FDA's Failure-to-Warn Pre-emption

Nearly one year after the U.S. Food and Drug Administration issued a pre-emption on filing failure-to-warn actions over federally approved drugs, rulings across the nation show a clear division over the issue.

The FDA declared that it possessed the pre-emptive power in the preamble to new rules for drug labeling issued on June 30, 2006. The pre-emption attempts to ban plaintiffs from filing the lawsuits if the drug has FDA approval. Plaintiffs' attorneys call the FDA pre-emption camouflaged tort reform, while defense counsel argue that a qualified arm of the federal government should call the shots on drug safety ' not judges and juries.

While some courts have upheld the FDA's pre-emption, others have rejected it. (Because of the diversity of the parties involved in the suits, these state tort claims are being filed in federal as well as state courts.) In Pennsylvania, a failure-to-warn lawsuit over the suicide risk of Paxil' and the generic version of Paxil is now on appeal in the Third U.S. Circuit Court of Appeals after a trial court upheld the drug maker's pre-emption argument, despite a husband's claims that the drug company's failure to warn about suicide risks caused his wife to kill herself with a razor. Colacicco v. Apotex Inc., No 05-cv-5500 (E.D. Pa.). A similar case is on appeal in the Fifth Circuit, where pre-emption also was upheld despite a widow's claims that fuller warning about the possible side effects of the antidepressant Effexor' would have affected the doctor's decision to prescribe the drug to her husband, who committed suicide. Ackermann v. Wyeth Pharmaceuticals, No. 4:05CV84 (E.D. Texas).

Pre-emptions Rejected

On the flip side, Pfizer is appealing a judge's dismissal of its pre-emption argument in a Zoloft' failure-to-warn lawsuit in which a woman claimed that an inadequate warning led to her father's suicide. The judge held that FDA's pre-emption preamble contradicts the agency's prior stance on such matters. McNellis v. Pfizer Inc., No. 06-5148 (3d Cir.).

In a similar ruling, a New Jersey superior court judge also denied a pre-emption argument in a Vioxx' case, holding that the FDA's position on pre-emption 'has nothing to do with science.' 'The preamble, as I see it, is a political statement by the FDA,' Judge Carol Higbee stated in a ruling last June. Dohery v. Merck, No. 2005M00638 (Atlantic Co., N.J., Super. Ct.). Despite losing the pre-emption argument, Merck went on to win that case in a jury trial.

In January, an FDA pre-emption argument by GlaxoSmithKline PLC was rejected in a wrongful death case involving Paxil. The plaintiffs argued that an inadequate warning regarding suicide risk was a substantial cause in the death of a 20-year-old man who jumped out of a 24th-story window in New York City. Steinberg v. GlaxoSmithKline, No. 1-04-CV-029096 (Santa Clara Co., Calif., Super. Ct.).

FDA officials declined to comment on the issue, saying only that 'the preamble speaks for itself.' Many expect a showdown before the high court. 'We think it will eventually end up [before the Supreme Court],' said plaintiffs' attorney Mark Burton at San Francisco's Hersh & Hersh, who has handled numerous cases where drug companies and medical device companies argue pre-emption as a defense. ”When?' is a great question ' With the FDA taking this stance, it makes it a little more ripe as a controversy out there that the Supreme Court is going to have to deal with it.'

Plaintiffs' attorneys often cite Medtronic v. Lohr, 518 U.S. 470 (1996), in which the U.S. Supreme Court held that a woman's claims that a defective pacemaker and inadequate warnings were the cause of her injury were not pre-empted by federal law, and rejected pre-emption rulings of the lower courts. Defense lawyers, however, point to the more recent decision, Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). The case involved plaintiffs who claimed that they were injured by the use of orthopedic bone screws in their spines. Plaintiffs sought damages under state tort law, claiming that the screws were fraudulently approved. The U.S. Supreme Court held that the claims conflicted with, and were therefore pre-empted by, federal law.

Expert Status

In the preamble to its drug-labeling rules, the FDA said that state law actions 'threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.' The FDA also stated that 'under existing pre-emption principles, FDA approval of labeling under [federal law], whether it be in the old or new format, pre-empts conflicting or contrary state law.'

