Press Releases’ Archives

Thomas M. Greene Testifies Before Congress on Fighting Health Care Fraud

Thursday, February 28th, 2013

On February 27, Greene LLP Partner Thomas M. Greene testified before Congress at a committee hearing entitled “Fostering Innovation in Fighting Health Care Waste, Fraud, and Abuse.”  Greene was called to testify because of his over twenty years’ experience representing whistleblowers, as well as his experience representing health insurance plans, Taft-Hartley Funds, and self-insured employers in health care litigation.

Greene drew on his experiences in False Claims Act litigation and private health insurance cases to answer several questions from members of the House Subcommittee on Health.  He first touted the success of the False Claims Act.  “The False Claims Act is a dynamic fraud-fighting machine,” he said, hailing the fact that the False Claims Act allows whistleblowers to pursue cases if they wish, even if the government does not intervene.  He noted that declined cases can foster innovation.  “When I filed the first off-label promotion False Claims Act case in 1996, government attorneys were not convinced of the viability of that theory,” said Greene.  “But once that case was settled in 2004, it set a precedent that kicked off $14 billion in other recoveries.”

Greene noted that in health care, “qui tam [whistleblower] cases outnumber government-initiated cases about five to one,” before giving a few representative examples.  “Health care cases do come in many forms.  You might have hospitals or nursing homes upcoding claims to get higher reimbursement rates, or billing for services not actually performed.  Laboratories, causing billing for unnecessary tests, or again for tests not performed.  There are cases based on violations of the Anti-Kickback Statute, or the Stark law, with doctors getting illicit payments or benefits, or lucrative self-referrals.  Durable medical equipment companies, billing for equipment that was never delivered.  And you could also have medical supplies be the basis of actionable fraud.  One of my cases, that actually got unsealed last month, involves unnecessary deliveries of oxygen supplies.”

Greene’s trial team is also the only one to have won a RICO case against a pharmaceutical company, winning $142 million for Kaiser Foundation Health Plan in 2010 for damages from fraudulent off-label promotion of Neurontin.  Greene noted that RICO was only available as an avenue of recovery for private payors when those who commit fraud form into RICO enterprises, as Pfizer had with other firms in the Neurontin litigation — but that frauds committed by one organization could be just as egregious.  He urged Congress to consider giving private payors a right of action to sue for health care fraud.  He testified that “it is possible that the government will be able to recover through the False Claims Act — but there is currently little that a private payor can do to recoup their own losses.  Without a right of action for even the most egregious of frauds, it is the public that eventually foots the bill through the increase of insurance premiums.”

A full version of Greene’s testimony is available here.

To view Thomas M. Greene’s opening statement, cue the video below to the 1:50:40 mark.

Off-Label Promotion Subject of Thomas M. Greene Presentation to ABA Antitrust Law Section

Wednesday, January 16th, 2013

The ABA’s most recent presentation on off-label promotion featured Greene LLP attorney Thomas M. Greene.  The panel, which was sponsored by the Health Care and Pharmaceuticals Committee of the ABA Section of Antitrust Law, was entitled “Off-Label Promotion of Pharmaceuticals: Application of the False Claims Act and Consumer Protection Acts to Promotional Strategies.”  Audio of the presentation is available here for section members.

Mr. Greene led off the presentation with a discussion of the statutory and regulatory scheme governing the promotion of drugs.  After introducing the Food, Drug and Cosmetics Act (FDCA) and the promotion regulations promulgated by the FDA, Mr. Greene went on to discuss the definition of “labeling” and how it relates to the statutory definition of “misbranding” – dissemination of misbranded drugs is a crime under the FDCA.  Mr. Greene also discussed the safe harbor for promoting drugs off label through use of reprints of peer-reviewed journal articles and reference publications, and that the safe harbor still prohibits all false or misleading off-label promotion.  Mr. Greene’s slides for the presentation are available here (slides 6 through 26).

Toward the end of the presentation, Mr. Greene referred to Neurontin as a compelling story of how the government and private health care organizations have fought back against false and misleading off-label promotion by the pharmaceutical industry.  Greene LLP attorneys, including Mr. Greene, handled the very first False Claims Act case to pursue the theory that off-label promotion can cause false claims and can lead to False Claims Act liability.  Filed in 1996, the case settled in 2004 for $430 million in civil fines and criminal penalties.

