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Contratto v. Ethicon

November 18, 2004



Before the Court is a Motion for a Protective Order filed by Ethicon, Inc., Johnson & Johnson, Lifecore Biomedical, Inc., and Vital Pharma, Inc. ("defendants"). Having reviewed the papers filed by the parties and held lengthy hearings, I DENY defendants' motion.

Plaintiff Rene Contratto underwent hernia surgery in August of 2002. Plaintiff's Second Amended Complaint ("Compl.") ¶17. During the surgery, plaintiff's doctors applied Gynecare Intergel Adhesion Prevention Solution ("Intergel") within her abdomen. Id. Intergel is a substance used by medical care providers to reduce the adhesions sustained by a patient during surgery. Id. at ¶1. Intergel is collectively manufactured, marketed, distributed, and sold by defendants. Compl. ¶1. Following plaintiff's surgery, the Intergel solidified within her body and seriously injured her. Id. at ¶9. Plaintiff sued defendants for negligence, products liability, and misrepresentation. Id. at ¶9.

In response to document requests propounded by plaintiff, defendants moved for an order precluding plaintiff from further discovery and all other litigation use of (1) voluntary and mandatory adverse event reports (sometimes called complaints) from device user facilities, physicians, patients or foreign users; and (2) medical device reports, complaint files, and any other documents from which information contained in any adverse event reports may be gleaned.*fn1 During the hearings, the issues were narrowed considerably. Plaintiff conceded that the medical device reports she sought are available on the Food and Drug Administration's ("FDA") website, and withdrew her requests for them. Defendants conceded that they have no grounds to protect complaints by patients or foreign users, and withdrew such documents from the scope of their protective order.

For regulatory purposes, the parties agree that Intergel is classified as a medical device. Any complaints defendants received about Intergel fall into two broad categories: mandatory reports and voluntary reports. Federal law requires a medical device manufacturer, such as some of the defendants, to report adverse event information to the FDA in cases involving death or serious injury. See 21 U.S.C. § 360i(a). Any mandatory report required by section 360i(a) is called a medical device report ("MDR"). See H.R. REP. No. 101-808, at 22 (1990), reprinted in 1990 U.S.C.C.A.N. 6305, 6314 (1990). The same law requires "device user facilities"*fn2 to report adverse events either to the FDA or to the manufacturer in specific circumstances ("user facility reports"). 21 U.S.C. § 360i(b)(1). Voluntary reports of adverse events are generated by patients, consumers and physicians and by device user facilities and manufacturers in situations in which mandatory reports are not required.

Defendants contend that production of the documents plaintiff requests is barred by 21 U.S.C. § 360i(b)(3), and would threaten the FDA's medical device safety reporting system.*fn3 Specifically, with respect to Intergel, defendants argue that section 360i(b)(3) prohibits plaintiff from discovering voluntary reports of adverse events and complaint files and related documents which contain information derived from, or which are based on, mandatory or voluntary reports. Section 360i(b)(3) states:

[N]o report made under [section 360i(b)(1)] by (A) a device user facility, (B) an individual who is employed by or otherwise formally affiliated with such a facility, or (C) a physician who is not required to make such a report, shall be admissible into evidence or otherwise used in any civil action involving private parties unless the facility, individual, or physician who made the report had knowledge of the falsity of the information contained in the report.

21 U.S.C. § 360i(b)(3).

Rule 26(b)(1) of the Federal Rules of Civil Procedure provides that "parties may obtain discovery regarding any matter, not privileged, that is relevant to the claim or defense of any party." FED. R. CIV. P. 26(b)(1). As the United States Supreme Court recognized in Hickman v. Taylor, with the enactment of the Federal Rules, "[t]he way is now clear, consistent with recognized privileges, for the parties to obtain the fullest possible knowledge of the issues and facts before trial." 329 U.S. 495, 500 (1947).

Absent section 360i(b)(3), defendants conceded during argument, complaints about Intergel would be routinely discoverable, just as complaint information is routinely discoverable in products liability suits involving other devices and products. See, e.g., Nemir v. Mitsubishi Motors Corp., 381 F.3d 540, 550 (6th Cir. 2004)(seatbelt); Smith v. Bic Corp., 869 F.2d 194, 201 (3d Cir. 1989) (disposable butane lighter); Fletcher v. Atex, Inc., 156 F.R.D. 45, 55 (S.D.N.Y. 1994) (computer keyboard); In Re Eli Lilly & Co., Prozac Prod. Liab. Litig., 142 F.R.D. 454, 461 (S.D. Ind. 1992) (prescription drug); Ericson v. Ford Motor Co., 107 F.R.D. 92, 95 (E.D. Ark. 1985) (automobile). The Supreme Court has consistently held that the discovery rules should be accorded a "broad and liberal scope." Schlagenhauf v. Holder, 379 U.S. 104, 114-15 (1964)(citing Hickman v. Taylor, 329 U.S. at 507). Unless information is specifically privileged or otherwise protected by statute, it is discoverable under Rule 26(b)(1).

User Facility and Voluntary Physician Reports

Section 360i(b)(3) states that reports covered by it shall not "be admissible or otherwise used in any civil action involving private parties." 21 U.S.C. § 360i(b)(3). Defendants interpret this language as prohibiting discovery of user facility reports generated pursuant to section 360i(b) and voluntary physician reports in this proceeding.

The reports defendants seek to protect are covered by section 360i(b)(3), but whether the statute prohibits plaintiff's discovery of these reports is less clear. While the statute is amenable to defendants' interpretation, a better interpretation is that admissibility or discovery of these reports is prohibited only in civil actions involving the maker of the report ("reporter"). Under this interpretation, section 360i(b)(3) does not apply to a suit by a patient against the manufacturer of the product that is the subject of the report.

Defendants' interpretation has little to commend it. It is at odds with the regulation adopted by the FDA to implement the statute. See 21 C.F.R. § 20.63(f). In proposing section 20.63(f), the FDA explained that the success of the "adverse event reporting system depends substantially on the guarantee of confidentiality given the identity of the reporter under FDA regulations." Protecting the Identities of Reporters of Adverse Events and Patients; Preemption and Disclosure Rules, 59 Fed. Reg. 3944, 3946 (proposed January 27, 1994). The FDA noted that Congress had provided some protection to physicians by enacting 21 U.S.C. 360i(b)(3). "This provision, however, may not be sufficient to prevent manufacturers from being compelled to release the reporters' or patients' identities pursuant to a discovery order." Id. (emphasis added). In fact, the FDA was aware of a number of lawsuits in which manufacturers were "requested or ordered" to provide the names of reporters of adverse events. Id. at 3947. The FDA had become involved in a number of these cases to inform the courts "of the potential damage the agency believes would be done to its post marketing surveillance program and the public health if the identities of patients and reporters were released to plaintiffs in these cases."

Id. at 3947. Had the FDA interpreted section 360i(b)(3) to prohibit the disclosure of the reports or their contents in discovery in lawsuits between patients and manufacturers, it would have had no need to adopt section 20.63(f) to protect the identity of the reporters. Such a regulation only became necessary if Section 360i(b)(3) was ...

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