Greene LLP Attorneys Win First Circuit Appeal in Proposed Neurontin Class Action

April 3rd, 2013

On April 3, 2013, the First Circuit Court of Appeals issued a favorable decision in a pharmaceutical marketing case handled by a team of attorneys including Greene LLP.  On behalf of three health insurance organizations and a proposed class, Greene LLP and others argued that Pfizer engaged in a fraudulent marketing scheme that pushed the epilepsy drug Neurontin for bipolar disorder, a condition for which Neurontin has not been approved.  Greene LLP attorneys argued that Pfizer’s off-label marketing constituted a pattern of mail and wire fraud that was actionable under the Racketeering Influenced and Corrupt Organizations Act (RICO).

Greene LLP attorney Thomas M. Greene handled the oral argument on behalf of the three proposed class representatives, Harden Manufacturing Corporation, ASEA/AFSCME Local 52 Health Benefits Trust, and Louisiana Health Service Indemnity Company, doing business as Blue Cross Blue Shield of Louisiana.  In 2010, the District Court entered summary judgment against the proposed class representatives, also declining in 2011 to certify a class of similarly situated health insurance plans’ claims against Pfizer for its marketing of Neurontin.  With its April 3 decision, the three-judge panel consisting of Chief Judge Sandra L. Lynch, Associate Supreme Court Justice David H. Souter and Judge Kermit V. Lipez reversed the District Court’s grant of summary judgment as to the health plans’ RICO claims.  It also vacated the grant of summary judgment as to the health plans’ state law claims, and vacated the denial of class certification, remanding the case for further proceedings in the District Court consistent with the First Circuit’s 25-page opinion.

“We are very pleased with this result, and this is a rewarding opinion for all of us who participated in this appeal,” said Thomas M. Greene.  “The briefing process took the better part of a year, and represents an enormous and strong effort by everyone involved.”  Greene was joined by Greene LLP attorneys Michael Tabb and Ryan P. Morrison on brief for the appellants.  Many others contributed to the briefing process, including Dr. Palko S. Goldman, Thomas M. Sobol and Kristen Johnson Parker of Hagens Berman Sobol Shapiro LLP, Elizabeth J. Cabraser and Daniel Seltz of Lieff Cabraser Heimann & Bernstein LLP, and Don Barrett of Barrett Law Group PA.

In a related decision on April 3, the First Circuit also affirmed the jury and judge verdicts for Kaiser Foundation Health Plan against Pfizer, also for off-label promotion of Neurontin.  Greene LLP was part of the trial team for the Kaiser trial, which resulted in a $142 million jury verdict under RICO and a bench judgment of just under $103 million on related state law claims.  In his closing argument at the Kaiser trial, Greene noted that Pfizer’s profits from Neurontin, which were originally expected to total $500 million over the lifetime of its patent, instead grew to $1 billion per year through off-label promotion.  The District Court’s findings in the Kaiser case also paved the way for the First Circuit’s favorable class decision.

The First Circuit opinions are merely the latest chapter in a seventeen-year story for Thomas M. Greene and Neurontin.  In 1996, Greene filed a first-of-its-kind False Claims Act case against Pfizer predecessor Parke-Davis for off-label promotion of Neurontin, which was eventually settled in 2004 for $430 million in civil fines and criminal penalties.  Since that settlement, over $14 billion has been recovered under the False Claims Act using the novel off-label theory that Greene pioneered.

Greene LLP is a complex civil litigation firm that specializes in pharmaceutical and health care litigation on behalf of plaintiffs.  Located in the heart of Boston, the six-attorney firm leverages decades of experience in False Claims Act and other complex civil litigation matters.  To learn more about Greene LLP, please visit www.greenellp.com or www.falseclaimsactattorney.com.

The Harden appeal is First Circuit case number 11-1806, and the First Circuit’s opinion is available here.  The Harden First Circuit judgment is available here.

The Kaiser opinion also released today concerns First Circuit case numbers 11-1904 and 11-2096, and is available here.  The corresponding First Circuit judgment is available here.

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

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

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.

Thomas M. Greene Again Named to Super Lawyers List

October 30th, 2012

In a repeat of last year, Greene LLP Managing Partner Thomas M. Greene was named to the 2012 New England Super Lawyers list.  The distinction is conferred on up to 5% of attorneys, using criteria that include verdicts and settlements, experience, honors and awards, and scholarly lectures and writings.

Greene has been profiled by Super Lawyers in a piece entitled “Unprecedented Success Representing Whistleblowers,” which 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 for a combined $430 million in civil fines and criminal penalties.  Since that time, over $12 billion has been recovered by the government through the use of Greene’s novel off-label promotion theory of recovery.

The Super Lawyers recognition follows a string of other honors and awards for Greene.  After selection as a finalist for the 2011 Public Justice Trial Lawyer of the Year award, Greene received an AV rating by Martindale-Hubbell in which Greene received a 5.0 out of 5.0 in Peer Rating under a new rating system, receiving perfect scores in legal knowledge, analytical capabilities, judgment, communication ability, and legal experience.

Greene LLP Investigating Compounding Pharmacies

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

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

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.

Greene LLP’s $14.5 Million Settlement Among the Largest Settlements in Massachusetts

January 23rd, 2012

Following a year in which the firm’s $142 million RICO verdict was the second biggest in Massachusetts, Greene LLP again registered a case on the 2011 leaderboard of top recoveries published by Massachusetts Lawyers Weekly (subscription only link here). The firm’s $14.5 million settlement of a False Claims Act case involving Detrol was the largest whistleblower case in the state in 2011.

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.”

Using RICO Against Pharmaceutical Companies Subject of Trial Magazine Article

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

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.