$14.5 Million Settlement with Pfizer, Inc. in False Claims Act Case Alleging Off-Label Promotion of Detrol

Greene LLP announces the $14.5 million settlement of a lawsuit alleging improper marketing of the prescription drugs Detrol and Detrol LA by defendant Pfizer, Inc.  The lawsuit was brought on behalf of the United States by two former employees of Pfizer under the False Claims Act, which permits individuals who have knowledge of frauds against the United States to sue on the federal government’s behalf and to keep a percentage of the recovery.  Relators David Wetherholt and Marci Drimer will receive 27% of the federal government’s portion of the settlement, and were represented by Thomas M. Greene, Michael Tabb and Ilyas J. Rona of Greene LLP.  The investigative efforts of Palko S. Goldman, M.D. were also instrumental in the case.

Detrol and Detrol LA are prescription drugs approved for the treatment of “over active bladder with symptoms of urge incontinence, urgency and frequency.” The lawsuit alleged that Pfizer improperly marketed the drug to men who were suffering from the signs and symptoms of benign prostate hyperplasia (BPH), which is commonly referred to as an enlarged prostate.  Although men suffering from an enlarged prostate exhibit many of the same symptoms as men who have an overactive bladder, the two conditions have different causes and relators contended that neither Detrol nor Detrol LA will have any therapeutic effect on males whose symptoms are caused by an enlarged prostate.

Relators Wetherholt and Drimer alleged in the suit that Pfizer caused false claims to be submitted to the United States and state governments by illegally marketing Detrol for BPH, Lower Urinary Tract Symptoms (LUTS), and Bladder Outlet Obstruction (BOO), uses for which Detrol has not been approved by the Food and Drug Administration.  Off-label prescribing of Detrol was detailed in the book Our Daily Meds by Melody Petersen, and is the subject of that book’s first chapter, entitled “Creating Disease.”

The Detrol suit marks the third time that Greene LLP attorneys have successfully resolved claims against Pfizer that the company illegally or fraudulently caused off-label prescriptions of its drugs.  After a five week trial in 2010, a jury awarded a $142 million Racketeer Influenced and Corrupt Organizations Act verdict to Greene LLP client Kaiser Foundation Health Plan after Pfizer fraudulently caused off-label prescriptions of its Neurontin epilepsy drug.  In that 2010 suit, Greene LLP attorneys successfully argued that Pfizer caused off-label prescriptions of Neurontin for migraines, general neuropathic pain, and bipolar disorder, despite a complete absence of any medically reliable evidence that Neurontin is effective for any of those off-label conditions.

The RICO case followed the first False Claims Act case to successfully allege that causing off-label prescriptions of a drug may be actionable under the False Claims Act.  Also involving Neurontin, Franklin v. Parke-Davis was resolved in 2004 by Greene LLP attorneys who settled with Pfizer for $430 million in civil penalties and criminal fines.  With the successful resolution of the Detrol case, there have been twenty-three False Claims Act cases involving off-label promotion of prescription drugs, with more than $8.5 billion recovered by the federal government since 2004 using the theory first successfully employed by Greene LLP attorneys in Franklin.

The Neurontin and Detrol False Claims Act cases were both successfully resolved after the government declined to intervene in the case.  Nonetheless, the United States Attorney’s Office for the District of Massachusetts and the National Association of Medicaid Fraud Control Units were integral in prosecuting the Detrol litigation.  In particular, Greene LLP wishes to recognize the contributions of Robert Patten, Managing Attorney in the Medicaid Fraud Division of the Massachusetts Attorney General’s Office and co-chair of the Global Case Committee of the National Association of Medicaid Fraud Control Units, as well as that of Assistant United States Attorney Zachary A. Cunha, Deputy Chief of Affirmative Civil Litigation in the Office of the United States Attorney for the District of Massachusetts.  Massachusetts often takes the lead in national False Claims Act cases involving the health care industry, with the District of Massachusetts responsible for more than one-third of the federal government’s recoveries in such cases within the last eight years.

Greene LLP is a complex civil litigation firm that specializes in False Claims Act litigation.  Its attorneys have nearly twenty years of experience representing whistleblowers, with a track record of successes in defense and health care industry cases.  Located in the heart of Boston, the leading area for health care industry False Claims Act cases, the six attorney firm has unparalleled experience in successfully pursuing whistleblower cases regardless of whether the government elects to intervene.

The case is United States ex rel. Wetherholt and Drimer v. Pfizer Inc., CV-06-10204, filed in the United States District Court for the District of Massachusetts.  The complaint in force at the time of settlement is available here.  The Department of Justice press release can be accessed here.

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