Bartlett v. Mut. Pharm. Co. Inc.

• Decision Date: 22 July 2010
• Docket Number: Civil No. 08–cv–358–JL.
• Citation: 742 F.Supp.2d 182
• Parties: Karen L. BARTLETTv.MUTUAL PHARMACEUTICAL COMPANY, INC.
• Court: U.S. District Court — District of New Hampshire

742 F.Supp.2d 182

Karen L. BARTLETT

v.MUTUAL PHARMACEUTICAL COMPANY, INC.

Civil No. 08–cv–358–JL.

United States District Court, D. New Hampshire.

July 22, 2010.

Bryan Ballew, Keith M. Jensen, Patrick J. O'Neal, Eric Roberson, Jensen Belew & Gonzalez PLLC, Fort Worth, TX, Christine M. Craig, Timothy P. Beaupre, Shaheen & Gordon, Dover, NH, for Karen L. Bartlett.Jeffrey D. Geoppinger, Joseph P. Thomas, Linda E. Maichl, Paul J. Cosgrove, Ulmer & Berne LLP, Cincinnati, OH, Stephen J. Judge, Wadleigh Starr & Peters PLLC, Manchester, NH, for Mutual Pharmaceutical Company, Inc.

MEMORANDUM ORDER

JOSEPH N. LAPLANTE, District Judge.

This products liability case presents numerous disputes over the admissibility of expert testimony. Plaintiff Karen Bartlett, who took the generic drug Sulindac and suffered severe side effects, brought suit against the drug's manufacturer, Mutual Pharmaceutical Company, asserting state-law claims of strict products liability and negligence based on defective design. She alleges, in particular, that Sulindac's safety risks outweigh its medical benefits, making it an unreasonably dangerous product. This court has subject-matter jurisdiction under 28 U.S.C. § 1332(a)(1) (diversity), because Bartlett is a New Hampshire citizen and Mutual is located in Pennsylvania.

Earlier in the case, this court denied Mutual's motion for judgment on the pleadings, see Fed.R.Civ.P. 12(c), rejecting the argument that Bartlett's claims were pre-empted by federal law. Bartlett v. Mut. Pharm. Co., 659 F.Supp.2d 279 (D.N.H.2009). After discovery, both parties moved for summary judgment. See Fed.R.Civ.P. 56. This court recently granted each of their motions in part, eliminating several claims and defenses, but allowing Bartlett to proceed to trial on her defective design claims. Bartlett v. Mut. Pharm. Co., 2010 DNH 112, 731 F.Supp.2d 135 (D.N.H.2010).

Both parties have now moved to exclude or limit the testimony of each other's expert witnesses at the upcoming trial. See Fed.R.Evid. 702. After reviewing their submissions, this court grants the motions in part and denies them in part. The parties' experts have sufficient qualifications and a sufficient foundation to support most of their proffered opinions. But they may not offer legal opinions that impinge upon the roles of the judge and jury, nor may they speculate about what the Food & Drug Administration (“FDA”) would have done in hypothetical circumstances.

I. Applicable legal standard

“The touchstone for the admission of expert testimony in federal court litigation is Federal Rule of Evidence 702.” Crowe v. Marchand, 506 F.3d 13, 17 (1st Cir.2007). Rule 702 provides:

If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education, may testify thereto in the form of an opinion or otherwise, if (1) the testimony is based upon sufficient facts or data, (2) the testimony is the product of reliable principles and methods, and (3) the witness has applied the principles and methods reliably to the facts of the case.

Fed.R.Evid. 702. As the structure of this rule suggests, before the jury can consider expert testimony over the adverse party's objection, the trial judge, serving as “gatekeeper,” must determine whether the testimony has a proper foundation. See, e.g., Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 597, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993). The party introducing the testimony bears the burden of proving its admissibility. Id. at 592, 113 S.Ct. 2786. “Rule 702 has been interpreted liberally in favor of the admission of expert testimony.” Levin v. Dalva Bros., Inc., 459 F.3d 68, 78 (1st Cir.2006).

While presented as Rule 702 challenges, many of the parties' requests would be more accurately described as motions in limine, since they seek to exclude testimony for lack of relevance rather than lack of foundation. Like all evidence, expert testimony must be relevant to the issues in the case. See, e.g., United States v. Pena, 586 F.3d 105, 110 (1st Cir.2009). Evidence is relevant if it has “any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence.” Fed.R.Evid. 401. The relevance standard is also interpreted liberally. See, e.g., Mitchell v. United States, 141 F.3d 8, 14 (1st Cir.1998).

II. Background

The factual and procedural background of this case is set forth in the recent summary judgment ruling, Bartlett, 2010 DNH 112, at 3–8, 2010 WL 2765358, at *1–5, 731 F.Supp.2d at 141–46, and need not be repeated here.