The story of Neurontin is ongoing, however, and is also a tale of how private health care organizations can seek to recover damages for fraudulently-induced off-label prescriptions.  The District of Massachusetts is the home of a multi-district litigation concerning the marketing of Neurontin; Mr. Greene is the Chairman of the Plaintiffs Steering Committee in the MDL.  One organization, Kaiser Foundation Health Plan, was selected by presiding judge Patti Saris as a bellwether trial.  The jury in that trial returned a $47 million RICO verdict which was trebled to $142 million; the consumer protection act in that case, the California Unfair Competition Law, was tried to the judge, who returned a judgment of over $102 million.  Efforts to certify a class of the remaining health care organizations has been briefed by Greene LLP attorneys for the First Circuit, with oral argument scheduled for February 6, 2013.

After successfully resolving the Neurontin False Claims Act case against Pfizer, Greene LLP attorneys have pursued other pharmaceutical companies under an off-label promotion theory of recovery.  Greene LLP attorneys represented a relator in the Bristol-Myers Squibb case concerning the drug Abilify which settled in 2007 for $519 million, as well as the relators in the Detrol case against Pfizer, whose case was settled for $14.5 million in 2011 without government intervention.

Greene LLP Investigating Compounding Pharmacies

Friday, October 19th, 2012

The Boston Globe recently reported that the number of patients who have contracted meningitis has risen to 245, with 19 confirmed deaths.  As many as 14,000 people are at risk of infection from tainted steroid injections from the New England Compounding Center, located in Framingham, Massachusetts.  Meningitis has been found in patients all over the United States, including Tennessee, Michigan, Virginia, Indiana, Maryland, New Jersey, Florida, Ohio, Idaho, Illinois, Minnesota, New Hampshire, North Carolina, Ohio, Pennsylvania, and Texas.

The FDA has not yet made a conclusive determination on how the medications from the Framingham pharmacy became contaminated.  Nonetheless, it has advised facilities and patients that any injectable drug from the New England Compounding Center should not be used if manufactured after May 21 of this year.

Although the NECC is under investigation by health officials and the US Attorney’s Office in Boston, government officials are most likely to pursue criminal remedies against the pharmacy, and are unlikely to fully vindicate the rights of those affected.

Greene LLP has been actively investigating compounding pharmacy practices and procedures for several months in connection with a previously-filed lawsuit unrelated to the NECC, and has recently broadened its investigation to the NECC and similar pharmacies.

Greene LLP is a Boston complex civil litigation firm with extensive experience in pharmaceutical and health care cases.  After a record $430 million in a False Claims Act case against Pfizer in 2004, Greene LLP attorneys have pursued many other pharmaceutical and health care cases under several laws, including state statutes and the federal Racketeering Influenced and Corrupt Organizations Act.  Greene LLP partner Thomas M. Greene has acted as Chairman of the Plaintiffs Steering Committee in a multi-district litigation against Pfizer, winning a $142 million jury verdict in 2010.

Thomas M. Greene and Palko S. Goldman of Greene LLP Co-Author Case Study on Publication Strategy, Reporting Bias in Off-Label Promotion

Thursday, September 27th, 2012

In a partnership between law and medicine characteristic of Greene LLP, attorney Thomas M. Greene and physician Palko S. Goldman have co-authored an article about Pfizer’s strategy of promoting Neurontin for unapproved indications instead of seeking additional indications from the FDA.  The article, published by the peer-reviewed journal Trials, is a case study in how a pharmaceutical company’s selective reporting of clinical trial results can affect medical literature.  “No regulatory body vets the clinical trial evidence of a drug’s effectiveness for off-label uses,” said Dr. Goldman.  “It is critically important for drug manufacturers to report results for off-label uses in the most unbiased manner possible,” he observed.

Experts in clinical trial methodology at the Johns Hopkins Bloomberg School of Public Health also co-authored the Trials article.  Said Goldman, “the medical community recognizes that true and unbiased clinical trial results are vital to prescribing decisions.”  The co-authors relied heavily on thousands of documents obtained through sixteen years of litigation spearheaded by attorney Thomas M. Greene, including those from an eight year False Claims Act case settled for $430 million in 2004 without government intervention.  As Chairman of the Plaintiffs Steering Committee for the Neurontin Multi-District Litigation centered in Massachusetts, Greene has also pursued cases by private parties against Pfizer, including an ongoing appeal to the First Circuit Court of Appeals and a $142 million RICO verdict for Kaiser Foundation Health Plan.

