Cisson v. C. R. Bard, Inc. (In re C. R. Bard, Inc., Pelvic Repair System Prods. Liab. Litig.)
| Decision Date | 23 July 2013 |
| Docket Number | 2:11-cv-00195,MDL No. 2187 |
| Court | U.S. District Court — Southern District of West Virginia |
| Parties | In re: C. R. BARD, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO CIVIL ACTION NUMBERS: Cisson, et al. v. C. R. Bard, Inc. |
(Plaintiffs' Motion for Clarification on the Court's Ruling on Bard's Failure to Test, and
for a Ruling on Bard's Objections to Evidence that Bard Claims "Implies Bard had a Duty
to Conduct Clinical Trials or Additional Testing)
Pending before the court is the Plaintiffs' Motion for Clarification on the Court's Ruling on Bard's Failure to Test, and for a Ruling on Bard's Objections to Evidence that Bard Claims "Implies Bard had a Duty to Conduct Clinical Trials or Additional Testing" [Docket 352].1 Bard filed a response, and this motion is ripe for review. For the reasons discussed below, the plaintiffs' motion is GRANTED. My clarifications and rulings are set forth below.
The instant motion implicates two evidentiary issues: evidence regarding Bard's failure to conduct testing and evidence related to the FDA 510(k) process. These issues were first raised in the parties' motions in limine, where the plaintiffs moved to exclude evidence related to the FDA 510(k) process and lack of enforcement and Bard moved to exclude evidence or argument that it owed or breached an independent duty to conduct additional testing or inspection. . I held that evidence related to the FDA 510(k) process and lack of enforcement should be excluded, but declined at the time to rule conclusively on the testing or inspection evidence, noting that "evidence regarding Bard's testing or inspection generally, or lack thereof, may be relevant to whether Bard 'knew or should have known' of the alleged dangers in the Avaulta products." (Mem. Op. & Order [Docket 302], at 6).
On Saturday, July 6, 2013, two days prior to trial, the parties informed the court of disagreements with regard to Bard's objections to the plaintiffs' deposition designations. I directed the parties to submit short briefs by the next morning, held a hearing, and ruled on the issue in the afternoon. The focus of the July 7, 2013, briefing and hearing was Bard's assertion that evidence regarding lack of clinical testing was "inextricably tied to the 510(k) process and FDA clearance." (Def. Bard's Br. in Supp. of its Objections to Pls.' Dep. Designations Related to the Lack of Clinical Trials [Docket 318], at 1). The plaintiffs focused on the issue of whether "Bard's testing (or failure to test) may bear on whether Bard 'knew or should have known' of the dangers of the Avaulta products." . The plaintiffs briefly argued that this evidence is "among the factors that bear on the reasonableness of a manufacturer's design decision" and that it would be unfair for Bard's witnesses to testify about testing and studies that were conducted while simultaneously excluding the plaintiffs from presenting evidence regarding testing and studies that were not conducted. (Id.). I ultimately ruled that:
(Mots. Hr'g Tr. [Docket 319], at 30:14-31:4) (emphasis added). In sum, my ruling only went to the admissibility of the lack of testing evidence in connection with the plaintiffs' failure to warn claim.
In the instant motion, the plaintiffs present three arguments.2 First, the plaintiffs offer evidence that they argue should satisfy my ruling requiring them to show that the testing that the plaintiffs allege Bard should have done would have revealed the defects or dangers that they allege Bard should have known and of which they should have warned. Second, the plaintiffs brief in full their assertion that evidence as to Bard's lack of testing is admissible for purposes of the risk-utility analysis under Georgia design defect law. Finally, the plaintiffs also brief in full their assertion that evidence as to Bard's lack of testing is admissible for the purpose of supporting their claim for punitive damages.
