Stefan Philip Kruszewski is an American clinical and forensic psychiatrist, active as a whistleblower in medically related cases. [1] He is principal in the company which bears his name, Stefan P. Kruszewski, M.D. & Associates, P.C. in Harrisburg, Pennsylvania. [2]
A graduate of Princeton University and Harvard Medical School, Kruszewski has over 30 years of clinical and teaching experience in the field of psychiatry, with particular focus on addictionology, neuropsychiatry and neuropharmacology. [3] [4]
Kruszewski is a forensic specialist and has worked with both plaintiff and defense litigation. He has testified as an expert witness [5] in a range of cases involving antipsychotic medications [6] ), antidepressant medications, [7] [8] [9] analgesic medications (including opioids), [1] [10] and a range of psychiatric illnesses. [11] [12] Kruszewski has been recognized as a "distinguished expert" by senior federal judge, the Honorable Jack B. Weinstein, United States District Court for the Eastern District of New York (June 2007). [6] He has been recognized as a psychiatric expert by the Honorable Patti B. Saris and testified in the Federal Daubert hearings in US District Court of Massachusetts (May 2009). [13] Honorable Judge Rhonda E. Fischer has also accepted and affirmed expert testimony by Kruszewski in the Frye Hearings in District Court of the County of Nassau, New York State (Jan-May 2009). [7] [14]
As a fraud investigator for the Commonwealth of Pennsylvania in 2003, Kruszewski uncovered the abuse and medical mistreatment of children and the mentally ill in residential treatment centers, and was eventually fired for trying to expose what he had discovered. [15] [16] Kruszewski brought suit for First Amendment claims against the Pennsylvania Department of Public Welfare and in June 2007 he was awarded a settlement. [17] Also resulting, Kruszewski filed his first qui tam lawsuit which settled in 2009 against Southwood Psychiatric Hospital. [18] [19]
He has been a relator in two additional successful qui tam lawsuits: the first against Pfizer for its drug Bextra which settled in October 2009, [20] [21] [22] [23] and the second against AstraZeneca for its drug Seroquel which settled in April 2010. [1] [24] [25] [26]
Kruszewski is a three-time successful whistleblower, with settlements from suits brought against Southwood Psychiatric Hospital, Pfizer, Inc., and AstraZeneca. Kruszewski became aware of inadequate care and the exploiting of state-committed mentally ill children through overmedication and physical and chemical restraints while working for the Department of Public Welfare, Bureau of Program Integrity for the Commonwealth of Pennsylvania. When he refused to keep silent about his discoveries, he was fired from his position at the state. [27] Kruszewski won settlements for both a First Amendment case against the state of Pennsylvania [17] as well as his first qui tam lawsuit against the hospital. [28] In the cases against pharmaceutical giants, Pfizer [29] and AstraZeneca, [30] Kruszewski highlighted clinical science that was misrepresented by the defendants in their marketing and promotion of certain drugs. He also demonstrated problems with off-label marketing (marketing that promotes uses, patients or doses that are not approved by the US FDA) which resulted in heightened, but often non-transparent, risk to the health of patients and exceptional costs to taxpayers and state and federal governments. [23] [25]
The False Claims Act of 1863 (FCA) is an American federal law that imposes liability on persons and companies who defraud governmental programs. It is the federal government's primary litigation tool in combating fraud against the government. The law includes a qui tam provision that allows people who are not affiliated with the government, called "relators" under the law, to file actions on behalf of the government. This is informally called "whistleblowing", especially when the relator is employed by the organization accused in the suit. Persons filing actions under the Act stand to receive a portion of any recovered damages.
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered at The Spiral in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer (1824–1906) and his cousin Charles F. Erhart (1821–1891).
Quetiapine, sold under the brand name Seroquel among others, is an atypical antipsychotic medication used for the treatment of schizophrenia, bipolar disorder, and major depressive disorder. Despite being widely used as a sleep aid due to its sedating effect, the benefits of such use may not outweigh its undesirable side effects. It is taken orally.
AstraZeneca plc (AZ) is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. It was involved in developing the Oxford–AstraZeneca COVID-19 vaccine.
Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is a selective cyclooxygenase-2 inhibitor. It was patented in 1995.
In common law, a writ of qui tam is a writ through which private individuals who assist a prosecution can receive for themselves all or part of the damages or financial penalties recovered by the government as a result of the prosecution. Its name is an abbreviation of the Latin phrase qui tam pro domino rege quam pro se ipso in hac parte sequitur, meaning "[he] who sues in this matter for the king as well as for himself."
James Barry "Jim" Gottstein is a mostly retired Alaska based lawyer who practiced business law and public land law, and is well known as an attorney advocate for people diagnosed with serious mental illness. Gottstein has sought to check the growth in the administration of psychotropics, particularly to children.
