Dead ducks: Three ideas that may (not) be kaput

June 5, 2014 – 9:46 AM | By Mark McCarty | No comments yet
Cute, but the next victim in the war on quack?

Cute, but is this little guy the next victim of the war on quack?

To say someone has floated a policy proposal in Washington is akin to saying the traffic in the DC area was bad yesterday. It happens every day, so who cares? Here are three policy proposals that emerged over the past year (or three), proposals that have either slipped beneath the waves or are struggling to stay afloat.

FDA’s clinical trial disclosure proposal: Dead duck

The idea that FDA would just up and disclose the results of clinical trials has been bouncing around inside the Beltway for a couple of years, but you don’t hear much about it of late. Is that good news or bad?

Last August, Boston Scientific sounded off on the notion with a comment to the docket citing a potential to freeze innovation, but the company also questioned whether the agency has the statutory authority to disclose such data unilaterally. Richard Samp of the Washington Legal Foundation echoed those views in an interview I had with him on this subject. WLF, just so you know, has won a battle or two with FDA.

In this case, I’m going with the notion that no news is good news. Had FDA believed it had both the statutory authority and the congressional backing to unilaterally disclose those data, it would likely have tried to do so by now, given that this is the third year since FDA commissioner Margaret Hamburg released this non-clinical trial balloon.

Patent reform redux: Dead duck (for now)

Patent wonks no doubt have heard all about the latest efforts to shore up the U.S. patent system. Among the issues was that of patent trolls hitting up mom-and-pop businesses for licensing fees for their Internet routers, but there were a few things relevant to holders of med tech patents.

One of these was a proposal that would have left the loser of a patent suit holding the bag for the winner’s legal fees in some cases. This fee-shifting problem is said to have kept a lot of Senate Democrats on the sideline, but there are reports emerging that the courts are well equipped to punish those who file frivolous lawsuits against patent holders.

In any event, word is that S. 1720 did not die in the Senate Judiciary Committee for lack of effort. The principal problem seems to have been that there were too many chefs in the kitchen, leading to a stalemate that killed the bill. As the Governator might say, though, it’ll be back.

Death to PMA preemption: Dead duck

Here again, lack of effort is not the reason FDA continues to exercise primacy over state common law where liability lawsuits against PMA devices are concerned. There are three cases of recent vintage, namely Stengel, Caplinger and Ramirez, all of which tagged Medtronic as the defendant.

It’s not that Medtronic has won each of these suits, but the Supreme Court recently evinced an interest in Stengel, and by some accounts will take the case despite carping by Solicitor General Donald Verrilli. The problem for opponents of preemption is that the Court is not constituted to gut preemption, and the Court will only take this case if at least four members of the Court think the Ninth Appeals Court got it wrong when it ruled against Medtronic. And the Court certainly would not have bothered Verrilli had it not already found four votes to hear Stengel.

If you want the Court to overturn preemption, the Obama administration would have to replace one of five Justices known to oppose any attempt to end preemption, at least based on the outcome in Riegel. If the GOP takes even a slight majority in the Senate in November, the White House will have to come up with a moderate jurist just to get that jurist to the bench. That’s a no-go for killing preemption.

So unless one or more of Justices Roberts, Thomas, Scalia, Alito or Kennedy kicks the bucket in the next five months, SCOTUS is not going to kill preemption. But don’t expect the lawsuits to suddenly die off as a result.


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