Healthy Skepticism Library item: 14947

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Publication type: news

Meier B.
Device Maker Sues a Doctor Who Called Its Product Flawed
The New York Times 2009 Jan 13
http://www.nytimes.com/2009/01/14/health/research/14heartside.html?_r=2&ref=research

Full text:

A scientific dispute has become a slander suit, in a legal case involving NMT Medical and its device for closing congenital holes in the heart.

The lawsuit, pending in London, was filed in 2007 by NMT Medical after a clinical trial failed to show that its device could eliminate migraine headaches in people with the congenital heart opening, known as a patent foramen ovale, or P.F.O.

NMT Medical contends that one of the British researchers in the study slandered and libeled it when he was quoted in an online publication as saying the trial may have failed because the product did not work well. The researcher, Dr. Peter Wilmshurst, was also quoted as saying the company had withheld trial data because it feared that it might undercut sales of the device for other uses, like stroke treatment.

“I’m not as concerned about the companies as I am about the fact that the patients who are in the studies will suffer,” Dr. Wilmshurst was quoted by the publication, theheart.org, which covers cardiology.

NMT Medical executives and another researcher involved in the trial dispute Dr. Wilmshurst’s suggestions. They say that Dr. Wilmshurst turned on them because the trial’s failure undermined his theory of a link between P.F.O. and migraine. “Everything was being completely torn to shreds by his attacks,” said John E. Ahern, the company’s chief executive. “We felt it was appropriate to protect the good name of this company and the work it does.”

Dr. Wilmshurst, a cardiologist in Shrewsbury, England, is known among his British colleagues as a whistle-blower. Among other things, he has helped expose research fraud and corporate conflicts of interest.

Dr. Wilmshurst responded through his lawyer to written questions. But in those responses, published interviews and court papers, he has said that the medical study may have been compromised because the NMT Medical device frequently failed to seal off blood flow within the heart. He has also claimed that the company failed to share all diagnostic tests with him, findings that might prove his contention.

For their part, NMT Medical officials said Dr. Wilmshurst became more irrational and demanding as the trial evolved and eventually proved impossible to deal with. They added that both American and British regulators had looked into his complaints and told the company it had done nothing wrong.

“All the other people involved in the study have been happy to accept the results,” said Dr. Andrew Dowson, a headache specialist in London, who also directed the study. Dr. Wilmshurst has said he continued to believe that there was an association between P.F.O. and migraine.

A trial date for the lawsuit has yet to be set. As for Dr. Wilmshurst, he said that he rejected an earlier offer from NMT Medical to settle the case by apologizing for his statements.

“I saw this as a bully’s attempt,” he stated. “To bow to such bullying would be a dangerous precedent which might prevent other doctors and researchers blowing the whistle.”