Doctor acquitted of shipping unapproved anti-addiction drug

A New Jersey doctor was found innocent of illegally shipping an unapproved drug shown to successfully curb opioid addiction after his defense attorneys questioned why the Department of Justice would pursue such a case in the middle of an opioid epidemic.

After a five-day trial in federal court in Los Angeles, a 12-person jury fully acquitted Dr. Lance L. Gooberman, who faced a 12-count felony indictment accusing him of misbranding and illegally shipping Naltrexone -- a drug approved by the Food and Drug Administration to treat opioid addiction but not in pellet form.

"100,000 people died of opioid overdoses during the first year of the coronavirus pandemic -- a record high and a 30% increase from the year before, all the while pharmaceutical companies are price-gouging FDA-approved products used to treat overdoses," Gooberman's defense team wrote in the motion seeking dismissal of the case in October.

Defense attorneys Melissa Weinberger of Touchton & Weinberger LLP, along with Megan A. Maitia and Jennifer L. Williams of Summa LLP, said the overdoses came after the government announced a criminal resolution with Oxycontin manufacturer Purdue Pharma -- which many say fueled the opioid crisis -- without a single criminal charge against an individual.

However, in March 2020, the DOJ charged Gooberman and his assistant, Susan Tickner, in a 12-count felony indictment, alleging Gooberman's Naltrexone pellets are "manufactured," "new," and "unapproved" drugs and subject to the prohibition on introducing unapproved drugs into interstate and foreign commerce under the federal Food, Drug, and Cosmetic Act.

Tickner pleaded guilty to a one-count, strict liability charge before the trial began but Maitia has asked that charge be dismissed in light of the jury acquitting Gooberman, she said.

Asked whether the DOJ, in light of the growing opioid crisis and recent jury verdict, plan to deprioritize cases like Gooberman's, Ciaran McEvoy said on behalf of the U.S. Attorney's Office, "Dr. Gooberman was charged with various felonies, including introducing an unapproved new drug into interstate commerce. As long as a drug is unapproved, those involved in importing or exporting it are subject to federal criminal prosecution."

Gooberman, 70, has specialized in addiction medicine since the 1980s, according to court documents. In the mid-1990s Gooberman developed the Naltrexone "pellet," which is inserted in a patient subcutaneously and dissolves over one to three months.

Naltrexone blocks the euphoric and sedative effects of opioids by binding and blocking opioid receptors in the brain, ultimately reducing and suppressing opioid cravings. There is no abuse and diversion potential with Naltrexone and it is generally considered safe, according to the Substance Abuse and Mental Health Services Administration.

Gooberman's compounding of Naltrexone products was not at issue in this case, and the government made no allegation that the products he sold were dangerous. One of prosecution's central contentions was that Gooberman, through a Hong Kong licensee, had shipped the pellets using improper labeling.

Drugs that do not comply with labeling or approval requirements can be imported into the U.S. under the FDA's "personal use" exemption, Gooberman argued. This exemption generally applies to drugs not commercially available in the U.S. that do not represent an unreasonable risk to the patient.

The jury took three hours last Tuesday to fully acquit Gooberman.

"The jury recognized that Dr. Gooberman is a hero, who has dedicated his life to serving a marginalized community with life-saving and affordable medication," Maitia wrote in a statement Tuesday. "We hope that with Dr. Gooberman's full acquittal, the U.S. Attorney's Office will take this opportunity to recognize that taxpayer-funded resources are much better spent supporting (rather than prosecuting) well-meaning physicians like Dr. Gooberman who are simply trying to navigate complex regulations in good faith."