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.

Zimmer NexGen® Knee Replacement Failures

November 2010

The Zimmer NexGen® knee replacement implant has been found to have a high rate of failure, loosening, pain and other issues / complications.

A surgeon and consultant to Zimmer Holdings called for a Zimmer NexGen® knee recall to be issued. The reason this action was taken was as result of repeated observation of problems, later to be followed by a study confirming the initial findings.

The model at issue, the NexGen® CR-Flex, is designed to provide a greater range of motion than the standard NexGen.

The most commonly used method of implanting an artificial knee is by using an adhesive to bond the thigh bone to the portion of the device that bends, cementing the two together. Some specialists avoid adhesives because cement can break down, causing failure of the device. Because of this, Zimmer sells an uncemented version of the CR-Flex that relies on the bone naturally growing into the implant. This uncemented version is the source of the problems and complaints.

“…he gave the device, which is supposed to last about 15 years, to about 125 patients in 2005, the first full year he used it. But by early 2006, some X-rays showed lines where the implant met the thigh bone, an indication that the device was loose and had not fused completely. Patients could walk, but they were reporting pain, apparently a result of the loose joint.”  – New York Times article titled “Surgeon vs. Knee Maker:  Who’s Rejecting Whom?” 18 June 2010

Several prominent surgeons, one the former consultant for Zimmer mentioned above, first presented their study at a medical meeting in the fall of 2009 and again this year at a national meeting of the American Association of Orthopedic Surgeons.

The uncemented Zimmer knee was found to fail in 9 percent of 100 patients featured in the study. Furthermore, the knee was observed to be loose in approximately 50% of the patients, requiring additional surgeries in some of the patients.

The Zimmer NexGen® CR-Flex Porous Femoral components are replacement knee products that have been associated with a high number of reports of:

•Loosening of Replacement Knees (50% in study mentioned above)
•Knee replacement failure
•Surgery required to correct complications
•Other knee complications and pain
If you or a loved one has been seriously injured after surgical implantation with any of the Zimmer NexGen® CR femoral components, please contact us immediately for a free consultation.

These problems could include:

•Unexplained pain following knee replacement
•Loosening of replacement knee
•Revision knee surgery to correct problems 

Who We Are
The Mulligan Law Firm, a national law firm located in Dallas, Texas, provides legal information and resources for injured individuals and their families. The firm has successfully resolved over $600,000,000 in claims for its clients. Formed in 1995, it has been helping people for almost 15 years, with the strength and experience to represent plaintiffs in all 50 states.

The Mulligan Law Firm is currently investigating injury claims involving Zimmer NexGen® Knee Replacements. 

If you or a loved one has been seriously injured after surgical implantation of a Zimmer NexGen® Knee Replacement, it is important that you consult with a legal professional immediately. The Mulligan Law Firm has experienced lawyers standing by to help you.

You may be entitled to compensation for your injuries. We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation.

Do not delay, as your rights and compensation may be lost forever if you wait.  Call us now at 866 529 0001, Extension 245, or simply fill a form out on this website.

Darvon® and Darvocet® Linked to Death, Heart Attacks, and Arrhythmia: California, Texas, Florida Lawyers Now Providing Free Potential Claim Evaluations

November 2010

Banned in the United Kingdom since 2005 and then the European Union in January 2009, an estimated 10 million patients have used these common painkillers.

On November 19, 2010 the FDA asked manufacturers of propoxyphene (Darvon®, Darvocet®) for a product recall. 

Propoxyphene is an opioid used to treat mild to moderate pain.  Approved by the FDA and available since 1957, propoxyphene is manufactured by Xanodyne Pharmaceuticals Inc., which markets the drug as Darvon® and Darvocet®. The difference between the two painkillers is that while Darvon® is composed entirely of propoxyphene, Darvocet® combines propoxyphene and acetaminophen.

Some of the other limitations of propoxyphene-containing medicines include:
·         As weak painkillers, they provide minimal benefits.
·         The combination of propoxyphene and acetaminophen (Darvocet®) is no more effective than acetaminophen on its own.
·         The difference between the dose needed for treatment and a harmful dose is too small, increasing the potential for overdose.
·         As an opioid, it is also addictive.

“The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.” – FDA News Release, November 19, 2010.

Severe and even fatal responses to Darvon® and other pain medications containing propoxyphene have been reported, such as:
Death
Heart Attack
Heart Arrhythmia
Suicide
Overdose

If you or a loved one have experienced any side effects such as these from taking these medications, please contact us as soon as possible for a free potential claim evaluation.  Please fill a form out on this website or call our toll free number for additional information.   Always consult carefully with your doctor prior to stopping any medication.

THE LAWYERS / ATTORNEYS AT THE MULLIGAN LAW FIRM WOULD LIKE TO SPEAK WITH YOU IF YOU HAVE SUFFERED SIDE EFFECTS AND TAKEN JANUVIA® AND/OR JANUMET®

July 2010

Side-Effects of Januvia® and Janumet® currently being investigated by The Mulligan Law Firm:

Severe and even fatal responses to Januvia® and Janumet® have been reported, such as:

•Death, Acute Pancreatitis, Necrotizing Pancreatitis, Hemorrhagic Pancreatitis

and

•Cutaneous Vasculitis

If you or a loved one have been prescribed Januvia or Janumet and have experienced any of these side-effects, please contact us immediately for a free consultation.