“Physicians have played an integral role in the Neurontin litigation,” said Greene.  “It takes a partnership between attorneys and physicians to piece together an off-label strategy like that of Neurontin, and that’s why someone like Dr. Goldman is so important.”  Palko S. Goldman, who has worked with Greene for over six years, helped to lead discovery efforts in Neurontin litigation, in which he and several attorneys sorted through millions of pages of documents.

Involving doctors in all stages of litigation has been a hallmark of Greene LLP’s practice in pharmaceutical cases.  “I firmly believe that having a physician intimately involved in the litigation process puts us at an advantage, against defendants but also as compared to other firms,” noted Greene.  “We have succeeded where other firms have failed, in large part because Dr. Goldman has seen things that others missed.”  Goldman’s presence at the firm, Greene added, is “one of the ways in which Greene LLP is uniquely qualified to handle a variety of cases against pharmaceutical companies.”

Greene LLP is a leader in pharmaceutical litigation, including the representation of qui tam whistleblowers in False Claims Act cases.  Its attorneys have nearly twenty years of experience representing whistleblowers, with a track record of successes in health care industry cases.  The five attorney firm has worked extensively in False Claims Act cases, and has also held pharmaceutical companies liable under other laws, including RICO and several state statutes.

Greene LLP Announces $1.6 Million Settlement of Back Injury Case

Monday, April 2nd, 2012

Greene LLP announces the recent $1.6 million settlement of a construction site accident on behalf of a construction laborer.  The firm’s client was working for Cicconi & Sons Construction Company excavating pieces of sidewalk in Boston when, he alleged, he was struck in the back by the bucket of a backhoe, rendering him disabled.  The $1.6 million settlement redresses the client’s loss of earning capacity and medical expenses.

The complaint alleged that the operator of the backhoe had a duty to ensure that the work zone was clear of workers before swinging the backhoe’s bucket into position over the work area.  The complaint also alleged that the defendant negligently failed to assign a foreman charged with the responsibility of communicating by hand signals with the backhoe operator to ensure that the work area was clear before the backhoe bucket was swung back into the work area.

Greene LLP’s client sustained significant injuries to his lower back, including disc extrusion, an annular tear at L5-S1, and impingement of nerve roots, leading to cortisone injections and two microdiscectomies, and alleged that these injuries resulted from being struck in the back by the defendant’s backhoe.  The client has incurred approximately $50,000 in medical expenses for his treatment and surgeries.

Attorneys Thomas M. Greene, Michael Tabb and Ilyas J. Rona represented the plaintiff, with assistance at all stages of the litigation by Dr. Palko S. Goldman.

Greene LLP is a complex civil litigation firm in downtown Boston, Massachusetts.  Its attorneys have been highly successful in litigating personal injury cases, setting records for the highest verdict for the death of a child in the state and the highest recovery resulting from a commercial airline crash.  The firm’s attorneys have also had a number of successes in construction site cases, including $5.2 million on behalf of an injured masonry worker and $3.6 million on behalf of a laborer who died in a scaffolding collapse.  With a medical doctor on staff and state of the art litigation technology, the Greene team is well positioned to handle any personal injury case.

Using RICO Against Pharmaceutical Companies Subject of Trial Magazine Article

Monday, November 7th, 2011

The November issue of Trial magazine includes an article by Greene LLP attorney Thomas M. Greene entitled “A New Weapon In Pharma Cases.”  The article discusses several legal elements of the Racketeer Influenced and Corrupt Organizations (RICO) Act, and how they may be satisfied in cases against pharmaceutical companies for fraudulent off-label promotion of drugs.  The article draws heavily from Greene’s experience in the In re: Neurontin Sales & Marketing Practices multi-district litigation, in which Greene is Chairman of the Plaintiffs’ Steering Committee, and from a 2010 trial in which a jury awarded a $142 million RICO verdict to Greene LLP client Kaiser Foundation Health Plan.

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.

Thomas M. Greene Named to 2011 Super Lawyers List

Wednesday, 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

Thursday, 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

Tuesday, 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”

Thursday, 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.