Pharmaceutical Quality Assurance Managers, Drug Calibration Specialists, and other Drug Safety Whistleblowers are stepping forward to blow the whistle on adulterated drugs, contaminated drugs, and poorly calibrated drugs that threaten the health and lives of children, women, and men that are taking the drugs.  Because of the danger of giving defective drugs to the sick and injured, it is extremely important that pharmaceutical whistleblowers continue to step forward to blow the whistle on drugs that threaten the health and safety of the people taking these drugs.  It is clear that the government will not tolerate any lapses in safety standards for pharmaceutical manufacturers.  Further, it is clear that pharmaceutical whistleblowers that blow the whistle on defective and dangerous drugs, may receive a large amount of money for properly reporting fraudulent disregard for safety standards.   

If you are a pharmaceutical quality assurance manager, drug calibration specialist, or other pharmaceutical safety or quality control specialist that is aware of adulterated drug fraud, illegal drug kickbacks, or other pharmaceutical manufacturing fraud, feel free to contact Pharmaceutical Adulterated Drug Fraud Whistleblower Lawyer Jason Coomer via e-mail message or our submission form about a potential pharmaceutical whistleblower qui tam lawsuit. 

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The Department of Justice is cracking down on Fraud and False Claims including Medicare Fraud, Tricare Fraud, Nursing Home Fraud, Hospice Fraud, and other Health Care Fraud.  This crackdown include adulterated drug fraud that threatens the health and lives of men, women, and children.  

GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant

BOSTON – SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, PLC (GSK), has agreed to plead guilty to charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility, the Justice Department announced today. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million.

The drugs, manufactured at the plant between 2001and 2005, are Kytril, Bactroban, Paxil CR and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug.

The Food, Drug and Cosmetic Act (FDCA) prohibits the introduction or delivery for introduction into interstate commerce of any drug that is adulterated. Under the FDCA, a drug is deemed adulterated if the methods used in, or the facilities or controls used for, its manufacturing, processing, packing or holding did not conform to or were not operated or administered in conformity with current good manufacturing practice to assure that such drug met the requirements as to safety and had the identity and strength, and met the quality and purity characteristics, which it purported or was represented to possess.

The criminal information filed today alleges that SB Pharmco’s manufacturing operations failed to ensure that Kytril and Bactroban finished products were free of contamination from microorganisms. The criminal information further alleges that SB Pharmco’s manufacturing process caused Paxil CR two-layer tablets to split. The splitting, which the company itself called a "critical defect," caused the potential distribution of tablets that did not have any therapeutic effect and tablets that did not contain any controlled release mechanism.

The criminal information also alleges that Avandamet tablets manufactured by SB Pharmco did not always have the Food and Drug Administration (FDA)-approved mix of active ingredients, and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect. Finally, the criminal information alleges that SB Pharmco’s Cidra facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle.

SB Pharmco has agreed to plead guilty to a criminal felony for releasing into interstate commerce adulterated Kytril, Bactroban, Paxil CR and Avandamet, in violation of the FDCA. Under the plea agreement, the company will pay a criminal fine of $150 million, which includes forfeiting assets of $10 million. The guilty plea and sentence is not final until accepted by the U.S. District Court in Boston.

Under the civil settlement, GSK has agreed to pay an additional $600 million to the federal government and the states to resolve claims that it caused false claims to be submitted to government health care programs for certain quantities of adulterated Kytril, Bactroban, Paxil CR and Avandamet. The United States contends that GSK sold certain batches, lots or portions of lots of drugs, the strength of which differed materially from, or the purity or quality of which fell materially below, the strength, purity or quality specified in the drugs’ FDA applications or related documents. GSK thereby knowingly caused false and/or fraudulent claims to be submitted to, or caused purchases by, Medicaid and the other federal health care programs.

The federal share of the civil settlement amount is $436,440,000, and GSK will pay up to $163,560,000 to states that participate in the agreement.

"Adulterated drugs undermine the integrity of the FDA’s approval process, can introduce substandard or ineffective drugs on to the market and, in the worst cases, can potentially put patients’ health at risk," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "We will continue to work with our law enforcement partners to hold pharmaceutical companies accountable for this type of conduct and protect taxpayers from fraud, waste, and abuse."