Plaintiffs' attorneys claim that the FDA pre-emption is a backdoor effort to bring about tort reform. Moreover, they argue, state courts have a legal right to police public health issues, as do injured plaintiffs have a right to have their warning-label claims heard by a jury. 'The FDA says it's our job as the FDA to decide what goes on a label. It's not for juries to decide,' said plaintiffs' attorney Harris Pogust at Pogust & Braslow in Conshohocken, Pa. He is appealing the failure-to-warn case in Colacicco. 'Unfortunately, the FDA doesn't do a very good job of monitoring and post-marketing adverse effects. That comes out through litigation.' According to Pogust, the lower court judge essentially bought the drug company's argument that 'the FDA says 'there shouldn't be a lawsuit.' '

Such deference to the FDA alarms Karen Barth Menzies, a plaintiffs' attorney at Los Angeles firm Baum, Hedlund, Aristei, Goldman & Menzies. She believes that pre-emption affords pharmaceuticals too much protection, and that 'lawsuits are the only meaningful safety check that remains' for victims of egregious conduct by drug companies. Having successfully defeated pre-emption arguments in recent drug lawsuits, Barth Menzies argues that the role of the FDA is to oversee drug-approval procedures and monitor safety, not adjudicate wrongdoing. That, she said, is the justice system's job. 'The FDA is not designed to provide an avenue for determining whether a drug company knew about a risk, but withheld or downplayed it,' Barth Menzies said. 'Litigation, with its discovery tools, is designed precisely for this purpose ' to determine what a drug company knew and, most importantly, when.' She added that the FDA's regulatory role 'is parallel to, not in conflict with, the judiciary system.'

Barth Menzies also noted that the FDA statement in its preamble 'is not a ruling, nor does it have the force and effect of law as the FDA did not go through the proper administrative procedures that would be necessary for such authority.'

No Second-Guessing

But defense lawyers representing drug companies maintain that the FDA should have the final say on drug safety matters, not judges and juries. 'It comes down to the issue of not allowing a jury to second-guess the FDA's authoritative conclusions. The FDA is in the business of understanding medicine. It studies it and studies it with one purpose in mind ' the health and safety of American people,' said Peter Antonucci of the New York office of Newark, NJ's Sills Cummis Epstein & Gross, who represents pharmaceutical companies in drug litigation. 'At the end of the day, if the FDA approves a product and its label, it's unfair to allow a plaintiff lawyer ' or to allow anyone ' to second-guess what the drug company should have done [about an unforeseen risk],' Antonucci said.

Antonucci, who has successfully raised pre-emption in a number of failure-to-warn cases and is in the process of raising it again, said the FDA's pre-emption doctrine offers much-needed protection for drug companies that have followed the rules and worked vigorously to put safe drugs on the market. 'Pharmaceutical companies were pleased that at last they were getting the comfort that they had wanted and had been advocating for years,' Antonucci said. 'It gave them the ability to put products on the market, feeling secure that once they had FDA approval they wouldn't be second-guessed about their warnings.'

And getting FDA approval is no easy feat, he added. 'They spend a lot of money on development. They do a lot of testing. They are required to go over it with the FDA, and the FDA tells them what to do. How much more do you want?' Antonucci said.

Pre-emption Long Overdue?

Dan Troy, former chief counsel to the FDA until 2004, said that the pre-emption doctrine was long overdue, 'given the explosion in tort suits.' He said state tort claims have long interfered with rational drug prescribing and labeling practices, often forcing drug companies to engage in defensive labeling. 'And the labeling was being written by lawyers, rather than by doctors for doctors,' said Troy, now a partner at Sidley Austin, which represents pharmaceutical companies in drug litigation.

Troy also disputed plaintiffs' lawyers claims that FDA rules set a minimum standard, and that states have the right to impose tougher rules for drug warnings. 'The FDA's regulations are not just a floor, they're also a ceiling,' said Troy, who also cautioned against 'taking [FDA] decisions that are made by M.D.s and Ph.D.s who are experts, and hav[ing] them second-guessed and undercut by state juries.'

Hope Freiwald of Dechert's Philadelphia office, who also represents drug companies, echoed that sentiment, saying that drug rules should be uniform across the country. Allowing state courts to interpret FDA policies disrupts that uniformity and leads to conflicting opinions, she said.

'When a pharmaceutical company has an FDA-approved label that's been subject to the kind of scientific review that labels are subject to under our regulatory system, there shouldn't be 50 potentially different standards on what that label should have said,' Freiwald said. She noted that the pre-emption argument is nothing new. Drug companies have long tried to use it, usually unsuccessfully. Now that the FDA has put its pre-emption policy in writing, she said, the pre-emption defense could carry more weight. 'The FDA has officially come forward and said, 'This is how we believe our authority should be interpreted,” she said.

It remains to be seen whether this interpretation will stick, Freiwald said, adding: 'I think we still are very much in the process of seeing how all this will work out in the appellate courts.'

Tresa Baldas is a reporter with The National Law Journal, a sister publication of this newsletter, in which this article first appeared.

