Thomas M. Greene Named to 2011 Super Lawyers List

October 26th, 2011

Thomas M. Greene was recently named to New England Super Lawyers magazine’s list of top lawyers, and was the subject of a profile within the magazine.  The distinction is conferred on up to 5% of attorneys.  Criteria for the annual list include verdicts and settlements, experience, honors and awards, and scholarly lectures and writings.

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.

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

October 20th, 2011

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.

Greene LLP Client Receives $2.29 Million Judgment in Personal Injury Case

September 13th, 2011

On September 1, Greene LLP attorneys obtained a $2.29 million judgment against a roofing company for the negligent conduct of its truck driver in a personal injury case.  In 2009, Greene LLP’s client, a 72 year old woman, was walking on a sidewalk in Worcester when an On Top Roofing and Renovations truck pulled out of a driveway in reverse at high speed, striking her.  The client was dragged fifteen feet into the street before the truck ran over her, fracturing her right leg.

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.

Greene LLP Attorneys Celebrated by Public Justice Foundation for “Punishing Big Pharma’s Marketing Fraud”

July 14th, 2011

The Public Justice Foundation recognized the work of Greene LLP attorneys Thomas M. Greene and Ilyas J. Rona in an awards gala in New York on July 12.  Along with other trial teams singled out for advancing access to justice in the court system and promoting public safety, the Greene team’s work in holding Pfizer accountable for years of off-label marketing of Neurontin was detailed by Public Justice Foundation Executive Director Arthur H. Bryant.

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.

 

Greene LLP Attorneys Named Finalists for Public Justice Trial Lawyer of the Year Award

June 23rd, 2011

The Public Justice Foundation, a non-profit promoting civil rights, names one trial attorney or trial team per year that has advanced Public Justices goals of access to justice through trial advocacy.  This spring, Greene LLP attorney Thomas M. Greene was nominated for the Trial Lawyer of the Year Award for his role in the Kaiser Foundation Health Plan RICO case tried in 2010, which resulted in a trebled jury verdict of $142 million over Pfizer’s fraudulent off-label marketing practices of Neurontin. This month, Greene and his trial team, including Ilyas J. Rona, were selected as finalists by Public Justice from among the nominations.

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.  Thomas M. Greene frequently presents 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.

Greene LLP Attorney Makes Presentation at ABA Health Care Fraud Conference on False Claims Act Changes

May 24th, 2011

This year’s American Bar Association Health Care Fraud Conference featured a panel entitled “False Claims Act Developments,” involving attorneys from all sides of False Claims Act litigation.  The panel drew attention to several recent developments in False Claims Act practice and procedure, including the 2009 Fraud Enforcement and Recovery Act (FERA), health care legislation in 2010, and recent litigation and settlements.  Greene LLP attorney Thomas M. Greene served as the representative of the relators’ bar, with an eye toward presenting how recent changes in the law will impact qui tam whistleblowers.

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.

Thomas M. Greene Interviewed on False Claims Act Cases, Experience as Whistleblower Lawyer

May 5th, 2011

On May 4, 2011, Suffolk University published an interview with Greene LLP Managing Partner Thomas M. Greene.  In the podcast, which is available on Legal Talk Network, Mr. Greene was interviewed by Suffolk University Law School Professor Linda Sandstrom Simard about recent changes to False Claims Act practice in qui tam cases.  Mr. Greene explained how the District of Massachusetts has become the epicenter for False Claims Act litigation, particularly since Greene’s 2004 settlement of Franklin v. Parke-Davis for $152 million. The Franklin case, which centered on Parke-Davis and Pfizer’s marketing practices of the drug Neurontin, set off a series of off-label promotion cases against pharmaceutical companies – contributing to the reputation of Massachusetts as a leader in health care fraud cases.

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.