"The industry has an obligation to ensure that all rules, regulations and laws are complied with," said U.S. Attorney Carmen Ortiz. "To do less erodes public confidence and compromises patient safety. As this investigation demonstrates, we will not tolerate corporate attempts to profit at the expense of the ill and needy in our society - or those who cut corners that result in potentially dangerous consequences to consumers."

“In fiscal year 2010, the Department of Health and Human Services, Office of the Inspector General (HHS-OIG) realized nearly $2.3 billion in settlements and judgments against the pharmaceutical industry,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “If all pharmaceutical manufacturers complied with the law, there would be no need for such massive settlements and judgments. But until they stop stealing from taxpayers and threatening the health and lives of Americans – as is alleged here today – HHS-OIG will continue to vigorously pursue these corporations and their executives.”

"FDA’s manufacturing standards are designed to ensure the safety and quality of drugs distributed to American consumers," said Mark Dragonetti, Special Agent in Charge, FDA New York Field Office. "FDA expects pharmaceutical companies to abide by these manufacturing standards and correct deficiencies in an expedited manner. FDA and its law enforcement partners will continue to aggressively pursue those companies that place the public health at risk by distributing products that do not comply with all FDA requirements."

"This settlement demonstrates that the government will not stand for sub-standard drug product. As a result of this extensive investigation, millions of dollars will be returned to the Department of Veterans Affairs’ Pharmaceutical Supply Fund for the direct benefit of our Nation’s veterans," said Jeffrey G. Hughes, Special Agent in Charge, Office of Inspector General for the Department of Veterans Affairs.

"Federal employees deserve health care providers and suppliers, including drug manufacturers, that meet the highest standards of ethical and professional behavior," said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. "Today's settlement reminds the pharmaceutical industry that they must observe those standards and reflects the commitment of Federal law enforcement organizations to pursue improper and illegal conduct that places health care consumers at risk."

The civil settlement resolves one lawsuit filed in federal court in the District of Massachusetts under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. As part of today’s resolution, the whistleblower - Cheryl Eckard - will receive approximately $96 million from the federal share of the settlement amount.

The criminal case is being prosecuted by the U.S. Attorney’s Office for the District of Massachusetts and the Department of Justice's Office of Consumer Litigation. The civil settlement was negotiated by the U.S. Attorney's Office for the District of Massachusetts and the Civil Division's Commercial Litigation Branch. The HHS Office of Counsel to the Inspector General, the Center for Medicare and Medicaid Services, FDA's Office of Chief Counsel, and the National Association of Medicaid Control Units provided assistance.

The case was investigated by agents from the FBI, the Department of Veterans Affairs, Office of the Inspector General, HHS-IG, the FDA’s Office of Criminal Investigations, the Defense Criminal Investigative Service and the Office of the Inspector General for the Office of Personnel Management.

This settlement is part of the government's emphasis on combating health care fraud. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover approximately $4.2 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department's total recoveries in False Claims Act cases since January 2009 have topped $5.4 billion.

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Through Whistle Blower Lawsuits, Qui Tam Lawsuits, and other Health Care Fraud Lawsuits, hundreds of billions of dollars have been recovered from dishonest pharmaceutical companies, marketing executives, health insurance companies, health providers, individuals and organizations that have committed health care fraud and stolen large amounts of money from the government.

Some of these pharmaceutical marketing fraud scams include providing false information about drugs and medications to push important doctors to help a drug get added to formularies and become the treatment standard for off label treatments despite the fact that the drug or medication is not approved for such indications.  These elaborate schemes can cause chairs of committees and other prominent physicians to approve medications based on false information.  For more information on Medicare Pharmaceutical Marketing Fraud and Off Label Whistleblower Lawsuits, please go to the following Medicare Pharmaceutical Marketing Fraud and Off Label Whistleblower Lawsuit Web Page. Further, some of these drug marketing scams include elaborate illegal kickback and bribe scenarios where physicians are handsomely rewarded for helping a drug become a standard of care in the local medical community and to get a specific drug on formularies.  For more information on Pharmaceutical Illegal Kickback and Bribe Whistleblower Lawsuits, please go to the following webpage on Pharmaceutical Illegal Kickback and Bribe Whistleblower Lawsuits.

