PFIZER RAP SHEET
Pfizer to Pay $430 Million Over Promoting Drug to Doctors
By Gardiner Harris
Pfizer, the world's largest pharmaceutical company, pleaded guilty yesterday and agreed to pay $430 million to resolve criminal and civil charges that it paid doctors to prescribe its epilepsy drug, Neurontin, to patients with ailments that the drug was not federally approved to treat. [...]
The company encouraged doctors to use Neurontin in patients with bipolar disorder, a psychological condition, even though a study had shown that the medicine was no better than a placebo in treating the disorder. Other disorders for which the company illegally promoted Neurontin included Lou Gehrig's disease, attention deficit disorder, restless leg syndrome and drug and alcohol withdrawal seizures.
[...] Neurontin was initially approved to treat epileptic seizures in patients who had failed to improve using other treatments, but it has become one of the biggest-selling drugs in the world, with sales last year of $2.7 billion. Nearly 90 percent of the drug's sales continue to be for ailments for which the drug is not an approved treatment, according to recent surveys.
"This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk," said the United States attorney in Boston, Michael Sullivan, in a statement yesterday. [...]
"Ninety percent of Neurontin's sales are for patients for which there is no proof that the drug works," he said. [...]
WARNER-LAMBERT TO PAY $430 MILLION TO RESOLVE CRIMINAL & CIVIL HEALTH CARE LIABILITY RELATING TO OFF-LABEL PROMOTION|
THURSDAY, MAY 13, 2004 WWW.USDOJ.GOV
WASHINGTON, D.C. — American pharmaceutical manufacturer Warner-Lambert has agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division’s illegal and fraudulent promotion of unapproved uses for one of its drug products, Associate Attorney General Robert D. McCallum, Jr. and Massachusetts U.S. Attorney Michael J. Sullivan announced today. The drug Neurontin was approved by the Food and Drug Administration in December 1993 solely for adjunctive or supplemental anti-seizure use by epilepsy patients.
Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses — any use not specified in an application and approved by FDA.
However, Warner-Lambert’s strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved. The company promoted Neurontin for the treatment of bipolar mental disorder, various pain disorders, Amyotrophic Lateral Sclerosis (ALS, a degenerative nerve disease commonly referred to as Lou Gehrig's Disease), attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug).
“The Department of Justice is committed to rooting out and prosecuting health care fraud,” said Associate Attorney General Robert McCallum. “It is of paramount importance that the Department use every legal tool at its disposal to assure the health and safety of the consumers of America’s health care system, and to pursue companies and individuals that steal from the taxpayers and inflict suffering on patients and families. The Department's commitment to effective health care fraud enforcement is driven by a mandate that wrongdoers be brought to justice, to deter conduct which threatens the safety and welfare of all Americans, and the need to protect the resources of the Medicare Trust Fund, state Medicaid programs, and other government health programs.”
Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective. For example, the company promoted Neurontin as effective for use as the sole drug (monotherapy) for epileptic seizures, even after solo use had been specifically rejected by the FDA. Similarly, the pharmaceutical company falsely promoted Neurontin as effective for treating bipolar disease, even when a scientific study demonstrated that a placebo worked as well or better than the drug.
“This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision making, thereby putting patients at risk,” stated U.S. Attorney Michael Sullivan. “This scheme deprived federally-funded Medicaid programs across the country of the informed, impartial judgment of medical professionals — judgment on which the program relies to allocate scarce financial resources to provide necessary and appropriate care to the poor. The pharmaceutical industry will not be allowed to profit from such conduct nor subject the poor, the elderly and other persons insured by state and federal health care programs to experimental drug uses which have not been determined to be safe and effective.”
As a consequence of the unlawful promotion scheme, patients who received the drug for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully-informed medical judgment, or whether the doctor was instead influenced by misleading statements made by, or inducements provided by, Warner-Lambert. Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the occurrence of unforeseen adverse effects because the drug was not studied in the type of patient it is being used for off-label and the appropriate dosage and course of treatment have not been established.
"The plea agreement and settlement announced today marks the end of an exemplary effort to use all of the appropriate anti-fraud weapons available to us in a concerted manner to send clear and unequivocal messages to the pharmaceutical industry," said Assistant Attorney General Peter D. Keisler. "To insure a just result, we in the Civil Division will vigilantly join our tools for fighting fraud on consumers with those available to remedy fraud on the federal health care programs."
Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors. The company’s agents also made false or misleading statements to health care professionals regarding Neurontin’s efficacy and whether it had been approved by the FDA for the off-label uses. Warner-Lambert also utilized "Medical Liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.
Warner-Lambert paid doctors to attend so-called "consultants meetings" in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics and Hawaii. There was little or no significant consulting provided by the physicians.
