Five months after ordering the Food and Drug Administration to allow the marketing of the emergency contraceptive Plan B to 17-year-olds without a prescription, a Brooklyn federal judge has refused to allow three Christian lobbying groups who oppose abortion to challenge the ruling.
In his latest decision in the case, Eastern District of New York Judge Edward R. Korman held that Concerned Women for America, Christian Medical & Dental Associations and Christian Pharmacists Fellowship International failed to show they were harmed by his March 23 ruling and thus lacked standing to challenge his decision to allow over-the-counter sales of the pill.
"Intervenors have not alleged a concrete organizational injury or any injury suffered by their members," Judge Korman wrote in Tummino v. Hamburg, 05-CV-366, in denying the groups' motion to intervene.
The judge's March decision, Tummino v. Torti, 603 F. Supp. 2d 519, capped years of litigation over the push to expand the distribution of the pill. The judge observed that the review of the drug had been marred by "repeated and unreasonable delays, pressure emanating from the White House ... and significant departures from the FDA's normal procedures and policies."
Korman also ordered the FDA to reconsider whether restrictions on sales to adolescents under 17 should be eased. The agency decided on April 22 not to appeal the ruling. In July, it approved the use of the drug for young women under 17 by prescription only.
Plan B is a synthetic hormone that blocks pregnancy when taken within 72 hours of sexual intercourse.
It was approved for prescription use in 1999 and in 2006 the FDA approved it for over-the-counter use for women 18 and older.
In rebuffing the proposed intervenors, Korman dismissed a series of arguments involving standing, all centering on the claim that his March ruling had injured the proposed intervenors.
First, he said the groups had not been deprived of access to data regarding the safety of the pill "that the FDA otherwise would have been required to consider and make available to the public before approving such use."
The FDA's own finding that the sale of the contraceptive to 17-year-olds was "consistent" with prior scientific research it had conducted rendered a safety data argument invalid, Korman held.
Next, he rejected a claim that his earlier ruling "short-circuited" the approval process to allow the expanded sale of the drug, which the intervenors argued would have given them a chance to oppose the switch.
ARGUMENT A 'STRETCH'
But Korman pointed to the 2008 District of Columbia case Ass'n of Am. Physicians & Surgeons v. FDA, 539 F. Supp2d, where Concerned Women for America and another group also alleged they were denied the opportunity to voice their opposition to relaxing Plan B restrictions.
Such allegations were ruled insufficient to establish standing in that case, the judge wrote, and the court's holding "applies with equal force here."
Korman also dismissed as a "stretch" a claim by the pharmacy lobbying group that its members in states that "require pharmacists to sell Plan B" would be "forced to distribute a 'misbranded' drug."
Noting that his decision did not compel pharmacists to do anything, the judge also pointed out that "intervenors have failed to identify a single state regulation or statute that compels them to dispense Plan B to 17 year olds without a prescription."
And, he continued, any fears of prosecution stemming out of the sale of a "misbranded" drug were "imaginary or speculative" because the FDA had already notified the maker of Plan B that it could market the drug without a prescription to women aged 17 and older.
Finally, Korman threw out an argument that his prior ruling conferred standing by legalizing prior illegal conduct -- selling the contraceptive without a prescription -- as a "nonstarter," citing Simon v. Eastern Kentucky Welfare Rights Org., 426 U.S. 26 (1976).
In that case, the U.S. Supreme Court held that plaintiffs lacked standing to challenge an Internal Revenue Service rule regarding taxing certain non-profit hospitals.
Similarly, here, the proposed intervenors had failed to show they had been harmed by the judgment, the judge wrote, because the FDA -- the agency actually impacted -- had already made clear it would not appeal, the judge said.
UNTIMELY MOTION
In addition to lacking standing to intervene, the judge ruled that the groups failed to make a timely motion to challenge his decision, despite the fact the underlying litigation and the FDA's decision not to contest the March ruling were "the subject of considerable discussion and national media coverage."
It was "beyond dispute" that Concerned Women for America was aware of the FDA's stance in April. Moreover, the other two intervenors knew or should have known of the decision at the same time. But the groups did not file their motion until two months later, on June 25. Thus, any prejudice to their cause from the denial of their request was their own fault, the judge noted.
"Once intervenors became aware that the FDA would not appeal, 'it was incumbent upon [them] ... to take immediate affirmative steps to protect their interests,'" he said.
"Permitting intervention at this point would force the parties who are directly interested in the subject of this litigation and who do not object to the final judgment to engage in yet another round of costly and time consuming litigation," he commented.
The judge also denied a request by the groups to extend the time for an appeal, which expired on May 26, ruling that the "failure to establish standing is fatal to their motion for an extension."
The intervenors claimed their failure to meet the deadline resulted from their difficulty in locating local counsel willing to represent them in what was a controversial matter. Korman questioned why the process had taken more than two months and pointed out that, in any case, local counsel was not required.
The unsuccessful intervenors were represented by Charles E. Holster of Mineola, N.Y. He could not be reached for comment.
Steven H. Aden, senior legal counsel for the Alliance Defense Fund, who also represented the intervenors, said the groups were evaluating their options but declined to comment further on whether they would appeal.
F. Franklin Amanat was lead counsel for the U.S. Attorney's Office for the Eastern District of New York, which had opposed the motion to intervene. A spokesman for the office declined to comment.
