Off-Label Criminal Prosecution Unconstitutional Under 1st Amendment, 2nd Circuit Says

NEW YORK - The federal government's criminal prosecution of a sales representative's off-label promotion of a drug is unconstitutional under the First Amendment right of free speech, a panel of the Second Circuit U.S. Court of Appeals said Dec. 3 in a 2-1 ruling (United States of America v. Alfred Caronia, No. 09-5006, 2nd Cir.; 2012 U.S. App. LEXIS 24831). View a complimentary copy of the opinion available in the pdf attached below.

Motorcycle Experts OK To Testify Against Alleged Kentucky Bike Thieves

LONDON, Ky. - Three experts in detecting stolen motorcycles applied a reliable methodology and are qualified to testify in a criminal case against an alleged bike-theft ring, a federal judge in Kentucky held Dec. 3 (United States of America v. Robert Jason Chapman, et al.,  No 11-51-GFVT, E.D. Ky., Southern Div.; 2012 U.S. Dist. LEXIS 171075).

K-V Pharmaceutical Owes United States $67.1M In Fines, Settlement, Lawsuit Says

NEW YORK - A U.S. attorney on Nov. 26 sued K-V Pharmaceutical Co., telling a New York federal court that the bankrupt company's $67.1 million debt of criminal fines and civil settlements are nondischargeable (In Re: K-V Discovery Solutions, Inc., et al., No. 12-13346, S.D. N.Y. Bkcy., United States of America v. K-V Pharmaceutical Company, No. 12-13346, S.D. N.Y.).

BP To Pay $4.5 Billion, Plead Guilty To Criminal Charges For Oil Spill

NEW ORLEANS - BP PLC announced Nov. 15 that it would plead guilty to a dozen felony charges brought by the federal government and pay $4.5 billion in penalties over its involvement in the explosion of the Deepwater Horizon oil rig and ensuing oil spill in the Gulf of Mexico.

Follow this link to view a complimentary copy of the complete Mealey's article.

Pfizer Says It Will Plead Guilty, Pay $546M To Settle Rapamune, Protonix Probes

NEW YORK - Pfizer Inc. on Nov. 9 disclosed that its Wyeth subsidiary will plead guilty to a misdemeanor and Pfizer will pay $546 million to settle federal criminal and civil investigations involving the drugs Rapamune and Protonix.

D.C. Circuit Vacates Restitution Order In Criminal Copyright Case

WASHINGTON, D.C. - A District of Columbia federal judge erred in ordering a criminal copyright infringement defendant to pay restitution to Adobe Systems Inc. in an amount equivalent to the revenue he received, the District of Columbia Circuit U.S. Court of Appeals ruled Nov. 9 (United States of America v. Gregory Fair, No. 09-3120, D.C. Cir.). Subscribers may view the decision available within the fill article.

Judge Rejects Government's Request To Empanel Jury To Determine CITGO's Fines

CORPUS CHRISTI, Texas - A federal judge in Texas on Nov. 6 rejected the U.S. government's request to empanel a jury to determine if CITGO Petroleum Corp. should face up to $1.1 billion in civil penalties as a result of being convicted on two criminal counts of violating the Clean Air Act, 42 U.S.C.S. § 7401, because selecting an unbiased jury would be difficult and because the issue is more complex than the government contends (United States of America v. CITGO Petroleum Corporation, et al.,  No. C-06-563, S.D. Texas; 2012 U.S. Dist. LEXIS 158743).

Colorado District Attorney, U.S. House Committee Probe Abound Solar's Bankruptcy

GREELEY, Colo. - The district attorney in Weld County, Colo., on Oct. 25 announced that he has begun a criminal investigation into bankrupt alternative energy company Abound Solar Manufacturing LLC regarding the possibility that the company may have committed securities fraud based on allegations that officials at Abound Solar knew that products the company was selling were defective but then asked investors to invest in the company without telling them about the defective products.

FDA Criminal Investigators Visit Compound Pharmacy In Meningitis Outbreak Probe

ROCKVILLE, Md. - Criminal investigators from the Food and Drug Administration on Oct. 16 were at the New England Compounding Center Inc. (NECC) in Framingham, Mass., the compounding pharmacy at the center of a fungal meningitis outbreak, the FDA confirmed to Mealey Publications.

