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Not every mental impression a lawyer writes down in an adversarial situation receives work-product protection. So it happened in In re Grand Jury Subpoena, 220 F.R.D. 130 (D. Mass. 2004), a cautionary decision that suggests the desirability of contemporaneous documentation of the anticipated litigation that justifies protection. A look at an ongoing regulatory violation Attorney (the court kept the names of all parties and other factual details confidential) represented XYZ Corp. in regulatory dealings with the Food and Drug Administration (FDA) relating to medical devices XYZ manufactured. The devices were failing to meet factory specifications, and there were failures in the field. Therefore, the devices were “adulterated,” and each shipment of the devices by XYZ into interstate commerce was technically a violation of the federal Food, Drug and Cosmetic Act (FDCA). In theory, any such violation, however minor, can lead to administrative, civil or criminal enforcement proceedings. In practice, however, FDA’s responses to a known problem of shipping an adulterated device range from a notice or warning to a civil seizure or injunction action, to a civil penalty proceeding or a criminal prosecution. For court litigation, FDA must refer a matter to the Department of Justice. Although, for a misdemeanor violation, no mens rea is necessary, in general criminal enforcement is limited to serious cases of morally culpable conduct. Every day, in factory inspections, FDA notifies companies of what it considers ongoing conditions that violate the statute. Most violations are of requirements that are part of a system of multiple protections, in which a temporary absence of one protection does not immediately put patients at risk. Commonly, unless there is significant risk to health or a deliberate flouting of the agency’s authority, FDA withholds enforcement litigation and permits a company to continue shipping while it diligently solves the problem(s). During this process, companies commonly discuss with FDA the nature of the problem(s) and their proposed corrective action program, and they update FDA on their progress. In so doing, they are not engaging in conduct that could fairly be called a crime or a fraud. Automatic cessation of shipments of products technically in violation of the FDCA would seriously disrupt the health care system and harm public health. Sometimes it is clear that a violation is more than technical, that it puts patients or consumers at unnecessary risk. Therefore shipments must stop, and products already shipped must be recalled. Sometimes, however, whether a violation may actually put patients at risk is a matter for analysis and discussion; commonly, in such situations, shipments continue until FDA reaches a conclusion. Sometimes, shipments must stop until a problem is solved, but a recall is unnecessary. XYZ and Attorney began discussions with FDA at a time when both knew that XYZ was shipping adulterated devices, and that a recall was a realistic possibility because testing results showed that the devices were not meeting labeled specifications. Eventually, there was a recall. It was followed by a grand jury investigation as to whether, during the previous conversations between FDA and XYZ/Attorney, XYZ and Attorney had withheld material information from FDA and had made untrue statements. The grand jury subpoenaed Attorney’s notes of the conversations. XYZ, Attorney and his law firm moved for a protective order in reliance on the work-product doctrine. The court viewed the notes as reflecting Attorney’s opinions and thus entitled to “near absolute” protection if they were work product, but held the doctrine inapplicable because the notes had been prepared neither in anticipation, nor because, of litigation. Accordingly, it denied the motion. In general, the work-product doctrine protects against compelled disclosure materials that a party or its attorney or representative prepares in anticipation of litigation. The doctrine’s purpose is to advance the public interest in well conducted litigation by protecting from free-riding the intellectual effort that parties, their attorneys and other representatives put into documents in anticipation of litigation. Materials reflecting the mental impressions, conclusions, opinions or legal theories of an attorney or other representative receive a higher level of protection than do materials containing other kinds of work product. See Rule 26(b)(3), F.R. Civ. P. The court analyzed the element of “anticipation of litigation” as intended to exclude from protection documents prepared in the ordinary course of business that would have been created in substantially the same form without regard to litigation. Thus, it viewed this element as consisting of three components: (i) some identifiable litigation; (ii) a subjective anticipation of litigation as a realistic possibility, which anticipation is also objectively reasonable; and (iii) preparation of the materials because of the prospect of litigation. A strong showing on component (ii) can compensate for a weak showing on component (iii), and vice versa. Attorney’s notes apparently did not identify any anticipated litigation. Certainly, there was no anticipation of the criminal investigation that later occurred. Moreover, in the court’s view, neither an FDA regulatory investigation, by itself, nor mere negotiation with FDA constituted “litigation” for purposes of work-product protection. The court’s analysis of the possibility of products liability litigation merged into its analysis of the possibility of criminal enforcement resulting from the underlying violations. Was there not anticipation of enforcement litigation by FDA? The court held that there was not-on reasoning that, despite the court’s scholarly exposition of the law of work product, is questionable. The only type of enforcement action the court appears to have considered is criminal prosecution, which would have been based on violations (shipments of adulterated devices) that were far more than technical. The court viewed XYZ and Attorney as a Catch-22: If, as they maintained, XYZ’s violations were merely technical, then there was no reasonable prospect of an FDA-initiated criminal prosecution; if, however, XYZ was continuing to ship products it knew were in more than technical violation (i.e., were actually putting patients at risk), such that criminal prosecution and products liability litigation were realistic possibilities, then the crime-fraud exception would apply. An anticipation that FDA would take criminal enforcement action against a mere technical violation is indistinguishable from any other anticipation that a potential litigant will act irrationally. Such an anticipation does not satisfy the second element of the doctrine. The court failed to address, however, the alternative scenario presented by FDA’s civil remedy of seizure, which depends not on morally culpable conduct but on a regulated product having been shipped in interstate commerce and having been, or thereafter having become, significantly out of compliance. FDA defines the term “recall” as “a firm’s removal or correction of a marketed product that [FDA] considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or stock recovery.” 21 C.F.R. � 7.3(g) (2003). Thus, when an FDA-regulated firm contemplates a “recall,” it necessarily contemplates a potential seizure action by FDA (i.e., civil litigation), and the violation that triggers a recall or seizure action need not be nearly as serious as one that triggers criminal enforcement. Although device failures to meet labeled specifications are likely to be significant, i.e., are likely to present a realistic risk to health, it is possible that here XYZ reasonably viewed its violations as merely technical but was concerned that FDA might reasonably view them as significant (though far from warranting criminal prosecution). It may be prudent to identify types of litigation In some circumstances, reasonable experts can differ as to whether the failure of a device to meet its labeled specifications actually puts patients at risk. In such a situation, civil litigation with FDA over a seizure would have been an objectively realistic possibility-without attributing to XYZ any criminal behavior or to FDA any irrational behavior. This concrete prospect of litigation, triggered by a specifically identifiable set of arguably merely technical, but also arguably significant, violations, distinguishes this situation from routine operation of a business regulated by FDA. Therefore, work-product protection of materials created in this kind of situation would not extend to materials created in the absence of such circumstances. A possible lesson from this decision is that sometimes it may be prudent to identify in work product, itself, or in a separate contemporaneous memorandum the type(s) of litigation counsel anticipates. Doing so would at least create contemporaneous evidence of subjective anticipation. Commonly, it will also be self-evident why that subjective anticipation is also objectively reasonable. Where it is not, it may be prudent to outline in the work product or separate memorandum the reasons why the anticipation is objectively reasonable. The risks in making such notations are that they will omit something, and thereby weaken a post hoc rationale for work-product protection developed in later briefing of the issue, and that, if the document has to be produced, it may be more incriminating than it otherwise would have been. These risks can be reduced by careful canvassing of the types of possible litigation, and by caution in what is written. The residual risk should be weighed against the potential benefit of strengthening a prospective work-product claim. Richard M. Cooper is a partner at Williams & Connolly in Washington. He can be reached via e-mail at [email protected].

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