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Debra Acree, As Independent Administrator of the Estate of William Acree, Jr., Deceased v. Watson Pharmaceuticals

November 23, 2012


The opinion of the court was delivered by: Matthew F. Kennelly, District Judge:


In this order, the Court rules on defendants' motions in limine.

A. Comparison of Watson's patch design with "matrix" design (motion 4) The Court denies defendants' request to bar evidence relating to alternative

designs for fentanyl patches, including evidence relating to "matrix"-type patches. Defendants contend that plaintiff has made no claim of a design defect that is distinct from her other claims. This is incorrect. Plaintiff has asserted claims of strict product liability design defect and negligent design. The evidence supporting these contentions overlaps with the evidence supporting plaintiff's contention that there was a manufacturing defect, but this is not a basis for precluding evidence to support the design-based claims.

The evidence is plainly relevant and admissible. Nor is it unfairly prejudicial in a way that substantially outweighs its probative value. See Fed. R. Evid. 403.

Defendants' argument to the contrary essentially asks the Court to weigh all of the other evidence favorably to defendants and then use that as a predicate to preclude the alternative-design evidence. Defendants cite no case supporting that approach, which is fundamentally inconsistent with how Rule 403 is supposed to work. Evidence-weighing is a function for the jury, not the Court, and the Court has already ruled in denying summary judgment that plaintiff has offered sufficient circumstantial evidence to permit a jury to find in her favor.

B. Evidence of "products under development" (motion 7)

Defendants ask the Court to bar evidence regarding their development of an alternative patch design -- again, a matrix patch. They contend this is irrelevant on the question of whether defendants' design was defective. Plaintiff notes in response that in a report regarding the alternative design, prepared in late 2008 (a time relevant to plaintiff's claims), a Watson representative stated that the company had decided to design a matrix patch because it would be "easier to process and manufacture than liquid reservoir style system [sic] and won't exhibit some of the critical defects associated with liquid reservoir systems such as inadequate reservoir seals and the leaking of fentanyl gel from the reservoir." Pl.'s Resp. to Defs.' Mots. In Limine, Ex. 69. This evidence is unquestionably relevant and properly admissible on the issues of defect and notice, as well as on the question of "the manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility," a relevant consideration in a design defect case. Jablonski v. Ford Motor Co., ___ Ill. 2d___, 955 N.E.2d 1138, 1154 (2011). The Court denies defendants' motion.

C. Bobrowicz report (motion 8)

Defendants have moved to exclude a July 2008 report prepared by Greg

Bobrowicz, a consultant defendants hired to review their fentanyl patch manufacturing process in preparation for an inspection by the Food and Drug Administration. The report describes, among other things, deficiencies in defendants' process.

Defendants' objection that the FDA did not make any adverse findings following its inspection has no bearing on the admissibility of the report. Rather, this affects (if anything) only the report's weight.

Defendants contend that the report is inadmissible hearsay. Even if it were hearsay, the report -- at least the parts of it that concern problems in defendants' manufacturing process -- would be admissible to show that the defendants were on notice of these issues. Contrary to defendants' argument at the motion hearing, evidence that defendants were told at a relevant time that there was something wrong (or more than one thing wrong) with their patch manufacturing process is unquestionably relevant on the question of whether they exercised reasonable care.

In any event, the report is not hearsay. The evidence reflects that defendants hired Bobrowicz to review their patch manufacturing process and gave him access to their facilities, employees, and records. Defendants then distributed the report to Watson personnel who used it to prepare for the FDA inspection. These factors are sufficient to make Bobrowicz's report admissible as non-hearsay under Federal Rule of Evidence 801(d)(2)(D). See, e.g., Reid Bros. Logging Co. v. Ketchikan Pulp Co., 699 F.2d 1292, 1306-07 (9th Cir. 1983).

Defendants argue that the report is irrelevant because it does not deal with the particular patch that Mr. Acree was using when he died or the lot from which that patch came. This is a roundabout way of suggesting that only direct evidence is admissible. That is not the case. Evidence that at times prior to Mr. Acree's death defendants had (and were aware that they had) a manufacturing process that arguably was replete with flaws that led to defective patches and that defendants had inadequate quality control is relevant even if his report does not concern the particular patch or lot at issue in this case. As plaintiff notes, the report concerned the same manufacturing plant and the same equipment and process used to manufacture the patches that Mr. Acree was wearing. The report (or at least parts of it) is relevant, and for the same reason it has significant probative value that is not substantially outweighed by any claimed unfair prejudice defendants would experience from its admission.

It is unlikely, however, that the entire report is relevant, at least for purposes of plaintiff's case in chief. The material in the report regarding leakages, other failures in the manufacturing process, and problems with quality control is relevant and admissible with regard to (if nothing else) the questions of negligence and notice, even if it does not concern leakages in particular. A good deal of the rest of the 21-page report may be sufficiently tangential or confusing in a way that might render those portions subject to exclusion under Federal Rule of Evidence 403. The Court directs plaintiff to be prepared to show, at an appropriate point at or near the outset of the trial, which portions of the report she proposes to introduce in its case in chief so that the Court can hear from defendants and make a determination. (The Court notes that if defendants offer testimony by their manufacturing process expert in their case, there is a good chance that the entire Bobrowicz report will be admissible in rebuttal.)

D. Opinions of Michael Anisfeld (motion 11)

Defendants have moved to exclude the opinions of Michael Anisfeld.

They target his opinions that defendants' manufacturing process did not comply with the FDA's "good manufacturing processes" and that defendants should have stopped manufacturing fentanyl patches. Defendants also challenge Anisfeld's opinion that there is no guarantee that Watson's patches were not ...

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