The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture. Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. Organizational ethics are best demonstrated through acts of fairness, compassion, integrity, honor, and responsibility.
The Drug Industry Documents Archive (DIDA) is a digital archive of pharmaceutical industry documents created and maintained by the University of California, San Francisco, Library and Center for Knowledge Management. DIDA is a part of the larger UCSF Industry Documents Library which includes the Truth Tobacco Industry Documents. The archive contains documents about pharmaceutical industry clinical trials, publication of study results, pricing, marketing, relations with physicians and drug company involvement in continuing medical education.
David Franklin is an American microbiologist and former fellow of Harvard Medical School who while employed by Parke-Davis filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (gabapentin) for off-label uses. Franklin's suit, filed on behalf of the citizens of the United States under the qui tam provisions of US federal and state law, uncovered illegal pharmaceutical industry practices and created new legal precedent that resulted in a cascade of criminal convictions and civil and criminal penalties against Pfizer and several other pharmaceutical companies totalling more than $7 billion. Civil cases also followed Franklin v. Parke-Davis. Insurance companies, led by Kaiser Permanente, sued Pfizer for fraud and violation of the federal Racketeer Influenced and Corrupt Organizations Act; the Kaiser case settled in April 2014 after Pfizer's appeal at the US Supreme Court was rejected. Franklin v. Pfizer also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin. Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions. The settlement was the first off-label promotion settlement under the False Claims Act.
Edward F. Blizzard is a pharmaceutical injury attorney and a founding partner of Blizzard Greenberg, PLLC based in Houston, Texas.
The pharmaceutical industry in the United Kingdom directly employs around 73,000 people and in 2007 contributed £8.4 billion to the UK's GDP and invested a total of £3.9 billion in research and development. In 2007 exports of pharmaceutical products from the UK totalled £14.6 billion, creating a trade surplus in pharmaceutical products of £4.3 billion.
United States v. GlaxoSmithKline was a case before the United States District Court for the Eastern District of Pennsylvania. Robert J. Merena was one of the first who filed claims against SmithKline Beecham Clinical Laboratories on November 12, 1993. The complaints alleged that GlaxoSmithKline, which operated a system of clinical laboratories, adopted myriad complicated procedures for the purpose of defrauding state and federal healthcare programs, in particular Medicare and Medicaid. The U.S. Justice Department publicly praised Robert Merena for his "cooperation and support" in helping the government collect the largest settlement ever involving a whistle-blower lawsuit. The SmithKline settlement is considered to be one of the largest whistleblower assisted recoveries in the history of the United States.
Franklin v. Parke-Davis is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer under the qui tam provisions of the False Claims Act. The suit was commenced by David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert. In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for prescriptions that were not reimbursable, triggering False Claims Act liability. The case was also significant in exposing the degree to which publication bias impacts the randomized controlled studies conducted by pharmaceutical companies to test the efficacy of their products. Ultimately, the parties reached a settlement agreement of $430 million to resolve all civil claims and criminal charges stemming from the qui tam complaint. At the time of the settlement in May 2004, it represented one of the largest False Claims Act recoveries against a pharmaceutical company in U.S. history, and was the first off-label promotion settlement under the False Claims Act.
Reuben A. Guttman, born 1959 in New York City, is an American attorney and a founding Partner of Guttman, Buschner & Brooks PLLC ("GBB"), a DC-based plaintiffs' firm His practice involves complex litigation and class actions. He has served as counsel in some of the largest recoveries under the False Claims Act. The International Business Times has called Guttman "one of the world's most prominent whistleblower attorneys," and he has been recognized as a Washingtonian Top Lawyer by Washingtonian Magazine.
Dan Markingson was a man from St. Paul, Minnesota who died by suicide in an ethically controversial psychiatric research study at the University of Minnesota. For nearly eleven years, University of Minnesota officials defended the conduct of its researchers, despite significant public criticism, numerous news reports, and pressure for an external investigation. In March 2015, an investigation by a state watchdog agency found a number of major ethical violations in the case, including serious conflicts of interest and financial incentives, poor oversight of the study, pressure on Markingson to join the study while he was in a highly vulnerable state, and a series of misleading public statements by university officials. Shortly afterward, the university suspended recruitment into psychiatric research studies. On April 9, 2015, Charles Schulz, MD, announced his resignation as Chair of the Department of Psychiatry.
Marketing of off-label use is advertising the use of drugs for purposes not approved by the regional government. The practice is often illegal and has led to most of the largest pharmaceutical settlements after Franklin v. Parke-Davis, in which a court ruled off-label marketing a violation of the False Claims Act.