The Justice Department also said in 2009 that Pfizer paid $1 billion to resolve allegations of civil misconduct under the False Claims Act that the company had illegally promoted Bextra and three other drugs: the antipsychotic Geodon, the antibiotic Zyvox and the antiepileptic drug Lyrica. Brigham Young University (BYU) said a chemistry professor, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that led to the development of Celebrex. BYU initially targeted a 15% royalty on revenues, equivalent to $9.7 billion. A research agreement had been reached between BYU and Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme that Dr. Simmons reportedly discovered that it would cause pain and inflammation while causing gastrointestinal problems, and Celebrex is used to reduce these problems. A six-year battle ensued because BYU claimed that Pfizer had obtained credit or compensation from Dr. Simmons, while Pfizer claimed that it had fulfilled all obligations related to the Monsanto deal. In May 2012, Pfizer settled the allegations by agreeing to pay $450 million.  Over the years, Pfizer has been sued for some of its most popular drugs.
Courts have dismissed thousands of lawsuits against Pfizer. The company has also agreed to solve cases of illegal marketing and healthcare fraud. NEW YORK, N.Y., August 11, 2022 – Pfizer Inc. (NYSE: PFE) – As in our since February 2020 in the United States. Securities and Exchange Commission, a number of lawsuits have been filed against many defendants, including Pfizer, in which Zantac is involved. Pfizer only sold Zantac between 1998 and 2006, and the withdrawal of Zantac products from the market in 2019 and 2020 did not affect Pfizer`s products. Pfizer has important defenses for this litigation and there are important legal and factual issues that have not yet been resolved by the courts. Pfizer also has significant claims against others that have been acknowledged by several manufacturers in their disclosures.
Therefore, at this stage, we believe that the outcome of the litigation is unlikely to be material to Pfizer. “Federal employees deserve health care providers, including drug manufacturers, who uphold the highest standards of ethics and professional conduct,” said Patrick E. McFarland, Inspector General of the U.S. Office of Personnel Management. “Today`s agreement reminds the pharmaceutical industry of the need to comply with these standards and reflects the commitment of federal law enforcement to pursue inappropriate and illegal behavior that puts health care consumers at risk.” The lawsuit was eventually settled out of court. Pfizer pledged to pay $35 million “to compensate the families of the study children,” an additional $30 million to “support health initiatives in Kano” and $10 million to cover legal costs. Payments began in 2011.  “Illegal behavior and fraud by pharmaceutical companies endanger public health, corrupt medical decisions of health care providers, and cost the government billions of dollars,” said Tony West, assistant attorney general of the Civil Division. “This civil settlement and the Pfizer settlement are another example of the sanctions that threaten when a pharmaceutical company puts profits above the well-being of patients.” A “whistleblower lawsuit” was filed against Wyeth in 2005, which was acquired by Pfizer in 2009, alleging that the company illegally marketed Sirolimus (Rapamune) for off-label applications, targeted certain doctors and medical facilities to increase sales of Rapamune, tried to get transplant patients to switch from their transplant drugs to Rapamune, and specifically targeted African Americans. According to the whistleblowers, Wyeth also provided bribes such as grants, donations, and other funds to doctors and hospitals that prescribed the drug.  In 2013, the company pleaded guilty to criminal charges of mislabelling under the federal Food, Drugs and Cosmetics Act. As of August 2014, he had paid $491 million in civil and criminal penalties related to Rapamune.
 In September 2009, Pfizer pleaded guilty to illegally marketing the arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care settlement at the time.  Pfizer promoted the sale of the drug for various applications and dosages, which the Food and Drug Administration specifically rejected due to safety concerns. The drug was withdrawn from the market in 2005.  This was Pfizer`s fourth such settlement in a decade.    The payment included $1.195 billion in criminal penalties for crimes against the federal Food, Drug and Cosmetic Act and $1.0 billion to resolve allegations that the drugs were illegally advertised for uses not approved by the Food and Drug Administration (FDA), resulting in violations of the Misrepresentation Act. Because refunds were sought from federal and state programs. The sentence was the highest ever imposed in the United States.    Pfizer entered into a corporate integrity agreement with the Office of the Inspector General requiring the company to implement significant structural reforms within the company and publish on its website its post-approval commitments and a searchable database of all payments made by the company to physicians.  In addition, Pfizer agreed to pay $1 billion to settle allegations under the False Civil Claims Act that the company illegally advertised four drugs – Bextra; Geodon, an antipsychotic; Zyvox, an antibiotic and Lyrica, an antiepileptic drug – and made false claims to state health programs for applications that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid bribes to health care providers to get them to prescribe these and other drugs. The federal portion of the civil settlement is $668,514,830 and the state Medicaid portion of the civil settlement is $331,485,170.
This is the largest civil fraud settlement in history against a pharmaceutical company. If he ultimately wins, the royalty in such cases is usually a “high single-digit” percentage of revenue, according to Jacob Sherkow, a professor at the University of Illinois School of Law who specializes in intellectual property issues in biotechnology. In June 2010, the Blue Cross Blue Shield Health Insurance Network (BCBS) filed a lawsuit against Pfizer for allegedly illegally marketing the drugs Bextra, Geodon and Lyrica.