FDA Bad Faith - Daniel Troy's pre-emption defense - Nat'l Law Journal
Fri, 26 Mar 2004
Federal regulations require drug label warnings if there is "reasonable evidence" of a link between adverse effects and drug action. An article in the National Law Journal shows how s FDA's chief counsel, Daniel Troy, subverted the requirement to warn physicians by use of an inappropriate legal strategy that increases health hazard for the public in order to shield drug manufactures from liability.
When drug manufacturer have been challenged in court for failing to issue warnings about potentially hazardous drug side effects, FDA's Chief Counsel has gone to court in support of manufacturers by invoking FDA pre-emption. Troy's use of the pre-emption defense is "the nullification of state actions that conflict with or supplement FDA decisions."
In a September 2002 Amicus Curiae brief, in support of Pfizer, Troy argued that only the FDA has authority to determine if and when to issue warnings. He said that the standard applied by the FDA requires proof of a causal connection, arguing that no state has the authority to add safeguards by requiring additional warnings not required by the FDA. Troy claimed that even if Pfizer would volunteer to add a warning on the Zoloft label about the drug's potential increase suicidal behavior risks, the FDA would not allow Pfizer to warn because that would "misbrand" the drug.
FDA's disclaimer-stating that antidepressant drugs may not be the precipitators of high risk, uncharacteristic behavior in children prescribed such drugs--contradicts the facts and is illogical. If the adverse reactions experienced by children (and some adults) bear no relation to the drugs' action, what's the logic of issuing warnings on the label of these drugs?
FDA's disclaimer, like Daniel Troy's legal strategy, serves the interests of the drug industry and those who have a financial stake in that industry as consultants and /or as shareholders.
FDA officials have failed to provide oversight to protect the public health. Their failure has resulted in preventable tragedies. that this oversight agency is itself in need of oversight and supervision.
Contact: Vera Hassner Sharav
THE NATIONAL LAW JOURNAL
March 5, 2004, Friday
SECTION: NEWS; Vol. 128; No. 44; Pg. 3
HEADLINE: FDA legal strategy would pre-empt tort suits
BYLINE: By Gary Young
NEW YORK - Under the Bush administration, the U.S. Food and Drug Administration has adopted a novel legal strategy that would, if successful, leave many consumers claiming injury from pharmaceuticals or medical devices with no recourse to tort law, critics and attorneys charge.
That strategy is pre-emption, basically the nullification of state actions that conflict with or supplement FDA decisions.
"The FDA's pre-emption argument would take away people's sole means of compensation," asserted Allison Zieve, an attorney with the Public Citizen Litigation Group, an organization involved in several lawsuits against drug and medical device manufacturers.
Almost as troubling to some FDA critics is the fact that pre-emption would close off one of the few avenues by which outsiders learn of safety and efficacy information that pharmaceutical companies do not publish and sometimes withhold from the FDA.
"The tort system provides an important check on the regulatory process that the pre-emption argument would take away," Zieve said.
The point of controversy is so-called "implicit pre-emption."
Explicit pre-emption occurs when Congress plainly states in statute that FDA decisions will pre-empt conflicting or supplementary state law requirements, as it did in 1976 with respect to labeling of nonprescription drugs and in 1997 for labeling of cosmetics, explained professor James O'Reilly of the University of Cincinnati College of Law, the author of a widely cited treatise on food and drug law.
Implicit pre-emption rests on the view that Congress meant for FDA decisions to pre-empt state requirements even though it made no explicit statement to that effect in statute. It is a view that has long been popular with manufacturers of drugs and medical devices.
But "the FDA stood against [implicit pre-emption] until this administration," O'Reilly said. "The FDA made an historic shift when it argued for implicit pre-emption at the end of 2002.
"The capture of the FDA by forces favoring judicial pre-emption is a travesty."
The FDA has intervened in a handful of lawsuits on the side of drug and medical device manufacturers, arguing that the public health will suffer if state courts are allowed to, in its words, "second-guess" the agency's regulatory decisions by ruling on consumers' tort claims.
Ironically, the FDA has taken that position in the face of a rising tide of criticism over its handling of selective serotonin reuptake inhibitors [SSRIs] - a class of anti-depressants that includes Paxil and Zoloft - and amid calls for the release of unpublished safety and efficacy data so that private researchers can more effectively second-guess the agency.
Last year, the Medicines and Healthcare Products Regulatory Agency, the British equivalent of the FDA, told doctors not to prescribe most SSRIs for children because of a risk of suicide.
Following the British action, the FDA warned doctors to be cautious when prescribing SSRIs for children and announced that it would review the evidence on SSRIs. But last month, two of the FDA's committees of outside advisors urged it to go a step further and immediately mandate a warning label on SSRI bottles.
Some FDA critics see in this chain of events evidence that the agency has been laggard, and have called for wider dissemination of safety and efficacy studies that drug companies share only with the FDA.
For instance, last month Representative James Greenwood, R-Pa., chairman of the House Oversight and Investigations Subcommittee, asked four SSRI manufacturers to turn over information about unpublished studies, noting that "[s]ome doctors and advocates are concerned that the lack of publication of these studies distorts the scientific record," according to the Washington Drug Letter, an industry newsletter.
In response to Recorder affiliate The National Law Journal's questions, FDA Chief Counsel Daniel Troy wrote in an e-mail, "I don't disagree with the [U.S. government] position on pre-emption. We have not rethought our legal views on pre-emption merely because the facts [on SSRIs] change."
