DocketNumber: C.A. Nos. 07-5058, 07-4048, 07-1706, 07-3666
Judges: GIBNEY, J.
Filed Date: 5/15/2009
Status: Precedential
Modified Date: 7/6/2016
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."
In August 2006, the first products liability claims related to the hernia patches in question were filed against the Defendants. Currently, there are over 1000 such cases pending before this Court against these Defendants. On October 23, 2008, the Court heard oral arguments on Plaintiffs' motion to compel production of the Quintiles documents. After considering the parties' arguments, the Court ordered that the Quintiles documents be produced for an in camera review. The Court has completed its review and will now render a decision. *Page 3
In determining whether a document was prepared in anticipation of litigation, Rhode Island uses the "because of" test. Cabral v.Arruda,
The "because of" test is also used by many federal circuit courts.See, e.g., United States v. Roxworthy,
Since the language of Sup. R. Civ. P. 26(b)(3) is substantially the same as the comparable federal rule, this Court may look to federal court interpretations for guidance in this matter. See Hall v. InsuranceCo. of North America,
In protecting only documents prepared in "anticipation of litigation," the "because of" test does not protect documents "assembled in the ordinary course of business, or pursuant to public requirements unrelated to litigation, or for other nonlitigation purposes." Fed.R.Civ.P.
The work product doctrine also applies to documents created by agents for the attorney, provided the documents were created in anticipation of litigation. United States v. Nobles,
As support for this contention, the Defendants have produced the affidavit of Bard's then-general counsel, Judith Reinsdorf, who avers that the Quintiles audits were undertaken at her direction "to prepare for anticipated litigation" and that she "informed Quintiles before they began work that their audits and investigations were to enable the Bard Legal Department to provide Bard with legal advice, and that information acquired in the audit should only be relayed to Bard counsel or to those whom Bard counsel may direct." (Reinsdorf Aff.) The Defendants note that the affidavit postdates the December 2005 recall of certain models of the Composix Kugel Patch due to reported ring breaks leading to patient injuries. In those circumstances, Defendants argue, it would be difficult to imagine a general counsel of a medical device company not contemplating litigation.
The Plaintiffs respond that Quintiles was not hired in anticipation of litigation, but for the ordinary business purpose of addressing ongoing FDA compliance. The Plaintiffs insist that the Quintiles documents would have been created in essentially the same form irrespective of the current litigation and, therefore, they fail to meet Rhode Island's "because of" test. In addition, Plaintiffs note that subsequent remedial measures are both discoverable and admissible in Rhode Island.
The Plaintiffs point to certain circumstantial evidence that they suggest shows that Quintiles was hired solely to comply with FDA regulations. The Plaintiffs first point out that Quintiles, by its own description on its website, provides assistance with product development, marketing, and FDA compliance, not litigation strategies. Furthermore, *Page 7 based upon certain documents that have already been produced, Plaintiffs assert that Quintiles was hired by Defendants for the purpose of addressing an FDA inspection which occurred nearly a year before any lawsuits were filed. Among other documents, Plaintiffs cite an executive summary of the work performed by Quintiles, which describes its audit as "a full Quality Systems audit and a verification of the corrective action to the FDA form-483 observations issued in the January 2006 FDA audit." (Pl's Ex. I.)
Lastly, Plaintiffs point to numerous examples wherein Defendants have changed the privilege asserted with respect to particular Quintiles documents from self-critical analysis "undertaken to evaluate and ensure future compliance with internal regulatory policies" to "prepared at request and direction of legal counsel in anticipation of litigation." These recent revisions of Defendants' privilege log, Plaintiffs suggest, are further evidence that the Quintiles documents were truly prepared for the purpose of FDA compliance.
The Plaintiffs first argue that this Court should not accord significant weight to the affidavit of Bard's general counsel because it is "conclusory" of the fact that Quintiles was hired in anticipation of litigation. The Court agrees that "mere conclusory assertions that the material [wa]s prepared in anticipation of litigation are insufficient."Ordner v. *Page 8 K-H Corp., 1999 U.S. Dist. LEXIS 20887 at 6 (D.R.I. 1999); see alsoHenderson v. Newport County YMCA, ___ A.2d ___, No. 2007-308-M.P. 8 (R.I. 2009) (stating that "a party cannot create work product solely by the nomenclature used to entitle documents.").
