The Detrol case against Pfizer was pursued under the False Claims Act’s qui tam provision, which allows persons with knowledge of fraud on the government to sue on the government’s behalf.  Although in many situations the government exercises its ability to intervene in such cases, the Detrol case was pursued without government intervention and was litigated entirely by Greene LLP attorneys.  On the Lawyers Weekly list, the $14.5 million settlement ranked third among government cases.  When compared with other verdicts and settlements obtained by private attorneys, the settlement obtained by Greene LLP attorneys in the Detrol case would also rank third in the state in 2011.

“Litigating the case was a group effort,” said lead attorney Thomas M. Greene.  ”We didn’t abandon the case once the government declined to intervene, like many other firms tend to do with False Claims Act cases.  The fact that we won a settlement among the highest in the state is a testament to the investigative lawyering of our entire team.”

Thomas M. Greene was previously profiled for his work in Neurontin litigation in the September 2010 issue of Trial with an article entitled “Justice After a 14-Year Battle.”  Click here for a .pdf version of the November 2011 article, or here for more information about the Kaiser case.

Greene LLP attorneys have led the way in litigation over improper marketing of drugs by pharmaceutical companies.  In addition to the Kaiser case, the first successful RICO case against a pharmaceutical company, Greene LLP attorneys were the first to successfully argue that off-label promotion can lead to false claims against the government under the False Claims Act.

Greene’s candidacy was bolstered by a string of successes in 2010 and 2011, including the first ever RICO verdict against a pharmaceutical company, a $142 million award against Pfizer on behalf of Kaiser Foundation Health Plan involving fraudulent off-label promotion of Neurontin. For his closing argument in that trial, Greene won “Most Compelling Argument” in Mass Lawyer’s Weekly’s 2010 Battle of the Lawyers; he was also selected as a Finalist for the Public Justice Trial Lawyer of the Year Award.  Greene further accented his role as a premier False Claims Act attorney in New England with several speaking engagements, including national conferences and a seminar at Johns Hopkins University, as well as acting as Chair of “Recent Developments in False Claims Act Litigation,” a two-day seminar at Suffolk University.

The Super Lawyers profile, which is titled “Unprecedented Success Representing Whistleblowers,” includes a brief description of the novel theory first used by Greene in Franklin v. Parke-Davis, a False Claims Act case settled in 2004.  Since that time, 22 other qui tam cases involving off-label promotion have been resolved, including a $14.5 million settlement announced by Greene LLP last week.

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.

The significant injuries suffered by Greene LLP’s client required multiple surgeries and prolonged stays in a hospital and rehabilitation facilities, leading to over $335,000 in medical expenses.  The court found that as a result of the defendant’s conduct, Greene LLP’s client “was severely injured and suffered permanent pain and impairment,” awarding her those medical expenses.  Though retired and therefore unable to collect for lost earnings, she was also awarded $1.5 million in past, present and future pain and suffering.  Together with interest, the award totals $2.29 million.  The judgment against the driver of the truck and On Top Roofing and Renovations is in addition to a separate settlement with the insurance carrier of the driver of the truck.

Bryant chronicled the Kaiser Foundation Health Plan v. Pfizer litigation, a case which included a five week trial in federal court in Boston.  Determining that there was no scientifically acceptable evidence that Neurontin is effective for treating bipolar disorder, migraines, or general neuropathic pain, or at dosages above that approved by the FDA, the jury rendered a RICO verdict of $47 million which was trebled under the statute to $142 million.  The resolution of the case was a result of more than fifteen years of litigation involving Neurontin by Greene LLP attorneys, who also successfully resolved the first off-label promotion case under the False Claims Act when Pfizer settled for $430 million in civil penalties and criminal fines in 2004 over its marketing practices of the drug.

