriate on Plaintiff Gleason's loss of consortium claim. All parties agree that this claim is derivative of Plaintiff West's substantive claims, which are not being summarily adjudicated. Finally, the Court will grant Defendant summary judgment on Plaintiff's gross negligence and punitive damages claims, because Plaintiffs consent to the dismissal of those claims.

I. BACKGROUND

Although the record before the Court is quite voluminous, the facts of this case are actually fairly straightforward. Plaintiff William P. West has Multiple Sclerosis ("MS"). Plaintiff was prescribed an injectable medicine called Betaseron to treat his MS. Defendant Bayer produces Betaseron. The Betaseron injection kits distributed by Bayer contain alcohol prep pads manufactured by Triad Group, Inc., Triad Pharmaceuticals, Inc., and H&P Industries, Inc., (collectively, "Triad"). Plaintiff had been using these kits for several years prior to 2010.3

On the evening of December 29, 2010, after using the provided Triad alcohol prep pads, Plaintiff self-administered his Bayer Betaseron injection. Immediately thereafter, he developed cellulitis in his abdominal wall. Plaintiff West had to be hospitalized for an extended period. During his hospitalization, Plaintiff had a number of cultures taken-some before and some after Plaintiff began receiving antibiotics-but none of those cultures definitively identified the specific bacterial source of Plaintiff's illness.

While in the hospital, Plaintiff received an e-mail from Bayer. The e-mail stated that "Bayer HealthCare Pharmaceuticals has become aware of a broad United States market recall of alcohol prep pads *87... manufactured by the Triad Group ... due to potential contamination of these products with the bacteria, Bacillus cereus ["B. cereus "], that could lead to life-threatening infections." Pls.' Ex. 1, ECF No. 127-3, at 1.4 The recall warned that "Triad alcohol prep pads packaged for use in the U.S. with Betaseron should not be used by patients." Id. As one might expect, Plaintiff immediately told his treating physician about this potential source of his illness.

Plaintiffs allege in this lawsuit that Plaintiff West's abdominal wall cellulitis was the result of an infection caused by B. cereus bacteria that was present on the Triad alcohol pads in the Betaseron injection kit that he used on December 29, 2010. Plaintiffs have proffered two expert witnesses that agree that this is the most likely explanation for Plaintiff's illness. Dr. Mark R. Abbruzzese is an infectious disease specialist licensed to practice in the District of Columbia. See Pls.' Ex. 2 (Pls.' Preliminary Expert Witness Designations), ECF No. 127-4, at 5. Dr. Paul G. Auwaerter is a board-certified internal medicine and infectious disease doctor who serves as the Clinical Director of the Division of Infectious Diseases at Johns Hopkins Medicine and is a professor of medicine at Johns Hopkins University School of Medicine. Id. at 8. Both experts have lengthy, relevant and impressive backgrounds relating to infectious diseases. See Pls.' Ex. 5 (Abbruzzese Curriculum Vitae), ECF No. 127-7; Pls.' Ex. 6 (Auwaerter Curriculum Vitae), ECF No. 127-8.

Dr. Abbruzzese treated Plaintiff during and after his hospitalization, and is expected to testify that, based on his expertise with infectious diseases, and "Plaintiff's clinical history and presentation, including the nature and severity of his infection and its sequelae... Plaintiff's abdominal wall cellulitis was caused by Bacillus cereus ." Pls.' Ex. 2 at 6; Depo. of Dr. Mark Abbruzzese, ECF No. 127-9 ("Abbruzzese Depo."), at 292:21-293:17 (testifying that "with a great deal of certainty, and I'm not sure what the metric is that you need, the answer is, of course" Plaintiff had a B. cereus infection). Dr. Abbruzzese initially diagnosed Plaintiff with cellulitis caused by an infection secondary to his self-injection with Betaseron, but did not specify the exact bacteria that caused this condition. See Abbruzzese Depo. at 163:4-11. While he was still in the hospital being treated by Dr. Abbruzzese, Plaintiff received the e-mail from Defendant Bayer warning users about the potential B. cereus contamination in Triad alcohol prep pads. Id. at 38:7-39:6. Plaintiff told Dr. Abbruzzese this information, id. , which, in combination with other factors, led Dr. Abbruzzese to conclude that B. cereus may have caused Plaintiff's infection, see, e.g., id. at 104:6-105:7, 286:2-290:21. Dr. Abbruzzese noted at the time that a B. cereus infection would explain Plaintiff's ailments, id. at 207:15-19, and recorded it in his records alongside two questions marks, id. at 203:18-22. He testified that he did not confirm Plaintiff had been infected with B. cereus with a culture because by the time he learned of the potential contamination, Plaintiff had already received antibiotics that would prevent the bacteria from being cultured. Id. at 39:23-40:12. Dr. Abbruzzese did not change Plaintiff's treatment plan when he learned of the potential contamination, because the drug Plaintiff was already prescribed at that point was effective against B. cereus. Id. 209:18-210:8 (testifying that *88he did not change Plaintiff's treatment plan after learning about the potential contamination because Plaintiff was already on "Avelox, which kills Bacillus cereus historically in the laboratory"). Plaintiff's infection cleared up.

In short, a fair summary of Dr. Abbruzzese's testimony is that he does not have evidence that definitively proves that Plaintiff's infection was caused by B. cereus (e.g.

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293 F. Supp. 3d 82, Counsel Stack Legal Research, https://law.counselstack.com/opinion/west-v-bayer-healthcare-pharm-inc-cadc-2018.