The pharmaceutical company implemented numerous teleconferences in which physicians were recruited by sales representatives to call into a pre-arranged number where they would listen to a doctor or a Warner-Lambert employee speak about an off-label use of Neurontin.
The company also sponsored purportedly "independent medical education" events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants.
Warner-Lambert misled the medical community beforehand about the content, as well as the lack of independence from the company’s influence, of many of these educational events. In at least one instance, when unfavorable remarks were proposed by a speaker, Warner-Lambert offset the negative impact by "planting" people in the audience to ask questions highlighting the benefits of the drug.
Warner-Lambert paid physicians to allow a sales representative to accompany the physician while he or she saw patients, with the representative offering advice regarding the patient’s treatment which was biased towards the use of Neurontin.
These tactics were part of a widespread, coordinated national effort to implement an off-label marketing plan. At the same time, Warner-Lambert decided not to seek FDA approval for any of the new uses because it was concerned that approval for any of the non-epilepsy uses would allow generic competitors of Neurontin, which was expected to go off-patent soon, to compete with a "son of Neurontin" drug that Warner-Lambert hoped to have approved by the FDA for both epilepsy and non-epilepsy uses.
Neurontin was launched into the marketplace in February of 1994; from mid-1995 to at least 2001, the growth of off-label sales was tremendous. While not all of these sales were the consequence of Warner-Lambert’s illegal marketing, the marketing scheme was very successful in increasing Neurontin prescriptions for unapproved uses.
The state Medicaid programs were harmed by Warner-Lambert’s aggressive promotion for off-label uses in numerous ways. The conduct caused doctors to write prescriptions for Medicaid patients when those medications were not eligible for Medicaid reimbursement in that the prescriptions were fraudulently obtained through false statements to doctors and by payment of illegal kickbacks, including so called "consulting fees" and trips for physicians.
The investigation was commenced in the District of Massachusetts when a former medical liaison for Warner-Lambert, Dr. David Franklin, filed a suit on behalf of the U.S. government. Private individuals like Dr. Franklin are allowed to file whistleblower suits under the federal False Claims Act to bring the United States information about wrongdoing. If the United States is successful in resolving or litigating the whistleblower’s claims, the whistleblower may share in part of the recovery. As a part of today’s resolution, Dr. Franklin will receive approximately $24.64 million of the civil recovery.
"Today’s settlement demonstrates the government’s continued scrutiny of sales and marketing practices by the pharmaceutical industry to ensure that those who do business with our programs act properly," said Acting Principal Deputy Inspector General Dara Corrigan for the Department of Health and Human Services, Office of Inspector General. "Our programs cannot afford the abuses we have seen by drug companies against our beneficiaries and the American taxpayers."
"The Health Care Fraud Squad in the Boston Office of the FBI is committed to weeding out fraud and corruption within our health care system," stated Special Agent in Charge Kenneth W. Kaiser of the Boston Office of the FBI. "Our agents will continue to work diligently along with other law enforcement agencies to protect Medicare and Medicaid from fraud and abuse to ensure that our most vulnerable citizens will continue to have health care coverage."
"This settlement achieves the goals of placing the welfare of our veterans first," stated Bruce Sackman, Special Agent in Charge of the Northeast Field Office of the Office of Inspector General for Department of Veterans Affairs. "Parke-Davis directly promoted off-label drug uses to Veterans Affairs physicians and pharmacists on a nationwide basis, in direct violation of FDA laws. From 1994 to 2002, sales of Neurontin to the Department of Veterans Affairs jumped from $287,000 to $43.2 million. These sales, in part, directly reflect the impact of Parke-Davis’ illegal marketing techniques. Hopefully, this settlement will serve as a deterrent to other firms thinking of engaging in this practice. The Department of Veterans Affairs will remain vigilant in its efforts to prevent illegal activities such as this in the future."
“We believe that this settlement goes a long way to protecting Americans against unlawful and inappropriate conduct by pharmaceutical companies,” stated Mark B. McClellan, M.D., Ph.D., Administrator of the Centers for Medicare & Medicaid Services. “It sends a strong message in advance of implementation of the Medicare prescription drug benefit that our first priority will be protecting beneficiaries and the programs that serve them.”bb
“Today’s action is a result of the close cooperation between the Department of Justice and FDA in investigating this matter and seeking appropriate redress for it,” said Acting FDA Commissioner, Dr. Lester M. Crawford. “These fines and penalties demonstrate that there is a strong system in place for ensuring that companies comply with the laws that safeguard Americans.”
