Pfizer False Claims Victory May Embolden Other Pharma Defendants

By Todd Hobbs, Judge K.K. Legett Fellow at Washington Legal Foundation and a rising third-year student at Texas Tech University School of Law

2nd CircuitIn May, the United States Court of Appeals for the Second Circuit upheld the dismissal of a qui tam lawsuit in U.S. ex rel. Polansky v. Pfizer, Inc.  Polansky, a former Pfizer Medical Director, brought suit under the federal False Claims Act (FCA) on behalf of the U.S. government. He alleged that Pfizer submitted a false claim for Medicare payment by illegally marketing its product for an off-label use.  The Second Circuit held that the complaint at issue failed to allege any off-label promotion and affirmed the district court’s dismissal on that basis.  Federal appeals courts have not considered many FCA lawsuits related to off-label marketing allegations, making the Polansky result worth closer review.

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North Carolina Supreme Court Grudgingly Adopts “Daubert” Standard for Expert Evidence Review

Tager_09181Featured Expert Column: Judicial Gatekeeping of Expert Evidence

By Evan M. Tager, Mayer Brown LLP, with Carl J. Summers, Mayer Brown LLP

Five years ago, the North Carolina General Assembly amended the North Carolina Rules of Evidence to mirror the Federal Rules of Evidence’s approach to expert testimony. In North Carolina v. McGrady, __ S.E.2d __, 2016 WL 3221096 (June 10, 2016), the Supreme Court of North Carolina finally confirmed that, as a result of the General Assembly’s adoption of language that mirrors that of the federal rules, the Daubert standard now governs the admission of expert testimony under state law.

The US Supreme Court first adopted the Daubert standard in 1993, interpreting Federal Rule of Evidence 702 to bestow a “gatekeeping role” on district courts. Shortly after Daubert, the Court elaborated on this standard in General Electric Co. v. Joiner and Kumho Tire Co. v. Carmichael. And in 2000, the Supreme Court adopted amendments to Rule 702 that, while not expressly mentioning Daubert in their text, were clearly intended to formally embed the Daubert standard in the Federal Rules of Evidence. Continue reading

Side-stepping the Issue: Federal Judge Makes Unprecedented Move in Rejecting Google’s First Amendment Defense

first-amendmentBy Erin Garza, Judge K.K. Legett Fellow at Washington Legal Foundation and a rising third-year student at Texas Tech University School of Law

Business success in America not only generates increased dividends for shareholders and opportunities for consumers, but it also, regrettably, attracts litigation. Take, for instance, the constant flow of lawsuits search-engine companies face from individuals and organizations unhappy with their placement in search results. Search-engine businesses have consistently prevailed in such suits, arguing that the First Amendment protects how they design and apply their search algorithms.

However, a May 12, 2016 federal district court decision, which rejected Google’s motion to dismiss and allowed a search-engine optimization firm’s lawsuit to proceed, departed from this positive First Amendment trend. Was the decision in E-Ventures Worldwide, LLC v. Google an aberration or has this plaintiff found a creative new way to avoid the First Amendment defense? Continue reading

WLF’s Annual End-of-Term Review Assesses Key Supreme Court Free-Enterprise Decisions

The U.S. Supreme Court: October 2015 Term Review

Speakers: The Honorable Jay Stephens, Kirkland & Ellis LLP; Andrew J. Pincus, Mayer Brown LLP; Elizabeth P. Papez, Winston & Strawn LLP; Jeffrey B. Wall, Sullivan & Cromwell LLP

Our speakers discussed Court rulings in the areas of class actions, arbitration, the federal False Claims Act, intellectual property, federal regulation, and property rights.

The First Circuit Weighs Competing Studies About Relative Risk

Tager_09181Featured Expert Column: Judicial Gatekeeping of Expert Evidence

By Evan M. Tager, Mayer Brown LLP, with Carl J. Summers, Mayer Brown LLP

When does an expert witness have an obligation to weigh competing studies and explain why she chose to rely on one study rather than another? On the one hand, this decision-making process goes to the core of whether an expert has employed a sound methodology in reaching her conclusions—a requirement that district courts must police under Daubert. But on the other hand, the selection of studies could be viewed as going to weight, not admissibility, and thus the jury, not the district court or the expert, should decide which study to credit.

This question was at the center of a recent U.S. Court of Appeals for the First Circuit decision. In Milward v. Rust-Oleum Corp., ___ F.3d ___, 2016 WL 1622620 (Apr. 25, 2016), a divided panel held that the district court did not abuse its discretion in excluding expert testimony on the ground that the expert failed to analyze conflicting epidemiological studies. Continue reading

The Supreme Court’s “Universal Health” Ruling: A Net Win for Federal Government Contractors

supreme courtThe U.S. Supreme Court’s June 16, 2016 decision in a closely watched False Claims Act (FCA) case, Universal Health Services, Inc. v. United States ex rel. Escobar, had a little bit in it for everyone.  It held (as had most of the federal appeals courts) that a contractor can be held liable under the FCA for making a fraudulent claim for payment from the federal government, even if the claim was never expressly made but was merely implied.  On the other hand, Universal Health unanimously vacated a First Circuit ruling that had reinstated the plaintiffs’ claims, concluding that the First Circuit applied an insufficiently rigorous test for determining whether the defendant’s allegedly false claims were “material.”

So which side really “won” the case?  If the correct answer to that question turns on whether the Court’s decision will make it more difficult for private relators to prevail in future FCA cases, then the decision was a win for FCA defendants.  For example, the Court unequivocally rejected assertions—frequently raised by FCA plaintiffs—that an FCA claim is proven any time a contractor submits a claim for payment of a contractual claim despite awareness that it has breached a significant provision of its contract. Continue reading

Post-“Spokeo,” More Suits Should Be Vulnerable to Article III Standing Attacks

supreme courtIn the wake of the U.S. Supreme Court’s decision in Spokeo Inc. v. Robins, defendants in pending cases where the only harm the plaintiff alleged is violation of a federal statute should be filing new motions to dismiss due to lack of Article III standing.  A Video Privacy Protection Act (VPPA) case decided recently by the First Circuit could provide an immediate opportunity to witness the impact of the Spokeo decision.

In Spokeo, the Court reaffirmed that plaintiffs must possess Article III standing to bring suit, and held that such standing required plaintiffs to allege that they were concretely injured by defendants’ actions.  The Court held that the Spokeo plaintiff’s mere allegation that the defendant violated the terms of the Fair Credit Reporting Act (FCRA) was not necessarily enough to provide standing.  Because Congress cannot abrogate standing requirements, even by providing private rights of action, each plaintiff must allege a concrete and particularized harm.  A “bare procedural violation” is not sufficient to confer standing, the Court explained.  Because the Ninth Circuit did not apply the correct standing test, the Court remanded the case for the lower court to determine whether the plaintiff could allege a concrete injury. Continue reading