From the Public Justice Foundation’s program for the event:

Kaiser Foundation Health Plan v. Pfizer

Punishing Big Pharma’s Marketing Fraud

When Pfizer, the world’s largest pharmaceutical company, embarked upon a massive campaign to market a popular epilepsy drug for uses that had not been approved by the Food and Drug Administration, the Greene team filed suit on behalf of the Kaiser Foundation, which provides health care coverage for nearly 8.6 million families.  To prove that Pfizer had defrauded the insurer into paying hundreds of millions for an inappropriately prescribed drug, the team sought to hold Pfizer accountable under the federal racketeering law known as “RICO.”  No pharmaceutical company had ever been held liable under the notoriously difficult statute.  To complicate things further, the attorneys had to pour over nearly three million pages of Pfizer documents; had to prove that the drug was ineffective for the various off-label uses Pfizer had touted; and had to walk the jury through the complex mechanics of a RICO enterprise.  In March 2010, a federal jury in Boston hit Pfizer with a $47.3 million damages award, which was automatically tripled under RICO to a total of more than $142 million.

Kaiser’s RICO claims were tried to a federal jury in Boston, and claims under the California Unfair Competition Law were tried by presiding judge Patti Saris, who found “no evidence” that Neurontin was effective for several off-label indications.  The judge found that Neurontin was no more effective than placebo for several indications that were off-label, including bipolar disorder, migraines, general neuropathic pain and at doses greater than 1800mg per day.  Greene LLP argued that in putting profits ahead of safety, Pfizer put thousands of people at risk – Neurontin has been linked to depression and suicide, but was marketed to one population particularly vulnerable to both: individuals with bipolar disorder.

In addition to holding Pfizer accountable for a decade of illegal, fraudulent off-label marketing and resulting prescriptions, the verdicts also blazed a trail for other off-label marketing cases.  The Kaiser trial is believed to be the first time that a non-governmental party has successfully sued a pharmaceutical company for fraudulent off-label promotion practices.

In concert with its False Claims Act practice, Greene LLP has a national reputation for off-label promotion cases against pharmaceutical companies.  Greene LLP professionals Thomas M. Greene, Ilyas J. Rona, and Dr. Palko Goldman frequently present on pharmaceutical marketing practices, to attorneys and academics and also to the medical community.  In 2004, Greene LLP attorneys successfully resolved a False Claims Act case filed in 1996 over off-label promotion of Neurontin, which was the first False Claims Act settlement for a case alleging off-label marketing of drugs and which was pursued without government intervention.  Since that settlement of $430 million in civil penalties and criminal fines, the government has recovered more than $7 billion in False Claims Act off-label promotion cases.

In threatening medicine’s evidence base, off-label promotion undermines the cornerstone of modern medicine.  As Mr. Rona and Dr. Goldman observed, most forms of publication bias and selective outcomes reporting are not correctible or even detectable without intervention from the legal system.  They reviewed the ways that the legal system can uncover the true evidence about drug treatments, and the resulting opportunities that are available to researchers, clinicians, and the academic community.  The talk concluded with questions from attendees, many of which related to whether evidence-based medicine can survive in the face of strong profit motives to distort clinical trial results in order to pad off-label sales.  Mr. Rona and Dr. Goldman also answered questions about recent efforts to force pharmaceutical firms to register clinical trials as part of the 2007 Food and Drug Administration Amendments Act (FDAAA), and whether those efforts will have a favorable impact on reducing the instances of publication bias and selective outcomes reporting.

Prior to their presentation at the Society for Clinical Trials, Mr. Rona and Dr. Goldman gave a similar presentation at the University of British Columbia.  The seminar was hosted by Dr. Thomas Perry, Jr., who chairs the Education Working Group at the Therapeutics Initiative, and Dr. James M. Wright, Managing Director of the Therapeutics Initiative.  Dr. Wright is also Professor of the university’s Departments of Anesthesiology, Pharmacology & Therapeutics and Medicine, which hosted the program as part of its Department Seminar Series.  Mr. Rona and Dr. Goldman presented background on the use of the American legal system as a tool to combat pharmaceutical fraud.  The recent trend of large settlements against drug manufacturers was presented, along with background on the False Claims Act, which triggers the bulk of U.S. government recoveries in cases involving false or fraudulent statements by the pharmaceutical industry.  Mr. Rona and Dr. Goldman then reviewed the case of Neurontin, whose manufacturers embarked on a plan to turn a niche epilepsy drug into a sales blockbuster by tapping into the lucrative pain, psychiatric, and migraine markets.  To accomplish this goal, negative evidence of inefficacy were hidden from the medical community long enough to allow the drug to remain an off-label juggernaut by the end of its period of marketing exclusivity.