5th Circuit Panel: Couple Failed To Show Dangers Existed In Casino Parking Lot

NEW ORLEANS - The Fifth U.S. Circuit Court of Appeals on Oct. 8 affirmed summary judgment for a casino in a premises liability action, concluding that the trial court did not err by determining that the defendant did not have notice of a dangerous criminal element on its property (Bettie Johnson, et al. v. HWCC-Tunica Inc.,   No. 12-60213, 5th Cir.; 2012 U.S. App. LEXIS 20891).

6th Circuit Affirms Ruling Upholding Criminalization Of RU-486 Off-Label Use

CINCINNATI - The Sixth Circuit U.S. Court of Appeals on Oct. 2 affirmed a lower court's ruling that Ohio's law banning off-label use of mifepristone, also known as the RU-486 abortion pill, is not constitutionally vague and does not interfere with a woman's right to protect her bodily integrity (Planned Parenthood Southwest Ohio Region, et al. v. Mike DeWine, et al., No. 11-4062, 6th Cir.). A complimentary copy of the opinion is available in the attached pdf. document.

2012 Sets Record With $6.6B In Drug Settlements, Public Citizen Study Says

WASHINGTON, D.C. - This year has seen a record amount of financial penalties assessed against the pharmaceutical industry, with $6.6 billion recovered through mid-July by the federal and state governments, according to a study released Sept. 27 by Public Citizen ("Pharmaceutical Industry Criminal and Civil Penalties: An Update," Sept. 27, 2012, S. Almashat, et al., Public Citizen).

AU Optronics Fined $500M; Executives Receive Prison Sentences For Conspiracy

SAN FRANCISCO - A federal judge in California on Sept. 20 sentenced Taiwan-based AU Optronics Corp. (AUO) to pay a $500 million criminal fine for engaging in a global conspiracy to fix worldwide prices of thin-film transistor-liquid crystal display panels for use in computer monitors and televisions in violation of Section 1 of the Sherman Act, 15 U.S.C.S. § 1 et seq.  (United States of America v. AU Optronics Corp., et al., No. 09-cv-0110 SI, N.D. Calif.). View related prior history, 2012 U.S. Dist. LEXIS 80605.

Woman Prosecuted For Using Abortifacient Can Challenge Idaho Abortion Law

SAN FRANCISCO - A federal appeals court panel on Sept. 11 retained a preliminary injunction against an Idaho state prosecutor for criminally prosecuting a woman who obtained an abortifacient drug over the Internet while the woman challenges the constitutionality of the state's stringent anti-abortion law (Jennie Linn McCormack v. Mark L. Hiedeman, et al.,  Nos. 11-36010 and 36015, 9th Cir.; 2012 U.S. App. 19051).

Transocean Says Obstacles Remain With Possible $1.5B Settlement With Government

WASHINGTON, D.C. - Transocean Ltd., the owner of the Deepwater Horizon oil rig that exploded in April 2010, resulting in a historic oil spill in the Gulf of Mexico, said in a Form 8-K filed Sept. 10 with the U.S. Securities and Exchange Commission that a number of obstacles have interfered with its ability to finalize a possible $1.5 billion settlement with the U.S. Department of Justice to resolve civil and criminal claims stemming from the accident. Subscribers may view the form available within the full article.

Reference To Nazi Gets Judge Booted From Florida Tobacco Trial

TALLAHASSEE, Fla. - A Florida judge who compared a former tobacco company chief executive officer to a Nazi war criminal was disqualified by the state's First District Court of Appeal on Sept. 5 from presiding over a tobacco case (Philip Morris USA Inc. v. Mary Brown, No. 1D12-3090, Fla. App., 1st Dist.).

Follow this link to view a complimentary copy of the complete Mealey's article.

Bankruptcy Judge: Ocala, TBW To Share Funds From Possible Deal With Auditor

JACKSONVILLE, Fla. - The federal bankruptcy judge presiding over the Chapter 11 proceeding of Taylor Bean & Whitaker Mortgage Corp. (TBW) on Aug. 27 approved a deal in which TBW and its lender and subsidiary, bankrupt Ocala Funding LLC, will share any recovery from a potential settlement with the auditor that TBW and Ocala claim failed to stop criminal fraud valued at $2.9 billion (In Re: Taylor Bean & Whitaker Corp., No. 09-07047, Chapter 11, M.D. Fla. Bkcy.). Subscribers may view the order available within the full article.

