Use this button to switch between dark and light mode.

Experience a New Era in Legal Research with Free Access to Lexis+

United States ex rel. Petratos v. Genentech Inc.

United States ex rel. Petratos v. Genentech Inc.

United States Court of Appeals for the Third Circuit

November 1, 2016, Argued; May 1, 2017, Filed

No. 15-3805

Opinion

 [*485]  OPINION OF THE COURT

HARDIMAN, Circuit Judge.

This appeal arising under the False Claims Act involves a multi-billion dollar cancer drug, Avastin, which was developed by Appellee Genentech. Relator Gerasimos Petratos, who was head of healthcare data analytics for Genentech, filed a qui tam action soon after leaving the company. He alleged that Genentech suppressed data that caused [**2]  doctors to certify incorrectly that Avastin was "reasonable and necessary" for certain at-risk Medicare patients. The District Court dismissed Petratos's suit for failure to state a claim. Although we disagree with the District Court's grounds for dismissal, we will affirm because Petratos failed to satisfy the False Claims Act's materiality requirement.

A widely prescribed cancer drug that has accounted for $1.13 billion a year in Medicare reimbursements, Avastin is approved by the FDA to treat several types of cancer. Petratos alleged that Genentech concealed information about Avastin's health risks. Specifically, he claimed the company ignored and suppressed data that would have shown that Avastin's side effects for certain patients were more common and severe than reported. According to Petratos, such analyses would have required the company to file adverse-event reports with the FDA, and could have resulted in changes to Avastin's FDA label. Genentech also allegedly suppressed information regarding Avastin's side effects for patients with renal failure despite a request to disclose that information by a "Key Opinion Leader," a recognized industry expert who "influence[s] peers' medical practice, [**3]  including but not limited to prescribing behavior." John Mack, A KOL by Any Other Name, 14-03 Pharm. Mktg. News 1, 1 (2015).

Petratos claimed Genentech's data suppression was part of a formal campaign, dubbed "Optimizing Data Value," during which the company avoided certain analyses and data sets that might yield negative results to mitigate its "business risk." App. 324-26. Petratos asserted that he tried to bring the safety risks inherent in this strategy to the attention of upper management, but was told "to stop any further work in [the] area," App. 318, and had his job "threatened," App. 314.

Read The Full CaseNot a Lexis Advance subscriber? Try it out for free.

Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.

855 F.3d 481 *; 2017 U.S. App. LEXIS 7667 **; 2017 WL 1541919

UNITED STATES OF AMERICA, ex rel. GERASIMOS PETRATOS, GERASIMOS PETRATOS, ex rel. UNITED STATES OF AMERICA; STATE OF CALIFORNIA; STATE OF COLORADO; STATE OF CONNECTICUT; STATE OF DELAWARE; STATE OF FLORIDA; STATE OF GEORGIA; STATE OF HAWAII; STATE OF ILLINOIS; STATE OF INDIANA; STATE OF LOUISIANA; STATE OF MARYLAND; COMMONWEALTH OF MASSACHUSETTS; STATE OF MICHIGAN; STATE OF MINNESOTA; STATE OF MONTANA; STATE OF NEVADA; STATE OF NEW HAMPSHIRE; STATE OF NEW JERSEY; STATE OF NEW MEXICO; STATE OF NEW YORK; STATE OF NORTH CAROLINA; STATE OF OKLAHOMA; STATE OF RHODE ISLAND; STATE OF TENNESSEE; STATE OF TEXAS; COMMONWEALTH OF VIRGINIA; DISTRICT OF COLUMBIA, Appellants v. GENENTECH INC; ROCHE GROUP; HOFFMAN LA ROCHE, INC.; ROCHE HOLDINGS, LTD.; F HOFFMAN - LA ROCHE, LTD

Prior History:  [**1] On Appeal from the United States District Court for the District of New Jersey. (D.C. No. 2-11-cv-03691). District Judge: Honorable Madeline C. Arleo.

United States ex rel. Petratos v. Genentech, Inc., 141 F. Supp. 3d 311, 2015 U.S. Dist. LEXIS 146525 (D.N.J., Oct. 29, 2015)

CORE TERMS

misrepresentation, district court, reimbursement, causation, regulations, patients, prescribed, recipient, leave to amend, noncompliance, health services, allegations, compliance, concedes, cancer, cases

Civil Procedure, Appeals, Standards of Review, De Novo Review, Defenses, Demurrers & Objections, Motions to Dismiss, Failure to State Claim, Abuse of Discretion, Pleadings, Amendment of Pleadings, Leave of Court, Governments, Federal Government, Claims By & Against, Public Health & Welfare Law, Providers, Reimbursement, Reasonable Cost Standard, Types of Providers, Physicians, Legislation, Interpretation, Record on Appeal, Standards of Review, Judgments, Preclusion of Judgments, Law of the Case, Responses, Motions to Dismiss