Always see your physician before you stop taking any medications, including Januvia® or Janumet®. 

If you have taken Januvia and have questions, please do not hesitate to contact us immediately.

THE MULLIGAN LAW FIRM IS NOW EVALUATING / INVESTIGATING DEPUY ORTHOPAEDICS HIP DEVICE INJURY CLAIMS

March 2010

The DePuy Articular Surface Replacement Hip Implant is a hip replacement cup manufactured by DePuy, a division of Johnson & Johnson.  DePuy Orthopaedics withdrew the hip device after more than two years of reports that the hip implant, called an ASR, failed in patients only a few years after implant.  This failure required costly and painful replacement operations. 

The device was first used in the United States in 2005.

Withdrawn from the Australian Market in December 2009, it is under scrutiny in the U.S. and has been withdrawn from the domestic market.

The FDA has received, beginning in 2008, about 300 complaints about the early failure of the implanted device.

On March 9, 2010, DePuy announced that the DePuy ASR Hip Replacement would be discontinued in the U.S. market because it was failing and requiring remedial surgeries.

The same release mentions a higher failure rate in smaller-boned patients and those with certain bone weaknesses.

There is no FDA recall at this time.  Please check back at this website for updates from time to time.

The ASR hip cup is a metal-on-metal ball and socket, large diameter hip resurfacing device.

The cause of the DePuy ASR Cup hip implant failures is still not known. 
 
Metal debris early in the life of this implant can cause inflammation, leading to damaged muscles and soft tissue.

Among the primary and most serious side-effects mentioned in the ASR hip cup revision reports:

>Implanted cup loosening or failing to bond
>Pseudotumour: a soft tissue mass that may be the result of a toxic reaction to an excess of particulate metal wear debris.
>ALVAL (Aseptic Lymphocyte Dominated Vasculitis Associated Lesion): an adverse tissue reaction to metal particles and ions.
>Metallosis: condition of excessive metal debris.

If you or a loved one has been seriously injured after surgical implantation of a DePuy Acetabular Cup, please contact us immediately for a free consultation as soon as possible.

If You Or A Loved One Have These Specific Diagnoses From Denture Cream Use – Contact Us Immediately

February 2010

We would like to speak with you immediately if you have any of the following diagnoses from denture cream use:

•  Neuropathy
•  Zinc Poisoning
•  Hypocupremia and/or 
•  Hyperzincemia

Denture Cream Injuries – Zinc Poisoning

February 2010

Various brands of denture creams help to adhere dentures to an individual’s gums and help stop pain and discomfort while wearing dentures. Zinc is found in some denture creams and can be harmful when individuals are exposed to toxic levels.

Fixodent® and Super Poligrip® are two denture creams that contain zinc.

Excessive zinc exposire can lead to several significant health problems.

Research has found that users of denture creams such as Fixodent® and Super Poligrip® are at risk for zinc poisoning.

Zinc Poisoning symptoms include:

- paralysis
- weakness in the extremities
- lack of coordination and/or poor balance
- pain in the extremities
- tingling or numbness
- difficulty urinating
- loss of sensation

Excess levels of Zinc in the blood can also result in the following diagnoses:

- ZINC POISONING
- MYELOPATHY (SPINAL CORD DAMAGE)
- COPPER DEFICIENCY – HYPOCUPREMIA
- NEUROPATHY
- ANEMIA
AND/OR
- BONE MARROW FAILURE

If you or a loved one have used denture creams of any kind and suffer from these or other significant symptoms / injuries, you may be entitled to compensation. Contact The Mulligan Law Firm immediately via this website or 1-866-529-0001, Ext. 245.  Se Habla Espanol

New Concerns: Byetta® now being examined in connection with kidney side-effects and renal failure

November 2009

Timeline

August 2008: the FDA issues a MedWatch alert about six new cases of hemorrhagic and necrotizing pancreatitis that had been reported to FDA.

March 2009: drug regulators in the UK published an article discussing two serious side effects potentially associated with Byetta®, pancreatitis and renal (kidney) impairment.

November 2009: more news from the FDA: in a limited study from April 2005 through October 2008, the FDA received reports of 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency) in patients using Byetta®.

The side-effects detailed in the study ranged from the mild, to death (4 cases).

The FDA carefully recognized that some of the cases concerned patients who already had kidney disease or had one or more risk factors for developing kidney problems already.

During the time period of the case study, Byetta® had been prescribed nearly 7 million times. (FDA)

What are the Side-Effects?

Milder side-effects include nausea, vomiting,  and diarrhea.

These were the most common side effects linked to with Byetta®; it is a possibility that these side effects contributed to the development of altered kidney function in the reported cases.

Side-effects that are more severe include kidney dysfunction, renal failure, pancreatitis, and even death.

If you or a loved one have been prescribed Byetta® and now have been diagnosed with renal failure, altered kidney function, or pancreatitis, please contact us immediately for a free consultation. You could be entitled to compensation.

Contact Eric W. Gruenwald, Lawyer, for more information at 866-529-0001 Extension 245.

Always consult with your physician before you stop taking any medications, including Byetta®.