The global agreement includes the following components:
(a) Warner-Lambert has agreed to plead guilty to two counts of violating the Food, Drug & Cosmetic Act with regard to its misbranding of Neurontin by failing to provide adequate directions for use and by introduction into interstate commerce of an unapproved new drug. Warner-Lambert has, as punishment for these offenses, agreed to pay a $240 million criminal fine, the second largest criminal fine ever imposed in a health care fraud prosecution. The Plea Agreement between the United States and Warner-Lambert specifically states that Warner-Lambert’s criminal conduct caused losses of $150 million and that the violations are felonies as a consequence of Warner-Lambert’s prior Food, Drug & Cosmetic Act conviction.
(b) Warner-Lambert has agreed to settle its federal civil False Claims Act liabilities and to pay the United States $83.6 million, plus interest, in civil damages for losses suffered by the federal portion of the Medicaid program as a result of Warner-Lambert’s fraudulent drug promotion and marketing misconduct.
(c) Warner-Lambert has agreed to settle its civil liabilities to the fifty states and the District of Columbia in an amount of $68.4 million, plus interest, for losses the state Medicaid programs suffered as a result of Warner-Lambert’s fraudulent drug promotion and marketing misconduct.
(d) Warner-Lambert has agreed to settle its civil liabilities to the fifty states and the District of Columbia in an amount of $38 million, plus interest, for harm caused to consumers and to fund a remediation program to address the effects of Warner-Lambert’s improper marketing scheme. This part of the global settlement agreement was negotiated by the Consumer Protection divisions of the fifty State Attorneys General.
(e) Pfizer Inc, Warner-Lambert’s parent company, has agreed to comply with the terms of a corporate compliance program, which will ensure that the changes Pfizer Inc made after acquiring Warner-Lambert in June 2000, are effective in training and supervising its marketing and sales staff, and ensures that any future off-label marketing conduct is detected and corrected on a timely basis. In addition, Warner-Lambert agreed to an injunction by a state court against continuing the improper conduct that was the subject of the States’ Consumer Protection Divisions investigation.
Pfizer Inc, the owner of Warner-Lambert since June of 2000, has also agreed to institute a compliance program. The charged conduct occurred prior to the acquisition.
The case was handled by Assistant U.S. Attorneys Thomas E. Kanwit and Sara M. Bloom of the U.S. Attorney’s Office for the District of Massachusetts, and by Trial Attorney Jill Furman of the Justice Department Office of Consumer Litigation. Assisting in the investigation were Jonathan Diesenhaus and Stanley Alderson of the Department of Justice’s Civil Fraud section. The Corporate Integrity Agreement was negotiated by Senior Counsel Mary Riordan in the Office of Counsel to the Inspector General for the Department of Health and Human Services. The states were represented by the National Association of Medicaid Fraud Control Units and the Consumer Protection Divisions of the States Attorneys General. The investigation was conducted by the Federal Bureau of Investigation, the Veteran’s Administration’s Office of Criminal Investigations, the Office of Criminal Investigations for the Food and Drug Administration and the Office of Inspector General for the Department of Health and Human Services.
Pfizer Pays $2.3 Billion to Settle Marketing Case
By GARDINER HARRIS
WASHINGTON — The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.
It was the largest health care fraud settlement and the largest criminal fine of any kind ever. [...]
"Among the factors we considered in calibrating this severe punishment was Pfizer’s recidivism," said Michael K. Loucks, acting United States attorney for the Massachusetts district.
Amy W. Schulman, Pfizer’s general counsel, said that Pfizer had reformed — again. [...]
The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales. [...]
Department of Justice|
Office of Public Affairs
Wednesday, September 2, 2009
Justice Department Announces Largest Health Care Fraud Settlement
in Its History
Pfizer to Pay $2.3 Billion for Fraudulent Marketing
WASHINGTON — American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses — i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.
In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs — Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug — and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.
As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter.
Whistleblower lawsuits filed under the qui tam provisions of the False Claims Act that are pending in the District of Massachusetts, the Eastern District of Pennsylvania and the Eastern District of Kentucky triggered this investigation. As a part of today’s resolution, six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery.
The U.S. Attorney’s offices for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky, and the Civil Division of the Department of Justice handled these cases. The U.S. Attorney’s Office for the District of Massachusetts led the criminal investigation of Bextra. The investigation was conducted by the Office of Inspector General for the Department of Health and Human Services (HHS), the FBI, the Defense Criminal Investigative Service (DCIS), the Office of Criminal Investigations for the Food and Drug Administration (FDA), the Veterans’ Administration’s (VA) Office of Criminal Investigations, the Office of the Inspector General for the Office of Personnel Management (OPM), the Office of the Inspector General for the United States Postal Service (USPS), the National Association of Medicaid Fraud Control Units and the offices of various state Attorneys General.
