Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

West v. Bayer Healthcare Pharmaceuticals, Inc.

United States District Court, District of Columbia

February 1, 2018

WILLIAM PRESTON WEST, JR., et al., Plaintiffs,



         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 for 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 . . . 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 he 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., a culture indicating that the bacteria existed in Plaintiff's system), nor can he definitively and absolutely prove that other bacteria (e.g., streptococcus or staphylococcus) were not the cause. However, based on Plaintiff's symptoms, history and clinical presentation-including the fact that Plaintiff's infection began immediately after he used a Triad alcohol prep pad and injected himself with Betaseron; that Plaintiff had not previously had serious complications from using these pads or injections in the past; and that the one time Plaintiff became infected after using them he was subsequently told that the alcohol prep pads were potentially linked to a B. cereus contamination-Dr. Abbruzzese concluded at the time he was treating Plaintiff that B. cereus was a possible cause of his patient's condition, and has since concluded that it is more likely than not that B. cereus was the culprit.

         Dr. Auwaerter's opinion is similar. Dr. Auwaerter is expected to testify that, having reviewed Plaintiff's medical records, Plaintiff's illness was “highly likely due to infection introduced by contaminated alcohol prep pads that failed to cleanse skin surface and introduced high burden of an infectious pathogen that was likely due to Bacillus species.” Pls.' Ex. 3 (Dr. Auwaerter Expert Report), ECF No. 127-5, at 3; Depo. of Dr. Paul Auwaerter, ECF No. 127-10 (“Auwaerter Depo”), at 207:11-12 (“I would just say more likely than not, bacillus cereus”). Dr. Auwaerter's conclusions largely mirror those of Dr. Abbruzzese. To summarize, Dr. Auwaerter concedes that his conclusions are not based on cultures, microbiological data or test results that might conclusively “prove” the cause of Plaintiff's illness, and that it is possible that Plaintiff's symptoms could have been consistent with other types of infections. However, based on a host of factors-including the fact that Plaintiff's clinical presentation, symptoms, and development throughout treatment were consistent with a B. cereus infection, the temporal proximity between Plaintiff's self-injection and his illness, the fact that Plaintiff had not had injection-related infections in the past, and the fact that, according to the recall e-mail, the Triad alcohol pad Plaintiff had used immediately prior to his infection may have been contaminated with B. cereus-Dr. Auwaerter concluded that B. cereus was the most likely cause.

         Defendant has moved the Court to exclude the expert testimony of Drs. Abbruzzese and Auwaerter, and has also moved for summary judgment. Both of those motions have been fully briefed and are now ripe for resolution.


         A. Motion to Exclude Expert Testimony

         Federal Rule of Evidence 702 governs the admission of expert testimony. That rule states that: “[a] witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert's scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.” Fed.R.Evid. 702. The trial judge has “considerable leeway in deciding in a particular case how to go about determining whether particular expert testimony is reliable.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 152 (1999).

         The Court's application of Rule 702 is informed by the Supreme Court's opinion in Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993). “Under Daubert, the district court is required to address two questions, first whether the expert's testimony is based on ‘scientific knowledge, ' and second, whether the testimony ‘will assist the trier of fact to understand or determine a fact in issue.'” Meister v. Med. Eng'g Corp., 267 F.3d 1123, 1126 (D.C. Cir. 2001) (quoting Daubert, 509 U.S. at 592). “The first inquiry forces the court to focus on ‘principles and methodology, not on the conclusions that they generate, '” and “demands a grounding in the methods and procedures of science, rather than subjective belief or unsupported speculation.” Id. at 1127 (quoting Daubert, 509 U.S. at 590, 595). “While rejecting a requirement of scientific certainty, the Supreme Court instructed that ‘in order to qualify as “scientific knowledge, ” an inference or assertion must be derived by the scientific method. Proposed testimony must be supported by appropriate validation-i.e., “good grounds, ” based on what is known.'” Id. (quoting Daubert, 509 U.S. at 590).

         In short, the Court is intended to perform a “gatekeeping” role and engage in “‘a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.'” Ambrosini v. Labarraque, 101 F.3d 129, 133 (D.C. Cir. 1996) (quoting Daubert, 509 U.S. at 592-93). “[T]he proponents of [expert] evidence . . . bear the burden to prove that the expert testimony is reliable by a preponderance of the evidence.” Arias v. DynCorp, 928 F.Supp.2d 10, 17 (D.D.C. 2013).

         B. Motion for Summary Judgment

         Summary judgment is appropriate where “the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a). The mere existence of some factual dispute is insufficient on its own to bar summary judgment; the dispute must pertain to a “material” fact. Id. Accordingly, “[o]nly disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). Nor may summary judgment be avoided based on just any disagreement as to the relevant facts; the dispute must be “genuine, ” meaning that there must be sufficient admissible evidence for a reasonable trier of fact to find for the non-movant. Id.

         In order to establish that a fact is or cannot be genuinely disputed, a party must (a) cite to specific parts of the record-including deposition testimony, documentary evidence, affidavits or declarations, or other competent evidence-in support of its position, or (b) demonstrate that the materials relied upon by the opposing party do not actually establish the absence or presence of a genuine dispute. Fed.R.Civ.P. 56(c)(1). Conclusory assertions offered without any factual basis in the record cannot create a genuine dispute sufficient to survive summary judgment. See Ass'n of Flight Attendants-CWA, AFL-CIO v. Dep't of Transp., 564 F.3d 462, 465-66 (D.C. Cir. 2009). Moreover, where “a party fails to properly support an ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.