Spilker v. Medtronic, Inc. et al

Filing 92

ORDER granting 78 Motion to Seal Confidential Document 76 PROPOSED SEALED Exhibit A. Signed by Magistrate Judge Robert B. Jones, Jr. on 4/13/2015. (Foell, S.)

IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NORTH CAROLINA
EASTERN DIVISION
No. 4:13-CV-76-H
ROBERTA SPILKER, individually and as
Executrix of the Estate of FRANKLIN J.
SPILKER, JR., deceased,

Plaintiffs,
vs.

ORDER

MEDTRONIC, INC., and
MEDTRONIC CRYOCATH LP,

Defendants.

This matter comes before the Court on the Motion of Defendants Medtronic, Inc. and
Medtronic Cryocath LP for an order to file under seal Volume I ofMedtronic's CryoCatheter
System's Pre-Market Application ("PMA") (DE-76). The Court, having considered the
motion, finds as follows:
1. Medtronic requests that the Court file under seal Docket Number 76, which is Exhibit A to
Medtronic's Motion And Memorandum Of Law For A Court Determination That Volume 1
Of The CryoCatheter System's Pre-Market Approval Application Is Properly Designated As
Highly Confidential.
2. This Highly Confidential document overcomes the presumption to access. The Seventh
Circuit confirmed that "in the context of Class III medical devices, much of the critical
information is kept confidential as a matter of federal law." Bausch v. Stryker Corp., 630
F.3d 546, 560 (2010). "The specifications ofthe FDA's premarket approval documents," the
court further explained, "are confidential, and there is no public access to complete versions

of these documents." Id. The public "cannot gain access to that information without
discovery." Id. The Freedom of Information Act specifically allows the FDA to withhold
documents containing matters that are "trade secrets and commercial or financial information
obtained from a person and privileged or confidential." 5 U.S.C. § 552(b)(4). The FDA
maintains the confidentiality of the CryoCatheter System's PMA Application because of the
trade secrets contained in it. See Judicial Watch, Inc. v. FDA, 449 F.3d 141, 149 (D.C. Cir.
2006) (noting that if a drug manufacturer's competitor "could obtain all the data in the
manufacturer's [application], it could utilize them in its own [application] without incurring
the time, labor, risk, and expense involved in developing them independently").
3. Medtronic submitted Volume I of the PMA application to the FDA confidentially in order for
Medtronic to obtain approval for its CryoCatheter System. This process necessarily requires
Medtronic to submit its trade secrets and confidential data to the FDA. Riegel v. Medtronic,
Inc., 552 U.S. 312, 316 (2008) (noting that the PMA process requires a manufacturer to

submit this detailed information to the FDA, which the FDA then reviews, spending an
average of 1,200 hours on each submission). And the document is thus full of sensitive
Medtronic trade secrets. The application contains data from various clinical studies
conducted by Medtronic and others; Medtronic's conclusions and recommendations; detailed
design specifications; detailed manufacturing specifications; and detailed marketing
information. See Reiter v. Zimmer, Inc., 897 F. Supp. 154, 157 (S.D.N.Y.1995) (noting that
the PMA process "requires the applicant to submit 'extensive safety testing data and
descriptions of manufacturing methods and materials"') (citations omitted); In re Eli Lilly &
Co., Prozac Products Liability Litigation, 142 F.R.D. 454, 460 (S.D. Ind. 1992) (holding

pharmaceutical company would suffer harm if the manufacturing process it has expended

time and money developing became known to competitors). "Applicants spend a great deal
of resources to obtain data for" FDA approval oftheir product applications. Judicial Watch.

Inc., 449 F.3d at 149.
4. Alternatives to filing under seal are unavailable. To file publicly, Medtronic would be
required to redact most of the document to hide its sensitive trade secrets, which is
impractical. The only viable option is to file the entire document under seal.
5. Plaintiff has consented to Medtronic filing Volume I ofthe CryoCatheter System's PMA
Application under seal.
NOW THEREFORE, IT IS ORDERED ADJUDGED AND DECREED that, for good cause
shown, the Court finds that Defendants' Motion To File Under Seal The Highly Confidential
Volume I To The Cryocatheter System's Pre-Market Application is GRANTED.
SO ORDERED, this the

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day of April, 2015.