"Today’s landmark settlement is an example of the Department of Justice’s ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud. It shows one of the many ways in which federal government, in partnership with its state and local allies, can help the American people at a time when budgets are tight and health care costs are increasing," said Associate Attorney General Tom Perrelli. "This settlement is a testament to the type of broad, coordinated effort among federal agencies and with our state and local partners that is at the core of the Department of Justice’s approach to law enforcement."
"This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,"said Kathleen Sebelius, Secretary of Department of Health and Human Services"The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste."
"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars," said Tony West, Assistant Attorney General for the Civil Division. "This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare."
"The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes," said Mike Loucks, acting U.S. Attorney for the District of Massachusetts. "Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws. Today’s enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated."
"Although these types of investigations are often long and complicated and require many resources to achieve positive results, the FBI will not be deterred from continuing to ensure that pharmaceutical companies conduct business in a lawful manner," said Kevin Perkins, FBI Assistant Director, Criminal Investigative Division.
"This resolution protects the FDA in its vital mission of ensuring that drugs are safe and effective. When manufacturers undermine the FDA’s rules, they interfere with a doctor’s judgment and can put patient health at risk," commented Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania. "The public trusts companies to market their drugs for uses that FDA has approved, and trusts that doctors are using independent judgment. Federal health dollars should only be spent on treatment decisions untainted by misinformation from manufacturers concerned with the bottom line."
"This settlement demonstrates the ongoing efforts to pursue violations of the False Claims Act and recover taxpayer dollars for the Medicare and Medicaid programs," noted Jim Zerhusen, U.S. Attorney for the Eastern District of Kentucky.
"This historic settlement emphasizes the government’s commitment to corporate and individual accountability and to transparency throughout the pharmaceutical industry," said Daniel R. Levinson, Inspector General of the United States Department of Health and Human Services. "The corporate integrity agreement requires senior Pfizer executives and board members to complete annual compliance certifications and opens Pfizer to more public scrutiny by requiring it to make detailed disclosures on its Web site. We expect this agreement to increase integrity in the marketing of pharmaceuticals."
"The off-label promotion of pharmaceutical drugs by Pfizer significantly impacted the integrity of TRICARE, the Department of Defense’s healthcare system," said Sharon Woods, Director, Defense Criminal Investigative Service. "This illegal activity increases patients’ costs, threatens their safety and negatively affects the delivery of healthcare services to the over nine million military members, retirees and their families who rely on this system. Today’s charges and settlement demonstrate the ongoing commitment of the Defense Criminal Investigative Service and its law enforcement partners to investigate and prosecute those that abuse the government’s healthcare programs at the expense of the taxpayers and patients."
"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 it 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."
"Health care fraud has a significant financial impact on the Postal Service. This case alone impacted more than 10,000 postal employees on workers’ compensation who were treated with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service’s Office of Inspector General. "Last year the Postal Service paid more than $1 billion in workers’ compensation benefits to postal employees injured on the job."
Pfizer to pay $142M for drug fraud|
Sales of drug total $300M annually in Canada
CBC News · Posted: Mar 26, 2010 11:00 AM ET | Last Updated: March 26, 2010
Pharmaceutical giant Pfizer has been ordered to pay $142 million US in damages for fraudulently marketing gabapentin, an anti-seizure drug marketed under the name Neurontin.
A federal jury in Boston ruled Thursday that Pfizer fraudulently marketed the drug and promoted it for unapproved uses. The jury sided with California-based Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals, the first to try a gabapentin case against Pfizer.
Data revealed in a string of U.S. lawsuits indicates the drug was promoted by the drug company as a treatment for pain, migraines and bipolar disorder — even though it wasn't effective in treating these conditions and was actually toxic in certain cases, according to the Therapautics Initiative, an independent drug research group at the University of British Columbia.
The trials forced the company to release all of its studies on the drug, including the ones it kept hidden.
A new analysis of those unpublished trials by the Therapeutics Initiative suggests that gabapentin works for one out of every six or eight people who use it, at best. The review also concluded that one in eight people had an adverse reaction to the drug.
"The much larger majority of people will not get any benefit and many of them will have chronic neurotoxicity or poisoning of the brain," said Dr. Tom Perry of the Therapeutics Initiative.
Dr. Harry Pollett, a pain specialist in North Sydney, N.S., calls gabapentin a so-so drug with potentially serious side-effects for patients. These include drowsiness, balance problems, fogginess and edema, or swelling.
"Weight gain is a very common problem and I see that a lot," Pollett said.
The drugs represent a waste of money for Canada's health-care system, said Perry, who questioned why some doctors continue to encourage people to take the drug even though the patients are not benefiting.
"We have been using probably somewhere in the order of around $300 million a year in Canada recently and this drug has been overused since the late 1990s," Perry said. "So, do the math. It's probably well in excess of a billion dollars."
