Whistleblower, False Claims Act & Qui Tam Information

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by The Law Offices of Jason S. Coomer, PLLC

Drug Quality Managers and Drug Safety Professionals Are Needed To Expose Drug Manufacturing and Calibration Fraud That Is Creating Adulterated Drugs and Contaminated Drugs That Are Sold In The United States by Confidential Drug Safety Fraud Whistleblower Reward Lawyer, Adulterated Drug Whistleblower Lawyer, and Drug Calibration Fraud Whistleblower Lawyer Jason S. Coomer

Drug Safety Fraud Whistleblowers, Drug Calibration Fraud Whistleblowers, and Contaminated Drug Whistleblowers are needed to expose dangerous drugs that are being produced through supply chain fraud and poor manufacturing practices.  Pharmaceutical Quality Assurance Managers, Drug Calibration Specialists, and other Drug Safety Professionals are being encouraged through large whistleblower rewards to step 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. 

If you are a pharmaceutical quality assurance manager, drug calibration specialist, or other pharmaceutical safety or quality control specialist that is aware of supply chain fraud, adulterated drug fraud, illegal drug kickbacks, or other pharmaceutical fraud, please feel free to contact Adulterated Drug Whistleblower, Drug Calibration Whistleblower, and Contaminated Drug Whistleblower Lawyer Jason Coomer via e-mail message or use our submission form to confidentially have your pharmaceutical drug safety whistleblower lawsuit reviewed. 

International Pharmaceutical Supply Chain Fraud Can Cause Adulterated and Dangerous Pharmaceuticals

Pharmaceutical suppliers of defective or dangerous raw materials to the pharmaceutical industry cause dangerous and adulterated drugs to enter the United States.  It is the United States Food and Drug Administration's expectation that current good manufacturing practices (CGMP) be used for the manufacturing, processing, packing, or holding (i.e., storage) of active pharmaceutical ingredients (APIs), intermediates, and excipients.  Further, the FDA recommends that laboratory controls should include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures to ensure that raw materials, intermediates, APIs, and containers conform to established standards of quality and purity.

For more information on International Pharmaceutical Supply Chain Fraud, please go to the following web page on International Pharmaceutical Supply Chain Fraud Whistleblower Reward Lawsuits.

Pharmaceutical Quality Assurance Fraud Whistleblower Lawsuits, Drug Safety Fraud Whistleblower Lawsuits, Adulterated Drug Whistleblower Lawsuits, Contaminated Drug Whistleblower Lawsuits, and Pharmaceutical Drug Calibration Fraud Whistleblower Lawsuits

It is extremely important that pharmaceutical whistleblowers including Drug Quality Assurance Whistleblowers, Drug Calibration Whistleblowers, and other Drug Safety Whistleblowers continue to step forward to blow the whistle on adulterated drugs that threaten the health and safety of the people taking medications.  Because of the serious potential danger to the public including men, women, and children that can be caused by giving contaminated drugs or improperly calibrated drugs, it is vitally important that whistleblowers help make sure that drugs are properly calibrated and not contaminated.  Further, it is clear that the government will not tolerate any lapses in safety standards from pharmaceutical manufacturers. 

Increased enforcement by FDA and the offer of large economic incentives to contaminated adulterated drug whistleblowers will expose pharmaceutical fraud that attempts to hide drug safety and quality violations. As such, it is important for pharmaceutical drug safety whistleblowers to not delay in coming forward with a False Claim Act Qui Tam Action as the first whistleblower to file is eligible to be a relator and may make a large recovery for exposing the drug safety fraud.  Additionally, when the fraudulent scheme is exposed, the people that kept the fraud secret can sometimes be found liable for criminal activity for not exposing the drug safety fraud that was being committed and be held liable for continuing criminal activity.

There are several keys to a successful False Claims Act Qui Tam Whistleblower action including 1) obtaining original and specialized information of the fraud, 2) being the first to file regarding the specific fraud, and 3) protecting the whistleblower for retaliation.  Pharmaceutical whistleblowers including Drug Quality Assurance Whistleblowers, Drug Calibration Whistleblowers, and other Drug Safety Whistleblowers that timely and properly blow the whistle on defective and dangerous drugs, may receive a large amount of money for being the first to properly report fraudulent disregard for safety standards and pharmaceutical policies that hide adulterated drugs.   

Pharmaceutical Quality Assurance Whistleblower Lawsuit Information, Drug Safety Fraud Whistleblower Lawsuit Information, Adulterated Drug Whistleblower Lawsuit Information, Contaminated Drug Whistleblower Lawsuit Information, and Drug Calibration Fraud Whistleblower Lawsuit Information

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 includes 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.

Off Label Drug Marketing Fraud Qui Tam Claim Lawyer, Pharmaceutical Marketing Fraud Qui Tam Claim Lawyer, and Pharmaceutical Whistleblower Qui Tam Lawyer (Off Label Marketing and Pharmaceutical Whistleblower False Claims Act Law Suits)

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.

Economic Incentives for Whistleblowers Lawsuits, Government Fraud Lawsuits, and Qui Tam Lawsuits

When a government imposes a penalty, for the doing or not doing an act, and gives that penalty in part to whistleblowers that will sue for the same, and the other part of the recovery goes to the government, and makes it recoverable by action, such actions are called "qui tam actions", the plaintiff is suing on their own behalf as well for the government and taxpayers.