The Court views the affidavit as evidence that Bard's General Counsel had a subjective belief that personal injury litigation was likely when she directed Quintiles to conduct audits and investigations into matters relating to the voluntary recall. Unless her belief is also "tempered by objective reasonableness," the affidavit, standing alone, is insufficient proof to establish entitlement to the work product privilege. See Martin v. Bally's Park Place Hotel Casino,
There is little question that the series of events that prompted the preparation of the Quintiles documents are ones that are likely to lead to litigation. The Court finds it significant that the December 2005 and March 2006 recalls were a direct response to reports that one of Bard's medical devices had allegedly caused serious patient injuries. Therefore, by the time Quintiles was hired, following the FDA inspection, potential products liability claims had already accrued. While it is true that the first lawsuits were not filed until some months later, it is not necessary that the documents be prepared after litigation has been commenced. Fireman's Fund Insurance Co. v.McAlpine,
Based upon the seriousness of both the reported injuries and the observations made by the FDA after the January 2006 inspection, the Defendants were on notice that it would almost certainly be facing claims. The Court disagrees with Plaintiffs' view that the situation gave rise to only "a remote prospect of future litigation." Binks Mfg.Co. v. National Presto Industries, Inc.,
The Plaintiffs next argue that the Quintiles documents would have been created in essentially similar form regardless of whether litigation ensued, and therefore, they fail to meet Rhode Island's "because of" test. See Cabral v. Arruda,
Nor is the Court persuaded that the Quintiles documents were prepared in the "ordinary course of business," as Plaintiffs contend. To the contrary, the facts suggest that Quintiles was hired due to extraordinary circumstances following events that would reasonably result in litigation. The Plaintiffs, however, argue that there is a distinction in the case law between "reports prepared in response to any unfortunate event that may well lead to litigation and material prepared as an aid to litigation." Ordner v. K-H Corp., 1999 U.S. Dist. LEXIS 20887 (D.R.I. Mar. 12, 1999) (citing Scott Paper Co. v. Ceilcote Co.,Inc.,
It is clear from the Court's review of the Quintiles documents that they are not simply "a more or less routine investigation" following unfortunate events. See id.; Binks,
The issue of whether a company complied or did not comply with FDA requirements is relevant to many aspects of the products liability lawsuit. For instance, the majority of states have held that violation of the Food Drug Cosmetic Act or its state law counterparts is negligence per se. See James T. O'Reilly, Food and DrugAdministration, § 26:1, note 5 (2d ed. 2005). The Plaintiffs allege negligence per se against these Defendants. (Brokaw complaint, ¶ 49.)
Compliance with FDA requirements is also a commonly asserted defense of drug and medical device manufacturers. See James L. Gilbert et al.,ALTA's Litigating Tort Cases, § 60:29 (2004). While only a few courts apply a complete "regulatory compliance defense," most courts considering the issue have held that "compliance with FDA *Page 11
regulations may be some evidence of due care." Id. at § 60:29;see, e.g., MacDonald v. Ortho Pharmaceutical Corp.,
Other than negligence, FDA compliance has a potential impact on other products liability theories as well:
Implied warranty litigation under Uniform Commercial Code theories is partially premised on the plaintiff's reliance on the FDA-regulated skill and judgment of the seller or manufacturer. . . . Misrepresentation theories are sometimes used where fraud is alleged, on the premise that the defendant manufacturer had knowledge of a material fact and concealed it from the FDA during the agency review process. And strict liability . . . operates without the need to prove negligence, where courts or legislative bodies have found a need for societal decisions to redistribute the costs of certain types of injuries once causation and injury have been established by the plaintiff. Food and Drug Administration, at § 26:1.
Here, in addition to negligence, the Plaintiffs allege breach of implied warranty, fraud, and strict products liability, among other theories that may implicate FDA policies and regulations. (Brokaw Complaint, counts 2, 5, and 7.)
Compliance with FDA requirements, therefore, often exerts a profound, yet subtle, effect on a products liability lawsuit. See Carl Tobias,FDA Regulatory Compliance Reconsidered, 93 Cornell L.Rev. 1003, 1004 (2008). Accordingly, the *Page 12 Court finds that hiring Quintiles to analyze and further Defendants' understanding of the FDA compliance issue is without question useful to this litigation.