Pfizer defends its actions and its drug. The company has already been hit with $430 million in penalties and fines for fraudulently promoting gabapentin in the U.S.
Federal Jury: Pfizer Violated US Racketeering Laws In Marketing Neurontin; Ordered To Pay $142 Million
William D. Kickham, Esq. 30Mar2010
Whether it’s Big Finance, Big Insurance, Big Tobacco or Big Pharma, overall, Big Business never seems to “get it” when it comes to acting ethically and obeying the laws they’re required to operate under in this country. This time the focus is on Big Pharma, though that’s nothing new.
Pfizer, Inc., that giant of the pharmaceutical industry, was found by a jury in U.S. District Court in Boston last week, with violating the federal Racketeer Influenced and Corrupt Organization Act (RICO,) a law designed to thwart and punish a variety of illegal activities dealing with financial transactions. Oddly enough, (or not so oddly), RICO was first passed by the U.S. Congress in response to organized crime’s (read: the mob’s) activities in transferring and hiding financial transactions across state lines. Now, Pfizer’s been found to have violated that Act.
What was Pfizer up to? It seems that for the past ten years, Pfizer embarked on a targeted campaign to promote their epilepsy drug, Neurontin, for officially unapproved uses. Kaiser Foundation Health Plans, Inc., and Kaiser Foundation Hospitals, alleged that over the course of ten years, Pfizer consistently promoted Neurontin to it for unapproved uses, representing to its doctors that Neurontin could effectively treat a number of different medical conditions, including migraines and bipolar disorder. Neurontin was approved by the FDA in 1993 to treat epilepsy, and nothing more. According to Tom Sobol, a lawyer for Kaiser, ”The jury found that Pfizer engaged in a racketeering conspiracy over a ten-year period. That bodes well for future (similar) cases.” The jury deliberated for two days before finding Pfizer guilty of violating RICO. They determined the damages owed Kaiser to be $47 million, but under RICO, the damages are tripled. Hence, the total cost to Pfizer is $142 million. The federal trial was based in Boston, as U.S. District Court Judge Patti Saris is charged with overseeing a number of federal lawsuits from across the United States, targeting Pfizer with personal injury claims and allegations of fraudulent marketing of this drug. These injury claims would take the form of Product Liability suits, rather than Medical Malpractice.
When will Big Business get it? When will they cease their relentless quest for profits, no matter what the cost to society at large, or to themselves? Do they never learn from the shameless corporate fools that went before them? The terms “Ford Pinto”, “Asbestosis”, “Predatory Mortgages”, “Tobacco Cancer” and “Corporate Greed” all ring loudly. Does it not shame the leadership of this global company that they have been found guilty under a statute originally passed to police and defeat organized crime?
And remember, readers: It’s these very kinds of companies and industries that want “tort reform” — Big Business. They’d just love to shrink your legal rights and expand their profits. Don’t let them do it.
Department of Justice|
Office of Public Affairs
Wednesday, September 12, 2012
Pfizer Agrees to Pay $55 Million for Illegally Promoting Protonix for Off-Label Use
Pfizer Inc. will pay $55 million plus interest to resolve allegations that Wyeth LLC illegally introduced and caused the introduction into interstate commerce of a misbranded drug, Protonix, between February 2000 and June 2001, the Justice Department announced today.
Wyeth manufactured and promoted Protonix tablets. Protonix is a proton pump inhibitor (PPI) that was used by physicians to treat various forms of gastro-esophageal reflux disease (GERD). Wyeth sought and obtained approval from the Food and Drug Administration (FDA) to promote Protonix for short-term treatment of erosive esophagitis &MDASH; a condition associated with GERD that can only be diagnosed with an invasive endoscopy. However, the government alleges that Wyeth fully intended to, and did, promote Protonix for all forms of GERD, including symptomatic GERD, which was far more common and could be diagnosed without an endoscopy.
Under the Federal Food Drug and Cosmetic Act, manufacturers must obtain FDA approval for any indication for use for which a manufacturer intends to market a drug. A drug is misbranded if its labeling does not bear adequate directions for use by a layman safely and for the purposes for which it is intended. A prescription drug must be prescribed by a physician and is only exempt from the adequate directions for use requirement if a number of conditions are met, including that the manufacturer only intended to sell that drug for an FDA-approved use. A prescription drug marketed for unapproved off-label uses does not qualify for the exemption and is misbranded.
