Example of Complaint for Injunction and Civil Penalty

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF ILLINOIS

  COMPLAINT FOR PERMANENT INJUNCTION AND FOR CIVIL PENALTIES

The United States of America, plaintiff, by its undersigned attorneys, respectfully represents to this Honorable Court as follows:

1. This action is brought pursuant to the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 360pp to:

1. enjoin and restrain the defendants from violating 21 U.S.C. 360oo(a)(1), (a)(2), and (a)(5)(B), and

2. enforce the Act’s radiological health civil penalty provisions, 21 U.S.C. 360pp(b)(1), in accordance with 28 U.S.C. 1355.

2. This Court has jurisdiction over this action pursuant to 21 U.S.C. 360pp(a) and 28 U.S.C. 1331, 1337, 1345, and 1355.

3. Venue in this district is proper pursuant to 21 U.S.C. 360pp(c), 28 U.S.C. 1391(b), and 28 U.S.C. 1395(a).

4. Defendant ABC Company, Inc. (ABC), is a corporation organized and existing under the laws of the State of Illinois and at all times relevant to the allegations in this Complaint, trading and doing business at 38 Main Street, Peoria, Illinois, within the jurisdiction of this Court. The firm became incorporated on March 23, 1967.

5. Defendant, Alan R. Smith, an individual, is and has been since 1989, the President and Chief Executive Officer of ABC. Prior to that time, Mr. Smith was the firm’s Vice President. He also currently holds the position of Corporate Treasurer. At all times relevant to this action, Mr. Smith performed his duties at 38 Main Street, Peoria, Illinois, within the jurisdiction of this Court. Mr. Smith has ultimate responsibility for all facets of the firm’s operations.

6. Defendants are, and at all times relevant to this action have been, engaged in the business of importing and manufacturing diagnostic x-ray systems which are "electronic products" within the meaning of 21 U.S.C. 360hh(2). Accordingly, each defendant was and is a "manufacturer" of electronic products within the meaning of 21 U.S.C. 360hh(3).

7. Pursuant to 21 U.S.C. 360ii(a), the Commissioner of Food and Drugs under authority delegated to him by the Secretary of Health and Human Services ("Secretary") under 21 CFR 5.10(a)(3), promulgated regulations prescribing performance standards for diagnostic x-ray systems and their major components. These regulations are codified, in pertinent part, at 21 CFR 1020.30-33.

8. On August 9, 1993, the United States Food and Drug Administration ("FDA") notified defendants that their model 12 x-ray systems failed to meet, inter alia, the light localizer illuminance requirements, the contrast ratio requirements, and the labeling and certification requirements, 21 CFR 1020.31(d)(2)(ii) and (iii) and 1010.2, respectively.

9. X-ray systems use a light localizer to define the light field so the operator of the equipment can adjust the x-ray field to the proper image receptor site. The contrast ratio requirement exists to permit the operator to align the film with the edges of the x-ray field. Failure of a system to meet these two requirements could cause the operator to visualize inaccurately the x-ray field, and could result in an x-ray field that is larger than necessary for the examination. An x-ray field that is too large or misaligned could overexpose the patient to radiation, and could unnecessarily expose sensitive body organs to radiation. If critical organs are exposed to radiation, there is an increased risk to the patient of cell damage and cancer.

10. Defendants met with FDA’s CDRH on September 24, 1993. At that time, CDRH notified defendants that their mobile and wall-mounted podiatry x-ray systems, models 13, 14, 15, and 16, and their portable, general purpose x-ray systems, models 17 and 18, all failed to meet the requirements cited in the Warning Letter of August 9, 1993. By follow-up letter dated October 5, 1993, and by second Warning Letter dated January 6, 1994, CDRH reiterated to defendants that all of the above-mentioned units were noncompliant. On February 16, 1994, CDRH approved a corrective action plan for the podiatry units defendants placed into commerce prior to August 9, 1993. CDRH notified defendants that they were to submit a corrective action plan for the general purpose x-ray systems. From August 9, 1993 through March 30, 1995, the defendants exchanged numerous correspondence with CDRH and FDA’s Chicago District regarding the noncompliance of the x-ray units.

11. Nevertheless, after September 24, 1993, the date on which FDA notified defendants that their mobile and wall-mounted podiatry x-ray systems and their portable, general purpose x-ray systems did not comply with the applicable performance standards, the defendants sold the following 22 units in violation of applicable performance standards, including 16 model 13 units, 1 model 15 unit, 1 model 17 unit, and 4 model 18 units:

Model 13 Units (16 total)

Model 15 Unit (1 total)