Archive for March, 2011

False Claims Act “Whistleblower” litigation increased in 2010

March 2011

False Claims Act “Whistleblower” litigation increased dramatically in 2010.
In the second half of 2010, the Department of Justice published settlements in many large cases against pharmaceutical companies.  Some examples:
• Abbot, Roxane, B. Braun Medical, and Dey Inc. – DOJ settled actions in 2010 against Abbot Laboratories, Inc., Roxane Laboratories Inc., B Braun Medical Inc., Dey Inc. and other related companies.  The settlements dealt with allegations that the companies illegally increased the reported “average wholesale price” of drugs.  This increased the reimbursement amount that the government paid for the drugs under  programs such as Medicare.    The companies paid $701.2 million dollars as part of the resolution of these claims.
• Elan Corp.  – DOJ settled actions in 2010 with Elan Corp., PLC and its related business Elan Pharmaceuticals Inc. related to the resolution of alleged illegal promotion of an epilepsy drug.  Elan agreed to pay approximately $100 million in criminal fines and about $102.9 million to resolve the FCA actions.
• A GlaxoSmithKline subsidiary settled actions in 2010, agreeing to plead guilty to criminal charges related to the distribution and manufacturing of adulterated drugs.  The company paid a criminal fine of $150 million and civil penalties of $600 million to resolve allegations that it caused the government to pay for adulterated drugs.  The whistleblower in this claim received approximately 96 million dollars.
• Novartis Pharmaceuticals Corp. settled claims in 2010 for $422.5 million to resolve criminal and civil liability that arose from alleged illegal marketing of various drugs. 
• Forest Laboratories subsidiary, Forest Pharmaceuticals Inc. came to resolution agreeing to pay $313 million to resolve claims that the company illegally distributed an unapproved drug known as Levothroid and also promoted “off label” uses for the drug Celexa.  It is also alleged to have caused false claims to be submitted to federal health care programs for Celexa, Lexapro, and Levothroid, in addition to paying kickbacks to doctors to prescribe Lexapro and Celexa. 
• Allergan Inc., agreed to pay a $600 million dollar settlement in 2010 to resolve claims that the company marketed Botox for “off label” uses.  The Food, Drug, and Cosmetics Act is alleged to have been violated in this instance. 

Please contact the attorneys of The Mulligan Law Firm at 866-529-0001 if you would like to discuss a qui tam whistleblower action.

Top 20 Largest Pharmaceutical Company Settlements, 1991-2010

March 2011

Top 20 Largest Pharmaceutical Company Settlements, 1991-2010

Company;  Total Penalty;  Violation(s);  Year;  Major Drug Products Involved;  Laws Allegedly Violated (if applicable)
 

  • GlaxoSmithKline; $3.4 billion; Financial Violation; 2006.
  • Pfizer; $2.3 billion; Unlawful Promotion / Kickbacks; 2009; Bextra / Geodon / Zyvox / Lyrica; False Claims Act / Food, Drug, and Cosmetics Act.
  • Eli Lilly; $1.4 billion; Unlawful Promotion; 2009; Zyprexa; False Claims Act / Food, Drug, and Cosmetics Act. 
  • TAP Pharmaceutical Products; $875 million; Overcharging Govt Health Programs / Kickbacks; 2001; Lupron; False Claims Act / Prescription Drug Marketing Act.   
  • GlaxoSmithKline; $750 million; Poor Manufacturing Practices; 2010; Kytril / Bactroban / Paxil CR / Avandamet; False Claims Act / Food, Drug, and Cosmetics Act.
  • Serono; $704 million; Unlawful Promotion / Kickbacks / Monopoly Practices; 2005; Serostim; False Claims Act.     
  • Merck; $650 million; Overcharging Govt Health Programs / Kickbacks; 2008; Zocor / Vioxx / Pepcid; False Claims Act / Medicaid Rebate Statute.     
  • Purdue; $601 million; Unlawful Promotion; 2007; Oxycontin; False Claims Act.   
  • Allergan; $600 million; Unlawful Promotion; 2010; Botox; False Claims Act / Food, Drug, and Cosmetics Act.    
  • AstraZeneca; $520 million; Unlawful Promotion / Kickbacks; 2010; Seroquel; False Claims Act.    
  • Bristol‐MyersSquibb; $515 million; Unlawful Promotion / Kickbacks / Overcharging Govt Health Programs; 2007; Abilify / Serzone; False Claims Act / Food, Drug, and Cosmetics Act.    
  • Schering‐Plough; $500 million; Poor Manufacturing Practices; 2002; Claritin; FDA Current Good Manufacturing Practices.    
  • Schering‐Plough; $435 million; Unlawful Promotion / Kickbacks / Overcharging Govt Health Programs; 2006; Temodar / Intron A / K‐Dur / Claritin RediTabs; False Claims Act / Food, Drug, and Cosmetics Act.    
  • Pfizer; $430 million; Unlawful Promotion; 2004; Neurontin; False Claims Act / Food,Drug, and Cosmetics Act.      
  • Cephalon; $425 million; Unlawful Promotion; 2008; Actiq / Gabatril / Provigil; False Claims Act / Food, Drug, and Cosmetics Act.    
  • Novartis; $423 million; Unlawful Promotion / Kickbacks; 2010; Trileptal; False Claims Act / Food, Drug, and Cosmetics Act.    
  • AstraZeneca; $355 million; Overcharging Govt Health Programs; 2003; Zoladex; Prescription Drug Marketing Act.    
  • Schering‐Plough; $345 million; Overcharging Govt Health Programs / Kickbacks; 2004; Claritin; False Claims Act / Anti‐Kickback Statute.    
  • Forest Laboratories; $313 million; Unlawful Promotion / Concealing Study Findings / Kickbacks / Illegal Distribution; 2010; Levothyroid /Celexa / Lexapro; False Claims Act / Food, Drugs, and Cosmetics Act.    
  • Johnson & Johnson (State settlement); $258 million; Unlawful Promotion; 2010; Risperdal; Medical Assistance Program Integrity Law.