As alleged in the government’s complaint, Wyeth’s illegal promotional campaign for Protonix was multi-faceted. Before Wyeth even began promoting Protonix, the FDA warned Wyeth that its proposed promotional materials were misleading because Wyeth had “overstated” its “erosive esophagitis indication” by “suggesting that Protonix is safe and effective in the treatment of patients with . . . GERD. Protonix is not indicated for treatment of GERD symptoms that occur in the absence of esophageal erosions.” Despite the FDA’s admonishment, the government alleges that Wyeth trained its sales force to promote Protonix for all forms of GERD, beyond its limited erosive esophagitis indication, and that Wyeth sales representatives frequently promoted Protonix to physicians for unapproved uses, such as symptomatic GERD.
In addition, Wyeth allegedly promoted Protonix as the “best PPI for nighttime heartburn,” even though there was never any clinical evidence that Protonix was more effective than any other PPI for nighttime heartburn. The allegations in the complaint are that this superiority slogan was formulated at the highest levels of the company. Wyeth retained an outside market research firm, at the cost of tens of thousands of dollars, to ensure that sales representatives delivered that misleading superiority message.
Finally, the government alleges that Wyeth used continuing medical education (CME) programs to promote Protonix for unapproved uses. CME programs are sponsored by accredited independent providers, such as universities, nonprofit organizations, or specialty societies.
Pharmaceutical companies are permitted to provide financial support for CME programs, but they are not permitted to use CME programs as promotional vehicles for off-label indications. According to the complaint, Wyeth spent millions of dollars providing “unrestricted educational grants” to CME providers, and these grants invariably included promises that Wyeth would not attempt to influence the content of the program in any way. Nevertheless, the government alleges that one of Wyeth’s core marketing tactics for Protonix was to use CME programs to drive off-label use of the drug. According to the complaint, the Protonix “brand team” influenced virtually every aspect of these CME programs: program topics, speaker selection, organization, and content. In addition, the government alleges that Wyeth even insisted that the CME program materials use the same color and appearance as Protonix promotional materials–a tactic that Wyeth and the vendor called “branducation.”
“Today’s settlement once again demonstrates our commitment to making sure drug manufacturers follow the rules,” said Stuart Delery, Principal Deputy Assistant Attorney General of the Department of Justice’s Civil Division. “Drug manufacturers should not be permitted to profit from misbranding their products; the disgorgement remedy here ensures that this does not happen in this case.”
“Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses,” said U.S. Attorney Carmen M. Ortiz. “Wyeth ignored the FDA’s warning not to promote Protonix off-label, and then went so far as to contaminate CME programs that physicians rely on for unbiased, independent scientific information. Today’s settlement reinforces this office’s historic commitment to holding drug companies responsible for their misconduct.”
This case was litigated by Assistant U.S. Attorneys David Schumacher and Susan Winkler of Ortiz’s Health Care Fraud Unit, together with former Trial Attorney Kevin Larsen and Deputy Director Jill Furman in the Department of Justice Consumer Protection Branch. This case was investigated by the FDA’s Office of Criminal Investigations; the Office of Inspector General of the Department of Health and Human Services, the Department of Veterans’ Affairs, and the FBI.
This civil complaint and settlement resolve the United States’ investigation of Wyeth related to the promotion of Protonix for unapproved uses. The claims settled by this agreement are allegations only, allegations which Pfizer denies; there has been no determination of liability. Pfizer acquired Wyeth in October 2009. Since August 2009, Pfizer has been under a Corporate Integrity Agreement with the Department of Health and Human Services, which agreement remains in effect.
Department of Justice|
Office of Public Affairs
Wednesday, April 27, 2016
Wyeth and Pfizer Agree to Pay $784.6 Million to Resolve Lawsuit Alleging That Wyeth Underpaid Drug Rebates to Medicaid
The Department of Justice announced today that pharmaceutical companies Wyeth and Pfizer Inc. have agreed to pay $784.6 million to resolve allegations that Wyeth knowingly reported to the government false and fraudulent prices on two of its proton pump inhibitor (PPI) drugs, Protonix Oral and Protonix IV. Pfizer, which is headquartered in New York City, acquired New Jersey-based Wyeth in 2009, approximately three years after Wyeth had ended the conduct that gave rise to the settlement.
“This settlement demonstrates our unwavering commitment to hold pharmaceutical companies responsible for pursuing pricing schemes that attempt to manipulate and overcharge federal health care programs – programs that protect the poor and disabled – for drugs sold to commercial customers at much lower prices,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division.
“This significant settlement illustrates that the government will not permit drug companies to dodge their obligations to the Medicaid program or create elaborate pricing schemes to deceive Medicaid into paying more than it should for drugs,” said U.S. Attorney Carmen Ortiz for the District of Massachusetts. “This settlement, after years of hard-fought litigation, shows our commitment to ensuring that healthcare businesses do not take advantage of the federal health insurance programs which serve those who need assistance most.”
