There’s always something going on in the world of medical devices, including in the policy, regulatory and legal spheres. Following is a trio of quick updates on stories that have emerged since the start of the year.
FDA pre-emption back in play
The question of FDA’s pre-emption of state regulation (via tort law) of medical devices has resurfaced. This involves Medtronic yet again, leading one to wonder if these pivotal pre-emption cases ever involve anyone else.
Stengel v. Medtronic went the company’s way when a three-judge panel in the U.S. Ninth Appeals Court ruled on it last year, but a full panel of judges at that same court reversed the decision at the beginning of this year, as was discussed in the Jan. 22 edition of Medical Device Daily. Richard Samp of the Washington Legal Foundation told me in an interview he thought Medtronic might win should it appeal to the Supreme Court, but to date I can’t find any indication the company has done so.
St. Jude Medical may have a chance to test out pre-emption over the Riata line of electrophysiology leads. Those suits have been filed in California, which is where the Ninth Appeals Court resides. It’s enough to make one wonder how appealing an appeal at Ninth Appeals might really be.
Durata case report
Speaking of St. Jude, three cardiologists in California (where else, right?) have reported a case of a single Durata lead that exhibited inside-out abrasion, the presumed central issue with the Riata leads. The problem with this story is that abrasion is not what caused the lead to fail. The lead failed because of separation between the body of the lead and the coil at the end of the lead.
It’s just one case, but it attracted a lot of attention largely because of the issues associated with the Riata series of leads. St. Jude says it has performance data on more than 300,000 Durata leads, and that the numbers are quite good. A prominent electrophysiologist, Ed Schloss of Christ Hospital in Cincinnati, told me he’s still not convinced about the need for narrower leads, but he also said the amount of slack in the lead in this case might have had something to do with the failure.
Let’s hope for the sake of all involved, especially the patients, that the Durata rides off into med tech history as an example of a device that performed superbly despite what some see as a troubled lineage. Technological advances will eventually make ICD and pacemaker leads obsolete, but we’re not there yet.
CBO to Congress: Our tax policy stinks
At first glance, this might seem like a facepalm story, but the more one slogged through the January 8 report from the Congressional Budget Office regarding U.S. tax policy and industrial flight, the more predictable the conclusion became. And that means policymakers had to have seen this coming from quite some distance, especially since CBO doesn’t just go around studying things for kicks and giggles.
As was discussed in the Jan. 15 edition of Medical Device Daily, CBO had concluded that the Magnificent 535 who make their living in the nation’s capital had, over a period of years, brewed a great recipe for making business want to do business in places where doing business wasn’t so much about the business of taxation. Thus all the talk of tax reform.
Add a 2.3% dollop of medical device tax on top of all that, and it’s a wonder more firms haven’t already booked flights to Anywhere But Here.
Despite the obvious urgency of the larger of these two tax issues, it seems likely that the Senate and the House will play dueling banjos, given the vast distance between the two chambers’ approaches to fiscal policy. I could be wrong, but they’ll probably just happily pick and pluck at breakneck speeds, grinning at one another like two fools until it’s time to shake hands. Then everyone will fold their arms and look away, and we’ll all look on nearly dumbfounded and ask each other, “what the [insert expletive here] just happened?”
It’s Washington. That’s what happened.