Case Briefing

TRO Issued in First-to-File Market Exclusivity Battle

Alpharma Inc. has announced that its wholly owned subsidiary, Purepac Pharmace, was granted a temporary restraining order Oct. 29 in a lawsuit in the U.S. District Court for the District of Columbia. Purepac brought this suit seeking first-to-file status on its version of Glucophage XR, a Bristol-Myers Squibb Type 2 diabetes drug. On Oct. 28, Ivax Corp. had announced it had received final approval and confirmation of its first-to-file status on its Abbreviated New Drug Application from the FDA. In obtaining the restraining order, Purepac effectively removed Ivax's product from the market, at least in the short term. Under the terms of the temporary restraining order, the FDA has been instructed to delay the effective date of approval of Ivax's ANDA on extended-release metformin hydrochloride tablets until mid-November, when a hearing on Purepac's claims can be held.

District Court Too Hasty in Ruling on Forum

In a suit dismissed due to forum non conveniens, the U.S. Court of Appeals for the Second Circuit vacated and remanded for consideration of the circumstances surrounding dismissal of a similar action in a Nigerian court, which might impact on the District Court's opinion that Nigeria offers an adequate alternative forum. Abdullahi v. Pfizer Inc., Nos. 02-9223 (L), 02-9303 (XAP), 2003 U.S. App. LEXIS 20704 (2d Cir. 10/8/03).

Numerous Nigerian plaintiffs (children and their guardians) brought suit against Pfizer, which is incorporated in Delaware and headquartered in New York. The case arose when Pfizer set up a treatment center in a Nigerian hospital in response to an epidemic of bacterial meningitis and, allegedly, without obtaining their parents' informed consent, treated children there with experimental drug Trovan' (trovaflozacin mesylate) rather than conventional medications. Plaintiffs also alleged that Pfizer administered lower-than-recommended doses to certain children of a conventional meningitis drug in order to make Trovan appear more effective by comparison. According to plaintiffs, five of the children who received Trovan and six of the children who were “low-dosed” with ceftriaxone died, and others treated by Pfizer suffered very serious injuries, including paralysis, deafness and blindness.

Plaintiffs filed their suit in the U.S. District Court for the Southern District of New York, asserting that one of the bases of jurisdiction in the District Court was 28 U.S.C. ' 1350, the Alien Tort Claims Act, because Pfizer purportedly violated the Nuremberg Code, the Declaration of Helsinki, article 7 of the International Covenant on Civil and Political Rights, FDA regulations and other norms of international law. In a Memorandum and Order dated Sept. 16, 2002, the District Court granted Pfizer's motion to dismiss the complaint on grounds of forum non conveniens because although plaintiffs had asserted that Nigeria's judicial system was so corrupt that it was highly unlikely that they could obtain justice there, the court found plaintiffs' evidence of such corruption inadequate.

On appeal, plaintiffs asked the Second Circuit to take judicial notice of a parallel case involving different plaintiffs but the same course of conduct by Pfizer that was brought in and dismissed by the Nigerian court system, asserting that the dismissal served as evidence of that court's corruption. (The notice of discontinuance in the case filed in Nigeria blamed an indefinite adjournment and the fact that the judge hearing the case declined jurisdiction “for personal reasons.”) Pfizer asked that judicial notice be taken of the same case, but for the purpose of proving that the Nigerian-filed case was, like the present case, without merit. The court here refused to take judicial notice of the Nigerian case because the reasons for its outcome were open to interpretation, but found that that case was relevant to the question whether Nigeria was an adequate alternative forum for plaintiffs. As such, the case was remanded to the District Court for proceedings to determine what precipitated the dismissal of the Nigerian suit and to evaluate whether it should impact an analysis of forum non conveniens in this case.

TRO Issued in First-to-File Market Exclusivity Battle

Alpharma Inc. has announced that its wholly owned subsidiary, Purepac Pharmace, was granted a temporary restraining order Oct. 29 in a lawsuit in the U.S. District Court for the District of Columbia. Purepac brought this suit seeking first-to-file status on its version of Glucophage XR, a Bristol-Myers Squibb Type 2 diabetes drug. On Oct. 28, Ivax Corp. had announced it had received final approval and confirmation of its first-to-file status on its Abbreviated New Drug Application from the FDA. In obtaining the restraining order, Purepac effectively removed Ivax's product from the market, at least in the short term. Under the terms of the temporary restraining order, the FDA has been instructed to delay the effective date of approval of Ivax's ANDA on extended-release metformin hydrochloride tablets until mid-November, when a hearing on Purepac's claims can be held.

District Court Too Hasty in Ruling on Forum

In a suit dismissed due to forum non conveniens, the U.S. Court of Appeals for the Second Circuit vacated and remanded for consideration of the circumstances surrounding dismissal of a similar action in a Nigerian court, which might impact on the District Court's opinion that Nigeria offers an adequate alternative forum. Abdullahi v. Pfizer Inc. , Nos. 02-9223 (L), 02-9303 (XAP), 2003 U.S. App. LEXIS 20704 (2d Cir. 10/8/03).

Numerous Nigerian plaintiffs (children and their guardians) brought suit against Pfizer, which is incorporated in Delaware and headquartered in New York. The case arose when Pfizer set up a treatment center in a Nigerian hospital in response to an epidemic of bacterial meningitis and, allegedly, without obtaining their parents' informed consent, treated children there with experimental drug Trovan' (trovaflozacin mesylate) rather than conventional medications. Plaintiffs also alleged that Pfizer administered lower-than-recommended doses to certain children of a conventional meningitis drug in order to make Trovan appear more effective by comparison. According to plaintiffs, five of the children who received Trovan and six of the children who were “low-dosed” with ceftriaxone died, and others treated by Pfizer suffered very serious injuries, including paralysis, deafness and blindness.

Plaintiffs filed their suit in the U.S. District Court for the Southern District of New York, asserting that one of the bases of jurisdiction in the District Court was 28 U.S.C. ' 1350, the Alien Tort Claims Act, because Pfizer purportedly violated the Nuremberg Code, the Declaration of Helsinki, article 7 of the International Covenant on Civil and Political Rights, FDA regulations and other norms of international law. In a Memorandum and Order dated Sept. 16, 2002, the District Court granted Pfizer's motion to dismiss the complaint on grounds of forum non conveniens because although plaintiffs had asserted that Nigeria's judicial system was so corrupt that it was highly unlikely that they could obtain justice there, the court found plaintiffs' evidence of such corruption inadequate.

On appeal, plaintiffs asked the Second Circuit to take judicial notice of a parallel case involving different plaintiffs but the same course of conduct by Pfizer that was brought in and dismissed by the Nigerian court system, asserting that the dismissal served as evidence of that court's corruption. (The notice of discontinuance in the case filed in Nigeria blamed an indefinite adjournment and the fact that the judge hearing the case declined jurisdiction “for personal reasons.”) Pfizer asked that judicial notice be taken of the same case, but for the purpose of proving that the Nigerian-filed case was, like the present case, without merit. The court here refused to take judicial notice of the Nigerian case because the reasons for its outcome were open to interpretation, but found that that case was relevant to the question whether Nigeria was an adequate alternative forum for plaintiffs. As such, the case was remanded to the District Court for proceedings to determine what precipitated the dismissal of the Nigerian suit and to evaluate whether it should impact an analysis of forum non conveniens in this case.