FDA whistleblowers sue FDA: A big deal?

February 1, 2012 – 4:08 PM | By Mark McCarty | No comments yet

Seriously, what's the big deal?

Fans of pro football may think the matter of whether Peyton Manning will ever play in the NFL again is taking forever to come to a conclusion, but they might want to examine the FDA whistleblower issue as a benchmark for drawn-out drama.

As has been reported in Medical Device Daily, former FDA employees, including Robert C. Smith, MD, and Julian Nicholas, MD, were among the authors of letters to Congress and the Obama administration over alleged suppression of dissent over medical device approvals. Those letters came out in 2008 and 2009, and the story of a new lawsuit by some of the authors of those letters against FDA is all over the Internet. The lawsuit alleges that FDA’s practice of monitoring e-mail communication on agency computers violated the privacy rights of the senders.

Smith is quoted in the Washington Post piece as saying (apparently in outrage): “Who would have thought they would have the nerve to be monitoring my communications to Congress?” He is said to have inquired further: “How dare they?”

Well, it seems FDA dares. The reader will pardon me for editorializing, but if your employer tells you up front that your computer activity may be monitored, you probably ought not use those computers to send out things that could get you in trouble.

As the saying goes, “duh.”

So what gives with the kindly Dr. Smith & Co.? Tough to say, but Smith had filed a whistleblower lawsuit against Yale New Haven Hospital (YNHH; New Haven, Connecticut) and several other hospitals that was dismissed in 2006. A few items in that decision are of special interest in this discussion, including that “the United States declined to intervene in the action.”

The decision states that Smith’s allegation that the hospital’s use of an autosign program disallows billing for the technical component of a radiological study ignores the separation of the technical and professional components of Medicare billing practices. The decision notes that the relator’s (Smith’s) argument would disqualify YNHH from being paid for services it had rendered “if the physician’s request or intended use of the study, deemed before the fact to be medically necessary, was found after the fact to be medically unreasonable and/or unnecessary.”

Other passages include that the relator “has failed to establish … subject matter jurisdiction over his claims” and “has not demonstrated that he is an original source of the facts on which his claims are based.”

Also in the text are the passages, “the allegations … are fraught with assumptions and conclusions which do not suffice to establish the essential facts” of a whistleblower claim, “and are devoid of the facts necessary to support such a claim.”

The decision also says that what the relator “alleges to be his observations are not shown to be within his personal experience,” and that his claims do not reflect “first-hand knowledge” or “direct, independent knowledge.”

As they say in the movies, capisce?

As my wife will tell you, I’m sort of inclined to crack wise at a lot of fuss and bother and can be heard asking from time to time, “what’s so mellow about melodrama?” So maybe I’m the wrong person to blog about all this. But still, the only question I have about this latest Smith-based dust-up is …

What’s Peyton Manning going to do?


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