A Protective Order will be Ineffective to Bar Disclosure of Data when the Public Interest in the Data Exceeds the Risk of Anti-Competitive Harm

Posted on December 3rd, 2019 by James L. McCrystal, Jr.James L. McCrystal, Jr.

The procedural and substantive requirements to frame the foundation for an enforceable protective order barring disclosure of data to the public were outlined in a recent decision by the 6th Circuit in a case coming out of the Opioid MDL, now pending in Cleveland. Derek Hartman and James McCrystal describe the issues and strategy necessary to protect information from disclosure to the public in a recent article, Buffing a Dent in the Armor: Mitigating the Risk of a Collateral Attack to a Stipulated Protective Order Using the Opioid MDL as a Case Study, featured in the November issue of the Cleveland Metropolitan Bar Association’s Bar Journal.

As a result of this recent decision, the FDA and drug manufacturing defendants were denied the right to keep data maintained by the FDA about opioid distribution and dispensing records (ARCOS data) from being disclosed to the media and public. Essentially the protective order was ineffective because the record did not show good cause for the entry barring the media from access to the data. The great public interest in solving the opioid crisis outweighed the risk of anticompetitive harm to the drug manufacturers. The 6th Circuit decision demonstrates that a protective order barring public disclosure of information must be supported by “a particular and specific demonstration of fact” justifying the Protective Order.