Mr. Rona and Dr. Goldman also held a seminar directed toward lawyers, at the downtown Vancouver offices of Bull Housser Tupper.  The legal seminar focused on whether the American legal system is succeeding or failing to hold drug companies accountable for fraud.  Mr. Rona and Dr. Goldman reviewed the various legal tools that are used to hold drug companies accountable, from qui tam actions under the False Claims Act, to direct actions by large health plans, to class actions.  They discussed the large fines levied against drug companies, evaluating whether they have had an effect or whether they have been treated as a cost of doing business.  A key aspect of the presentation also included the question of whether industry executives have been emboldened by the fact that few, if any, may ever go to jail for their conduct, including a update of the role of the Park doctrine as a tool to hold executives accountable.

On the panel, Mr. Greene led discussions of particular consequence to current and potential whistleblowers, most of which related to developments with retaliation claims under the False Claims Act, and to the Patient Protection and Affordable Care Act.  With respect to anti-retaliation protections under “section (h)” of the False Claims Act, Greene discussed Congress’s wishes to extend protections to a wider variety of potential qui tam whistleblowers.  With ever more complicated contracting and subcontracting relationships among companies paid by the government, Congress extended the Act’s robust protections beyond persons in normal employer-employee relationships.  Thanks to amendments by FERA and the 2010 Dodd-Frank Act, persons are protected from retaliation for attempting to stop fraud on the government or for pursing qui tam complaints on the government’s behalf, even if they are merely agents or independent contractors of the company at issue.

With regard to health care legislation, Mr. Greene presented changes to the False Claims Act’s public disclosure bar, which is designed to prevent private litigants from pursuing qui tam actions if their information is based on information that is already within the public domain.  In most respects, the PPACA changes to the public disclosure bar make it easier for qui tam relators to survive such challenges.  Mr. Greene also discussed how PPACA-instituted health insurance exchanges will impact False Claims Act procedure, particularly in light of a series of significant settlements within the health care industry.

The panel was moderated by Robert Patten, Managing Attorney at the Massachusetts Office of the Attorney General’s Medicaid Fraud Division.  In addition to soliciting input from the panel, Mr. Patten discussed the state False Claims Act recertification process – in order to receive preferential treatment when settlement proceeds are received by the government, states must have a False Claims Act as powerful as the federal version, and the number of recent changes to the federal law have prompted changes at the state level.  Representing the government, Mr. Patten was joined on the panel by Michael Granston, Assistant Director of the Commercial Litigation Branch, Civil Division, at the U.S. Department of Justice.  Mr. Granston discussed changes to the Anti-Kickback Statute, the False Claims Act’s conspiracy provision, the government’s enhanced authority to issue Civil Investigative Demands, and the retroactivity of recent legislation.

Representing the defense bar were Kirsten V. Mayer of Ropes & Gray in Boston and John T. Boese of Fried Frank in New York.  Ms. Mayer addressed emerging issues in false certification liability, including courts’ acceptance of implied certification theories of liability, and also discussed the status of Freedom of Information Act reports as public disclosures.  Mr. Boese presented on retention of overpayments as a basis for False Claims Act liability and differing interpretations of who may be an “original source,” a status which functions as an exception to the public disclosure bar.

False Claims Act litigation has been a core practice area for Greene LLP since the firm’s inception.  Click here to learn more about the False Claims Act, recent changes, and how Mr. Greene started a career in False Claims Act litigation.