Two former Johnson & Johnson (J&J) executives have been charged and convicted on off-label marketing charges spotlighting prosecutions taking place in the drug business. The former CEO and Sales Vice President of Acclarent, bought by J&J devices subsidiary Ethicon in 2010, were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act. They were acquitted of more serious fraud charges, but face up to a year in prison for each of the ten violations.
The charges are not unfamiliar in pharmaceutical sales. After a closely followed six-week trial, the Boston jury decided that the two former executives promoted an Acclarent product for uses that the U.S. Food and Drug Administration (FDA) had not approved.
The Relieva Stratus Microflow Spacer was approved to keep sinuses open, but Acclarent also promoted the drug as a steroid delivery device. This was a use that was not only unapproved, but expressly rejected by the FDA. The violations began in 2006 and the two former executives remained with J&J after the Ethicon buyout. The pair then left the company in 2011.
Personal injury attorneys at Parker Waichman have extensive experience and success in pharmaceutical litigation. Lawyers at the firm are available to answer legal questions for any individuals seeking information for a potential lawsuit.
A Not Guilty Verdict Raises Red Flags
The convictions come following a former Warner Chilcott sales chief’s not guilty verdict who was cleared last month of federal conspiracy charges.
Attorneys have viewed the Warner Chilcott and Acclarent trials as test cases for the Justice Department’s agenda. In the “Yates memo” issued last year, Deputy Attorney General Sally Quillian Yates laid out her intention to pursue individuals for their companies’ misbehavior.
The Warner Chilcott sales chief was among the very few pharma executives arrested on criminal charges for alleged marketing violations perpetrated by a company. The Justice Department’s failure to get a conviction showed the difficulty of pursuing individuals in these kinds of cases. However, federal prosecutors said after that verdict that they are not giving up, and the Acclarent decision is potentially giving the federal investigators added confidence.
Continuing Pursuit of Alleged Wrongdoing by High Level Executives
Even after the acquittal of the sales chief, the Justice Department did not back down on its accusations against him. The U.S. Attorney whose office handled the case told FiercePharma at that time, that although the jury’s verdict was respected, it was believed that the charge filed against the accused was supported by the facts and the law.
The U.S. Attorney added that cases against high level business executives are difficult to prove, but that it is essential to not give up such cases in order to deter corporate executives from engaging in wrongful conduct that inappropriately attempts to influence doctors.
Off-Label Marketing Convictions
Off-label marketing, is allegedly common in the pharmaceutical world. But this time the charges were different as the former executive had been accused of conspiring to pay kickbacks to doctors in return for increased prescriptions for Warner Chilcott drugs, which included the bone drug Actonel.
The FDA’s power to pursue off-label enforcement, given recent free speech decisions, were apparently watered down, so prosecutions have recently focused on kickbacks. The FDA is ready to unveil new guidance for off-label marketing that will take free speech concerns into consideration.
Additional Kickback Cases
Two former sales representatives at the pain drug company Insys are involved in another kickback case. The two former sales reps are accused of paying $259,000 in kickbacks, including expensive dinners and visits to strip clubs, to two physicians who wrote prescriptions for Insys’ powerful, fast-acting opioid drug, Subsys. Those scrips were allegedly worth $6 million in Subsys sales, according to the Justice Department.
Earlier this year, a former Insys sales representative pleaded guilty to conspiracy fraud charges that included participation in kickback schemes. In 2016, a nurse practitioner also pleaded guilty to prescribing Subsys in exchange for $83,000 in kickbacks. Subsys is a spray form of the high-powered painkiller fentanyl approved only for use in cancer patients, but has been widely prescribed for off-label uses. According to CNBC, the nurse practitioner pleaded guilty in federal court in Alabama to conspiracy to commit healthcare fraud including kickback schemes for Insys.
Legal Advice and Information Regarding Pharmaceuticals
If you or someone you know suffered injuries associated with pharmaceuticals, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).