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District Court Tosses Complaint After Finding of Misconduct

On April 28, 2017, the United States District Court for the District of Massachusetts dismissed a relator’s qui tam complaint in United States ex rel. Leysock v. Forest Laboratories, Inc. after concluding that the complaint relied on information obtained resulting from deceptive conduct by the relator’s counsel.

In Leysock, the relator alleged that the defendant caused the submission of false claims to Medicare by promoting Forest’s dementia drug, Namenda, for off-label label use. After the United States declined to intervene, Forest filed a motion to dismiss, which the Court denied, largely based upon detailed allegations about eight prescribing physicians who prescribed Namenda for off-label use by Medicare beneficiaries. These allegations, the Court reasoned, were sufficient to satisfy Federal Rule of Civil Procedure 9(b), which in False Claims Act cases typically requires plaintiffs to plead specific allegations regarding the alleged fraud, tying alleged misconduct to the submission of false claims to a government payor.

Through discovery, Forest subsequently learned that relators’ counsel had obtained the information underlying these detailed allegations from a survey conducted by an individual whom relators’ counsel had contracted. This contractor misled the physicians about why he was conducting the survey (not disclosing that he had been retained by the relators in a False Claims Act action) and coaxed the physicians into turning over detailed patient information to the contractor.

In response, the Court concluded that this deception violated Massachusetts Rules of Professional Conduct Rule 4.1(a), which prohibits a lawyer or his agent from knowingly making a false statement of material fact or law to a third person. Consequently, the court concluded, this conduct violated Local Rule 83.6.1 of the United States District Court. As a remedy, the Court struck these allegations, noting that “[the contractor’s] study was conducted solely for the purpose of ensuring that the complaint survived a motion to dismiss,” i.e., to ensure that the complaint satisfied Rule 9(b)’s particularity requirement.

Although the relators’ conduct in this case is unlikely to be repeated in future cases, this case underscores the challenges relators can face in meeting Rule 9(b)’s particularity requirement. These challenges are particularly acute in non-intervened qui tam cases, where the government fails to provide the relator with information about specific false claims that the defendant allegedly submitted or caused to be submitted. Imposing these challenges will continue to chill would-be relators, without firsthand knowledge of wrongdoing, from bringing meritless qui tam cases.




District Court Dismisses FCA Claims Based on Fraudulent Off-Label Promotion for Lack of Particularity

On May 23, 2016, the US District Court for the District of Massachusetts dismissed several of the claims in a False Claims Act (FCA) whistleblower suit against Medtronic, Inc. and its wholly-owned subsidiary Medtronic MiniMed, Inc. (Medtronic) related to its insulin pumps and integrated diabetes management systems.

In United States ex rel. Witkin v. Medtronic, Inc., the relator, Witkin (a former employee of Medtronic) alleged that certain of Medtronic’s promotional activities related to its insulin pumps and the pediatric use of its integrated diabetes management systems designed for adult use were false or misleading, resulting in false claims for reimbursement.  The district court held that Witkin failed to plead his claims with sufficient particularity pursuant to Fed. R. Civ. P. 9(b).  The district court emphasized the particularity requirement in this case, observing that “the alleged fraudulent promotional activity permits only a weak inference of resulting false claims.”  Specifically, the district court held that, with respect to allegations that Medtronic promoted its insulin pumps for use with a type of insulin that is not approved for administration with a pump, Witkin failed to connect allegations of fraudulent promotion to any false claims for reimbursement of either the pumps or the insulin. In addition, with respect to the pediatric use of adult integrated diabetes management systems, the District Court invoked the often-cited principle that “Witkin had alleged an elaborate fraudulent scheme with some detail, but without particularity as to the ‘who, what, where, and when’ of the underlying fraudulent promotion or eventual false claims.”

Accordingly, the district court dismissed the claims that relied on a theory of off-label promotion on Rule 9(b) grounds.  Notably, the district court distinguished the alleged off-label promotion at issue in this case from claims in other cases that premise FCA liability on truthful off-label promotion, noting that there is a question about whether imposing liability in such circumstances would run afoul of the First Amendment (citing the Second Circuit’s 2012 holding in United States v. Caronia, which we discussed in our post on May 26).

The particularity of the pleading was also an issue in a claim unrelated to off-label promotion.  The district court also dismissed, on Rule 9(b) grounds, Witkin’s claims that Medtronic assisted patients in fabricating eligibility criteria for pump therapy because Witkin failed to include particularized allegations of patient targets or when or what information was falsified “let alone allegations of doctors who endorsed the fabricated certifications of medical necessity and thereafter made false claims to the government health care programs.”

The decision was not a total loss for Witkin, however, as the district court permitted certain FCA claims to continue, based on payments to physicians allegedly in violation of the Anti-Kickback Statute (AKS).  In addition, the district court allowed Witkin’s retaliatory discharge claims to continue.  As to the dismissed claims, however, the district court indicated that it was not inclined to allow Witkin to amend.  The district court warned that, as Witkin had already been allowed two amended complaints, the court was [...]

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Decade Old Device Off-Label Marketing Case Ends with Manufacturer Win

On April 7, a Texas jury handed a victory to Abbott Laboratories in a 10-year False Claims Act litigation battle with the relator concerning the off-label use of its products by physicians.  This is the latest in several cases over the past few years that cast doubt on the viability of an off-label marketing theory to form the basis of an FCA action.

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