Qui tam provisions of the False Claims Act are based on the theory that one of the least expensive and most effective means of preventing frauds on taxpayers and the government is to make the perpetrators of government fraud liable to actions by private persons acting under the strong stimulus of personal ill will or the hope of gain.

The strong public policy behind creating an economic gain for whistleblowers is that  the government would be significantly less likely to learn of the allegations of fraud, but for persons in certain positions with specialized knowledge of fraud that has been committed. Congress has made it clear that creating this economic incentive is beneficial not only for the government, taxpayers, and the realtor, but is an efficient method of regulating government to prevent fraud and fraudulent schemes.

The central purpose of the qui tam provisions of the False Claims Act is to set up incentives to supplement government regulation and enforcement by encouraging whistleblowers with specialized knowledge of fraud going on in the government to blow the whistle on the crime.

The whistleblower's share of recovery is a maximum of 30 percent and the government's prior knowledge of fraud now does not necessarily bar a whistleblower from collecting lost revenue. If the government takes over the lawsuit, the relator can "continue as a party to the action." The defendant is also required to pay for the relator's attorney fees. The whistleblower is also protected from retaliatory actions by his or her employer. As a result a 1986 amendment to the False Claims Act, qui tam lawsuits have increased dramatically.   Though the amendment was first made for corrupt defense contractors, the amendment has uncovered billions of dollars in health care fraud and will probably apply to fraudulently obtained TARP and Bail Out Funds.

Pharmaceutical Quality Assurance Whistleblower Lawyers, Drug Safety Whistleblower Lawyers, Contaminated Drug Whistleblower Lawyers, Adulterated Drugs Whistleblower Lawyers, and Pharmaceutical Drug Calibration Whistleblower  Qui Tam Lawyers (Drug Quality, Adulterated Drugs, and Pharmaceutical Quality Assurance Whistleblower False Claims Act Law Suits)

In the past few years, pharmaceutical whistleblowers have exposed fraud where drug companies have defrauded the United States Government out of Billions of dollars.   The pharmaceutical whistleblowers have received rewards of hundreds of millions of dollars for exposing drug company fraud.   Pharmaceutical Quality Assurance Whistleblower Lawyers, Drug Safety Whistleblower Lawyers, Contaminated Drug Whistleblower Lawyers, Adulterated Drugs Whistleblower Lawyers, and Pharmaceutical Drug Calibration Whistleblower  Qui Tam Lawyers are working with Pharmaceutical Quality Assurance Whistleblowers, Drug Safety Whistleblowers, Contaminated Drug Whistleblowers, Adulterated Drugs Whistleblowers, Pharmaceutical Drug Calibration Whistleblowers, and other drug company whistleblowers to blow the whistle on pharmaceutical fraud that hurts the United States. 

The Increase in Government Health Care Spending including Medicare Spending, VA Spending, Tricare Spending, and Medicaid Spending is creating More Health Care Fraud, Medicare Fraud, Medicaid Fraud, and VA Medical Fraud and the need for more Medicaid Billing Fraud Whistleblower Lawsuits, Medicare Billing Fraud Whistleblower Lawsuits, and other Health Care Fraud Whistleblower Lawsuits

Health Care Fraud costs United States Tax Payers approximately $90 billion each year through Medicare, Medicaid, and other government health care programs.  Because the Medicare budget, the Medicaid Budget, the VA Budget, the TRICARE Budget, Medicaid Fraud, and Medicare Fraud are continuing to increase each year, it is vitally important that Medicare Fraud Whistleblower Lawsuits, Medicare Fraud Upcoding Fraud Whistleblower Lawsuits, Medicare Medicaid Fraud Hospital Whistleblower Lawsuits, Hospice Medicare Fraud Whistleblower Lawsuits, CHIP Fraud & Medicaid Fraud Whistleblower Lawsuits, and Medicare Medicaid Fraud Nursing Home Whistleblower Lawsuits continue to step forward and blow the whistle on health care fraud.

Pharmaceutical Quality Assurance Whistleblower Lawsuit Information, Drug Safety Whistleblower Lawsuit Information, Adulterated Drug Whistleblower Lawsuit Information, Contaminated Drug Whistleblower Lawsuit Information, and Pharmaceutical Drug Calibration Whistleblower Qui Tam Lawsuit Information by Drug Quality Whistleblower, Contaminated Drug Whistleblower, Adulterated Drug Whistleblower, and Pharmaceutical Quality Assurance Whistleblower Lawyer Jason S. Coomer 

If you are aware of a large health care company, financial institute, drug company, defense contractor, government contractor, or individual that is defrauding the United States Government out of millions or billions of dollars, it is important that you are the first to step forward with evidence of the fraud to report the fraud.  It is also important to understand potential whistleblower protections under the False Claims Act and to discuss with an attorney how to prepare for potential retaliation or aggressive attacks by the employer or contractor.  For more information on this topic please go to the following web page on False Claims Act Lawsuit Whistleblower Protections

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 Adulterated Drug Whistleblower, Drug Calibration Whistleblower, and Contaminated Drug Whistleblower Lawyer Jason Coomer via e-mail message or our submission form about a potential pharmaceutical quality control whistleblower lawsuit, drug calibration whistleblower lawsuit, or other pharmaceutical drug safety whistleblower lawsuit. 

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