Opinion ID: 187198
Heading Depth: 1
Heading Rank: 4

Heading: Adequacy of the Amendment to the Complaint

Text: The LWD plaintiffs filed their amended complaint on June 1, 2005; because that complaint does not relate back to the filing of the original complaint, the LWD plaintiffs, who claim the defendants violated § 2 of the Sherman Act, 15 U.S.C. § 2, must allege the defendants injured them during the four year period starting June 1, 2001, or state facts sufficient reasonably to give rise to an inference of such an injury. See § 4B of the Clayton Act, 15 U.S.C. § 15b (providing any suit for damages under the federal antitrust laws shall be forever barred unless commenced within four years after the cause of action accrued); see also Twombly, 127 S.Ct. at 1966; Aktieselskabet, 525 F.3d at 17. On appeal the LWD plaintiffs argue that, but for Biovail's acquisition of the '463 patent, Biovail and Forest in February 2001 would have entered into long-term contracts to sell to wholesalers, including the plaintiffs, generic Diltiazem HCl beyond June 1, 2001 and the plaintiffs were injured because they were unable to purchase generic drugs from the defendants pursuant to those hypothetical contracts. They made no similar allegation, however, in the amended complaint, their opposition to Biovail's motion to dismiss, or their request under Rule 56(e) for further discovery. At oral argument, counsel for the LWD plaintiffs was unable to say when, if ever, they made this argument in the district court and as far as we can tell they never did. Absent a showing that `injustice might otherwise result,' and the plaintiffs offer none, we do not entertain an argument made for the first time on appeal. Ben-Kotel v. Howard Univ., 319 F.3d 532, 535 (D.C.Cir.2003). As the defendants argue, without the allegation that Biovail and Forest would have entered into long-term contracts to sell wholesalers generic Diltiazem HCl, the LWD plaintiffs have no basis upon which to claim that, but for Biovail's acquisition of the '463 patent, the defendants would have sold them generic Diltiazem HCl after June 1, 2001. Because, as we have held, the LWD plaintiffs cannot show Andrx would have sold Diltiazem HCl prior to May 2003, when Andrx received final approval and long after they allege either defendant had engaged in any misconduct, it follows that the defendants would have faced no competition until then. [] There is no provision of law that would have required Biovail and Forest to sell or continue selling a generic version of Diltiazem HCl in competition with Biovail's branded product once it became clear, as it would have done in early 2001, that Andrx could not get FDA approval to enter the market. Nor does the complaint advance any fact suggesting Biovail and Forest would have done so. (The plaintiffs do not argue on appeal that any firm other than Andrx sought to enter the market.) These gaps are fatal to the plaintiffs' case. In sum, the factual allegations of the LWD plaintiffs' amended complaint, taken as true, are inadequate to make out a timely action under the antitrust laws. Therefore, we affirm the dismissal of the amended complaint.
Finally, we turn to the LWD plaintiffs' objection to the failure of the district court to address their Rule 56(e) affidavit before entering judgment. The LWD plaintiffs sought to discover from Andrx any communications between it and the FDA tending to show the FDA would have given final approval of Andrx's ANDA in February 2001. They also sought to discover from Andrx information regarding what it would have done had it obtained final approval from the FDA in February 2001 but subsequently discovered problems manufacturing the drug, and from Biovail and Forest information relating to their alleged plan preemptively to sell a generic version of Tiazac. If the district court's inattention to the plaintiffs' affidavit was an error, then it was surely harmless. 28 U.S.C. § 2111; Colbert v. Potter, 471 F.3d 158, 165, 168 (D.C.Cir.2006). As for the first request, the communications the plaintiffs seek would be insufficient to sustain a jury verdict in their favor; the FDA did not again even tentatively approve Andrx's ANDA until May 2001 and final approval remained by law subject to the FDA being satisfied with any update Andrx might file. [] Any information responsive to the plaintiffs' second request would be immaterial because, as we have held, no reasonable juror could find that but for Biovail's conduct the FDA would have finally approved Andrx's application in February 2001. Because the proposed amendments to the complaint were untimely and insufficient, any information responsive to the third request is likewise immaterial.