Archive for October, 2018

Abbott Laboratories To Pay $25 Million To Settle Non-Intervened Whistleblower Lawsuit Alleging that it Illegally Promoted its Cholesterol Drug TriCor and Paid Kickbacks to Prescribing Physicians

Monday, October 29th, 2018

PHILADELPHIA, PA – The United States Attorney’s Office for the Eastern District of Pennsylvania announced on Friday, October 26, 2018, that global healthcare giant Abbott Laboratories (“Abbott”) has executed a settlement agreement and will pay $25 million to settle a non-intervened whistleblower lawsuit alleging that it illegally promoted its blockbuster cholesterol drug Tricor for off-label uses and paid kickbacks to prescribing physicians.

In September 2009, Amy Bergman, a former Abbott sales representative, filed a qui tam whistleblower lawsuit in federal district court before the Honorable C. Darnell Jones, II in Philadelphia alleging that Abbott violated the federal False Claims Act (“FCA”) and numerous state false claims laws by:

  • ILLEGALLY PROMOTING TRICOR FOR OFF-LABEL USES SUCH AS COMBINATION THERAPY WITH STATINS AND AS A FIRST-LINE TREATMENT FOR PATIENTS WITH DIABETES; and
  • VIOLATING THE FEDERAL ANTI-KICKBACK STATUTE BY PAYING KICKBACKS TO PHYSICIANS TO INCENTIVIZE THEM TO PRESCRIBE TRICOR

In 2012, the United States, and all of the plaintiff states receiving payment from this settlement, declined to intervene in Ms. Bergman’s lawsuit. Thereafter, Ms. Bergman and her legal team from Pietragallo Gordon Alfano Bosick & Raspanti, LLP, Nicholson & Eastin, LLP and Kelley/Uustal, continued litigating the case on behalf of federal and state taxpayers, as well as their client on their own. After years of litigation, including robust motion practice, discovery and depositions, they ultimately secured the global $25 million settlement announced by the government. The federal government will receive $23.2 million and state Medicaid programs will receive $1.8 million. Ms. Bergman will receive a relator’s share of over $6,000,000, plus pro rata interest, for her efforts and those of her entire legal team.

The United States Attorney for the Eastern District of Pennsylvania William McSwain said in his press statement:

“We thank Ms. Bergman for coming forward and providing essential assistance to the government. Preserving government program funds would be far more difficult without relators who are willing to shine a spotlight on alleged illegal practices like the ones involved in this case. Ms. Bergman’s efforts, and those of her attorneys, were critical to our favorable resolution of this case.”

Marc S. Raspanti, co-lead counsel for Ms. Bergman and founder of the False Claims Act practice at Pietragallo Gordon Alfano Bosick & Raspanti, commented that “Patients deserve to know that their medical professional is making decisions based on their best interests and not because a company is marketing its drugs for unapproved uses or offering incentives to steer patients to specific drugs.” Michael Morse, co-lead counsel for Ms. Bergman, commented that “the significant recovery for federal and state taxpayers in this case was the result of Ms. Bergman’s courage in stepping forward as well as the tremendous work, over many years, of her entire legal team who handled the case in a non-intervened posture.”

The Off-Label Marketing Allegations

Under Food and Drug Administration (“FDA”) rules, prescription drug manufacturers and marketers may only promote their products for approved uses. Physicians are free to prescribe drugs for conditions beyond those for which approval has been received but marketing to induce off-label, unapproved use is not permitted.

Ms. Bergman’s Complaints alleged that, from 2000 through 2008, Abbott marketed TriCor for purposes not approved by the FDA, and not supported by relevant medical compendia. The alleged off-label uses included the use of Tricor in combination therapy with statins, as a first line treatment in diabetics, and to address cardiac risk factors in diabetics. Medicare, Medicaid and other federally-funded health insurance programs do not cover off-label uses of drugs. Therefore, insurance claims submitted for Tricor for the unapproved uses were not payable by these programs.

The Kickback Allegations

The federal Anti-Kickback Statute (“AKS”) and similar state rules prohibit the offering, paying, soliciting or receiving remuneration to induce referrals of items or services covered by federally funded programs. The Anti-Kickback Statute is intended to ensure that a physician’s medical judgment is not compromised by improper financial incentives and is instead based on the best interests of the patient.

Ms. Bergman’s Qui Tam Complaints alleged that Abbott increased sales of Tricor by directly and indirectly providing remuneration to prescribing physicians in order to incentivize the physicians for prescribing Tricor. This remuneration included, but was not limited to, gift baskets and certificates and other items of value.

The Legal Team

The settlement announced today by the government was achieved through the significant efforts of Ms. Bergman’s whistleblower legal team, including: Marc S. Raspanti, Michael A. Morse, and Pamela Coyle Brecht from Pietragallo Gordon Alfano Bosick and Raspanti, LLP; Robert N. Nicholson and Parker Eastin from Nicholson Eastin, LLP; and John J. Uustal and Cristina M.  Pierson from Kelley/Uustal.

