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Judge Decertifies Class Action Over Off-Label Use of Epilepsy Drug
The Legal Intelligencer
February 11, 2009
A month before a pharmaceutical class action was set for trial, a Philadelphia judge decertified the class of users of an epilepsy and neuralgia drug seeking reimbursement from the drug's maker after being prescribed the drug for uses not approved by federal regulators.
Judge Mark I. Bernstein granted a pharmaceutical company defendant's motion for class decertification in Clark v. Pfizer Monday. The case was set to go to trial March 9.
Bernstein had previously granted class certification to the class in 2007. Class representatives Gregory Clark of Philadelphia and Linda Meashey of Annville, Lebanon County, brought claims of misrepresentation, negligence, negligence per se and breach of express warranty on behalf of other users of the drug Neurontin, or the generic equivalent, gabapentin. The proposed class was made up of people prescribed the drug for medical conditions other than epilepsy and the management of pain associated with herpes zoster rash outbreaks. The plaintiffs sought a refund of all noninsured payments for the drug.
The plaintiffs argued that defendant, Warner-Lambert Co., and its merger partner, Pfizer Inc., violated a federal law that prohibits drug manufacturers from marketing Food and Drug Administration-approved drugs for off-label uses, or uses not approved by federal regulators, according to court papers. The plaintiffs claimed that the drug company defendants conducted a campaign to promote the wider use of Neurontin and gabapentin.
Bernstein wrote in his opinion that he granted Pfizer's motion for decertification of the class because there was a question of fact about whether each class member had benefited or been harmed from their off-label prescriptions for Neurontin.
"Since some class members have benefited from the use of Neurontin and other class members have not benefited, individual questions of fact are presented making the case unsuitable for class resolution," Bernstein said. "Whether an individual class member suffered a compensable loss is an inherently individualized question which predominates making class resolution impracticable and nearly impossible."
A $40 million promotional budget was devoted to the off-label marketing efforts, including the insertion of anecdotal articles in medical journals, paying physicians considered to be opinion leaders and sponsoring continuing medical education conferences that actually were paid promotional events, according to an earlier Bernstein opinion. At least 200,000 prescriptions for Neurontin were written in Pennsylvania, and the defendants earned between $53 million and $64 million on the drug per quarter in the state, according to court papers.
Warner-Lambert entered a criminal plea agreement in the U.S. District Court of Massachusetts, including a $240 million fine and a cessation of all off-label marketing efforts, Bernstein said.
Pfizer's counsel, Robert C. Heim of Dechert, said that Bernstein originally certified the class on the plaintiffs' claim that there would be no credible evidence that Neurontin and its generic version were effective for patients who were prescribed the drug for an off-label use.
However, Heim said that subsequent discovery involving the depositions of a sample of six Pennsylvania physicians -- Dr. Amy Fitzsimmons, Dr. Brian Ahlstrom, Dr. Thomas Graham, Dr. Kenneth D. Hoellein, Dr. Charles Norelli and Dr. Jeffrey Esper -- established that some doctors who had no contact with Pfizer or Warner-Lambert prescribed Neurontin for off-label uses and that Neurontin was effective in treating their patients.
These doctors prescribed Neurontin "because they in their clinical judgment found Neurontin worked for pain and for other conditions. And they had prescribed it for years and for many, many patients," Heim said. "Once that evidence emerged, the judge looked again at whether there was a predominance of common issues."
The plaintiffs were not able to show that all visits by defendants' sales representatives to doctors' offices were improper off-label promotion, which shows that the Clark class lacks "competent, common proof of causation," according to the defendants' Nov. 10 reply memorandum in support of their decertification motion.
In an interview, Heim also pointed to the fact that Clark's physician, Dr. Michael Okin, and Meashey's physician, Dr. Richard Brown, both testified in depositions that they continued to prescribe Neurontin for off-label use to some patients.
Plaintiffs attorney John K. Weston, of Sacks & Weston in Jenkintown, Pa., said trial was about to start in October when Pfizer sought the court's permission to take the depositions of a sample of doctors who prescribed Neurontin to Pennsylvania patients.
Weston said that the new depositions involved doctors "cherry-picked" by Pfizer. He said their testimony does not involve adequate scientific proof that Neurontin is efficacious for off-label use because there could have been a placebo effect or another reason that these doctors' patients felt better after taking Neurontin.
In court papers, Weston also said that the deposed doctors couldn't remember if they learned about Neurontin because of the defendants' sales representatives, and that they formed their prescribing decisions based on their peers, which was what Pfizer's "illegal marketing campaign" expected to happen as a result of the campaign.
"The essence of defendants' off-label marketing campaign was to poison the information sources which doctors rely upon to form their opinions of a drug's effectiveness," according to the plaintiffs' Oct. 31 supplemental memorandum of law opposing the decertification motion. "Each of the ... physicians was exposed to these tainted sources -- to conferences, speakers' bureaus, medical liaisons and, always, to peers who themselves might have been exposed to Warner-Lambert's initial information plants."
The fact that Bernstein changed his mind about the certification of the class after the development of new evidence shows that judges really do hold up class certifications to "the light of the evidence," Heim said.
Weston said he hopes to win his appeal of Bernstein's decision and try the case in front of Bernstein in about year.
Bernstein's order said that trial will proceed on individual claims March 9 unless a continuance is requested. Weston said his firm will ask the judge to postpone the individual trials, while undertaking an appeal.
"It doesn't make sense to have a two-week trial for an approximate claim of $15 and an approximate claim of $900," Weston said.
The miniscule size of each plaintiff's claims makes a class action in this instance very important, Weston said.
Heim called the difference between defending a class action and the individual claims the difference between lightning and a lightning bug.
Heim said he expects that very few individual claims will be brought because many claimants will understand that not every drug will work for them, and claimants won't expect to get their money back if their physicians prescribed Neurontin in good faith.
Bernstein also granted Pfizer's motion for summary judgment on plaintiffs' class claims for breach of warranty and Pfizer's motion for summary judgment regarding members of the class who benefited from the off-label use of Neurontin.
Bernstein said that members of the class who benefited from the off-label use of Neurontin haven't suffered an injury and aren't entitled to reimbursement. However, Bernstein denied Pfizer's motion for summary judgment regarding defendants who did not benefit from an off-label Neurontin prescription.
Bernstein said the claim of express warranty has not been proven because there was no evidence that the plaintiffs received any warranties as part of a publication campaign that Neurontin could be used off-label from FDA-approved uses.
"The alleged fraud on the medical profession which is the essence of plaintiffs' claims does not create any warranty," Bernstein said.
Bernstein denied all of Pfizer's other motions for summary judgment, including a motion arguing that the fact that Warner-Lambert's marketing campaign resulted in criminal penalties and negative publicity nullified later problems with continued off-label prescriptions of Neurontin.
In March, Bernstein ruled that Pfizer and Warner-Lambert have a legal duty to plaintiffs for money spent on the generic version of the companies' name-brand drug. The generic drug was produced by a third-party manufacturer.
A decision about certifying a similar class of Neurontin users in a federal multidistrict litigation is pending before U.S. District Court Judge Patti B. Saris of the U.S. District Court of Massachusetts.
Plaintiffs' co-counsel include Charles E. Mangan and Julie C. Parker of Sacks & Weston.
Defense co-counsel include Judy L. Leone and Donald C. Le Gower of Dechert and James P. Rouhandeh, Edmund Polubinski III and Neal A. Potischman of Davis Polk & Wardwell of New York.