Nearly one year after the U.S. Food and Drug Administration issued a pre-emption on filing failure-to-warn actions over federally approved drugs, rulings across the nation show a clear division over the issue.

The FDA declared that it possessed the pre-emptive power in the preamble to new rules for drug labeling issued on June 30, 2006. The pre-emption attempts to ban plaintiffs from filing the lawsuits if the drug has FDA approval. Plaintiffs' attorneys call the FDA pre-emption camouflaged tort reform, while defense counsel argue that a qualified arm of the federal government should call the shots on drug safety ' not judges and juries.

While some courts have upheld the FDA's pre-emption, others have rejected it. (Because of the diversity of the parties involved in the suits, these state tort claims are being filed in federal as well as state courts.) In Pennsylvania, a failure-to-warn lawsuit over the suicide risk of Paxil' and the generic version of Paxil is now on appeal in the Third U.S. Circuit Court of Appeals after a trial court upheld the drug maker's pre-emption argument, despite a husband's claims that the drug company's failure to warn about suicide risks caused his wife to kill herself with a razor. Colacicco v. Apotex Inc., No 05-cv-5500 (E.D. Pa.). A similar case is on appeal in the Fifth Circuit, where pre-emption also was upheld despite a widow's claims that fuller warning about the possible side effects of the antidepressant Effexor' would have affected the doctor's decision to prescribe the drug to her husband, who committed suicide. Ackermann v. Wyeth Pharmaceuticals, No. 4:05CV84 (E.D. Texas).

Pre-emptions Rejected

On the flip side, Pfizer is appealing a judge's dismissal of its pre-emption argument in a Zoloft' failure-to-warn lawsuit in which a woman claimed that an inadequate warning led to her father's suicide. The judge held that FDA's pre-emption preamble contradicts the agency's prior stance on such matters. McNellis v. Pfizer Inc. , No. 06-5148 (3d Cir.).

In a similar ruling, a New Jersey superior court judge also denied a pre-emption argument in a Vioxx' case, holding that the FDA's position on pre-emption 'has nothing to do with science.' 'The preamble, as I see it, is a political statement by the FDA,' Judge Carol Higbee stated in a ruling last June. Dohery v. Merck, No. 2005M00638 (Atlantic Co., N.J., Super. Ct.). Despite losing the pre-emption argument, Merck went on to win that case in a jury trial.

In January, an FDA pre-emption argument by GlaxoSmithKline PLC was rejected in a wrongful death case involving Paxil. The plaintiffs argued that an inadequate warning regarding suicide risk was a substantial cause in the death of a 20-year-old man who jumped out of a 24th-story window in New York City. Steinberg v. GlaxoSmithKline, No. 1-04-CV-029096 (Santa Clara Co., Calif., Super. Ct.).

FDA officials declined to comment on the issue, saying only that 'the preamble speaks for itself.' Many expect a showdown before the high court. 'We think it will eventually end up [before the Supreme Court],' said plaintiffs' attorney Mark Burton at San Francisco's Hersh & Hersh, who has handled numerous cases where drug companies and medical device companies argue pre-emption as a defense. ”When?' is a great question ' With the FDA taking this stance, it makes it a little more ripe as a controversy out there that the Supreme Court is going to have to deal with it.'

Plaintiffs' attorneys often cite Medtronic v. Lohr , 518 U.S. 470 (1996), in which the U.S. Supreme Court held that a woman's claims that a defective pacemaker and inadequate warnings were the cause of her injury were not pre-empted by federal law, and rejected pre-emption rulings of the lower courts. Defense lawyers, however, point to the more recent decision, Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). The case involved plaintiffs who claimed that they were injured by the use of orthopedic bone screws in their spines. Plaintiffs sought damages under state tort law, claiming that the screws were fraudulently approved. The U.S. Supreme Court held that the claims conflicted with, and were therefore pre-empted by, federal law.

Expert Status

In the preamble to its drug-labeling rules, the FDA said that state law actions 'threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs.' The FDA also stated that 'under existing pre-emption principles, FDA approval of labeling under [federal law], whether it be in the old or new format, pre-empts conflicting or contrary state law.'