Pfizer to pay record $2.3B penalty over promotions Repeat offender Pfizer paying record $2.3B settlement for illegal drug promotions By Devlin Barrett, Associated Press Writer On Wednesday September 2, 2009, 3:47 pm EDT

"WASHINGTON (AP) -- Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world's largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets."

Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.

Taketa-Abbott Pharmaceutical Pharmaceutical Products Inc. to pay $875 million to resolve criminal charges and civil liabilities in connection with fraudulent drug pricing and marketing of Lupron, a drug sold for the treatment of prostate cancer. Of this amount, $559,483,560 was recovered under the False Claims Act. In addition, TAP pled guilty to a conspiracy to violate the Prescription Drug Marketing Act and paid a $290 million criminal fine, the largest criminal fine ever in a health care fraud prosecution. Under the Lupron scheme, TAP gave doctors kickbacks by providing free samples with the knowledge that the physicians would bill Medicare and Medicaid $500 per dose. At the time the Lupron fraud was discovered, Lupron accounted for 10% of the money spent on prescription drugs under Medicare Part-A. As part of the settlement, TAP entered into what prosecutors called a "sweeping" corporate integrity agreement.

Schering-Plough agreed to pay a total of $435 million to resolve criminal charges and civil liabilities in connection with illegal sales and marketing programs for brain tumor medication Temodar, and Intron-A which is used in the treatment of bladder cancer and hepatitis C. The Schering settlement also covers best price violations related to Claritin RediTabs (an antihistamine), and K-Dur, which is used in the treatment of ulcers.

Serono agreed to pay $704 million to settle a fraud case involving Serostim, a human growth hormone product used to fight AIDS-related wasting. The charges involved kickbacks to doctors for prescribing Serostim, kickbacks to specialist pharmacies for recommending Serostim, illegal off-label marketing of the drug, and non-FDA approved diagnosis equipment designed to spur more Serostim prescriptions. Serostim cost as much as $20,000 for a three-month regime. Of the total $704 million settlement, $567 million is earmarked to settle federal and state civil claims ($305 million federal), with $136.9 million paid as a related criminal fine.

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Through Whistle Blower Lawsuits, Qui Tam Lawsuits, and other Health Care Fraud Lawsuits, hundreds of billions of dollars have been recovered from dishonest pharmaceutical companies, health insurance companies, health providers, individuals and organizations that have committed health care fraud and stolen large amounts of money from the government.

It is extremely important that Whistle Blowers continue to expose fraudulent marketing practices, billing practices and unnecessary treatments that cost hundreds of billions of dollars.   Off Label Drug Marketing Fraud Lawyer Jason Coomer works on Off Label Pharmaceutical False Claims Act Lawsuits and commonly works with other Pharmaceutical Whistleblower Lawyers, Qui Tam Whistleblower Lawyers, and Health Care Fraud Whistleblower Lawyers. 

If you are a pharmaceutical whistleblower that is aware of fraudulent off label drug marketing practices by a pharmaceutical marketing department, feel free to contact Pharmaceutical Off Label Drug Marketing Fraud Whistleblower Lawyer Jason Coomer via e-mail message or our submission form about a potential pharmaceutical whistleblower, off label pharmaceutical marketing fraud, or other pharmaceutical whistleblower qui tam lawsuit. 

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If you are aware of a large health care company or individual that is defrauding the United States Government out of millions or billions of dollars, contact Health Care Fraud lawyer Jason Coomer.  As a Texas Health Care Fraud Lawyer, he works with other powerful qui tam lawyers that handle large Health Care Government Fraud cases.  He works with San Antonio Health Care Fraud Lawyers, Dallas Health Care Fraud Lawyers, Houston Medicare Fraud Lawyers, and other Texas Health Care Fraud Lawyers as well as with Health Care Fraud Lawyers throughout the nation to blow the whistle on fraud that hurts the United States. 

If you are a pharmaceutical whistleblower that is aware of fraudulent off label drug marketing practices, drug price fixing, drug kickbacks, or other pharmaceutical fraud by a pharmaceutical marketing department, health care provider, or drug company, feel free to contact Pharmaceutical Off Label Drug Marketing Fraud Whistleblower Lawyer Jason Coomer via e-mail message or our submission form about a potential pharmaceutical whistleblower, off label pharmaceutical marketing fraud, or other pharmaceutical whistleblower qui tam lawsuit.