Case Briefing

Suit Alleges Devices Faulty, FDA Standards Violated

The United States filed a complaint on June 25 in Federal Court to seize and condemn allegedly faulty patient lift devices being stored by Moving Solutions Inc., in Downers Grove, IL. The lifts, manufactured in Denmark and distributed in the United State by Moving Solutions, are mechanical sling-like devices used to lift and move patients from one place to another, as from a bed to a wheelchair. Approximately 850 of these patient lifts have been distributed to hospitals, nursing homes and private homes throughout the United States. According to the lawsuit and reports received by the FDA, one patient has died and another was seriously injured when the bolt that supports the hanger bar and the patient sling broke, dropping the patients. Moving Solutions allegedly failed to report the patient death to the FDA and violated the FDA's Quality System regulations by lacking procedures to handle complaints, and failing to verify that servicing of the product met specified requirements.

FOIA Request Trumps Trade Secret Claim

The court ordered the defendant under the Freedom of Information Act, 5U.S.C. ' 552 (FOIA), to give the plaintiff an unredacted copy of a university professor's grant application made to obtain funds to pursue scientific research that might some day lead to a marketable pharmaceutical product because the scientist was not a commercial research scientist, but employed by a public institution. Physicians Committee for Responsible Medicine v. Nation Institutes of Health, Civ. Act. No. 01-2666 (RBW), 2004 U.S. Dist. LEXIS 12464 (D.D.C., 6/29/04).

The action concerned a Freedom of Information Act (FOIA), 5 U.S.C. ' 552 (2000) request by plaintiff physicians committee seeking discovery of a grant application made by a scientist/professor employed by a public university to the United States for the purpose of research. For all of the material at issue, the agency provided redacted documents and stated that it was withholding some information because it “could reveal confidential commercial information obtained from a person,” citing, among other things, 5 U.S.C. ' 552(b)(4) as authority for its position. Sec. 552(b)(4) (Exemption 4) protects from disclosure trade secrets and commercial or financial information obtained from a person that is privileged or confidential.

The defendant argued that the scientist who applied for the grant believed that the development of his scientific theory was proprietary research, because his model system had the potential for pharmaceutical drug development. The defendant also contended that the grant application showed the subject of the doctor's research was innovative, that he had invested substantial effort into it and that it could lead to the development of a commercially viable trade commodity. Accordingly, the defendant argued, the redacted information constituted trade secret material properly withheld under Exemption 4.

The plaintiff countered that the grant applicant was a noncommercial scientist, affiliated with a public educational institution, whose research was fully funded by U.S. taxpayers. Moreover, the plaintiff opined that just because the scientist believed his research had the potential for pharmaceutical drug development, that he had been studying it for 7 years or that he had a good faith goal of commercialization, these facts did not lead to the conclusion that the redacted information was a “trade secret.” The court sided with plaintiff, finding that the research design in the grant application was not exempt from disclosure under the FOIA as a trade secret. Citing to Wash. Research Project Inc. v. Dep't of Health, Educ. & Welfare, 164 U.S. App. D.C. 169, 504 F.2d 238 (D.C. Cir. 1974), the court concluded that a “noncommercial scientist's research design is not literally a trade secret or item of commercial information, for it defies common sense to pretend that the scientist is engaged in trade or commerce. This is not to say that the scientist may not have a preference for or an interest in nondisclosure of his research design, but only that it is not a trade or commercial interest. To the extent that [the scientist's] interest is founded on professional recognition and reward, it is surely more the interest of an employee than an enterprise, and we are far from persuaded that Congress intended in Exemption 4 to apply terms drawn from the business context to the employment market.”

Suit Alleges Devices Faulty, FDA Standards Violated

The United States filed a complaint on June 25 in Federal Court to seize and condemn allegedly faulty patient lift devices being stored by Moving Solutions Inc., in Downers Grove, IL. The lifts, manufactured in Denmark and distributed in the United State by Moving Solutions, are mechanical sling-like devices used to lift and move patients from one place to another, as from a bed to a wheelchair. Approximately 850 of these patient lifts have been distributed to hospitals, nursing homes and private homes throughout the United States. According to the lawsuit and reports received by the FDA, one patient has died and another was seriously injured when the bolt that supports the hanger bar and the patient sling broke, dropping the patients. Moving Solutions allegedly failed to report the patient death to the FDA and violated the FDA's Quality System regulations by lacking procedures to handle complaints, and failing to verify that servicing of the product met specified requirements.

FOIA Request Trumps Trade Secret Claim

The court ordered the defendant under the Freedom of Information Act, 5U.S.C. ' 552 (FOIA), to give the plaintiff an unredacted copy of a university professor's grant application made to obtain funds to pursue scientific research that might some day lead to a marketable pharmaceutical product because the scientist was not a commercial research scientist, but employed by a public institution. Physicians Committee for Responsible Medicine v. Nation Institutes of Health, Civ. Act. No. 01-2666 (RBW), 2004 U.S. Dist. LEXIS 12464 (D.D.C., 6/29/04).

The action concerned a Freedom of Information Act (FOIA), 5 U.S.C. ' 552 (2000) request by plaintiff physicians committee seeking discovery of a grant application made by a scientist/professor employed by a public university to the United States for the purpose of research. For all of the material at issue, the agency provided redacted documents and stated that it was withholding some information because it “could reveal confidential commercial information obtained from a person,” citing, among other things, 5 U.S.C. ' 552(b)(4) as authority for its position. Sec. 552(b)(4) (Exemption 4) protects from disclosure trade secrets and commercial or financial information obtained from a person that is privileged or confidential.

The defendant argued that the scientist who applied for the grant believed that the development of his scientific theory was proprietary research, because his model system had the potential for pharmaceutical drug development. The defendant also contended that the grant application showed the subject of the doctor's research was innovative, that he had invested substantial effort into it and that it could lead to the development of a commercially viable trade commodity. Accordingly, the defendant argued, the redacted information constituted trade secret material properly withheld under Exemption 4.

The plaintiff countered that the grant applicant was a noncommercial scientist, affiliated with a public educational institution, whose research was fully funded by U.S. taxpayers. Moreover, the plaintiff opined that just because the scientist believed his research had the potential for pharmaceutical drug development, that he had been studying it for 7 years or that he had a good faith goal of commercialization, these facts did not lead to the conclusion that the redacted information was a “trade secret.” The court sided with plaintiff, finding that the research design in the grant application was not exempt from disclosure under the FOIA as a trade secret. Citing to Wash. Research Project Inc. v. Dep't of Health, Educ. & Welfare , 164 U.S. App. D.C. 169, 504 F.2d 238 (D.C. Cir. 1974), the court concluded that a “noncommercial scientist's research design is not literally a trade secret or item of commercial information, for it defies common sense to pretend that the scientist is engaged in trade or commerce. This is not to say that the scientist may not have a preference for or an interest in nondisclosure of his research design, but only that it is not a trade or commercial interest. To the extent that [the scientist's] interest is founded on professional recognition and reward, it is surely more the interest of an employee than an enterprise, and we are far from persuaded that Congress intended in Exemption 4 to apply terms drawn from the business context to the employment market.”