AYERST's "DEAR PHARMACIST" LETTER AGAINST GENERIC PROPRANOLOL SUBSTITUTION FOR POST-MI INDICATION LEGALLY PRESENTED LIABILITY QUESTION, N.Y. MAGISTRATE RULES

Executive Summary

Ayerst's 1986 "Dear Pharmacist" letter warning against generic substitution for Inderal for post-myocardial infarction legally raises the issue of pharmacist liability, New York Federal Court Magistrate Naomi Reice Buchwald concluded in an April 30 order. The order dismissed Sherman Antitrust Act and Lanham Act complaints against Ayerst brought jointly by the National Association of Pharmaceutical Manufacturers (NAPM) and Zenith. Buchwald concluded that "we do not find it [Ayerst's letter] to be 'deceptive" as a matter of law." The court said that the letter stated that it was "sent in the context of an ongoing public debate concerning the 'potential liability resulting from substitution on Inderal prescriptions.'" The court added that "Ayerst's letter fairly states that the issues discussed are open ones and that the views expressed are its own" and, therefore, the court would have difficulty in finding the letter in violation of the antitrust laws. In ruling that Ayerst's letter was not deceptive, Buchwald pointedly disregarded the conclusion reached by FDA's Division of Drug Labeling and Advertising that the letter "is regarded as false and misleading" in that "it serves only to confuse and intimidate pharmacists into dispensing only Inderal for the exclusive indication by suggesting unknown perils and distorting the true content of the Waxman-Hatch Act." In regard to FDA's comments, the court said "at the outset, we reject any suggestion that this Court is bound by the conclusion of an FDA staff member that Ayerst's letter was false and misleading." One of FDA's specific objections was Ayerst's assertion in its letter to pharmacists that: "We believe . . . you will want to dispense Inderal tablets, the only propranolol product with the approved indication for reduction of mortality post-MI." FDA also objected to the absence of information on the "good faith" practice, which exempts pharmacists from liability of generic substitution. The agency said it regarded this as "an attempt to intimidate pharmacists to always dispense Inderal." FDA disapproved of another statement which suggested that pharmacists must dispense Inderal for post-MI. In the April 30 court order, the court found that "the plaintiffs [Zenith and NAPM] lack standing to bring both the antitrust claim and the Lanham Act claim, and . . . found that the plaintiffs fail to state a cause of action under either the antitrust laws or the Lanham Act." The order said that Zenith lacks antitrust standing because it "does not have a protectable interest in the sale of propranolol for post-MI indications" since it cannot lawfully sell its generic propranolol for post-MI indications. The court stated that "the causal connection between the Ayerst letter which states only dispense Inderal for post-MI patients, and Zenith's sales of generic propranolol for other purposes is too slender as a matter of law to allow plaintiffs standing." In dismissing the antitrust claim, the court noted that Zenith and NAPM failed to allege that Ayerst's conduct accomplished an anticompetitive effect. The court "found fatal the absence of an allegation of Ayerst's acquiring or maintaining a monopoly or a dangerous probability of success of obtaining such a monopoly." In regard to Zenith and NAPM's standing under the Lanham Act, the court decided that "the plaintiffs do not have a 'reasonable interest to be protected' and therefore do not have standing to bring this action under the Lanham Act." The court further found that Zenith and NAPM's allegations do not involve a "misrepresentation regarding Ayerst's product Inderal" and are "insufficient to state a claim for a violation . . . of the Lanham Act." NAPM said it would appeal the court's decision.