III. AnalysisA. Bartlett's motion

Bartlett has made 37 requests to exclude or limit testimony by Mutual's experts. Some of her requests will be analyzed together, since they involve closely related issues.

i. Generic drug labeling (Requests 1–8, 22, 29–30)

The first issue raised by Bartlett's motion is whether Mutual's experts may testify about federal law, FDA policy and procedure, or industry practice with regard to generic drug labeling.¹ This court has already ruled that federal law allows generic drug manufacturers to strengthen a generic drug's safety warning unilaterally. See Bartlett, 659 F.Supp.2d at 302. But Mutual's experts intend to testify that such changes would be inconsistent with the “real-life” FDA policy and industry practice, which is for only the manufacturer of the brand-name or “reference listed” drug to make such changes. Bartlett argues that this testimony must be excluded from trial because it would be contrary to this court's legal ruling and thus confusing to the jury.

Since “it is the judge's role, not a witness's, to instruct the jury on the law,” this court “has broad discretion to exclude expert opinion evidence about the law that would impinge on the roles of the judge and the jury” or would cause “jury confusion.” Pelletier v. Main St. Textiles, LP, 470 F.3d 48, 54–55 (1st Cir.2006). Indeed, “[e]xpert testimony proffered solely to establish the meaning of a law is presumptively improper.” United States v. Mikutowicz, 365 F.3d 65, 73 (1st Cir.2004); see also Nieves–Villanueva v. Soto–Rivera, 133 F.3d 92, 99 (1st Cir.1997). And even if such testimony has independent factual significance, i.e., aside from the content of the law, it still may be excluded “if its probative value is substantially outweighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury.” Fed.R.Evid. 403; see also United States v. Ahrendt, 560 F.3d 69, 76 (1st Cir.2009).

As an initial matter, Mutual concedes that its experts cannot and will not “provide testimony that interprets any statutes or regulations.” This concession is well taken. Again, such testimony would be presumptively improper. See Mikutowicz, 365 F.3d at 73. It would also be unfairly prejudicial to Bartlett and confusing to the jury, because it would conflict with this court's legal rulings and, presumably, its jury instructions. Since Mutual has not opposed that part of Bartlett's request, it is granted. No defense experts may testify about the meaning or applicability of the law. See Fed.R.Evid. 403; Pelletier, 470 F.3d at 54–55 (affirming exclusion of expert testimony regarding applicability of federal workplace safety regulations).

Mutual argues that, so long as its experts steer clear of the actual statutes and regulations, they should be allowed to testify about FDA policy and procedure. But such testimony raises many of the same concerns, because it is based largely on FDA documents that analyze or parrot the language of the relevant statutes and regulations. Indeed, they are some of the very same documents that this court interpreted in its earlier ruling. See, e.g., Bartlett, 659 F.Supp.2d at 293 n. 19 (rejecting Mutual's interpretation of 2004 industry guidance); id. at 294 n. 21 (rejecting Mutual's interpretation of “the FDA's remarks in proposing and promulgating these regulations”). The testimony is thus a roundabout way of challenging this court's ruling. As such, it creates the same danger of undue prejudice and confusion as testimony about the statutes and regulations themselves. See Fed.R.Evid. 403.

Moreover, Mutual's experts have not pointed to any evidence of the supposed policy in action, so their testimony about it amounts to little more than “speculation as to what FDA might have done in hypothetical circumstances.” In re Rezulin Prods. Liab. Litig., 309 F.Supp.2d 531, 550 (S.D.N.Y.2004) (excluding such speculation). Both parties seem to agree that there is no historical evidence, at least in this record, that the FDA has either accepted or rejected previous attempts by generic drug manufacturers to unilaterally strengthen a drug warning. So the policy is not based on what the FDA has actually done; rather, it is based on what the FDA purportedly believed or would have done, according to former FDA officials. Such testimony is not sufficiently reliable to satisfy Rule 702(2).

If Mutual had “simply no other practical means to prove the point,” then this court might be more inclined to admit the testimony about FDA policy and procedure, despite its problems. United States v. Fields, 871 F.2d 188, 198 (1st Cir.1989); see also United States v. Scott, 270 F.3d 30, 51 (1st Cir.2001) (noting that the “availability of other means of proof” is an “appropriate factor” to consider in determining whether evidence should be excluded). But that is not the case. Mutual can make its point effectively through testimony about industry practice, without needing to try to cast it as a matter of FDA policy and procedure. Specifically, Mutual's experts can testify that the longstanding industry practice is for the manufacturer of the brand-name or “referenced listed” drug to make changes to the drug's label, and for generic manufacturers...