BARTLETT v. MUTUAL PHARMACEUTICAL COMPANY, INC. (N.H. 7-22-2010)

Bartlett seems to believe that these principles apply only when the expert is wrong about the law, but that is not so. They apply even when the expert is right. See, e.g., Nieves-Villanueva, 133 F.3d at 100 ("the judge's expert knowledge of the law makes any such assistance at best cumulative, and at worst prejudicial") (emphasis added). Mutual's request to exclude such testimony is therefore granted. See Fed.R.Evid. 403. If Bartlett wants the jury to know what relevant FDA regulations require, she can propose appropriate jury instructions. And if she wants to show the jury that Mutual violated them, she may do so by introducing evidence of Mutual's acts or failures to act, rather than conclusory opinions from her experts.

iv. Calling Mutual "negligent" (Request B.3)

A related issue is whether Bartlett's experts may describe Mutual's conduct as "negligent," which they repeatedly do in their expert reports. The general rule is that "testimony in the form of an opinion or inference otherwise admissible is not objectionable because it embraces an ultimate issue to be decided by the trier of fact." Fed.R.Evid. 704(a). But that rule "does not vitiate the rule against expert opinion on questions of law."Nieves-Villaneuva, 133 F.3d at 100. Nor is it "a carte blanche for experts to substitute their views for matters well within the ken of the jury." Dinco v. Dylex Ltd., 111 F.3d 964, 973 (1st Cir. 1997).

Courts have generally prohibited experts from using the term "negligent" to describe the defendant's conduct in a negligence case where the opposing party objects to it. See 4 Weinstein's Federal Evidence § 704.04[1], at 704-10 (2d ed. 1997) (citingAndrews v. Metro N. Commuter R.R., 882 F.2d 705, 708 (2d Cir. 1989), and Owen v. Kerr-McGee Corp., 698 F.2d 236, 240 (5th Cir. 1983)); see also Persinger v. Norfolk W. Ry. Co., 920 F.2d 1185, 1189 (4th Cir. 1990); Shahid v. City of Detroit, 889 F.2d 1543, 1547 (6th Cir. 1989). In light of Mutual's objection, Bartlett's experts may not use that term at trial to describe Mutual's conduct.

v. Qualifications (Request C)

Mutual also argues that Drs. Tackett and Salisbury lack sufficient expertise to testify about drug labeling and FDA regulatory procedures, because neither has ever worked for the FDA or a drug manufacturer, and both misused FDA terminology at their depositions. "It is not required," however, "that experts be `blue-ribbon practitioners' with optimal qualifications."United States v. Vargas, 471 F.3d 255, 262 (1st Cir. 2006) (affirming admission of fingerprint expert's testimony even though he could not answer certain questions about fingerprint characteristics). They need only be sufficiently "qualified . . . by knowledge, skill, training, or education" to offer a reliable opinion. Fed.R.Evid. 702.

Dr. Tackett easily meets that standard. He has been a pharmacologist for more than 30 years, is a professor of pharmacology at the University of Georgia (where he has offered classes on FDA regulations and even conducted workshops for FDA employees), and has worked as a research investigator for various drug manufacturers. He also recently received a grant from a group of state Attorneys General to educate health care professionals about how to evaluate drug information. As another federal court recently concluded in allowing Dr. Tackett to testify, this "extensive experience" is enough to qualify him as an expert in this area. Lofton v. McNeil Consumer Specialty Pharms., 05-cv-1531, 2008 WL 4878066, at *9 (N.D. Tex. July 25, 2008).

Dr. Salisbury's qualifications make for a closer call. He is certainly well qualified to testify about SJS/TEN by virtue of his 36 years as a burn surgeon and his treatment of more than 400 patients with the disease. But his experience with drug labeling and the FDA is less extensive. His most significant credential is that he served as the lead author of a citizen's petition filed with the FDA in 2005, after Bartlett's injuries, that resulted in the addition of a more explicit SJS/TEN warning to NSAID labels. See Bartlett, 2010 DNH 112, at 15 n. 6. In his capacity as a professor of plastic surgery, he also "instructs his students [on] how to review [drug] labels . . . so that they can appropriately communicate warnings to their patients."Lofton, 2008 WL 4878066, at *9.

