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Hard Cases Sometimes Make Good Law

By James M. Beck and Mark Herrmann

Confidentiality issues often arise in drug and device cases, usually when plaintiff lawyers want to send confidential company documents to the New York Times. But every once in a while it's the plaintiffs who get impaled on the issue. That's what happened in In re Viagra Products Liability Litigation, MDL No. 06-1724, slip op. (D. Minn. April 14, 2010). Pfizer had earlier been unable to knock out one of plaintiffs' general causation experts on Daubert grounds because the court had been sufficiently impressed by a peer reviewed article by that expert on the issue in question (whether Viagra caused a certain vision disorder).

But mass torts have their ups and downs, and Pfizer followed up in a very smart way. It used discovery to obtain from the University of Alabama-Birmingham ("UAB") the source documents underlying the article. Guess what? The article wasn't quite as rigorous as it seemed. As we discussed here, the article had misrepresented some pretty key findings and methodologies. The expert had even labeled some subjects as "exposed" when they were, in fact, "unexposed." Kind of important, don't you think?

Last August the court found that the new information showed that the expert's study was unreliable (to put it charitably), and that "[p]eer review and publication mean little if a study is not based on accurate underlying data." What happened here is something that should keep journal editors up at night. In any event, so much for that expert.

But the study is still in the books. Pfizer had obtained the underlying materials pursuant to a protective order. While Pfizer was able to tell the journal that the underlying documents cast doubt on the article, and while the court published an opinion discussing why that was so, the only way to make those materials available to the journal was if the judge issued an order permitting disclosure. UAB opposed such disclosure. Meanwhile, the journal referred the matter to the Committee on Publication Ethics ("COPE"), an organization designed to deal with questions of scientific integrity on behalf of medical journals.

Pfizer argued that permitting the journal to review the data is in the interest of public health. That seems right. People (including doctors and academics, to say nothing of judges and juries) trust the peer review process. People are making potentially important decisions based on findings in medical journals. Indeed, the articles are written for precisely that purpose. If those findings are deficient, strained, distorted (or worse), the journal should have an opportunity to review the evidence and, if appropriate, amend or even retract that article -- as recently happened in the case of a notorious article that purported to link a vaccine to autism.

Contrast that genuine public health interest with the usual bloviations from plaintiff lawyers who (a) force companies to spend millions of dollars to produce millions of pages of documents, (b) grudgingly agree to protective orders -- which are perfectly reasonable and necessary given that the defendant operates in a stiffly competitive industry, and then (c) seek to dedesignate confidential documents for a litigation advantage but under the guise of public health. Not to put too fine a point on it, this plaintiff strategy is predictable and disingenuous. Whenever hundreds of employees are working on a product over many years, there are always going to be some documents that can be taken out of context and used to create misimpressions about what was intended or done. Lately, plaintiff lawyers have taken to holding press conferences so they can give their swell little take on what the documents mean. Turgid or unclear prose gets translated as "dollars over lives, blah blah blah."

Meanwhile, the company is hemmed in by laws and regulations that reinforce an actual need to be circumspect, so the corporate response is bland and flaccid. It's an unfair fight. Confidentiality becomes just another pressure point for plaintiffs, having little or nothing to do with truth, public health, or the merits of the case. The dedesignation of confidential documents in such instances is all about affecting the stock price and influencing the jury pool. And yet many courts are reflexively hostile to claims of confidentiality, so plaintiffs get to play the game.

In this case, things were reversed and it was a third-party -- and an academic one at that -- that fought disclosure. But UAB at least agreed that it would turn the documents over to COPE. Relying upon that agreement, on April 14, 2010 the court issued a three page order declining to force turnover of the documents to the journal. Even there, the court's ruling was without prejudice. Clearly, the court was more than a little dismayed by the performance of plaintiffs' expert, and expects to see academic, as well as legal, justice done.

Kudos to Pfizer for pursuing the right legal strategy. It's one that warrants emulation. We've seen other cases where plaintiff experts have authored peer-reviewed studies that lost all credibility when confronted by the underlying materials. (There's a famous example from tobacco litigation where a plaintiff expert wrote an article purporting to document the effect of Joe Camel advertising on kids, but his correspondence during the write-up shed new light on both findings and motives.) Such discovery always meets lots of resistance, but, as in this case, the battle is well worth it. Pfizer's approach resulted in the correct Daubert ruling, offered a cautionary tale to other overreaching experts, and stood up for truth and public health.

Full post as published by Drug and Device Law on April 19, 2010 (boomark / email).