November 13, 2014

New York Law Journal / Written by: Harvey M. Stone, Richard H. Dolan

This column reports on several significant, representative decisions handed down recently in the U.S. District Court for the Eastern District of New York. Judge Edward R. Korman reversed a Food and Drug Administration decision, imposed on the agency by the Secretary of Health and Human Services, denying over-the-counter access to a contraceptive drug. Judge Jack B. Weinstein remanded a case involving an autistic student for additional administrative findings as to whether the specialized public school selected by the New York City Department of Education met the standards of the Individuals with Disabilities Education Act Judge. Dora L. Irizarry, largely denying the parties' motions for summary judgment, found triable issues of fact that could establish the civil liability of defendant Crédit Lyonnais under the Antiterrorism Act of 1992. And Judge Frederic Block denied motions to dismiss civil claims against New York City brought by a criminal defendant exonerated after his lengthy incarceration.

Over-The-Counter Access

In Tummino v. Hamburg, Commissioner of Food and Drugs, 12 CV 763 (EDNY, April 4, 2013), Judge Korman reversed a decision by the Food and Drug Administration (FDA) denying a Citizen's Petition to make "Plan B," a two-dose contraceptive drug, available over-the-counter without age or point-of-use restrictions.

The court's prior decision in Tummino v. Torti, 603 F.Supp.2d 519 (EDNY 2009), had vacated FDA's refusal to approve over-the-counter sale of Plan B without age restrictions as arbitrary and capricious, citing "overwhelming evidence of political pressure underlying the agency's actions." Korman had remanded for renewed agency consideration, both because the change in leadership accompanying a new administration "suggested that the FDA could be 'trusted to conduct a fair assessment of the scientific evidence'" and because, assuming improper considerations would not intrude, such a decision should be made by FDA "and not by a federal district judge." Slip op. 4 (internal citation omitted).

FDA did not act on the remanded application for almost three years. During that time, it separately agreed to approve a single-dose version of the same drug (Plan B One-Step) for over-the-counter sale without age restrictions, finding "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for non-prescription use for all females of childbearing potential." Slip op. 5 (quoting Statement of FDA Commissioner Margaret Hamburg). FDA found that any special concerns for younger users could be adequately addressed through labeling.

However, Kathleen Sebelius, Secretary of Health and Human Services, overrode that determination, and no appeal was taken. Sebelius noted the prospect of availability to 11- and 12-year-old girls and "significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age." She determined that "[t]he label comprehension and actual use studies submitted to FDA [by the Plan B One-Step sponsor] do not include data on all ages for which the drug would be approved and available over-the-counter," so "the data submitted for this product do not establish that prescription dispensing requirements should be eliminated for all ages." Slip op. 6, 40 (quoting memorandum from Sebelius to Hamburg.)

This obliged FDA to deny the Citizen's Petition concerning the two-dose Plan B product — which it did five days later — "because it suffered from exactly the same defect." Slip op. 40.

Korman considered the facts surrounding the Plan B One-Step denial in order to evaluate FDA's denial of the Citizen's Petition concerning the two-dose product. FDA had found the safety and efficacy of Plan B One-Step to be established in the pediatric population, and the one-dose two-dose distinction raised no significant issues because timing of the second dose within a wide time frame did not affect either factor. Moreover, a label comprehension survey confirmed that the separate doses did not raise any issues regarding user comprehension.

Korman found the Secretary's "ukase" (a Tsarist decree) forced FDA "to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability." Slip op. 9, 34. While the court considered the Secretary's political motivations manifest, the denial of the Citizen's Petition that her pronouncement compelled could not survive even if motive were put aside. Detailed review of the scientific evidence showed that Plan B "would be probably among the safest drugs approved for over-the-counter sale for the pediatric population," and the unexplained departures from long-standing FDA procedures required by the Secretary's decree confirmed that FDA was placing burdens on the constitutionally protected right to contraception that were not applied to other drugs. Slip op. 7-8, 39.