PPI drugs are used to treat symptoms of, among other things, acid reflux. In a complaint filed in 2009, the government alleged that Wyeth failed to report deep discounts on Protonix Oral and Protonix IV that it made available to thousands of hospitals nationwide. As part of the settlement, Wyeth and Pfizer do not deny the government’s allegations.
According to the government’s complaint, Wyeth sold Protonix Oral and Protonix IV through a bundled sales arrangement in which a hospital could earn deep discounts on both drugs if it placed them on formulary and made them “available” within the hospital. Through this bundled arrangement, Wyeth sought to induce hospitals to buy and use Protonix Oral, which hospitals otherwise would have had little incentive to use, because other pre-existing oral PPI drugs were priced competitively and were considered to be as safe and effective. Wyeth wanted to control the hospital market because patients discharged from the hospital on Protonix Oral were likely to stay on the drug for long periods of time, rather than switch to competing PPIs, during which time payers, including Medicaid, would pay nearly full price for the drug.
Under the Medicaid program, which is the nation’s provider of health insurance to the poor and disabled, drug companies must report to the government the best prices they offer other customers for their brand name drugs. Based on these reported best prices, the drug companies pay rebates to the state Medicaid programs so that Medicaid, a large purchaser of drugs, receives the benefit of the same discounts drug companies offer to other large customers in the marketplace.
The government alleged that Wyeth hid from Medicaid the bundled discounts Wyeth gave to hospitals on Protonix Oral and Protonix IV. As a result, Wyeth wrongfully avoided paying hundreds of millions of dollars in rebates to Medicaid during the period from 2001 to 2006. Under the terms of today’s settlement, Wyeth will pay $413,248,820 to the federal government and $371,351,180 to state Medicaid programs.
“When we make agreements with others we expect follow-through,” said Special Agent in Charge Phillip Coyne of the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG). “Similarly, taxpayers rightly expect large pharmaceutical companies will not falsely report prices to boost profits. Any drug company shirking those responsibilities can expect to be held accountable for its deception.”
“This litigation and settlement demonstrate the commitment of my office and other state attorneys general across the country to ensuring that pharmaceutical companies live up to their obligations to the Medicaid program,” said New York Attorney General Eric T. Schneiderman.
The settlement resolves allegations filed under the False Claims Act by Lauren Kieff, a former hospital sales representative for the pharmaceutical company AstraZeneca Pharmaceuticals, LP, and William St. John LaCorte, a physician practicing in New Orleans, Louisiana. Under the False Claims Act, private parties may sue on behalf of the government for false claims for government funds and to receive a share of any recovery. The relator share in this case will be $98,058,190 and will be paid from the proceeds of the federal and state settlements.
The settlement was the result of close cooperation between the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the District of Massachusetts, the state attorneys general and other law enforcement entities including Medicaid Fraud Control Units, and the HHS-OIG.
This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by the Attorney General and the Secretary of Health and Human Services. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in this effort is the False Claims Act. Since January 2009, the Justice Department has recovered a total of more than $29 billion through False Claims Act cases, with more than $17.5 billion of that amount recovered in cases involving fraud against federal health care programs. The case is captioned United States ex rel. Kieff and LaCorte v. Wyeth and Pfizer, Inc., Nos. 03-12366 and 06-11724-DPW (D. Mass.).
Proton Pump Inhibitor (PPI) Lawsuits
PPI lawsuits blame the drugs for causing kidney disease, kidney injury, kidney failure and acute interstitial nephritis, or AIN. Lawsuits against Nexium, Prilosec, Prevacid, Protonix and other PPI brands claim manufacturers AstraZeneca, Takeda and Pfizer failed to warn of the dangers of proton pump inhibitors.
|By Terry Turner
|Edited By Sophia Clifton|
|Legally Reviewed by Tess Schulman, PhD|
|This page features 37 Cited Research Articles|
Last modified: October 19, 2020
More than 15,000 PPI lawsuits have been filed against the manufacturers of prescription versions of Nexium, Prilosec, Prevacid, Protonix and Dexilant — as well as over-the-counter Prilosec OTC, Nexium 24HR and Prevacid 24HR.
The lawsuits argue that manufacturers didn’t do enough to warn patients and medical professionals about the possible risks as the companies became aware of them. Some Prilosec lawsuits allege that AstraZeneca knew of kidney risks for at least 10 years before warning the public.
As of January 2020, there were [13,400] proton pump inhibitor lawsuits pending in federal court — out of a total of 15,164 that had been filed. A judicial panel combined the cases into a multidistrict litigation, or MDL, in August 2017.
The number of lawsuits grew quickly, tripling during the first three months of 2019 alone. By mid-2019, it had become the second-largest mass litigation in the United States.
Attorneys expect the MDL could include thousands more PPI lawsuits. The judge overseeing the litigation has scheduled the first bellwether trial for Sept. 21, 2020. [...]