This list of Top 20 Largest Pharmaceutical Company Settlements is located in:  Sammy Almashat, M.D., M.P.H.,  Charles Preston, M.D., M.P.H., Timothy Waterman, B.S., Sidney Wolfe, M.D., Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry:  1991 – 2010, Public Citizen’s Health Research Group, December 16, 2010.

If you or a loved one have a whistleblower claim we would like to speak with you.   The Mulligan Law Firm is particularly interested in speaking to individuals with claims in Texas, Pennsylvania, California and Florida, but please call regardless of where you live in the United States or elsewhere if you believe you have a Qui Tam Whistleblower action to discuss with our attorneys. 

Any delay may cause you to lose your potential legal rights permanently.

The Mulligan Law Firm is Investigating Potential Qui Tam Whistleblower Claims

March 2011

If you have information about any of the following, please contact us immediately.  The Mulligan Law Firm is investigating potential Qui Tam Whistleblower claims, especially involving the pharmaceutical industry.

• Pharmaceutical Companies or sales representatives paying kickbacks and inducements to doctors / physicians, pharmacists, and/or hospitals to prescribe or in any manner favor their drugs.
• Off-label marketing of drugs / medications.
• Selling, manufacturing, or distributing adulterated pharmaceutical drugs;  i.e. where the required standards of safety, quality, correct strength, and/or purity of drugs have not been met. 
• Kickbacks or any other fraudulent activity by pharmaceutical companies.
• Providing false data to the FDA or withholding negative information / data from the Food and Drug Administration (FDA) concerning the efficacy of a drug and/or medical device during clinical research trials to get FDA approval to sell / market the medication, drug, or device. 
• Manufacturing, diverting, selling, etc., tainted or substandard drugs.
• Misrepresentation of the “federal ceiling price” or “best price” or other benchmark prices that pharmaceutical companies report to the Medicaid and Medicare programs.
• Overcharging on “340B” program drugs.
• Excessive markup on external vendor services and products resold to the government.
• Excessive and unnecessary products and services on goods / contracts sold to the government.
• Delivery of poor quality goods or services to the government.
• Non-conformance to government contract specifications.
• Fraudulently billing the government for work not performed.
• Overvaluing leases or rents that the government must pay.
• Passing incomplete work off as complete.
• Improper billing practices.
• Over pricing of any kind.
• Inappropriate travel grants.
• Wasteful University Studies.
• University Grant Fraud.
• Accounting not in compliance with GAAP.
• Deliberate delivery delay for government contracted services.
• Deliberate production delay for government contracted services
• False or overstated “padded” legal billing for government entities by major law firms.
• Non-conformance with federal wage and employment laws.
• Quality Control Failures on Government Contracted Services
• Double billing.
• Final billing on unfinished contracts.

Please fill out a form on this website or call us immediately at the number on our home page if you have information about any of the above.