First, the Secretary's intervention in a matter "which Congress entrusted primarily to the FDA" was unprecedented. Second, she offered no reason for failure to make Plan B available to adolescents "between the ages 13 and 16 . . . despite the ample evidence that this age group" was able to understand the label directions and use the drug correctly. Third, her conclusion that there was "insufficient data" on label comprehension for younger girls ignored the fact that, as to the ability of small populations of potential younger users, FDA routinely extrapolates from the results of older users where, as here, it is not feasible to test a narrowly targeted age group. (For this reason, FDA had instructed the manufacturer that it required no such data for 11- to 13-year-old girls.) Fourth, "when the FDA has declined to extrapolate because of safety concerns, it used labeling to indicate that the drug was not to be made available to children," as it did with drugs such as Prilosec (a heartburn medication) and Alli (a weight loss drug).

Finally, the Secretary's sale restrictions — that "the product be sold only at pharmacies and health clinics and that it be kept behind the counter at pharmacies" — also failed. Items are either prescription or non-prescription. In court, FDA belatedly identified a provision allowing an interim tier that could be subject to such restrictions. But at the time of the agency's action, FDA did not rely on that provision, which in any event applies only to "highly toxic" drugs or those that treat "a serious or life-threatening illness."

Upon remand, FDA was directed to make Plan B available without prescription or point-of-sale restrictions within 30 days. "FDA may determine whether any new labeling is necessary. Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product." Slip op. 57.

Disabilities Education Act

In T.L., a student with a disability, by her parents, A.L. and R.L. v. The New York City Department of Education, 12 CV 4483 (EDNY, April 12, 2013), plaintiffs claimed that defendants failed to offer their autistic daughter "T.L." a free "appropriate" public education as required by the Individuals with Disabilities Education Act (IDEA), 20 U.S.C. §1400 et seq. Judge Weinstein remanded the case to the State Review Officer (SRO) for additional findings. In addition to relying on the administrative record, Weinstein conducted site visits with counsel and both parents to two schools — the Kennedy School, a specialized public high school offered by defendant to deal with T.L.'s needs; and the Rebecca School, a private day school selected by her parents.

T.L., now 18 years old, was diagnosed at age 3 with Autism Spectrum Disorder and moderate/profound mental disabilities. She also suffers from PICA, a neurological disorder causing her to grab inedible objects and place them in her mouth. T.L. attended specialized New York City public schools for years. In September 2009 her parents unilaterally enrolled her in the Rebecca School, where she remains. Defendant reimbursed the parents for T.L.'s tuition for the 2010-2011 academic year.

In May 2011 a Committee on Special Education team met to develop an Individualized Education Program (IEP) for T.L. to begin in the fall of 2011. The IEP recommended placement at a specialized public school with services geared to T.L.'s needs. Defendant chose the Kennedy School for this purpose. Objecting to this placement, the parents told defendant that they intended to re-enroll T.L. in the Rebecca School and seek reimbursement for tuition, transportation and certain paraprofessional services.

The parents filed an administrative complaint requesting a hearing pursuant to IDEA. The Impartial Hearing Officer (IHO) made findings and concluded that defendant had failed to offer T.L. a free appropriate public education and thus had to reimburse T.L.'s parents for expenses related to her placement at the Rebecca School, which was appropriately addressing T.L.'s needs. Defendant appealed and the SRO reversed, finding that the Kennedy School offered an appropriate education for T.L.

Both parties moved for summary judgment in the Eastern District proceeding. The issue here was whether the administrative record and other evidence show compliance with IDEA.

Weinstein remanded the case to the SRO for "clarification and additional factfinding, if necessary," as to how the Kennedy School would have dealt with T.L.'s disabilities. "In particular," the court stated, "further analysis is required for how the proposed public school placement would have provided an educational environment that assured T.L.'s severe PICA disorder did not interfere with her classroom instruction. The administrative record is deficient in its analysis of this issue." Slip op. 23-24.

