Consultant’s Report Held to be Privileged Work Product

In Brokaw v. Davol (a state court case in the Kugel Mesh hernia patch litigation), Superior Court Judge Alice Gibney denied plaintiff’s motion to compel a consultant’s report and related documents over which the defendants had asserted the work product privilege. Here’s the factual background:

The disputed documents consist of an audit report and supporting documentation prepared by Quintiles Consulting (“Quintiles”), an independent consulting firm retained by Bard following Bard’s decision to voluntarily recall certain models of the Composix Kugel Hernia Patch in December 2005 and March 2006. The voluntary recalls were prompted by reports of patient injuries allegedly caused by the malfunction of a ring component inside some of the hernia patches. The first recall was followed by an inspection by the Food and Drug Administration (“FDA”) of Davol’s facilities in Cranston, Rhode Island in January and February 2006.1 Following the inspection, the FDA issued a Form 483 letter and an Establishment Inspection Report (“EIR”), which together made certain critical observations relative to Davol’s compliance with applicable federal regulations. Bard hired Quintiles shortly after the FDA inspection, and Quintiles consultants first appeared at the Davol site in May 2006. Quintiles subsequently issued several audit reports, one major report in June 2006 and two other reports in September and October 2006. The reports were addressed to Bard’s then-Vice President and General Counsel Judith Reinsdorf, and bear the label “subject to attorney work product doctrine.”

Judge Gibney said that Rhode Island’s “because of” test (from Cabral v. Arruda) provided for the protection of the defendants’ reports:

Based upon a review of the Quintiles documents and the circumstances surrounding their preparation, this Court concludes that it can fairly be said that one of the purposes behind their creation was anticipation of products liability litigation. Moreover, the documents would not have been prepared “but for” the prospect of litigation reasonably resulting from the reported injuries preceding the December 2005 and March 2006 recalls. The fact that the Quintiles documents also serve a regulatory purpose does not override the litigation purpose.

Finally, Judge Gibney found that the plaintiffs did, in fact, demonstrate a substanial need for the privileged documents.  However, the Court held that the plaintiffs had additional ways for discovering the information contained in the reports.


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