Janssen, J&J Lose Washington State Opioid Case Discovery Battle

Johnson & Johnson and Janssen Pharmaceuticals’ discovery victory to gain access to more consumer prescription data in a Washington state opioid case was reversed on discretionary review by a state appellate panel.

The trial court wrongly dismissed a special master’s finding that giving the entities—collectively referred to in the opinion as Janssen—the additional patient information requested would put the state in violation of the federal Health Insurance Portability and Accountability Act, according to the July 31 opinion written by Judge Linda Coburn of the Court of Appeals of Washington. Janssen, according to its website, is the “Pharmaceutical Companies of Johnson & Johnson.”

The lower court “abused its discretion” when it found that the expert determination method put forward by Janssen’s expert satisfied federal health privacy law, Coburn wrote.

The case comes as Washington faces an ongoing opioid epidemic. Drug-caused deaths involving opioids increasing 190 percent between 2020 and 2022, according to a University of Washington study. The state attorney general accused Janssen in its lawsuit of creating a “public nuisance” by contributing to this crisis, the opinion said.

Central to the case is the subject of “de-identified” data. US Department of Health and Human Services guidance states that experts should consider the extent to which such anonymyzed data can be linked to other information that can help reveal a person’s identity, according to the opinion.

Janssen had requested Washington supplement its de-identified Medicaid claims data with the months and dates of service and prescriptions, saying it needed the information to determine the extent to which prescriptions for its medications predated opioid use disorder, the opinion said. The state objected, saying disclosure of full dates—not just years—would lead the health-care authority to violate HIPAA.

“Records identifying any patient receiving treatment or rehabilitation for a substance used disorder under a federally conducted or funded program, such as Medicaid, are required to be ‘confidential,’” Coburn said in the opinion.

In 2021, the special master provisionally granted Janssen’s motion given that the company provide “expert certification” proving that the disclosure of dates for data didn’t have potential for reidentification. Janssen submitted a declaration from M. Laurentius Marais, an expert witness from a “consulting firm that specializes in applied mathematical and statistical analysis” who asserted there was “virtually no risk” of identification, according to the opinion.

Washington state submitted a report by expert Latanya Sweeney, refuting Marais’ claims. Disclosure of full dates could allow the de-identified data to be “re-associated” with patients’ identities when joined with other public and private information, according to Sweeney.

After two subsequent hearings, the special master ultimately decided that Janssen didn’t meet the burden of proving “the risk is very small.” The trial court, however, ruled in favor of the pharmaceutical companies to compel discovery. The state then sought the appellate court’s discretionary review.

The trial court was required under the law to find good cause and require notice be provided before enabling disclosure, according to Coburn’s opinion, but it didn’t grant the motion to compel under such requirements.

Judges Lori Smith and Ian Birk also sat on the panel.

Washington state is represented by attorneys from the Office of the Attorney General. The respondents are represented by Morgan Lewis & Bockius LLP, Kendall Scott Esq Cowles, Arete Law Group, and O’Melveny & Myers LLP.

Washington’s office of the attorney general didn’t immediately respond to a request for comment, nor did Johnson & Johnson or Janssen.

The case is State v. Johnson & Johnson, Wash. Ct. App., Div. 1, No. 84140-8-I, 7/31/23.