Energy Four, Inc. v. Dornier Medical Systems, Inc.

765 F. Supp. 724, 1991 U.S. Dist. LEXIS 7139, 1991 WL 91021
CourtDistrict Court, N.D. Georgia
DecidedFebruary 27, 1991
DocketCiv. A. 1:90-CV-1287-JOF
StatusPublished
Cited by20 cases

This text of 765 F. Supp. 724 (Energy Four, Inc. v. Dornier Medical Systems, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Georgia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Energy Four, Inc. v. Dornier Medical Systems, Inc., 765 F. Supp. 724, 1991 U.S. Dist. LEXIS 7139, 1991 WL 91021 (N.D. Ga. 1991).

Opinion

ORDER

FORRESTER, District Judge.

This matter is before the court after a consolidated hearing on both parties’ motions for preliminary injunction. Plaintiff/counterclaim defendant Energy Four, Inc. and defendant/eounterclaim plaintiff Dornier Medical Systems, Inc., each ask the court to enjoin the other from making false and misleading statements that allegedly violate the Lanham Act, 15 U.S.C. § 1116(a), and the Georgia Uniform Deceptive Trade Practices Act, O.C.G.A. § 10-l-373(a). Plaintiffs motion for sanctions is also before the court.

I. FINDINGS OF FACT

Plaintiff Energy Four, Inc. (Energy Four) and Dornier Medical Systems, Inc. (Dornier) are both Georgia corporations. Dornier’s parent company, Dornier Mediz-intechnnik GmbH, manufactures lithotripsy machines which are medical devices that use shock waves to fragment kidney stones. The shock waves are produced by electrodes which must be replaced after a certain number of shocks, generally after each patient treatment. Dornier’s parent company also manufactures replacement electrodes for its lithotripsy machines. Dornier distributes machines and replacement electrodes manufactured by its parent. Energy Four competes with Dornier by refurbishing used electrodes at a cost less than the price of new replacement electrodes. Energy Four is the nation’s largest supplier of electrode refurbishment services. There are approximately 250 li-thotripsy machines currently being used in the United States. All Dornier lithotripsy machine users are potential customers of Energy Four.

*727 The Food and Drug Administration regulates the sale of lithotripsy machines and electrodes in the United States by requiring vendors to submit a Pre-Market Approval Application (PMA). The first electrodes sold by Dornier in the United States were approved for marketing with a 700-shock life rating at a setting of 18 kilovolts of electricity. Later versions of the Dornier electrode were approved for marketing in the United States with rated shock lives of 1100, 1500, and 2,000 shocks. The FDA approved a PMA Supplement allowing Dor-nier to market its electrodes for 1500 shocks when used in the range of 14 to 20 kilovolts in 1987.

The electrode approved for sale in the United States by Dornier as a 1500 shock electrode was, at least for some period, simultaneously marketed as a 2,000 shock electrode outside of the United States. In March of 1989 Dornier changed the tolerance range for the hardness coefficient of the electrode tips. Coefficients equal to or greater than 680 kilopons per square millimeter were previously acceptable. The new electrodes were manufactured with a tolerance range of 680 to 790 kilopons per square millimeter. The court was unable to determine, on the basis of evidence produced at the hearing, whether the tips of any old 1500 shock electrodes exceeded the new upper limit. Apparently, the other electrode specifications were unchanged.

There was conflicting evidence as to when Dornier began marketing 1500 shock electrodes that were produced under the new tolerance range. Defendant’s own witnesses gave contradictory testimony concerning the length of time involved. It is undisputed that the only change made in the then rated 1500 shock electrode, when Dornier began marketing it for a 2,000 shock life in February of 1990, was the color of the plastic locking ring. All electrodes marketed for 2,000 shocks in the United States were manufactured with a blue plastic locking ring.

Both the old 1500 shock electrodes and the new 1500 shock electrodes produced under the stricter hardness coefficient controls were manufactured with a white plastic locking ring. Consequently, it may be impossible to distinguish between the old and new 1500 shock electrodes by visual inspection. Because Energy Four destroys the Dornier label during the refurbishing process, it is difficult for the end user to determine when the refurbished electrode was originally manufactured.

Dornier requested approval for the increased number of shocks per service life by submitting Supplement No. 22 to Pre-Market Application Number P840008, dated May 3, 1989. The supplement identifies “improved steel production techniques which allow better control of the hardness coefficients” of the electrode tips as a modification in the electrode producing a higher number of shocks per service life. No other modifications in the electrode itself are identified.

The PMA does not identify the tolerance range for the hardness coefficient. The specification sheets produced by Dornier for the 2,000 shock electrode (S2000/18) and the 1500 shock electrode (S1500/18) are identical. Neither specifies the hardness coefficient range. However, the FDA approval for marketing at 2,000 shocks was based on demonstrations of extended shock life produced by electrodes manufactured under the new .tolerance ranges.

On August 26, 1987 Jeffrey S. Mesquita, now president of Energy Four, wrote the FDA regarding the development of a process to refurbish Dornier electrodes. The FDA informed Mesquita that, *728 In a letter dated August 21, 1990, the FDA stated,

*727 As long as your refurbishing operation brings the electrodes back to the original specifications that were approved in the Pre-Market Approval Application and you do not take actual title to them, we would not require the registration of your refurbishing operation nor would we require your firm to submit a pre-market notification or seek pre-market approval for its operation. If, however, your firm changes the specifications of the electrodes either on its own behalf or upon the request of the owner of the electrode then the above decision would have to be reconsidered.
*728 From what we have been able to determine at this time, Energy Four does not acquire ownership of the lithotripter electrodes they refurbish, and therefore is exempt from our current policy.

The FDA conducted an on-site inspection of Energy Four’s facilities sometime in the spring of 1990. As of yet, the FDA has not issued any inspection report, notice of deficiency, or any finding that Energy Four was in compliance with the Food, Drug and Cosmetic Act.

As competition between Dornier and electrode refurbishers intensified during 1989 and early 1990, Dornier began an intensive campaign to discourage its customers from using the refurbished electrodes. These efforts were aggressively countered by Energy Four. Users of Dor-nier lithotripter machines were bombarded by information from both parties containing conflicting information regarding both new Dornier electrodes and Dornier electrodes refurbished by Energy Four. Dor-nier questioned the safety and reliability of refurbished electrodes, emphasizing that refurbished electrodes had not been tested or “approved” by the FDA. Energy Four told customers that Dornier had misled them about differences between the S1500/18 and the S2000/18 electrodes and promised that it could refurbish S1500/18 electrodes for a 2,000 shock life.

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765 F. Supp. 724, 1991 U.S. Dist. LEXIS 7139, 1991 WL 91021, Counsel Stack Legal Research, https://law.counselstack.com/opinion/energy-four-inc-v-dornier-medical-systems-inc-gand-1991.