The 2011 IEP for T.L. recommends:  "The classroom environment should be organized in [a] manner that is not overstimulating, clean and clear and not have a lot of objects she can put in her mouth." The parents had expressed concerns that the Kennedy School would be inadequate for those purposes. The IHO opinion also identifies concerns about the Kennedy School facilities given T.L.'s PICA. For example, it pointed to the overstimulating wide hallways and paper hanging on either side of the walls.

"Absent from the SRO decision is any analysis" of those PICA-related concerns. Slip op. 27. Rather than providing more detail about the physical environment, it discussed the school's educational techniques. Such omissions warranted a remand. Slip op. 29-30.

Antiterrorism Act Of 1992

By joint decision in Strauss v. Crédit Lyonnais, 06 CV 702, and Wolf v. Crédit Lyonnais, 07 CV 914 (EDNY, Feb. 28, 2013), Judge Irizarry granted in part and denied in part each side's motions for summary judgment in a case seeking recovery for deaths and injuries sustained as a result of attacks allegedly committed or facilitated by the Hamas terrorist organization, from 2002 to 2004, with the support of the defendant bank's customers.

More than 200 individuals and estates brought claims under the Antiterrorism Act of 1992 (ATA), 18 U.S.C. §2333(a), alleging Crédit Lyonnais had knowingly provided "material support or resources" to Hamas, in violation of 18 U.S.C. §2339B(a)(1), and/or had provided or collected funds for it "with the knowledge that such funds [were] to be used, in full or part, in order to carry out" terrorist acts, in violation of 18 U.S.C. §2339C(a)(1). Violation of either criminal provision allows civil recovery under 18 U.S.C. §2333(a).

In 1997, defendant had flagged its client, the Committee for Palestinian Welfare and Relief (CBSP; acronym from the French name), for internal review based on suspicious activities regarding 13 Islamic charities (referred to here as the 13 Charities). In 2000 and again in 2001, defendant referred CBSP for review by the French government, based on a suspicious increase in activities corresponding in time to the Second Intifada. None of these incidents resulted in any finding of impropriety. In August 2003, the United States designated CBSP a Specifically-Designated Global Terrorist (SDGT). Defendant closed CBSP's accounts later that year, remitting the funds on deposit.

Defendant moved for summary judgment on all claims for lack of triable issues concerning scienter, proximate causation, and the responsibility of Hamas for the attacks in question. Plaintiffs opposed, and a subset of them moved for summary judgment regarding a particular attack on the Café Hillel in Jerusalem.

The court denied most of defendant's motion for summary judgment: (1) As to whether defendant "knew or was deliberately indifferent to the fact that CBSP was financially supporting terrorist organizations," Irizarry found triable issues based on defendant's own suspicions. (2) As to proximate cause, Irizarry emphasized the volume of activity, overlaps between personnel of Hamas and the 13 Charities, and intelligence findings regarding the 13 Charities. The court also rejected the argument that plaintiff must show that specific funds from defendant were used in terrorist acts. (3) As to Hamas' responsibility for the attacks, Irizarry pointed to Israeli legal judgments and plaintiffs' expert reports.

Partial summary judgment was granted defendant on the one attack for which plaintiffs identified no admissible evidence concerning Hamas' responsibility.

Plaintiffs' motion for summary judgment with respect to the Café Hillel attack was denied. That the attack occurred after the United States had designated CBSP a SDGT did not establish the bank's scienter. The designation merely establishes civil penalties for covered organizations that engage in transactions with SDGTs:  "there is nothing in either the ATA or the regulations [governing SDGT designations] suggesting that providing services for a SDGT is a violation per se of the ATA." The ATA "xplicitly prevents only doing business with" a designated "Foreign Terrorist Organization," and CBSP had not been so designated. Proximate cause for this attack also presented a triable issue. Because Hamas' responsibility for the Café Hillel attack was established by admissible Israeli criminal convictions, summary judgment was granted as to "the Hamas responsibility element" of the Café Hillel attack. Slip op. 56-60.

