Bartlett v. Mutual Pharmaceutical

2010 DNH 131
District Court, D. New Hampshire·Decided August 2, 2010·No. CV-08-358-JL·Published·Cited by 4 cases

Opinion

Bartlett v. Mutual Pharmaceutical CV-08-358-JL 8/2/10

UNITED STATES DISTRICT COURT DISTRICT OF NEW HAMPSHIRE

Karen L. Bartlett

v. Civil No. 08-cv-358-JL Opinion No. 2010 DNH 131

Mutual Pharmaceutical Company, Inc.

SUMMARY ORDER

Mutual has moved in limine to exclude various types of evidence from the upcoming trial. See L.R. 16.2(b)(3). This court will address each of its motions in turn.

Motion #1: Adverse event reports Mutual seeks to exclude evidence of adverse drug event reports received by the Food & Drug Administration ("FDA") or the World Health Organization ("WHO"), arguing that such reports are hearsay and that Bartlett has not demonstrated that the underlying cases involved sufficiently similar circumstances. This motion is granted in part. The reports are indeed hearsay "if offered to prove the truth of the matter[s] asserted" in them, i.e., that Sulindac caused SJS/TEN in a particular case. Fed. R. Evid. 8 0 1 (c). Bartlett has not argued that they fall within any hearsay exception. Thus, the reports may not be offered for that purpose.

The reports are not hearsay, though, if offered to prove that the FDA was on notice of Sulindac's safety risks, or that Mutual should have been on notice of such risks.1 See Kelley v. Airborne Freight Corp., 140 F.3d 335, 346 (1st Cir. 1998); Golod v. Hoffman La Roche, 964 F. Supp. 841, 855 (S.D.N.Y. 1997) (adverse event "reports are not hearsay, because they are offered not as proof of the fact that [the drug] caused the reported blindness, but as evidence that [the defendant] was on notice of potentially serious optical side effects"). If Bartlett seeks to admit them for that purpose. Mutual may reguest a limiting instruction and/or seek other limits on their use (e.g., to reguire redactions, or allow only summaries rather than the reports themselves) to prevent any unfair prejudice. See Fed. R. Evid. 403.

This court disagrees, however, with Mutual's argument that the underlying cases need to be similar to this case "in all respects" for the reports to be admitted on the issue of notice. They need only be "substantially similar." Moulton v. Rival Co., 116 F.3d 22, 26-27 (1st Cir. 1997); McKinnon v. Skil Corp., 638

'This court recently ordered the parties to brief the issue of whether Bartlett has trialworthy claims for negligence or enhanced compensatory damages and, if not, whether evidence of Mutual's alleged fault is admissible to support her claim for strict liability (see doc. 281). The court expresses no opinion on those issues here, other than to note that any pre-trial evidentiary rulings that reject challenges to evidence of Mutual's fault may need to be revisited after such briefing.

F.2d 270, 277 (1st Cir. 1981). Here, each of the reports concerns a patient who allegedly suffered SJS/TEN after taking Sulindac. That is a sufficient similarity to support their admission, at least for notice purposes. See Golod, 964 F. Supp. at 855.

Finally, Bartlett's experts may testify based on the reports if, and to the extent that, they are "reasonably relied upon by experts in the particular field," notwithstanding any hearsay problems. Fed. R. Evid. 703; see also In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 200 (S.D.N.Y. 2009) (allowing experts to testify based on such reports in another case involving a rare disease, but noting a split of authority on that issue). The reports themselves "need not be admissible in order for the [expert] opinion or inference to be admitted." Fed. R. Evid. 703. That does not mean, however, that Bartlett's experts may recite the contents of the reports or share copies with the jury. Id.

Motion #2: Other litigation Mutual seeks to preclude references to other litigation involving Sulindac or other NSAIDs. Since Bartlett has no objection to this motion, it is granted. See Fed. R. Evid. 401- 403; Bartlett v. M u t . Pharm. Co., 2010 DNH 125, 9 (granting a

similar motion in limine filed by Bartlett). This ruling does not restrict either party from cross-examining each other's expert witnesses about their involvement in other cases, even if those cases involved Sulindac or other NSAIDs.

Motion #3: FDA's resources Mutual seeks to exclude evidence of the FDA's alleged lack of resources and inability to monitor the safety of all drugs, arguing that such evidence has no probative value and is unfairly prejudicial. This motion is denied. Such evidence is relevant in determining how much weight, if any, should be given to the FDA's approval of Sulindac as safe and effective for its directed uses, and the FDA's approval of the drug's warning. See Fed. R. Evid. 401, 402. As a counterpoint to Mutual's evidence of those FDA approvals, the evidence is not unfairly prejudicial. See Fed. R. Evid. 403. Bartlett is reminded, however, that her use of such evidence may "open the door" to contrary evidence from Mutual about the FDA's resources and abilities. See Bartlett, 2010 DNH 125, at 10.

Motion #4: Subsequent label changes Mutual seeks to exclude evidence of certain changes to Sulindac's warning label that occurred after Bartlett's

prescription, arguing that they are inadmissible as "subseguent remedial measures," see Fed. R. Evid. 407, and are unfairly prejudicial, see Fed. R. Evid. 403. The label changes resulted from a citizen's petition filed with the FDA by a group of doctors (including two of Bartlett's experts) in 2005. Although the petition related specifically to the drug ibuprofen and its risk of SJS/TEN, the FDA responded by reguiring the manufacturers of all NSAIDs, including Sulindac, to insert a specific SJS/TEN warning into their drug labels. See Bartlett v. Mut. Pharm. Co., 2010 DNH 112, 15 n.6 (guoting the warning).

Many courts have deemed evidence of post-prescription label changes inadmissible as "subseguent remedial measures" under Rule 407. See, e.g., Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 270-72 (5th Cir. 2002); DeLuryea v. Winthrop Labs., 697 F.2d 227, 229 (8th Cir. 1983); Werner v. Upjohn Co., 628 F.2d 848, 853 (4th Cir. 1980). This case is different, though, because the changes were mandated by the FDA for an entire class of drugs, not implemented by Mutual as a remedial measure specific to Sulindac. "Rule 407 applies only to subseguent remedial measures taken voluntarily by the defendant," Raymond v. Raymond Corp., 938 F.2d 1518, 1524 (1st Cir. 1991) (emphasis in original), and thus does not apply to broader government-mandated measures of this sort. See, e.g., 2 Weinstein's Federal Evidence § 801.30[4], at 801-55 (2d ed. 1997) (citing Sabel v. Mead Johnson & Co., 737 F. Supp.

135, 141 (D. Mass. 1990), which admitted FDA letter recommending that manufacturer strengthen its drug label).

Since Rule 407 presents no barrier to admission of the post­ prescription label changes, this court "must consider under Rule 403 whether [their] probative value is outweighed by the danger of unfair prejudice and confusion." Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 94 (2d Cir. 1980); see also Raymond, 938 F.2d at 1524. Of course, such changes can be highly probative of the label's adeguacy, in that they may indicate an inaccuracy or omission in the prior label. But the danger is that they could be valued too highly by the jury, i.e., viewed as an implicit admission of inadeguacy by the manufacturer. Some courts have excluded evidence of label changes on that basis. See, e.g.. Gray v. Hoffman-La Roche, Inc., 82 Fed. Appx. 639, 646 (10th Cir. 2003); Lindsay, 637 F.2d at 94.

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