Johnson & Johnson (J&J) and its Janssen Pharmaceutical Companies say they will appeal a $572-million civil judgement entered in Cleveland County District Court in the State of Oklahoma’s lawsuit against opioid manufacturers. 

Oklahoma’s Cleveland County District Judge Thad Balkman ruled that the company’s marketing and promotion practices of opioids targeting Oklahoma doctors, patients and the public qualifies it as an action liable under Oklahoma’s public nuisance law.

In response, J&J said that the state of Oklahoma failed to present evidence that the company’s products or actions caused a public nuisance and that the ruling disregarded precedent in public nuisance law, which it says has traditionally been applied to resolve property disputes, not lawsuits involving the sale of goods. “This judgment is a misapplication of public nuisance law that has already been rejected by judges in other states,” said Michael Ullmann, Executive Vice President, General Counsel, Johnson & Johnson, in an August 26, 2019 company statement. “The unprecedented award for the State’s ‘abatement plan’ has sweeping ramifications for many industries and bears no relation to the Company’s medicines or conduct.” The $572-million judgment covers one year of costs under the state’s abatement plan to address the opioid crisis. 

J&J noted that its products, Duragesic (fentanyl), Nucynta (tapentadol hydrochloride), and Nucynta ER (tapentadol hydrochloride), have accounted for less than 1% of total opioid prescriptions in Oklahoma as well as the United States. Duragesic is a transdermal patch. Nucynta is an immediate-release tablet, and Nucynta ER is an extended-release tablet. J&J says the FDA-approved labels of these medicines provided clear information about their risks and benefits.

The company says it will move to stay enforcement of the judgement pending the resolution of its appeal. It noted that the length of the appeal process varies from case to case, taking into account time for post-trial motions, preparation of the trial record, and briefing to the appellate court. In this case, this process is anticipated to extend into 2021, and the company says it is confident that it has strong grounds to appeal the court’s decision.

J&J noted that the ruling in Oklahoma does not have a binding impact on other courts, including those involved in ongoing federal litigation, litigation in other states, or how the company approaches those matters given the different laws, defendants, and claims in these other cases. Upcoming federal multidistrict litigation (MDL), currently scheduled for October 2019, includes multiple defendants and a number of different claims. The company says it remains open to viable options to resolve these cases, including through settlement.

As disclosed in the company’s most recent Form 10-Q, the company has been named in more than 2,000 lawsuits brought by certain state and local governments related to the marketing of opioids. Some of these have been consolidated into a federal MDL proceeding. Defendants include different companies spanning the opioid supply chain, including manufacturers, distributors and pharmacies. Two of those cases have been selected for an initial trial beginning October 21, 2019.

Oklahoma previously reached settlements with two other opioid drug makers: a $270-million settlement with Purdue Pharma for OxyContin (oxycodone hydrochloride) and an $85-million settlement with Teva Pharmaceuticals, a manufacturer of generic drugs.

Source: Johnson & Johnson and Ruling by Oklahoma’s Cleveland County District Judge Thad Balkman