is clearly the optimal method for regulating the industry, the FDA is hard-pressed to support its claim that voluntary submissions are somehow more efficient.
Accordingly, this Court rejects defendants' impairment claim. It does not appear that the FDA will be in a worse position if it requires compliance with its regulations. In fact, if the FDA compels submission of the materials it needs to do its job, the public will obviously be better protected than it is now. With an effective PMA regulation, all silicone breast implant manufacturers will be compelled to do research and testing which will better protect the public health.
Neither have defendants supported their argument regarding the competitive injury prong of exemption 4. Plaintiff has requested that the FDA disclose those animal studies which yielded "positive" or "inconclusive" results; as for studies yielding "negative" results, plaintiff has requested only the protocols and final results. Moreover, plaintiff has limited his request to exclude information concerning Dow Corning's silicone gel product specifications, marketing strategies, and the names of individuals and independent contractors who participated in the studies.
Defendants contend that the research data constitute trade secrets or confidential commercial information whose disclosure would cause Dow Corning substantial competitive injury. Defendants state that disclosure could potentially work commercial harm on Dow Corning by facilitating its competitors' safety testing. According to defendants, this harm is even more apt to occur given the approaching deadline for the promulgation of a PMA regulation for silicone breast implants. It is defendants' contention that competitors could use Dow Corning's test results, both positive and negative, as a road map to facilitate their own testing, thus taking advantage of the research funds and time expended by Dow Corning.
This Court first notes that disclosure of the positive tests, which demonstrate that a product poses a danger when used in a certain manner, is unquestionably in the public interest. To argue that this type of information is confidential suggests that, in order to protect whatever marginal commercial benefit Dow Corning may get from having independently discovered certain risks, other manufacturers be permitted to blindly put out potentially damaging products. Certainly Dow Corning, as a good citizen, would not risk the public health in this manner. The benefit of releasing this type of information far outstrips the negligible competitive harm that defendants allege.
While it is true that the negative studies are arguably useful to Dow Corning's competitors because they demonstrate the safety of the tested material, it is inconceivable that disclosure of the protocols and results alone will facilitate a competitor's premarket approval application. Pursuant to the FDA's recently drafted PMA regulation for silicone breast implants, a manufacturer must submit not only the protocols and test results, but the raw data supporting those results. See 55 Fed. Reg. 20572. In the absence of the raw data, an applicant cannot demonstrate the requisite safety and effectiveness necessary to obtain FDA approval.
At oral argument, the FDA indicated that it was unable to define whether the studies were "negative" or "positive." If the agency is unable to characterize the studies' usefulness in terms of proving the safety or risks of breast implants, it is unlikely that the research will be useful to competitors submitting their own PMA applications. Against this background, it is unclear how Dow Corning's competitors can use such inconclusive tests to assist them in avoiding the expenditure of time and money on "blind alleys."
This Court also notes that most of the studies at issue here were prepared as much as 20 years ago. It can hardly be claimed that Dow Corning's competitors can use this information to any substantial extent in preparing current PMA applications. It is unlikely that competitors would look in any meaningful way to studies undertaken by Dow Corning over 20 years ago in order to satisfy 1990 testing requirements. The FDA admits that protocols have changed substantially in the intervening years and that the documents have not been analyzed for their continued relevance. Defendants have introduced no evidence which would demonstrate the current significance of these tests. Given the explosion of technology in recent years, this Court cannot accept, absent substantiation, that studies from the 1960's and 1970's are the most productive route for Dow Corning's competitors to pursue.
Manufacturers of silicone breast implants will be required to submit PMA applications in the very near future; this was known to all manufacturers ever since silicone breast implants were classified as Class III devices by the FDA. This Court has received no evidence that these manufacturers have failed to do independent testing in anticipation of their product's possible removal from the market. At this late date, only months away from the PMA deadline, the disclosure of the animal studies could not possibly help Dow Corning's competitors unless they have done no research, hoping instead that Dow Corning's research data would be fortuitously released in time to be of use.
Defendants have simply not sustained their claim of substantial competitive injury with specific and direct evidence:
Conclusory and generalized allegations are indeed unacceptable as a means of sustaining the burden of nondisclosure under the FOIA, since such allegations necessarily elude the beneficial scrutiny of adversary proceedings . . . . and generally frustrate the fair assertion of rights under the Act.
National Parks and Conservation Ass'n v. Kleppe, 178 U.S. App. D.C. 376, 547 F.2d 673, 680 (D.C. Cir. 1976). Dow Corning has foreclosed this Court from having access to pertinent information it could have used to determine the competitive worth of the animal studies.
During discovery, plaintiff learned of two expert witnesses familiar with Dow Corning's animal studies. These individuals were expert witnesses in breast implant product liability suits brought against Dow Corning. These witnesses were proffered by plaintiff on the issue of the value of Dow Corning's animal studies and the carcinogenicity of silicone breast implants. Dow Corning precluded their testimony because of protective orders obtained in product liability suits settled by Dow Corning. What is particularly troubling is that Dow Corning insisted on enforcing these protective orders in order to preclude even an in camera proceeding which would have allowed the Court to obtain the benefit of this obviously important testimony. As a result this Court was forced to strike the declaration of Dow Corning's principal witness on basic fairness grounds. Without the testimony of this witness, Dow Corning has not been able to support its position that disclosure of the studies would cause it competitive harm. The Court cannot accept Dow Corning's contention of competitive harm when it is based on unsupported allegations.
From the information available to this Court, it seems that any injury which might result would certainly not be substantial enough to mandate shielding the information from disclosure. Furthermore, this Court is not convinced, based on the age and form of the studies, that Dow Corning would necessarily undergo any competitive injury. "Like all FOIA exemptions, exemption 4 is to be read narrowly in light of the dominant disclosure motif expressed in the statute." Washington Post Co. v. U.S. HHS, 275 U.S. App. D.C. 101, 865 F.2d 320, 324 (D.C. Cir. 1989) (citations omitted). Defendants have not proved the applicability of an exemption 4 "competitive injury" claim.
It is the decision of this Court that the animal studies and the complaint summary are subject to disclosure and were wrongly withheld by the FDA. Accordingly, summary judgment will be entered for the plaintiff.
An Order accompanies this Opinion.
ORDER - November 27, 1990, Filed
Upon consideration of the parties' cross-motions for summary judgment, oral argument, and the entire record in this case, it is hereby
ORDERED, that plaintiff's motion for summary judgment is GRANTED; and it is further
ORDERED, that defendant FDA's motion for summary judgment is DENIED; and it is further
ORDERED, that defendant-intervenor Dow Corning's motion for summary judgment is DENIED; and it is further
ORDERED, that FDA release the animal studies and the complaint summary as specified in plaintiff's FOIA request.