Mass Layoffs At NJ Pharma Company After Liver Drug Linked To 19 Deaths

MORRIS COUNTY, NJ — A Morris County-based pharmaceutical company is laying off nearly 150 employees after a medication it created was linked to 19 deaths, according to the Food and Drug Administration (FDA).

Intercept Pharmaceuticals, in Morristown, has announced it will be letting go of 146 employees between Dec. 31 and June 30. A Chicago-based law firm, Strauss Borrelli PLLC, is investigating the company to see if it violated the Worker Adjustment and Retraining Notification (WARN) Act by not giving the soon-to-be laid-off employees the 60-day notice it's required to.

The legal issues came weeks after Intercept Pharmaceuticals’ Ocaliva, a medication to treat a chronic liver disease called primary biliary cholangitis (PBC), was pulled from the market.

PBC is a rare, progressive, and chronic autoimmune disease that is most prevalent in women over 40. It affects roughly 1 in 10,000 women over 40 and can cause cirrhosis, the need for a liver transplant, or death if left untreated.

Ocaliva was approved by the FDA in 2016. It was years later when the federal agency connected 19 deaths to patients on Ocaliva, finding that it was deteriorating livers rather than treating them, and also linked to heart complications. Dozens of other “serious” health cases were connected to the drug, according to the FDA.

Additionally, 2024 FDA data shows Ocaliva users face a 377 percent increased risk of liver transplant or death, even in some non-cirrhotic patients.

“In the five years since Ocaliva’s accelerated approval, FDA identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with cirrhosis, both in those without clinical signs of cirrhosis (compensated) or in those with clinical signs of cirrhosis (decompensated),” a 2021 FDA statement read. “After starting Ocaliva, the pace of the liver decompensation or failure reported suggested these adverse events, which resulted in liver transplant in a small number of cases, were related to the drug rather than progression of the underlying PBC.”

The drug would continue to remain on the market in a restricted capacity, not to be given to patients with advanced cirrhosis, until Intercept Pharmaceuticals pulled it this past November at the FDA's request.

Despite pulling the drug from the market, Intercept says Ocaliva’s benefits outweigh its health risks.

“We continue to believe the totality of clinical and real-world evidence supports OCALIVA’s use for appropriate patients, and we are proud of the contribution OCALIVA has made in advancing care for people living with PBC,” said Vivek Devaraj, US President at Intercept. “While our view of OCALIVA’s benefit-risk profile differs from FDA’s, we respect its request and have made this difficult decision to provide clear guidance for patients and prescribers. We remain committed to innovation in hepatology and to serving the needs of patients and physicians.”

Intercept’s job cuts are just some of the 16,000 layoffs that have swept the state this year.

Read More: NJ Job Losses Reach 16K For 2025; What Does 2026 Hold?