Nephron faces lawsuit over pain med competitor says it sold without FDA approval

Lexington County-based Nephron Pharmaceuticals is being sued by another drug manufacturer, which claims Nephron products are being marketed as a replacement for its own drug without FDA approval.

Pacira Biosciences claims Nephron’s promotion of two drug compounds — called BKK and RKK —has undercut its own drug Exparel, an FDA-approved non-opioid medication meant to reduce pain after surgeries. The Florida-based company claims the marketing is deceitful because Nephron’s compounds have not been reviewed or studied for surgical pain relief by the FDA.

“This is a deeply troubling case in which Nephron, inflating its profits while potentially putting patients in grave danger, is claiming that its drug cocktail products are safe, effective, and approved by the Food and Drug Administration (“FDA”) (when they are none of those things),” Pacira claims in a lawsuit filed with the federal court in Columbia.

An attorney for Nephron vigorously denied Pacira’s claims in a statement to The State, as well as alleging the rival drug manufacturer’s claim was moot.

“More than a year before Pacira made any of these claims, all of which Nephron unequivocally denies, Nephron stopped making the medications at issue for completely unrelated business reasons,” Nephron attorney Nikole Mergo of law firm Maynard Nexsen said in a statement. “Nephron is committed to producing safe and affordable life-saving medications for patients across the country and does not let claims like these distract the company from this critical work.”

“Nephron intends to defend the claims vigorously,” Mergo added.

This is not the first lawsuit Pacira has brought over its pain medication. Last year, a federal court in New Jersey dismissed a defamation suit the company brought against the American Society of Anesthesiologists after the society’s journal ran articles examining Exparel. A judge found the articles represented legitimate scientific opinion about the drug’s effectiveness.

In 2020, Pacira agreed to pay $3.5 million after the U.S. Justice Department accused the company of paying kickbacks in the form of research grants to health care providers who purchased Exparel. Prosecutors said the company passed on the grants without any requirement to follow a proposed research topic or meet certain milestone before receiving payment.

“In many cases, Pacira did not follow up with the grant recipient to ensure that the work was being performed, and in some cases, the grant recipient did no work at all,” the Justice Department said in a statement announcing the settlement.

The company’s latest lawsuit claims Nephron is using a legal loophole to ”flood the market with its illegal drugs as fast as possible.”

An exception to federal drug law called the “503B exemption” allows pharmaceutical manufacturers to sell compounded drugs — drugs that are a combination of other drugs — without FDA approval so long as they met a drug shortage or critical need.

Pacira says the compounds of Nephron’s drugs may meet those standards, but Nephron’s specific BKK and RKK compounds do not. Both drugs contain ketamine and ketorolac, with BKK adding bupivacaine and RKK ropivacaine, the lawsuit claims.

“While its drugs have not been approved by the FDA, Nephron has distributed misleading advertisements and marketing materials that were intended to and implied the FDA has approved them,” according to the lawsuits.

Among other claims, Pacira’s lawsuit claims Nephron sells the drugs on its website under a banner that says “Nephron is fully inspected and approved by the FDA,” and features the FDA logo on its website.

“Using unapproved drugs that have not been evaluated for efficacy and safety presents inherent – and needless – risks to patient health and safety,” the lawsuit says.