Also, Troy did not concede that the FDA's British counterpart had pressured the FDA to take action on the warning labels involving SSRIs and children.
"It is not clear yet that labeling changes are indeed needed," Troy replied.
In some ways, tort litigants may be in a better position than the FDA to keep drug companies honest, since they sometimes see evidence that the agency doesn't.
Karen Barth Menzies of Los Angeles' Baum Hedlund, who represents thousands of one-time users of the anti-depressant Paxil in a suit against Paxil manufacturer GlaxoSmithKline PLC, said court-ordered discovery allowed her to see raw data on safety and efficacy, while the FDA saw only the completed write-ups.
Also, Menzies saw the company's internal communications about how to approach the agency, which the FDA never saw, she said.
"If we could show you what we see, you'd see how much disdain the drug companies have for the FDA," she charged. The discovery materials are subject to protective order. In re Paxil Litigation, 01-07937 [C.D. Calif.].
GlaxoSmithKline did not respond to telephone messages requesting comment.
Troy is widely credited by both plaintiffs' and defendants' lawyers with being the architect of the FDA's pre-emption strategy.
Prior to coming on board the FDA in 2001, Troy was a partner at Washington's Wiley Rein & Fielding, where he handled high-profile cases advancing the interests of pharmaceutical and tobacco companies against the FDA, according to Troy's writings, interviews with the press and court documents.
In 1993, Troy filed an administrative petition and then a lawsuit on behalf of the conservative Washington Legal Foundation, ultimately forcing the FDA to weaken its rules prohibiting drug companies from promoting "off-label" uses of its medications. "Off-label" refers to uses that were not known when the drug received FDA approval. Washington Legal Found. v. Friedman, 36 F.Supp.2d 418 [D.C. Cir. 2000].
In hindsight, there is some irony in that lawsuit, since Troy achieved victory in part by undercutting the FDA's claim that its labeling rulings should not be second-guessed by the drug companies.
On behalf of Brown & Williamson, Troy filed a lawsuit that resulted in a Supreme Court decision putting a stop to the Clinton-era FDA's efforts to regulate the tobacco industry as a drug. Food and Drug Admin. v. Brown & Williamson Tobacco Co., 529 U.S. 120.
In 2000, Troy filed a lawsuit for the Washington Legal Foundation and two other public interest groups challenging a 1998 FDA regulation requiring pediatric testing of new drugs. The regulation was struck down in 2002 [by which time Troy had left the case]. Assoc. of American Physicians and Surgeons v. FDA, 226 F.Supp.2d 204 [D.D.C. 2002].
Troy embarked on the pre-emption strategy after being approached in 2002 by a former client, Pfizer Inc., the manufacturer of the anti-depressant Zoloft, according to a December 2002 report in the Boston Globe that quoted both Troy and a Pfizer lawyer.
The FDA intervened in a lawsuit filed by the widow of a man who had committed suicide while taking Zoloft.
In its September 2002 brief before the Ninth Circuit U.S. Court of Appeals, the agency argued that because it had repeatedly determined that Zoloft did not pose a risk of suicide, the manufacturer not only had no duty to issue a warning, but would have been in violation of the law if it had. Motus v. Pfizer Inc., 02-55372.
The FDA brief went so far as to say that pre-emption prohibited Pfizer from giving a warning recommended by the FDA's British counterpart: "Tell your doctor immediately if you have any distressing thoughts or experiences [during the first few weeks on Zoloft]."
Also in September 2002, Troy intervened in the suit brought by Menzies, which alleged that GlaxoSmithKline, the manufacturer of Paxil, failed to give adequate warning of withdrawal symptoms.
The FDA's brief belittled outside efforts to second-guess the agency: "A regime in which lawsuits motivated by individual, local concerns [even though sincere] may overrule FDA's considered actions in its own defined area of expertise clearly poses an obstacle to the full accomplishment [of] Congressional objectives."
Pfizer did not respond to telephone calls requesting comment.
In the Paxil litigation, Judge Mariana Pfaelzer of the Central District of California ruled that the pre-emption argument "contravenes common sense" and "vitiates, rather than advances, the [Food, Drug, and Cosmetic Act's] purpose of protecting the public."
In the Zoloft case, the Ninth Circuit was able to sidestep the issue because it found that the widow had not proved that an adequate label would have prevented her husband's suicide.
In 2003 and 2004, the FDA intervened in still-pending Tennessee and California state court tort suits dealing with medical devices.
In his e-mail message, Troy noted that the briefs were filed jointly by the FDA, the Department of Health and Human Services and the Department of Justice.
O'Reilly, the University of Cincinnati professor, suggested that Troy was able to achieve "a sea change" in FDA policy because there was a policy vacuum in 2002, the FDA commissioner not having been confirmed yet.
Murray Levin of Philadelphia's Pepper Hamilton, who has defended manufacturers in medical device cases, said that while the pre-emption strategy was "a bit of a departure" for the FDA, it was "not radical, but measured," giving the problem of conflicting state and federal standards.
Another attorney who has represented manufacturers, Joseph Leghorn of the Boston office of Nixon Peabody, said the FDA's new strategy reflects the fact that "[w]hat may be good from a public health standpoint may not be good from the standpoint of a particular individual.
"That's the tightrope the FDA has to walk," Leghorn said. The balance achieved by the agency is upset by tort judgments, he said.
Gary Young is a reporter with The National Law Journal, a Recorder affiliate based in New York City.
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