The plaintiffs argue that "[w]hile requiring Plaintiffs to prove what unperformed testing would have shown imposes an improper and onerous burden, the evidence in this case demonstrates what "[r]easonable, developed human skill and foresight" would have revealed if Bard had done the testing that Plaintiffs contend should have been done." (Pls.' Mot. for Clarification [Docket 352], at 10). Nonetheless, the plaintiffs' very motion states that "Bard . . .had a legal duty to warn of every danger or effective condition involving the Avaulta products that "reasonable, developed skill and foresight" would have revealed." (Id.) (emphasis added).
Bard frames my ruling as requiring the plaintiffs to lay a foundation by presenting evidence regarding "1) what results [a] study would have shown; 2) whether the results constituted information of a new risk or defect; and 3) whether the newly identified risk or defect is causally related to the injuries alleged." (Bard's Resp. [Docket 354], at 11). My prior ruling is hereby clarified to require all three of these elements to lay the foundation for the plaintiffs' evidence regarding Bard's failure to test in connection with the plaintiffs' failure to warn claims. First, without evidence as to what the study would have shown, the failure to test is merely speculative of what Bard "should have known." Second, if the results would not have shown a new risk or defect, the failure to test would not be relevant to what Bard "should have known."
After reviewing the evidence proffered by the plaintiffs, I FIND that such evidence is insufficient to lay the foundation for admitting evidence regarding Bard's lack of testing on the plaintiffs' failure to warn claim. The plaintiffs point to studies that Dr. James Ross, Bard's medical consultant, proposed. The plaintiffs argue that one study was proposed "to determine the cause, incidence and appropriate treatment of delayed healing and mucosal erosion." (Pls.' Mot. for Clarification [Docket 352], at 10). The plaintiffs argue that a second study was proposed, after the product was on the market, to "collect additional data validating the long-term safety and effectiveness of the Avaulta Plus, and was expressly intended to examine the onset date, resolution date, severity, seriousness, frequency, treatment and outcome of potential adverse events." (Id. at 11) (internal quotation marks removed) (emphasis removed).
The plaintiffs then conclude that "[i]f Bard had undertaken to perform the study proposed by its medical advisor, it would have learned these critically important facts." (Id. at 12)(emphasis added). The plaintiffs reason that "Bard cannot dispute that these are facts that Bard would have learned had it conducted this proposed study because learning such facts was the very purpose of the study." (Id.). Additionally, the plaintiffs also argue that "actual clinical results" of Bard's products is evidence of what Bard would have learned from the studies proposed by Dr. Ross. (Id. at 13). Essentially, the plaintiffs reason that the studies Bard failed to conduct would have revealed adverse reactions because Dr. Ross proposed studies intending to study these reactions and because evidence shows that these reactions exist. The proposed studies and the evidence, however, do not answer the question of whether the studies, if actually conducted, would have revealed these adverse reactions.
Additionally, the plaintiffs argue that "Bard has the results of actual clinical studies done on the original Avaulta device (made by Sofradim), as well as more recent studies done on the Avaulta Plus and/or Avaulta Solo devices." (Id.). In support, the plaintiffs cite to six papers published between 2008 and 2013 involving studies conducted on various Avaulta products. However, the plaintiffs appear to offer these studies as standalone evidence. Statements contained in learned treatises, such as those at issue in these studies, only fall within the hearsay exception under Federal Rule of Evidence 803(18) if "the statement is called to the attention of an expert witness on cross-examination or relied on by the expert on direct examination" and "the publication is established as a reliable authority by the expert's admission or testimony, by another expert's testimony, or by judicial notice." Fed. R. Evid. 803(18). If both conditions are met, the statement is admissible and "may be read into evidence but not received as an exhibit." Id.
The plaintiffs provide no basis for how they intend to introduce these clinical studies at trial; they simply argue that "Bard cannot plausibly deny that the results of these recent studiesare relevant and reflective of what clinical studies would have revealed, had Bard not refused to conduct them." (Pls.' Mot. for Clarification [Docket 352], at 14). Furthermore, a review of these scientific studies reveals that they may not be entirely applicable to the instant matter. The product implanted in Ms. Cisson was the Avaulta Plus Posterior Biosynthetic...
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