Second Circuit Affirms Summary Judgment Ruling in Favor of HHS, FDA, and Sarepta Therapeutics

An opinion was issued on Friday in the Second Circuit by Circuit Judges Chin, Lohier, and Robinson. The suit originated in the Southern District of New York, where it was appealed by plaintiff Charles Seife. The court had ruled in favor of the Food and Drug Administration (FDA), Department of Health and Human Services (HHS), and Sarepta Therapeutics, Inc.

The plaintiff had filed suit seeking records from the FDA and HHS relating to Sarepta’s accelerated application with the defendants regarding a drug that would treat neuromuscular disease. Of the 45,000 pages of documents that came from the process of approval, some were redacted under Exemption 4 of the Freedom of Information Act (FOIA). The Southern District of New York Court granted the defendant’s motion for summary judgment, which the opinion explains is common in FOIA cases, since the redacted information fell under Exemption 4 of FOIA, which protects from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.”

The district court had determined that the redactions were appropriate since the information that had been concealed did fall under the FOIA exemption and the defendants had accurately determined that the disclosure of the information would harm an interest that was protected under Exemption 4 of FOIA.

The plaintiffs argued in their appeal that the district court had incorrectly concluded that the defendants satisfied the foreseeable harm requirement necessary to qualify under the exemption. While plaintiff Seife conceded that the redacted information did fall under Exemption 4, he claimed that the information would not cause foreseeable harm to Sarepta’s interests.

Ultimately, the Second Circuit concluded that the “defendants have shown as a matter of law that the contested information falls within Exemption 4 and that disclosure would foreseeably harm Sarepta’s commercial or financial interests.” They ruled that the interests protected by Exemption 4 and FOIA were the commercial and financial interests of Sarepta, and that the defendants had explained in “reasonably specific detail” the harm that would be caused to these interests in the event that the redacted information was public record.

Lastly, the court ruled that plaintiff Seife “failed to present any evidence that meaningfully controverts Defendants’ showing of foreseeable harm.” Last Friday, the ruling in favor of the defendants was affirmed by the Second Circuit.