 

Greene LLP Settles with UnumProvident and Paul Revere Over Bad Faith Income Insurance Claim Denial

May 2nd, 2011

Last month, Greene LLP attorneys resolved a bad faith insurance case against Unum Life Insurance Company and subsidiary The Paul Revere Life Insurance Company.  The case alleged that Unum wrongfully denied claims made by a Greene LLP client under two income insurance policies purchased in the 1980s.  The settlement amount of $700,000 resolves all claims by Greene LLP’s client under M.G.L. c.93A and c.176D(3) and for breach of contract related to the income insurance policies.

Greene LLP’s client, a licensed social worker in private practice, was diagnosed with a mental illness several years after purchasing the income insurance policies.  As a result, he was unable to maintain his practice, triggering benefits under the two policies.  Due to the same mental illness, the Greene LLP client was unable to keep up with UnumProvident and Paul Revere’s onerous requirements to justify benefits.

In 2004, insurance regulators in Massachusetts, Maine and Tennessee, on behalf of themselves and other states and jurisdictions, conducted an investigation into the claim denial practices of Unum, Paul Revere, and Provident Life and Accident Insurance Company.  The regulators levied a $15 million fine after they found systematic and widespread “unfair claim settlement practices” by the companies, including failures to evaluate “the totality of the claimant’s medical condition.”  The regulators also found “a significant number of instances” in which an inappropriate burden had been placed on claimants to justify eligibility for benefits.

Greene LLP argued that both of these unfair practices played a role in a bad faith denial of its client’s claims for benefits.  By improperly shifting a burden to prove eligibility to the insured, Greene LLP attorneys argued, Unum and Paul Revere took advantage of someone who was especially ill-equipped to fight their practices – because of his mental illness, the very reason he suffered a loss of income in the first place.  “Unum’s claim denial practices were unreasonable,” said lead attorney Thomas M. Greene.  “Individuals like my client should not have to prove their eligibility for benefits by responding to mountains of paperwork, especially if mental illness makes it particularly difficult to do so.  That’s bad faith.”

Greene LLP Attorney Presents at AAJ Conference on “How to Win a RICO Case Against Pharmaceutical Giants for Fraudulent Off-Label Promotion”

April 27th, 2011

The successful Kaiser case which resulted in a $147 million jury verdict led the American Association for Justice to invite Greene LLP attorney Thomas M. Greene to present at the AAJ’s Winter Conference during its “Sunrise at Litigation” panel, a staple at AAJ semiannual conventions.  Leading members of the plaintiff’s bar are invited twice a year to present developing new legal theories that have been successfully applied by plaintiff’s attorneys.  Mr. Greene’s presentation, entitled “How to Win a RICO Case Against Pharmaceutical Giants for Fraudulent Off-Label Promotion,” was featured on February 9.  His written paper of the same name was included in the written materials for the convention, and was also republished by the AAJ’s Section on Toxic, Environmental and Pharmaceutical Torts in its Spring newsletter.

In the presentation, Mr. Greene described the myriad difficulties involved in satisfying RICO’s robust legal requirements.  Arguing it had suffered millions of dollars in damages by paying for worthless off-label prescriptions, Kaiser Foundation Health Plan established a pattern of racketeering activity by Pfizer and its associates: mail fraud that misrepresented the proven efficacy of Neurontin for a variety of off-label indications.  Before the trial phase of litigation, an “enterprise” was established between Pfizer and its medical marketing firm, in addition to a second enterprise formed through Pfizer’s association with its advertizing agency. Kaiser proceeded to trial against Pfizer as the “bellwether case” selected by Judge Saris, who presides over the Neurontin Multi-District Litigation.

In March 2011, Judge Saris entered judgment in the Kaiser case, officially trebling the jury’s verdict of $47 million to $142 million and updating Kaiser’s Unfair Competition Law damages.  Said Greene, “only through treble damages provisions like that of RICO or of the False Claims Act can we prevent pharmaceutical companies from engaging in off-label promotion and treating the verdicts or settlements that result as a cost of doing business.”