Plaintiffs' attorneys claim that the FDA pre-emption is a backdoor effort to bring about tort reform. Moreover, they argue, state courts have a legal right to police public health issues, as do injured plaintiffs have a right to have their warning-label claims heard by a jury. 'The FDA says it's our job as the FDA to decide what goes on a label. It's not for juries to decide,' said plaintiffs' attorney Harris Pogust at Pogust & Braslow in Conshohocken, Pa. He is appealing the failure-to-warn case in Colacicco. 'Unfortunately, the FDA doesn't do a very good job of monitoring and post-marketing adverse effects. That comes out through litigation.' According to Pogust, the lower court judge essentially bought the drug company's argument that 'the FDA says 'there shouldn't be a lawsuit.' '

Such deference to the FDA alarms Karen Barth Menzies, a plaintiffs' attorney at Los Angeles firm Baum, Hedlund, Aristei, Goldman & Menzies. She believes that pre-emption affords pharmaceuticals too much protection, and that 'lawsuits are the only meaningful safety check that remains' for victims of egregious conduct by drug companies. Having successfully defeated pre-emption arguments in recent drug lawsuits, Barth Menzies argues that the role of the FDA is to oversee drug-approval procedures and monitor safety, not adjudicate wrongdoing. That, she said, is the justice system's job. 'The FDA is not designed to provide an avenue for determining whether a drug company knew about a risk, but withheld or downplayed it,' Barth Menzies said. 'Litigation, with its discovery tools, is designed precisely for this purpose ' to determine what a drug company knew and, most importantly, when.' She added that the FDA's regulatory role 'is parallel to, not in conflict with, the judiciary system.'

Barth Menzies also noted that the FDA statement in its preamble 'is not a ruling, nor does it have the force and effect of law as the FDA did not go through the proper administrative procedures that would be necessary for such authority.'

No Second-Guessing

But defense lawyers representing drug companies maintain that the FDA should have the final say on drug safety matters, not judges and juries. 'It comes down to the issue of not allowing a jury to second-guess the FDA's authoritative conclusions. The FDA is in the business of understanding medicine. It studies it and studies it with one purpose in mind ' the health and safety of American people,' said Peter Antonucci of the New York office of Newark, NJ's Sills Cummis Epstein & Gross, who represents pharmaceutical companies in drug litigation. 'At the end of the day, if the FDA approves a product and its label, it's unfair to allow a plaintiff lawyer ' or to allow anyone ' to second-guess what the drug company should have done [about an unforeseen risk],' Antonucci said.

Antonucci, who has successfully raised pre-emption in a number of failure-to-warn cases and is in the process of raising it again, said the FDA's pre-emption doctrine offers much-needed protection for drug companies that have followed the rules and worked vigorously to put safe drugs on the market. 'Pharmaceutical companies were pleased that at last they were getting the comfort that they had wanted and had been advocating for years,' Antonucci said. 'It gave them the ability to put products on the market, feeling secure that once they had FDA approval they wouldn't be second-guessed about their warnings.'

And getting FDA approval is no easy feat, he added. 'They spend a lot of money on development. They do a lot of testing. They are required to go over it with the FDA, and the FDA tells them what to do. How much more do you want?' Antonucci said.

Pre-emption Long Overdue?

Dan Troy, former chief counsel to the FDA until 2004, said that the pre-emption doctrine was long overdue, 'given the explosion in tort suits.' He said state tort claims have long interfered with rational drug prescribing and labeling practices, often forcing drug companies to engage in defensive labeling. 'And the labeling was being written by lawyers, rather than by doctors for doctors,' said Troy, now a partner at Sidley Austin, which represents pharmaceutical companies in drug litigation.

Troy also disputed plaintiffs' lawyers claims that FDA rules set a minimum standard, and that states have the right to impose tougher rules for drug warnings. 'The FDA's regulations are not just a floor, they're also a ceiling,' said Troy, who also cautioned against 'taking [FDA] decisions that are made by M.D.s and Ph.D.s who are experts, and hav[ing] them second-guessed and undercut by state juries.'

Hope Freiwald of Dechert's Philadelphia office, who also represents drug companies, echoed that sentiment, saying that drug rules should be uniform across the country. Allowing state courts to interpret FDA policies disrupts that uniformity and leads to conflicting opinions, she said.

'When a pharmaceutical company has an FDA-approved label that's been subject to the kind of scientific review that labels are subject to under our regulatory system, there shouldn't be 50 potentially different standards on what that label should have said,' Freiwald said. She noted that the pre-emption argument is nothing new. Drug companies have long tried to use it, usually unsuccessfully. Now that the FDA has put its pre-emption policy in writing, she said, the pre-emption defense could carry more weight. 'The FDA has officially come forward and said, 'This is how we believe our authority should be interpreted,” she said.

It remains to be seen whether this interpretation will stick, Freiwald said, adding: 'I think we still are very much in the process of seeing how all this will work out in the appellate courts.'

Tresa Baldas is a reporter with The National Law Journal, a sister publication of this newsletter, in which this article first appeared.