Schering Corp. v. Vitarine Pharmaceuticals, Inc.

124 F.R.D. 580, 1989 U.S. Dist. LEXIS 2368, 1989 WL 22441
CourtDistrict Court, D. New Jersey
DecidedMarch 10, 1989
DocketCiv. A. No. 88-4046
StatusPublished
Cited by3 cases

This text of 124 F.R.D. 580 (Schering Corp. v. Vitarine Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Schering Corp. v. Vitarine Pharmaceuticals, Inc., 124 F.R.D. 580, 1989 U.S. Dist. LEXIS 2368, 1989 WL 22441 (D.N.J. 1989).

Opinion

OPINION

BARRY, District Judge.

On September 16,1988, counsel for plaintiffs Schering Corporation and Key Pharmaceuticals and counsel for defendants Vitarme Pharmaceuticals and Major Pharmaceuticals appeared in my chambers on plaintiffs’ application for an order to show cause. Plaintiffs’ complaint sought, inter alia, injunctive relief as to two claims: first, advertisements falsely claiming that Murray Drug Corporation’s 100 and 200 mg. Inwood theophylline was bioequivalent to plaintiffs’ Theodur theophylline1 and, second, the “billboarding,” in Murray’s advertisements, of the Theodur name and mark, in prominent size and color, and the use of misleading “compares to” and “competes with” claims. See Complaint HIT 9-27. Plaintiffs asserted the former claims pursuant to 15 U.S.C. § 1125(a) and the latter claims pursuant to 15 U.S.C. § 1114(a) and, as to both claims, sought a prompt hearing and expedited discovery. Significantly, paragraph 21 of the complaint, presented to me in chambers that day, stated that “[defendants’ aforesaid acts have caused and, unless enjoined by this Court, will continue to cause ... present hazards to the public, for which there is no adequate remedy at law.” Plaintiffs’ memorandum in support of the order to show cause emphasized the “paramount public interest factor” warranting injunctive relief (p. 8), i.e. the “clear risk to patients” (p. 5), the “risk of harm to the public” (p. 6), and the “hazards defendants’ acts cause for patients ____” (p. 9).

The recollections of the parties differ as to what was said at the conference of September 16, which, unfortunately, was not transcribed. As relevant here, they disagree as to what was said by plaintiffs’ lead counsel, Samuel D. Rosen, Esq., regarding the health risk posed by the substitution of Inwood theophylline for Theodur in the 100 and 200 mg. strengths. John Sullivan, Esq., one of defendants’ counsel, recalls that Rosen asserted the presence of a “serious risk to public health,” and that he posed the possibility of ordering the product (Inwood 100 and 200 mg. theophylline) to be removed from the marketplace. Sullivan Aff., 113. Rosen contends that he made no representation that defendants’ product posed “an imminent health danger or any risk more severe or pronounced than the general risk described in the [medical] literature.” Rosen Aff., If 8. He asserts that he limited his argument before me to the claim that any substitution of one theophylline product for another, absent bioequivalence, “presented] a potential health risk,” and that he did not intimate that substitution of defendants’ product for Theodur “would, in fact, injure the patient.” Id. 119. Moreover, Rosen claims that he did not suggest that a recall of defendants’ products would be necessary. Id. 1112.

Whatever the precise assertions, and more will be said about those later, it was made absolutely clear to me that if I did not act, and act immediately, trouble—real trouble—loomed ahead for any patient subjected to a substitution of defendants’ product for Theodur in the 100 mg. and 200 mg. dosages. Rosen thus invested his application with an importance and an urgency which would prove to be wholly unwarranted by the facts.

Following the arguments of counsel, I set down October 24 as the hearing date on plaintiffs’ application, with submissions of briefs by October 17, and informed counsel that they were to petition the Honorable Stanley R. Chesler in the event that expedited discovery could not be agreed upon by the parties. The October 24th date was set only because of the potential health risk, for I was aware that I would be and, indeed, I was in the midst of a lengthy and important criminal trial on that date.

[583]*583On September 23,1988, counsel appeared before Magistrate Chesler on plaintiffs’ application for expedited discovery. Although the expedited discovery was granted, the parties again disagree as to the Magistrate’s reasons for ordering that discovery. Defendants maintain that the hearing before Magistrate Chesler one week following the filing of the complaint and the expedited discovery ordered on that date were the result of representations by plaintiffs’ counsel of serious danger to the public health from substitution of In-wood theophylline for Theodur. See Defendants’ Memorandum of Law in Support of Motion for Sanctions at 3; Rosen Aff., Exh. 8, at p. 7 (letter from William Purcell, Esq. to Magistrate Chesler, dated October 12, 1988). Plaintiffs contend that, as before me on September 16, nothing was said regarding “any actual harm emanating specifically from defendants’ products.” Rosen Aff., ¶ 17. Accordingly, their argument goes, expedited discovery was ordered not on the basis of any perceived health threat, but rather so that plaintiffs could obtain discovery, in time for the October 24 hearing, of defendants’ purported defenses to plaintiffs’ application. Id., and ¶ 32.

The parties thereupon commenced what I later described as “extraordinarily] expedited discovery.” Transcript of Hearing of October 24, 1988 (hereinafter “Hearing”) 3:18-19. This discovery involved two in-person conferences before Magistrate Chesler, on September 16 and October 11, and at least six phone conferences, on September 28, October 5, October 6, October 14, October 20, and one undated conference. See Rosen Aff., Ml 46, 48, 51, 61, 63, 87-89; Purcell Aff., MI 5, 8, 12, 14. Moreover, at least five depositions were conducted (those of Emil Scheller, Fred Bondy, James Audibert, Roy English, and Roger Jordan), and thousands of pages of documents were produced for my review in connection with the preliminary injunction hearing scheduled for October 24.

At the very outset of the hearing, I observed that no evidence had yet been presented as to the “serious health risk” posed by defendants’ product, which risk had placed the matter “on a very fast track.” Id. 3:15-18. I further observed that Magistrate Chesler had been prevailed on at least once and probably two or three times, and that I had almost no sleep for three nights so that I could go through each page of the extensive submissions. Id. 3:18. • Where, I asked, was evidence of the serious health risk that prompted or required so many people to drop everything and move with this case? Id. 3:23-25. Rosen responded that health risk was the first issue on which plaintiffs wished to present evidence, id. 4:5-7, and conceded that there was, as yet, no such evidence of record. Subsequently, I again raised the health risk issue, observing that, aside from any claim that defendants’ advertising falsely indicated bioequivalence, evidence of adverse health consequences was relevant to the entry of preliminary relief as to plaintiffs’ billboarding and passing-off claims. Id. 26:2-4.2 Rosen indicated his agreement with that observation. Id. 26:5.

With respect to the health risk issue, Rosen represented that he would present evidence “to demonstrate that in the real world [of] doctors treating there is, indeed, more than a prima facie showing that substitution of theophylline products, including defendant’s product, has produced prima facie indications of serious adverse consequences.” Id. 5:3-8. He thereupon called as witnesses Dr. Leonard Lachman, medical director for Inwood Laboratories (one of defendants’ witnesses), id. 32-75, and Dr.

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124 F.R.D. 580, 1989 U.S. Dist. LEXIS 2368, 1989 WL 22441, Counsel Stack Legal Research, https://law.counselstack.com/opinion/schering-corp-v-vitarine-pharmaceuticals-inc-njd-1989.