The Plaintiffs next contend that since Defendants and all medical device manufacturers are required to comply with FDA regulations, the Quintiles documents were prepared pursuant to "regulatory requirements" and are therefore not protected. Nat'l Union,
Here, there is little question that one of the purposes, indeed the immediate purpose, behind creation of the Quintiles documents was to help Defendants comply with FDA regulations. However, the presence of a regulatory purpose does not defeat work product protection under the "because of" standard. "The `because of' approach is more inclusive than the approach taken by courts that require a document to be prepared `primarily or exclusively to assist in litigation." Moore, FederalPractice 3d, *Page 13 § 26.70[3][a]. As explained by the Ninth Circuit Court of Appeals inIn re Grand Ju Subpoena,
[t]he "because of" standard does not consider whether litigation was a primary or secondary motive behind the creation of a document. Rather, it considers the totality of the circumstances and affords protection when it can fairly be said that the "document was created because of anticipated litigation, and would not have been created in substantially similar form but for the prospect of that litigation[.]" In re Grand Jury Subpoena,
357 F.3d at 908 (quoting Adlman,134 F.3d at 1195 ).
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.
The Restatement provides the following definition of "litigation" in the context of the work product doctrine and is used by many courts:
`Litigation' includes civil and criminal trial proceedings, as well as adversarial proceedings before an administrative agency, an arbitration panel or a claims commission, and alternative-dispute-resolution proceedings such as mediation or mini-trial. It also includes a proceeding such as a grand jury or a coroner's inquiry or an investigative legislative hearing. In general, a proceeding is adversarial when evidence or legal argument is presented by parties contending against each other with respect to legally significant factual issues. Restatement (Third) of the Law Governing Lawyers § 87 cmt. h (2000).
"`Adversarialness' is the touchstone of this approach to the `litigation' question. . . ." In re Grand Jury Subpoena,
There is little question that the FDA has vast enforcement authority.Food and Drug Administration, at § 6:1. Indeed, the FDA's strongest enforcement powers appear to be within the medical device area.Id. at 18:13. A sampling of the FDA's device enforcement authority includes traditional methods, such as criminal prosecution, seizure, and injunctions, as well as special powers, like banning, notification, repair, refund, and replacement, administrative detention, device restriction, and civil penalties. Id.
Not all dealings with the FDA, of course, are "litigation" for purposes of the work product doctrine. Most courts have concluded that a governmental investigation itself generally does not constitute litigation, but that once a governmental investigation has begun, a corporation may reasonably be said to anticipate litigation. In re GrandJury Subpoena,
Accordingly to Professor Moore, "substantial need for material otherwise protected by the work product doctrine is demonstrated by establishing that the facts contained in the requested documents are essential elements of the requesting party's prima facie case."Federal Practice, § 26.70[5][c]. The Plaintiffs argue that they have *Page 16 "substantial need" for the Quintiles documents because they contain information essential to proving their negligence claim, i.e., how Defendants allegedly failed to comply with FDA regulations. Specifically, Plaintiffs allege that Defendants "breached their duty by failing to comply with state and federal regulations concerning the study, testing, design, development, manufacture, inspection, production, advertisement, marketing, promotion distribution, and/or sale of the Composix Kugel Patch." (Brokaw Complaint, ¶ 49.) In addition, the Plaintiffs point out that Defendants have pleaded affirmative defenses that make their compliance with FDA regulations relevant. (Def.'s answer, defenses 9, 14, 23.)
As discussed supra, the issue of whether Defendants complied with FDA regulations is highly relevant in this litigation. The information is an important aspect of Plaintiffs' negligence case and important to disproving Defendants' regulatory compliance defense, should the Court recognize it. The Court, therefore, accepts Plaintiffs' argument that they have substantial need for information about whether Defendants complied with FDA regulations.
However, the Court does not agree with Plaintiffs that the only way they can discover this information is through obtaining an audit report created by Defendants' consultant. A great deal of useful information on this issue is available directly from the FDA under the Freedom of Information Act. See Food and Drug Administration, § 26:2. Furthermore, to the extent that Plaintiffs hope to introduce the actions Defendants took following the recall, including hiring Quintiles, as evidence of subsequent remedial measures, those facts may be obtained though other means of discovery, such as depositions. The work product doctrine "does not protect facts concerning the creation of *Page 17 work product, or facts contained within work product." Moore,Federal Practice 3d, § 26.70[2][a]. The Plaintiffs have not yet taken the depositions of Defendants' employees who were involved with the recall process. What they did in response to the recall, the remedial measures that were taken, are discoverable, even though the Quintiles reports are not. The work product doctrine protects the analysis contained in the Quintiles reports, not what Defendants' employees did in response to Quintiles recommendations. Therefore, the Court concludes that Plaintiffs have thus far failed to make a sufficient showing that they are unable without undue hardship to obtain what they need through other discovery options. As discovery proceeds, however, the Court may revisit this issue if necessary.
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