What do plaintiffs lawyers look for in deciding whether to file a product liability suit against a pharmaceutical company?

Robert Jenner, of Janet Jenner & Suggs, said he focuses on several things: the pervasiveness of a problem; documents showing the drug caused the injury; whether a case can stand on its own; and which attorneys are pursuing litigation.

As for documentation, Jenner doesn’t think FDA warning letters are a primary basis for bringing a suit. And if a company has issued a “Dear Doctor” letter, he is likely to take a pass on the case.

Jenner spoke at a Nov. 11 meeting of the American Bar Association Section of Litigation, which was held at Johnson & Johnson’s corporate headquarters in New Brunswick, N.J. He and fellow panelist Kathleen O’Connor, a partner at Dechert, engaged in a lively discussion about current issues in pharmaceutical litigation, from the correlation between FDA regulatory actions and civil litigations to the recent indictment of a former GlaxoSmithKline attorney.

Meridia And The Evolution of Causation

In analyzing a case, Jenner said the first thing he does is determine if enough people have been harmed by a drug to make advertising the case and cost of litigation worthwhile. One of the cases he took on was litigation against hormone replacement therapy, which he said at one time was the number one prescribed drug. He is on the plaintiff’s steering committee of the HRT federal multidistrict litigation.

Another primary factor, of course, is whether causation is provable. He noted that when Meridia (sibutramine) litigation was tried five or six years ago the science wasn’t yet there to prove a link, but it eventually emerged and the drug was withdrawn from the market last month (Also see "REMS Cannot Save Abbott's Obesity Drug Meridia In Face Of Cardiovascular Issues" - Pink Sheet, 8 October, 2010.).

Jenner commented that he took a pass on Avandia litigation. “I looked at Avandia and thought this is worse than Rezulin and Vioxx combined, who would take this case?” he said.

He noted that Mark Lanier and others did so and made a lot of money. GlaxoSmithKline has agreed to pay about $500 million to settle 10,700 Avandia suits (Also see "Grassley And Baucus Turn Up Heat On GSK With Attack On Avandia Data Handling" - Pink Sheet, 13 July, 2010.).

Jenner added that another thing to consider is who else is involved in litigation. For example, Lanier won the biggest jury verdict against Merck in a Vioxx case, $253 million, which a judge slashed to $26 million.

Individual Liability May Help Plaintiffs

Panelists were asked whether there is a correlation between government enforcement actions and litigation. O’Connor, who was previously inhouse at Merck where she managed Vioxx litigation, said she wonders now whether almost any government action will trigger interest by the plaintiffs, particularly since the government has said it will start going after individuals.

“Obviously that’s a place where plaintiffs may look to try to leverage a situation against a company, where the company is staring down having its executives indicted,” O’Connor said.

The Department of Justice’s recent indictment of a former GSK lawyer for obstruction and making false statements to FDA in an investigation of off-label use of Wellbutrin SR (bupropion) has sent tremors through industry (Also see "DoJ Case Against GSK Lawyer Flags What Individual Behavior Government May Target" - Pink Sheet, 9 November, 2010.).

O’Connor said the indictment has created a different dynamic in litigation. Asked if she was worried that corporate officials may take the Fifth Amendment, O’Connor acknowledged that this is a concern.

“My assumption is plaintiffs lawyers will have this in the back of their mind, and they are going to be taking depositions with this in their head and thinking about ‘how can I get information out that’s going to put these guys in a bind that will then try to force a settlement,’” she stated.

A plaintiff’s lawyer in the audience asked if the chance that something may be uncovered in civil discovery that could create liability with the government is a factor in deciding to resolve litigation.

O’Connor said that if a company sees it's got a real problem it may voluntarily disclose the matter to the government and settle those cases.

“In my experience it’s really not that clear cut,” she said. “There’s almost nothing I work on now where I don’t have the overlay of a government investigation of some sort. And yet I have never had a client where I’ve actually thought they did anything that was illegal. So I can’t then advise them to settle a case early on because I’m concerned about criminal exposure.”

O’Connor emphasized that it is important for lawyers to know what happened in a situation and to analyze the documents before they interview anyone.

"Dear Doctor" Letter May Prevent Litigation

The panel chair noted that FDA is issuing more warning letters and asked what impact that may have on litigation.

Jenner said the letters are important because they provide information but indicated that they are not the basis of litigation since a warning letter is issued on every alert and is now very narrow. “If we responded to every warning letter we’d be investigating and not doing enough litigating,” he said, adding that he is more concerned about recalls.

A state court in West Virginia found that J&J made false and misleading statements to healthcare providers about its antipsychotic Risperdal and pain medication Duragesic based on FDA warning letters. But an appeals court reversed the ruling (Also see "FDA Warning Letters Do Not Prove Wrongdoing, Appeals Court Finds" - Pink Sheet, 29 November, 2010.).

Jenner said that one document is a disincentive for filing suit: a “Dear Doctor” letter. He noted that there are some pharmaceutical companies that are sending out Dear Doctor letters based on one report or one incidence of hepatotoxicity and said this has nothing to do with causation and everything to do with informed consent.

“I don’t understand why when pharmaceutical companies and medical device manufacturers [see] there is reasonable evidence of an association you are not sending out these letters,” he said. “If I see a lot of people hurt but I see Dear Doctor letters that go out I’m done. I won’t bring that litigation.”

O’Conner responded that companies generally do this when they see a problem but she said it is rare that you get study results where it’s clear there is a problem and there is also concern about over warning.

FDA is revising its standards for creating "Dear Doctor" letters, and its more hands-on approach could make it easier for companies to challenge liability could endow the documents with even stronger liability fighting abilities (Also see "FDA Standardizing “Dear Doc” Letters To Fix Problems With Recipients As Much As Senders" - Pink Sheet, 29 November, 2010.).

DDMAC Letters And Foreign Labels

Asked what information he tries to have included or excluded in trial, Jenner said in an over-promotion case he looks for letters from FDA’s Division of Drug Marketing, Advertising, and Communications that discuss the promotion of a drug for an unapproved use, as well as internal FDA documents about ongoing discussions with the company.

O’Connor said she typically tries to keep out DDMAC letters that have nothing to do with the case and seeks to bring in information that shows FDA has thoroughly explored the issue at hand. “A jury feels much better about the drug and going to the good company story if you show the company providing information proactively to FDA,” she stated.

She also usually tries to exclude foreign labels and foreign instructions.

“This is kind of a nightmare from a defense perspective because there are so many different regulatory regimes and what you can and cannot say,” she stated. “There are few things that would aggravate a juror more than knowing that somebody in Japan was told something that they were not.”

“I think there is no litigation that I’m involved in where this issue hasn’t emerged and I think it’s a really significant one,” O’Connor added.

By Brenda Sandburg

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