Ms. Bergman and her legal team would like to express their appreciation for the efforts by the team of federal and state government supervising lawyers, and, in particular the substantial efforts of Assistant United States Attorney Charlene Keller Fullmer, Deputy Chief of Affirmative Litigation for the United States Attorney’s Office for the Eastern District of Pennsylvania, who helped steer this matter to its successful conclusion.

In executing the settlement agreement in this case, Abbott expressly denied liability, wrongdoing, or that it engaged in any improper or illegal conduct. Moreover, Abbott denied all the allegations raised in Ms. Bergman’s complaints. The government did not file a complaint.

The lawsuit is styled as U.S. ex rel. Amy Bergman v. Abbott Laboratories, Civil Action Civil Action No. 2:09-cv-04264999 (CDJ), which has been pending in the United States District Court for the Eastern Pennsylvania before U.S. District Judge C. Darnell Jones.

A copy of Ms. Bergman’s Complaints, along with other pleadings publicly filed in the case, can be found at www.FalseClaimsAct.com or on the Department of Justice’s website.

Whistleblowing: French Style

Thursday, October 18th, 2018

What Happened?

On December 9, 2016, the French Parliament enacted Sapin II: “the law on transparency, the fight against corruption and the modernization of economic life.” This marked the first time in French history that a whistleblower was offered protection in an anti-corruption case.

The Background

Before the historical enactment of Sapin II, France was governed by a series of anti-corruption laws and enforcement agencies from the enactment of Sapin I in 1993 to the establishment of the National Financial Prosecutor, the High Authority for Transparency in Public Life, and the Central Bureau of Anti-Corruption and Investigation of Financial Crimes in 2013. However, the French government focused on the transparency of and prevention of bribery in public officials, and neglected to mention anything about the whistleblower. The courts looked to European case law, the French Constitution’s principles of freedom of expression, and the European Convention of Human Rights for guidance on how to treat the whistleblower, but this lead to rampant inconsistency and ineffectiveness.

The Motivation

Without any incentives or guarantees for protection whistleblowers were not coming forward and corruption was perceived to be rampant in French companies and public officials. This led to widespread criticism by the Organization for Economic Co-Operation and Development (OECD) and various other international anti-corruption agencies. This condemnation motivated the French government to enact Sapin II which offered whistleblower protection for the first time in French history.

Who Can Be A Whistleblower Under The French Law?

Sapin II defines a whistleblower as:
a physical person who reveals or reports, in a selfless manner and in good faith, a crime or an offense, a grave and obvious violation of an international commitment lawfully ratified or approved by France, of a unilateral Act of an international organization taken on the ground of said commitment, of the law or regulation, or a grave threat or harm to the general interest, of which this person has acquired personal knowledge.
This requires the whistleblower to be selfless and report the violation in good faith. In order to ensure the whistleblower is motivated by their desire to protect the general public and not their own personal interests, French law prohibits the whistleblower from being monetarily rewarded. This automatically excludes those who are employed to report matters of general interest, such as news reporters and journalists, from receiving whistleblower status. From this definition, the whistleblower does not have to be an employee of the violating company. Aside from selfness and good faith, the only other whistleblower requirements are personal knowledge of the violation, and reasonable grounds to believe the violation did happen.

What Protections Can A Whistleblower Receive?

Since the whistleblower is not offered any financial incentives, the French government standardized a set of protections offered to the whistleblower, for the first time in French anti-corruption law, to entice the whistleblower to come forward. Under Sapin II, procedures to guarantee the confidentiality of the whistleblower must be established. This works to prevent retaliation of any kind from taking place including, but not limited to, firing or imposing hardships on the employment conditions of the whistleblower. If a company does not set up confidentiality protocols or is caught retaliating against a whistleblower, the company will be subject to fines based upon the company’s size. Also, the whistleblower is not held liable for revealing any information protected by law (aside from military secrets, Hippa information, or conversations protected by attorney-client privilege). Even though the whistleblower is not rewarded per se, the whistleblower is guaranteed that they will not be punished for reporting a violating company; a promise that was not offered prior to the enactment of Sapin II.

How To Blow the Whistle In France

In addition to the protections offered, Sapin II also includes reporting requirements for the whistleblower. First, the whistleblower must report the violation to their employer. The report could be made to the whistleblower’s supervisor or to the person designated by the whistleblower’s employer to handle this type of matter. Then, if the employer does not respond in a reasonable time, the whistleblower can report the violation to a judicial authority or administrative authority. Finally, if the authority does not respond in a reasonable time, the whistleblower may go to public with the information in order to have their concerns heard.

The Take Away

Sapin II’s unique take on the whistleblower signifies the French government’s intent to eliminate corruption. By incorporating the term “selflessness” into the definition and forbidding monetary rewards, the French government is working to ensure that all whistleblower claims have merit and are in the best interests of the country. Instead of financial compensation, the whistleblower is rewarded with the guarantee that they will not be punished for the act of whistleblowing itself. While this might not seem like much of an incentive compared to those countries who offer monetary payments like the United States, this is the first time in France’s history that whistleblowers are offered protection of any kind. Only time will tell if the French method is effective in getting whistleblowers to come forward and root out foreign corruption.