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Sprint Fidelis FOIA Spat

By James M. Beck and Mark Herrmann

Here's a Freedom of Information Act (FOIA) tangent to the Sprint Fidelis Products Liability Litigation:

Plaintiffs requested information about Medtronic's Sprint Fidelis Leads from the FDA under FOIA.

The FDA produced documents, but redacted portions of the documents under an exemption to FOIA.

Plaintiffs sought "an order compelling Medtronic to consent to a production of its [unredacted] documents by the Federal Food and Drug Administration . . . and to amend the Protective Order in this case to specifically protect the confidentiality of these documents produced by the FDA." In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., No. 08-1905 (RHK/JSM), slip op. (D. Minn. May 11, 2009) (link here).

In the boring part of the opinion, Magistrate Judge Janie Mayeron denied plaintiffs' motion because the presiding trial judge, Richard Kyle, had previously stayed discovery pending his ruling on a motion to dismiss. Id. at 10. The magistrate judge would not effectively reverse that decision.

In the interesting part of the decision, Magistrate Judge Mayeron also denied plaintiffs' motion because the court did not view itself as able to order "selective disclosure" under FOIA. That is, plaintiffs wanted the court to compel disclosure of the unredacted documents only to plaintiffs, and the protective order entered in the product liability litigation would then prevent further disclosure of the confidential information. But Magistrate Judge Mayeron did not believe this was possible; if the FDA produced the unredacted documents to plaintiffs under FOIA, the agency would also have to produce those documents to others who requested them:

"[P]roduction of unredacted documents by the FDA to a select few who need the documents in order to prosecute a legal action, while at the same time denying access to other requesting parties on the basis of a statutory exemption, is contrary to the notion that information produced under FOIA by agencies belongs to the public." Id. at 13.

"Indeed, disclosure of a document to one individual may serve as a waiver by an agency of an exemption when it attempts to assert it against another individual seeking the same document." Id. at 14. "'[W]hile information disclosed during discovery is limited to the parties and can be subject to protective orders against further disclosure, when a document must be disclosed under FOIA, it must be disclosed to the general public and the identity of the requester is irrelevant to whether disclosure is required.'" Id. at 15 (citation omitted).

For good measure, the court also noted that it lacked jurisdiction to enjoin the FDA from withholding documents because there was no FOIA complaint pending before the court. Id. at 16.

(Although we're drawing this case to your attention, we pass no judgment on the propriety of the court's decision. We suspect that we, or our colleagues, may in the future have clients that believe Magistrate Judge Mayeron decided this case wrongly. Maybe she did; maybe she didn't -- heck if we know. We're taking no position on whether the result was right or wrong. We're just passing on the news that this decision came down. At that point, use the precedent as you will. Good luck with it.)

Full post as published by Drug and Device Law on May 15, 2009 (boomark / email).