Are Individual Privacy Rights to Medical Information Protected From the Reach of Big Pharma? (Hint: In California, the Answer Is Yes!)

Fortin Law Group

Published: September 09, 2021

On June 15, 2021, the Court of Appeal, Fourth Appellate District, Division One of the State of California issued an opinion in the consolidated cases of County of Los Angeles v. Superior Court of Orange County (Johnson & Johnson) D077794 and County of Alameda v. Superior Court of Orange County (Johnson & Johnson) D077795 (petitions for writ of mandate).

To simplify the underlying facts, the State of California, through various County Counsel’s/District/City Attorneys, filed suit against various pharmaceutical manufacturers (“Big Pharma”) who were involved in the manufacture, marketing, distribution and sale of prescription opioid medications. Specifically, the State alleged that the various pharmaceutical companies (Johnson & Johnson, Janssen Pharma, Ortho Pharma), made false and misleading statements as part of a marketing scheme to minimize risk and inflate the benefits of certain opioid pharmaceuticals. The State claims that as a result of the alleged deception, a public health crisis ensued, dramatically increasing the number of opioid prescriptions, use, abuse and related deaths.

During the course of the underlying action, the Big Pharma defendants served subpoenas on the Counties of Los Angeles and Alameda (neither of which were parties to the underlying action). The subpoenas sought records of individual patient prescription records related to substance abuse of patients involved in various county-sponsored programs.

The Counties objected. Big Pharma brought a motion to compel production of the patient records. The Superior Court granted the motion and compelled production. Seemingly, in an effort to protect private information, the Court ordered that the individual patient medical records and information be provided to a third-party vendor (Rawlings Association) who would then “de-identify” the patient information and make it cross-referenceable against other de-identified data previously processed. The “de-identified” data would then be provided to the Big Pharma defendants (or any other party) for use in their defense of the case.

The two Counties filed a petition for writ of mandate regarding the discovery order to produce the records. The Appellate Court was tasked with determining whether the discovery order violated State constitutional privacy rights. The task involves balancing privacy interests with claims for access. (Hill v. National Collegiate Athletic Assn. (1994) 7 Cal.4th 1). First, there must be a viable privacy interest (i.e. legally protected privacy interest, reasonable expectation of privacy, and a serious threatened intrusion to that right). The party seeking the records then must set forth the competing interest that disclosure would serve.

The Appellate Court ruled the Big Pharma defendants failed to demonstrate that their interest in disclosure outweighed the substantial invasion of the constitutional privacy rights of the patient’s prescription data and substance abuse medical treatment records that would result from disclosure. The Court found that the very nature of these records render disclosure a serious invasion. The records contain “matters of great sensitivity” often regarding a “stigmatized condition”. There was a need for “robust protection”. The patients were not notified of the proposed disclosure and had no opportunity to object. Despite the protections of de-identification by a third-party (i.e. protection against public disclosure), access of personal information by the government, even without dissemination, does not protect privacy interests of individuals.

Protection of individual, constitutionally protected privacy rights is of paramount importance to the State and local governmental entities. Navigating the precarious waters on behalf of local government to ensure this protection is a goal of our firm. Please feel free to contact us should you wish to receive additional information.

This article was provided by Fortin Law Group, Costa Mesa, California. This article is intended to provide the reader with general information regarding current legal issues. It is not construed as specific legal advice or as a substitute for the need to seek competent legal advice on specific legal matters.

Tags: 2021, Business

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