Pfizer Agrees to Two Protonix Settlements Totaling $839 Million
In 2016, Pfizer agreed to a $784 million settlement with the U.S. government. The government had accused Pfizer’s Wyeth unit of overcharging Medicaid for Protonix.
In 2012, Pfizer agreed to pay $55 million plus interest to resolve allegations by the government that the company misbranded the drug. The government said Pfizer’s sales force promoted the medication to physicians for unapproved uses.
Sales reps were only supposed to market it for specific forms of GERD. However, the company trained its salespeople to push it for treatment of all forms of the condition, according to the U.S. Justice Department. It announced the settlement on Dec. 12, 2012.
Pfizer Lawsuits and Settlements
Pfizer faces a growing number of lawsuits in 2018 involving some of its most popular drugs. In the past, courts dismissed thousands of lawsuits against Pfizer. The company also agreed to settle cases over illegal marketing and health care fraud. [...]
PFIZER'S UNAPPROVED CLINICAL TRIAL
People are suing Pfizer over Protonix. Protonix lawsuits say Pfizer failed to warn about the risk of kidney problems. In 2013, Pfizer agreed to pay $55 million to settle criminal charges. The U.S. Department of Justice said Wyeth promoted Protonix for unapproved uses in 2000 and 2001. Pfizer acquired Wyeth in 2009.
Nearly 10,000 women filed Prempro breast cancer lawsuits against Pfizer. By 2012, Pfizer settled most of the claims for more than $1 billion.
About 3,000 people filed Chantix lawsuits against Pfizer. They claimed Chantix caused suicidal thoughts and severe psychological disorders. In 2013, the company set aside about $288 million to resolve these cases. One case settled for an undisclosed amount just before trial in 2012.
More than 6,000 testosterone therapy lawsuits were pending in May 2018. The lawsuits say testosterone products caused strokes, blood clots and heart attacks.
A federal panel closed the consolidated Effexor litigation in 2013. Lawsuits claimed birth defects.
A judge dismissed Zoloft cases in 2016. Lawsuits included similar claims to Effexor XR. The judge did not disagree that Zoloft caused birth defects. But the judge concluded there was insufficient evidence to definitively link the two.
A judge dismissed a group of federal Eliquis cases in 2017. Injured patients continue to file severe bleeding claims in Delaware state court.
A judge dismissed Lipitor lawsuits in 2017. Women who took the drug filed lawsuits after developing Type 2 diabetes. There is currently an appeal pending.
Pfizer Drug Recalls
Pfizer has had to recall some of its popular products due to quality issues and poor packaging. Effexor XR and Prempro are two products affected by recalls.
In 2013, Pfizer announced it was recalling five lots of Prempro. Prempro is a hormone replacement therapy drug. Routine testing revealed the strength of the drug was low.
In 2014, Pfizer recalled two lots of its antidepressant drug Effexor XR. Tikosyn was discovered in an Effexor XR bottle. Tikosyn is one of the company’s heart pills. Pfizer warned that the combination of the two different drugs could be deadly.
In 1996, Pfizer conducted an unapproved clinical trial. It involved children with meningitis in Nigeria, CBS News reported. The trials led to the deaths of 11 children. Dozens more were left disabled.
The unauthorized trial involved tests on 200 children with Pfizer's antibiotic Trovan.
Pfizer: Nigeria drug trial victims get compensation
US-based pharmaceutical giant Pfizer has made the first compensation payment to Nigerian families affected by a controversial drug trial 15 years ago.
11 August 2011
It paid $175,000 (£108,000) each to four families in the first of a series of payments it is expected to make.
The payouts are part of an out-of-court settlement reached in 2009.
In 1996, 11 children died and dozens were left disabled after Pfizer gave them the experimental anti-meningitis drug, Trovan.
The payouts were made to the parents of four of the children who died.
Their parents told the BBC they welcomed the payment, but it would not replace the loss of their loved ones.
The children were part of a group of 200 given the drug during a meningitis epidemic in the northern city of Kano as part of a medical trial comparing Trovan's effectiveness with the established treatment.
For years Pfizer maintained that meningitis — not the drug — caused the deaths and disabilities.
But after a lengthy and expensive litigation process, it reached a settlement with the Kano government in northern Nigeria. [...]
Trovan is a drug severely restricted in use because of its potential to cause liver damage. Injury to the liver as a result of taking Trovan can lead to liver failure and death.
In 2011, Pfizer paid $700,000 to four families who lost children during the Trovan trials.
In addition, the company set up a $35 million fund for those affected by Trovan. Pfizer also agreed to sponsor health projects in Kano, Nigeria.
PFIZER RAP SHEET