Much like how the Neurontin False Claims Act case has spurred over $7 billion in subsequent litigation, the Kaiser case may prove to be a template for other cases against pharmaceutical companies for fraudulent off-label marketing of drugs.  “Fraudulent off-label promotion endangers public safety,” said Greene.  “We have only begun to turn the tide.”

 

New Frontiers and False Claims Act Settlements Discussed at Second Day of Recent Developments Program

April 4th, 2011

On March 31, the Recent Developments in False Claims Act Litigation program concluded at Suffolk University with two panels discussing new frontiers in liability and emerging trends in causation, claims analysis and settlements in False Claims Act cases. Each panel featured leaders in the field, including several government attorneys. While all sides of False Claims Act cases were presented, Greene LLP attorney Ilyas J. Rona wound up the program with a close look at the experience of whistleblowers, substantiating the importance of their involvement in cases that involve industries particularly prone to fraud on the government, particularly health care. Mr. Rona submitted a paper for the program backed by litigation statistics and feedback from False Claims Act whistleblowers entitled “The Whistleblower Perspective: Why They Do It, and Why We Need Them.”

After program chair and moderator Thomas M. Greene introduced the members of the first panel, Assistant United States Attorney Paul Levenson led off the evening with a description of the SEC’s new whistleblower regulations, which have been proposed and are due to become final in less than three weeks. Mr. Levenson, who serves as Chief of the Economic Crimes Unit of the U.S. Attorney’s Office in Massachusetts, commented on the “tug of war that has erupted” over the SEC’s proposed regulations, and noted that unlike False Claims Act cases and the IRS whistleblower program, the conduct potentially at issue which could result in rewards for SEC tipsters does not necessarily involve fraud on the government. Attorney Suzanne Durrell then presented on the changes made by the Patient Protection and Affordable Care Act on health care providers’ obligation to return Medicare and Medicaid overpayments. Marty Murphy of Foley Hoag and Assistant United States Attorney Susan Winkler, Chief of the Criminal Division’s Health Care Fraud Unit in Massachusetts, concluded the first panel with a discussion of increasing efforts to hold executives in the health care industry accountable through criminal prosecutions. In particular, the discussion honed in on an apparent revival of the Park doctrine, through which executives may be prosecuted for misdemeanors due to the conduct of their companies.

Robert Patten, Managing Attorney in the Medicaid Fraud Division of the Massachusetts Attorney General’s Office, started the night’s second panel with a discussion of parallel civil and criminal investigations in False Claims Act cases. Mr. Patten cited the “strong link” between both types of investigation, noting that like most state Medicaid Fraud Units, his office has both civil and criminal authority. In fraud cases in which there may be criminal conduct with national implications, the federal government generally takes the lead; Assistant United States Attorney Zachary Cunha, Deputy Chief of Affirmative Civil Litigation in the Massachusetts United States Attorney’s Office, explained that when the United States Attorney’s Office picks a track for investigations, they must then be careful that information is not improperly disseminated between civil and criminal divisions. Panelist Brien O’Connor, a partner at Ropes & Gray in Boston, credited the skill of both state and federal attorneys, noting that investigations are often “very much a joint federal and state effort.” Mr. O’Connor highlighted the additional role played by the Office of the Inspector General of the Department of Health and Human Services, which has authority to exclude individuals and companies from participation in government health care programs.

Mr. O’Connor also introduced many of the intricacies in False Claims Act settlement negotiations, leading to a lively discussion among the panelists. Mr. Cunha noted that whether the federal government has intervened becomes a main determinant in how settlement discussions progress, that claims data is often a big factor and that defendants typically want a global resolution in settlement negotiations. Mr. Patten added that coordinating the claims of all participating states is a difficult process because only sovereign states can sue under their own false claims laws, and because “some states don’t have the same arrows in their quiver” that Massachusetts has. The panel concluded with Mr. Rona’s presentation on whistleblowers and their perspective, which drew questions from program attendees.