Deprivation Of Liberty

In Collins v. City of New York, 11 CV 766 (EDNY, Feb. 15, 2013), Judge Block denied the city's motion to dismiss plaintiff Jabbar Collins complaint under Monell v. Department of Social Services, 436 U.S. 658 (1978), upholding two theories for recovery: (1) that Brooklyn District Attorney Charles Hynes was deliberately indifferent to the conduct of an assistant district attorney, and (2) lack of training amounted to deliberate indifference by the New York Police Department to the actions of defendant Officers Vincent Gerecitano and Jose Hernandez.

Plaintiff was incarcerated for 16 years for the murder of Abraham Pollack. His conviction allegedly resulted from manufactured evidence and fake testimony coerced by Officers Gerecitano and Hernandez and members of the District Attorney's Office. Police received an anonymous phone call blaming plaintiff for the murder. Plaintiff voluntarily appeared at the police station, but none of four eyewitnesses viewing a line-up recognized him. The police released him.

A few days later, one Edwin Oliva was booked on attempted robbery charges. Gerecitano and Hernandez allegedly coerced him into signing a statement falsely accusing plaintiff of planning to rob Pollack.

Plaintiff also alleged that, after his indictment, Oliva told Assistant District Attorney Michael Vecchione and two district attorney investigators that his statement had been coerced and he had no knowledge of plaintiff's involvement. In Vecchione's office Oliva was allegedly "threatened with prosecution, imprisonment, and bodily harm unless he agreed to stand by his prior statement." Slip op. 4. He complied after resisting. Vecchione also allegedly coerced two other witnesses into testifying falsely. Plaintiff was convicted in March 1995.

In 1995, 1996, 2002 and 2005, plaintiff made specific New York Freedom of Information Law (FOIL) requests for information relating to the witnesses against him at trial. In response to each request, the district attorney's office represented that no records could be located.

Plaintiff filed a federal habeas petition in 2008. Judge Irizarry allowed him to proceed with discovery and scheduled an evidentiary hearing. In response to discovery demands, the office produced numerous documents, including many responsive to plaintiff's FOIL requests, and conceded that Oliva had recanted his testimony. Following revelations by another trial witness that his own testimony was false and obtained through illegal confinement and threats of prosecution and violence, the district attorney consented to an order vacating plaintiff's conviction and dismissing the charges against him with prejudice. The district attorney's office stood behind Gerecitano, Hernandez and Vecchione and later announced to the news media that there would be no investigation. Irizarry "lambasted" the Kings County District Attorney and called its conduct "shameful" and a "tragedy." Slip op. 9.

Plaintiff claimed here that Vecchione and other assistant district attorneys deprived him of his right to a fair trial and violated his constitutional rights by withholding exculpatory evidence sought in his FOIL requests. Without denying that they had intentionally presented false testimony, the assistant district attorneys argued that they were entitled to absolute immunity.

Prosecutors are immune from liability for acts that are associated with the judicial phase of the criminal process, but not for acts related to the investigative phase. As Block concluded, "the only plausible reading of the complaint is that Vecchione took all of the actions he is alleged to have taken to ensure his success at trial." Slip op. 14. Thus, all assistant district attorney defendants had absolute immunity for actions taken at trial, post-trial and in responding to FOIL requests, even though they had a duty to disclose Brady material, because "Brady and Giglio duties are functionally prosecutorial." Slip op. 21 (internal quotations omitted).

The city cannot be held vicariously liable under §1983 for constitutional violations of its employees, but it can be held liable under Monell if a municipal policy or custom caused a constitutional injury. As Block noted, "a policymaker's response to constitutional violations can support an inference that the violation conformed to preexisting policy." Slip op. 24. Here, when Vecchione was accused of wrongdoing, the district attorney expressed support for him and took no corrective action. This response "might reflect a tacit policy on Hynes's part to condone whatever his subordinates deemed necessary to secure a conviction." Slip op. 25. Block found plausible plaintiff's theory that Hynes was so deliberately indifferent to his subordinates' tactics that his attitude could be viewed as encouragement.

Additionally, Block found that the 1994 Mollen Report on police corruption in the NYPD established that the misconduct underlying this case was sufficiently widespread to support an inference of deliberate indifference on the part of the NYPD. Slip op. 29.