Pfizer Pays $60.1M In Fine, Disgorgement, Interest For 3 Foreign Bribery Cases

WASHINGTON, D.C. - A subsidiary of Pfizer Inc. will pay $60.1 million in a fine, disgorgement and interest to settle federal criminal and civil allegations that Pfizer and Wyeth paid bribes to officials and doctors in several foreign countries to induce them to buy the companies' drugs, according to settlements announced Aug. 7 by the U.S. Department of Justice (DOJ), the U.S. Securities and Exchange Commission and Pfizer (United States of America v. Pfizer H.C.P. Corporation, No. 1:12-cr-169, U.S. Securities and Exchange Commission v. Pfizer, Inc., No 12-1303, and U.S. Securities and Exchange Commission v. Wyeth LLC, No. 12-1304, D. D.C.).  Subscribers may view the agreement documents, consent and proposed judgment  available within the full Mealey's article.

Orthofix Criminal Sentencing Delayed By Judge's Concerns; To Resume Sept. 6

BOSTON - A Massachusetts federal judge on July 23 delayed accepting the guilty plea of medical device maker Orthofix Inc. until Sept. 6 and ordered federal prosecutors and the company to file briefs (United States of America v. Orthofix, Inc., No. 1:12-cr-10169, D. Mass.). Related prior history, 2010 U.S. Dist. LEXIS 129580.

U.S. Government Charges CEO Of Bankrupt Peregrine Financial With Wire, Mail Fraud

CEDAR RAPIDS, Iowa - The U.S. government on July 13 filed a criminal complaint against Russell Wasendorf Sr., the CEO of bankrupt Peregrine Financial Group Inc., alleging that he committed fraud in the operation of Peregrine (The Unites States of America v. Russell Wasendorf Sr., No. 12-131, N.D. Iowa). Subscribers may view the criminal complaint available within the full article.

Glaxo To Plead Guilty, Pay $3 Billion Stemming From Drug Marketing

BOSTON - GlaxoSmithKline LLC (GSK) on July 2 agreed to plead guilty and to pay $3 billion to resolve broad-ranging criminal and civil allegations in Massachusetts federal court regarding the promotion of several prescription drugs, failure to report safety data and alleged false-price reporting practices (United States ex rel. Greg Thorpe, et al. v. GlaxoSmithKline PLC, No. 11-10398-RWZ; United States of America v. GlaxoSmithKline LLC, No. 1:12-cr-10206-RWZ, D. Mass.).

Follow this link to view a complimentary copy of the full Mealey's article.

Full Stay Of Civil Antitrust Case During Criminal Matter Is Lifted

LOS ANGELES - The federal judge in California overseeing the multidistrict antitrust litigation brought by direct purchasers of aftermarket automotive lighting products against manufacturers and distributors of the products lifted a stay on the civil litigation on June 21 after a related criminal trial was continued (In Re: Aftermarket Automotive Lighting Products Antitrust Litigation, No. 2:09-ml-02007, C.D. Calif.). Subscribers may view the minutes available within the full Mealey's article.

In Reversal, 6th Circuit Orders Return Of Forfeited Funds To Bank

CINCINNATI - Reversing a district court decision, the Sixth Circuit U.S. Court of Appeals on June 14 ruled that a bank is entitled to the proceeds of a deposit account that were seized by the government as part of a criminal forfeiture proceeding (United States of America v. Huntington National Bank, No. 10-2071, 6th Cir.; 2012 U.S. App. LEXIS 12040).

Convicted Ponzi Schemer Stanford Sentenced To 110 Years In Federal Prison

HOUSTON - The federal judge in Texas overseeing the criminal case of convicted Ponzi scheme mastermind R. Allen Stanford on June 14 sentenced Stanford to 110 years in federal prison (United States of America v. Robert Allen Stanford, No. 09-342, S.D. Texas).  Follow this link to read a complimentary copy of the complete Mealey's article.

Orthofix Pleads Guilty, Pays $42M In Fines, Penalties For Device Sales Tactics

BOSTON - Orthofix Inc. on June 7 pleaded guilty to a federal felony count of obstructing a federal audit and agreed to pay nearly $42 million in criminal fines and civil penalties for illegal promotion of its bone-growth stimulators (United States of America v. Orthofix, Inc., No. 1:12-cr-10169, United States of America, ex rel. Jeffrey Bierman v. Orthofix International, N.V., et al., No. 1:05-cv-10557, D. Mass.). Review a complimentary copy of the complete Mealey's Emerging Drugs & Devices Bulletin.