While Dr. Salisbury may not be the optimal witness for this type of case, another federal court recently concluded that "his extensive practical experience with SJS/TEN patients and the efficacy of warning labels in the clinical setting" qualified him to testify about the adequacy of an NSAID's label. Id. This court agrees. Dr. Salisbury falls in the same camp as Mutual's corresponding expert Dr. Stern: both of them clearly know more about SJS/TEN than about drug labeling, but nevertheless have enough knowledge and experience to testify about the adequacy of Sulindac's safety warning as it relates to SJS/TEN. See Part III.A.ix, supra. Mutual's request to exclude Drs. Tackett and Salisbury from testifying due to a lack of qualifications is therefore denied.

vi. Mutual's ethics and motives (Requests D.1.a, D.2)

Mutual argues that Drs. Tackett and Salisbury should be precluded from testifying about the ethics or morality of Mutual's decisions or about Mutual's motive or state of mind in making them. Bartlett concedes, in response, that "other than state of mind as might plainly appear on a document or from deposition testimony," she will not "offer any opinions from Drs. Tackett or Salisbury on ethical obligations, state of mind, knowledge or intent." In light of that concession, which the court interprets to cover motive as well, Mutual's request to exclude such testimony is moot. Any remaining objections in this area that Mutual may have can be made at trial.

vii. Generic drug labeling (Requests D.1.a, D.2)

Mutual also seeks to preclude Drs. Tackett and Salisbury from testifying that if Mutual had attempted to strengthen Sulindac's safety warning, the FDA would have approved those changes based on the information in the medical literature. Such testimony is indeed speculative on this record, for reasons that this court explained in its recent summary judgment ruling, see Bartlett, 2010 DNH 112, at 15, and in denying Bartlett's analogous request to exclude Mutual's experts from speculating that the FDA wouldnot have allowed such changes. See Part III.A.i, supra (citing In re Rezulin, 309 F. Supp. 2d at 550, which excluded an expert's "speculation as to what FDA might have done in hypothetical circumstances"). As such, it lacks a sufficient foundation to satisfy Rule 702. Mutual's request to exclude such testimony is granted. viii. Sulindac's risk of SJS/TEN (Request D.1.b)

Next, Mutual argues that Bartlett's experts should not be allowed to suggest that Sulindac carries a higher risk of SJS/TEN than other NSAIDs or other drugs. Mutual argues that such testimony is speculative, because the available evidence on that point — including, in particular, the adverse event data reported by Maja Mockenhaupt et al., The Risk of SJS and TEN Associated with NSAIDs: A Multinational Perspective, 30 Journal of Rheumatology 2234-2240 (Oct. 2003) — is largely anecdotal and not statistically significant. But Bartlett's experts acknowledged the limits of the data at their depositions, so this is really an issue for cross-examination, as opposed to outright exclusion. Moreover, a recently discovered draft of the study suggests that the data might be more extensive than is apparent from the published article. See document no. 251 (ordering supplemental depositions regarding that draft). Mutual's request to exclude testimony on this topic is denied.

Mutual also argues that Dr. Tackett should be prohibited from using information about Bactrim, another drug that Mutual manufactures and that has been linked to SJS/TEN, to support his opinion about what Mutual should have done with respect to Sulindac. Mutual argues that whether Bactrim creates a risk of SJS/TEN has no bearing on whether Sulindac creates such a risk and that, even it did, Mutual acquired Bactrim only one month or so before Bartlett filled her prescription. But those issues also go to weight, not admissibility. Mutual's request to exclude such testimony is denied.

ix. Treating physicians (Request E)

Finally, Mutual seeks to exclude Bartlett's treating physicians from offering any expert testimony at trial, since they did not prepare expert reports pursuant to Fed.R.Civ.P. 26(a)(2)(B). Both parties agree, however, that "Rule 26(a)(2)(B) reports are not required as a prerequisite to a treating physician expressing opinions as to causation, diagnosis, [and] prognosis . . . where they are based on the [plaintiff's] treatment," provided, as is the case with each doctor, that the witness has been properly designated as an expert under Rule 26(a)(2)(A). Sprague v. Liberty Mut. Ins. Co., 177 F.R.D. 78, 81 (D.N.H. 1998) (Muirhead, M.J.); see also Aumand v. Dartmouth Hitchcock Med. Ctr., 611 F. Supp. 2d 78, 87-89 (D.N.H. 2009). Bartlett has disavowed any intent to present testimony that goes beyond that scope.

To the extent that the parties may disagree about where the line should be drawn between "treatment" opinions and "non-treatment" opinions (which is not entirely clear from their briefing), those disagreements can be resolved at trial, in accordance with the basic principle set forth above. As a general matter, Bartlett's treating physicians may testify about whether Sulindac caused Bartlett's injuries, provided that they reached that conclusion in a reliable manner while examining and treating Bartlett. See Sprague, 177 F.R.D. at 81. But they should not be asked "hypothetical question[s]" about causation that "include[] information not learned during the course of treatment." Vosburgh v. Bourassa, 2008 DNH 133, at 7-8 (McAuliffe, C.J.). Such opinions would render them "witness[es] . . . retained or specially employed to provide expert testimony in the case," requiring expert reports under Fed.R.Civ.P. 26(a)(2)(B), which were not produced.

As set forth above, Bartlett's motion to exclude or limit Mutual's expert testimony is GRANTED in part and DENIED in part. Mutual's corresponding motion to exclude or limit Bartlett's expert testimony is also GRANTED in part and DENIED in part.