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In an apparent case of first impression, a Philadelphia judge ruled that a medical publications company involved in clinical research did not owe a duty of care to plaintiffs who used the antipsychotic drug Risperdal.

Philadelphia Court of Common Pleas Judge Arnold L. New, writing in a June 19 opinion in Kreves v. Ortho-McNeil-Janssen Pharmaceuticals, said that he granted summary judgment in the case last October in favor of Elsevier, a publisher of scholarly works, and Excerpta Medica, a wholly owned subsidiary of Elsevier and a medical communications company.

Some of the male plaintiffs in the Risperdal mass tort allege that their use of their antipsychotic caused them to have enlargement of breast tissue, which is called gynecomastia.

Excerpta Medica published articles about Risperdal in peer-reviewed journals as well as posters and abstracts presented at medical conferences, New said.

The plaintiff has argued that Excerpta Medica and Elsevier were liable under a common law theory of negligent undertaking, which allows a plaintiff to recover from a third party, which while not owing a duty initially, assumes a duty of care to a plaintiff through its actions, according to the opinion. The plaintiff further argued Excerpta Medica and Elsevier undertook a prescription drugmaker’s duty to publish truthful, accurate information concerning Risperdal and its safety.

The defendants countered that Excerpta Medica’s publications all had to be published or presented with the approval of Janssen and “their contractual obligations were conducted under the Janssen defendants’ ultimate direction and control,” New said.

The judge reasoned that the record did not support a finding that Excerpta Medica assumed a duty of care to the plaintiff or his prescribing physician.

“Contrary to plaintiff’s argument, [Excerpta Medica] was not the ‘gatekeeper’ for the publication and distribution of Risperdal-related information,” New said. “The Janssen clinical team and independent authors maintained the ultimate discretion in the information included or omitted from [Excerpta Medica’s] drafts and thus, were responsible for vetting the medical accuracy of all Risperdal-related articles, manuscripts and/or posters. Further, and perhaps most significant, plaintiff failed to provide evidence suggesting [Excerpta Medica] consented to monitor the safety data from any clinical Risperdal study and to alert Janssen, or any of its agents or related subsidiaries, of any potential safety concern to report medical events and/or side effects to the [U.S. Food and Drug Administration].”

The Risperdal litigation “appears to be the first instance in which [Excerpta Medica] has been used in a private action in connection with its medical communication services regarding Risperdal or any other prescription drug,” New said. “Thus, no Pennsylvania court has addressed this specific issue.”

The judge also said that Pennsylvania law, not the law from the plaintiff’s home state of Arkansas, governed the Good Samaritan duty alleged by the plaintiff.

New also rejected the plaintiff’s arguments on causation under the negligent undertaking tort and the plaintiff’s arguments on claims of fraud.

For example, while the plaintiff argued that Excerpta Medica was guilty of ghostwriting and off-label marketing, the judge said the plaintiff’s expert did not demonstrate Excerpta Medica knowingly or recklessly made any material misrepresentation about Risperdal in the alleged ghostwriting or off-label marketing.

The judge also rejected the plaintiff’s claim of a violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law and the Arkansas Deceptive Trade Practices Act.

While the Superior and Commonwealth courts have reasoned that the post-1996 amendment to Pennsylvania’s consumer protection law eliminated the requirements of common law fraud, the trial judge said in a footnote that not requiring plaintiffs suing drugmakers to have to establish justifiable reliance would “effectively make a drug manufacturer the absolute guarantor of the anticipated results and effects of a prescription drug.”

New undertook a similar analysis in other Risperdal cases, such as S.B. v. Ortho-McNeil-Janssen Pharmaceuticals, issued June 12 and involving a Missouri plaintiff, and a pair of April 5 opinions, Banks v. Ortho-McNeil-Janssen Pharmaceuticals, involving a Texas plaintiff, and A.B. v. Ortho-McNeil-Janssen Pharmaceuticals, involving a Texas plaintiff.

In the Banks and A.B. cases, New noted that the Pennsylvania Supreme Court has not yet interpreted the catch-all provision in the consumer protection law that prohibits “‘fraudulent or deceptive conduct which creates a likelihood of confusion or of misunderstanding’” and that the case law regarding the catch-all provision is in flux.

Sheller P.C. and Howard J. Bashman, a Willow Grove, Pa., solo practitioner, are representing the plaintiff in Kreves.

Drugmakers have been found liable regarding ghostwriting, Bashman said, and a third party hired to perform that same conduct that “improperly minimizes the risks of that medication” can foreseeably envision that “where the risks of a drug are improperly downplayed … that harm can result to the users of the medication that would not have resulted if the physician prescribing it had received proper risk-benefit information.”

It is a jury question on whether Excerpta Medica defendants or the drugmaker defendants had the responsibility to protect the users of Risperdal, Bashman said. Granting summary judgment on the basis that the Janssen defendants had all of the control is “not properly viewing the evidence in the light most favorable to the plaintiff at the summary judgment stage,” he said.

Bashman is a columnist for The Legal.

Excerpta Medica is represented by Stephen J. Imbriglia of Gibbons P.C. and Proskauer Rose of New York.

Imbriglia did not respond to a request for comment before deadline.

The cases are on appeal to the Superior Court now. The parties are going to seek consolidation of all four cases in the Superior Court, Bashman said.

Other companies that provided medical communication services regarding Risperdal were not sued, New said.

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