Searching Content indexed under Litigation, Mediation & Arbitration by Ropes & Gray LLP's Government Enforcement/White Collar Crime Practice ordered by Published Date Descending.
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Ropes & Gray Advises Pacira Pharmaceuticals In Reaching Landmark Settlement Agreement With FDA
A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA.
United States
17 Dec 2015
Amarin Court Holds Truthful Off-Label Speech Entitled To First Amendment Protection
On August 7, 2015, the U.S. District Court for the Southern District of New York issued an opinion in Amarin Pharma, Inc. v. FDA...
United States
13 Aug 2015
Second Circuit Holds First Amendment Bars Conviction Based Solely On Off-Label Promotion Of FDA-Approved Drug
In its long-awaited decision in United States v. Caronia, the Second Circuit ruled today that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug.
United States
4 Dec 2012
U.S. District Court Issues False Claims Act Judgment For Defendants In Case Challenging Competitive Bidding For DME Contract
After a fourteen-day bench trial, a Mississippi federal court in United States ex rel. Jamison v. McKesson Corp., et al., Civ. A. No. 2:08-cv-214-SA-JMV (N.D. Miss. Sept. 28, 2012), rendered a complete verdict for the defense, holding that in this federal False Claims Act case based on the Anti-Kickback Statute ("AKS") , the United States had failed to carry its burden to prove that illegal remuneration had been offered or accepted, or that any defendant had acted with the scienter required by t
United States
2 Nov 2012
Supreme Court Holds That The Government Must Prove To A Jury Beyond A Reasonable Doubt Any Fact That Increases The Maximum Available Criminal Fine
The Supreme Court held yesterday that the Sixth Amendment requires the government to prove to a jury beyond a reasonable doubt any fact that increases the maximum available criminal fine.
United States
27 Jun 2012
D.C. Circuit Confirms Broader Applicability Of Net Loss Approach To FCA Damages Calculations
Last week, the D.C. Circuit held in "United States of America, ex rel. Davis v. District of Columbia", that in suits under the False Claims Act ("FCA") alleging false claims for Medicaid reimbursement, the calculation of damages must take into account the value of the medical services actually received.
United States
9 Jun 2012
First Circuit’s Oral Argument In "Rost" Revisits Prior Case Law Expanding False Claims Act Liability
On May 8, 2012, the United States Court of Appeals for the First Circuit heard oral arguments in "United States ex rel. Rost v. Pfizer, Inc." (10-2215).
United States
23 May 2012
DOJ/SEC Bring First FCPA Case Involving Private Fund Investment Adviser
On April 25, 2012, the Securities and Exchange Commission (the "SEC") charged a former Managing Director in Morgan Stanley's Chinese real estate investment and fund advisory group with violations of the Foreign Corrupt Practices Act.
United States
9 May 2012
Sorrell v. IMS Health Inc. — Supreme Court Strikes Down Law Restricting Pharmaceutical Manufacturers’ Speech
On Thursday, the Supreme Court issued its decision in Sorrell v. IMS Health Inc., a case testing the constitutional limits of governmental restrictions on the speech of pharmaceutical manufacturers. By a vote of 6-3, the Court held that the law at issue — a Vermont statute that prohibits pharmaceutical manufacturers from obtaining or using "prescriber-identifiable information" collected from pharmacists for the purposes of "marketing or promoting a prescription drug" — is a "speaker- and content
United States
30 Jun 2011
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