Big Noise in the Mitten State: Part 5 – Pinocchio Unbound
On February 22, what had been unthinkable a year earlier actually happened. The Michigan House passed a bill to rescind the drug industry's absolute immunity from civil liability in our state. The vote on the main bill was 70-39, with about one-third of the House Republicans joining with all but one Democrat to support rescinding. That proportion pretty much parallels the state as a whole, in which polls show that approximately 70% of Michigan citizens favor repealing drug industry immunity.
For those of us who had been working on the issue for a long time, this was big noise indeed. Thanks to the Democrats winning the majority in the House in the November elections, the primary obstacle to getting a floor vote – the former Republican Speaker of the House – was history. It was no accident that acting on this bill was the first order of business for the new leadership. The immunity issue had itself played an important role in the elections. As the Lansing State Journal put it, it was time to correct what had been an eleven-year-old mistake.
The problem was that the State Senate was still controlled by a Republican majority who found that mistake to their liking. Heavily lobbied by the Michigan Chamber of Commerce, the Senate was not about to go along for the ride. Indeed, besides condemning the House vote, the Senate's Majority Leader suggested that addressing immunity was "not a priority." In the distance, a toilet flushed.
So there remain hurdles indeed. But the immediate casualty was reality. Knowing they had the Senate in their pocket, it is hard to understand why so many on the pro-immunity side became truth-challenged. But that is certainly what happened.
The Michigan Chamber of Commerce took the lead.. As reported in the last Big Noise installment, full-page ads invoked the demonology of "greedy trial lawyers" in virtually every sentence; sometimes twice in a single line. (1) Rather than "drug industry immunity," the Chamber refers to our statute as the "FDA defense law." Fair enough. It is when they begin to paraphrase that law's provisions that things get slippery.
For example, a repeated refrain has been that there is some sort of "established administrative procedure" – a "citizen petition" – that Michigan citizens can file with the FDA if they believe they have been unfairly injured by a drug. Since our law requires felony fraud conviction, along with a resulting drug withdrawal, as minimal conditions for potential civil litigation, it is difficult to see how an "average citizen" would have access to evidence that the FDA had been defrauded. But even if a citizen somehow did have such information, how likely is it that they would share it (or the FDA would post it) in a "citizen petition" – a public document displayed on the FDA's website?
To clarify the question, I called some people at the FDA. – in the Office of Regulatory Affairs, the Office of Chief Counsel, and the Office of Criminal Investigation. They are a diverse group, but they were uniform in their response. Every one of them laughed out loud. The laughs varied – there was a subdued snicker, a deep guffaw, and one hearty invocation of Divinity. But the verdict was the same. Citizen petitions concern specific regulatory actions: e.g., a particular product should be withdrawn. A criminal investigation, on the other hand, is not initiated because some Joe in Michigan thinks there might be something fishy going on. To paraphrase one official: "If you wanted to get actionable evidence to the feds about a child porn ring, would you write about it in a Letter to the Editor?"
I guess not.
Still, the Unbound played on. In the House debate on rescinding, one Representative stated specifically that "anyone who believes they have been injured by a pharmaceutical company can file suit once they have made the case before the Food and Drug Administration."(2) He failed to mention that, over the past twenty-five years, there has not been a single instance of the kind of case, and the FDA action that would have to follow, that meets the conditions of our immunity law. (3) In a somewhat surprising turn, another pro-immunity Representative took off after the FDA itself. "Most of the drugs currently being reviewed in the United States are already available in other countries," he asserted. (4) The truth is that the majority of new drugs – about 60% - first become available in the United States. An even higher percentage of new drugs are first reviewed here. (5)
Walter Olson also did some traveling not long after the Michigan House vote. In a recent opinion piece, he declared, "Michigan enacted a pioneering law limiting suits against prescription drugmakers, but it has had scant impact since lawyers representing Detroit pill-takers can still head for, say, New Jersey to sue over claimed side effects." (6)
The reality is that "Detroit pill-talkers" can take their claims nowhere. Precisely because of our law, Michigan citizens have been shut out of court across the country. It is ironic that Olson invokes New Jersey. Just in the past few days, the New Jersey Supreme Court specifically rejected (reversing a contested Appellate decision) a Michigan citizen's attempt to file there on the grounds that Michigan's immunity law prevails. (7)
So it looks like those "Detroit pill-takers" will have to go elsewhere. Perhaps they will head for, say, Fantasyland. They are sure to meet Pinocchio along the way.