Much to my father’s utter disappointment I’m sure, I did not inherit the sci-fi appreciation gene. I never understood the cult phenomenon created by Star Trek and have always preferred living in the now over fantasizing about the future. While I’ll never be able to call myself a Trekkie, I have slowly gained an appreciation over the years for technology that seems to have been plucked right off the fictional starship USS Enterprise. A fascinating example of this, as Spock would say, is the rise of 3-D printing.
The advancement of 3-D printing, also known as additive manufacturing, is predicted to revolutionize the way medical devices are produced. This week, in a three-part series, Medical Device Daily will explore the potential of this seemingly science-fictional technology, the challenges it presents for the medical industry, and the areas of healthcare that it will likely have the greatest impact.
Some doctors and biomedical engineers have already saved lives with the help of 3-D printing, but the technology is still very much in its infancy. Nobody can know for certain just how much this ability to make solid objects from a digital file will change the medical landscape. But as Enterprise captain James Kirk might say, I can’t wait to watch as this science continues to boldly go where no technological development has gone before.
[caption id="attachment_3188" align="alignleft" width="256"]The preemption waiting game goes on at 1 First St. NE, Washington[/caption]
The news is out that the Supreme Court (SCOTUS) passed on the chance to hear Medtronic v. Stengel, one of the more recent cases tackling FDA’s preemption of state tort law for PMA devices, so maybe it’s time for a preemption check-up.
First, it may be instructive to ask “why not Stengel?” The case had bounced from a district court (which dismissed the suit against Medtronic) to the U.S. Ninth Appeals Court, which handed it back to the lower court after seeming to suggest the plaintiff’s attorneys have little chance of success. One might assume Medtronic would let it go at that, but the company nonetheless applied for cert, which the Supreme Court took the better part of a year to consider.
Medtronic may have figured it had little to lose by taking the case to Washington, but the company might also have imagined the odds were long that the Court would grant cert in the first place. Either way, next up is Medtronic v. Caplinger. The company’s Infuse bone morphogenic is alleged to have been the subject of off-label discussions between the company and doctors (specifically about anterior versus posterior access to the spine), which is a somewhat different set of issues than those brought forth by Stengel, which was a failure-to-warn claim for an infusion pump presumably used on label.
Also on tap for Medtronic (why is it always Medtronic?) is Coleman v. Medtronic, which according to this analysis was decided for the plaintiff in a rather qualified fashion. Not much has happened since the California Court of Appeals (a state court) decided the case in January, but one assumes it would end up in Ninth Appeals should it graduate to the federal level.
The interesting thing about Caplinger is that it presents the third federal appeals court venue (Tenth Appeals Court) for preemption of the past four years or so and hence might trigger another examination of preemption at SCOTUS (bear in mind that the last time the Supreme Court examined this issue was Riegel in 2008, another Medtronic case, and another case in which Allison Zieve of Public Citizen represented the plaintiff).
A quick tally of the two concluded appeals court cases leaves us with one case that probably had no chance of changing anything (Stengel), and one that was probably a long shot to change things had the Supreme Court heard it, namely the Sprint Fidelis electrophysiology lead litigation decided in the Eighth Appeals Court four years ago affirming preemption.
The losing party in Caplinger will appeal for cert, there’s no question about that. If SCOTUS passes again, it will likely hear from the loser in Coleman should that case get through the federal appeals system. Given the foregoing, it seems unlikely the Supreme Court will take Caplinger if Tenth Appeals affirms preemption. None of this argues, however, that SCOTUS wouldn't pass on Caplinger if the case takes a very limited swipe at preemption.
On the other hand, the Supreme Court may feel it's time to act if Coleman hits the appeals court system and generates a decision that seems to add yet more noise to the preemption question.
Absent any change to the overall make-up of the Supreme Court, we might assume any preemption cases the Court takes would come out reinforcing at least the principal tenets of preemption. Still, there is a tremendous amount of activity and groups like Public Citizen seem determined to put an end to preemption.
About the only thing the layperson can say conclusively about all this is that any decision at SCOTUS on this question in the near future won’t change things much. A death or retirement of one of the conservative jurists while President Obama is still in office would torque the situation drastically, but that might be the only window for ending preemption over the next decade, given the voters’ collective penchant for switching parties in the White House every eight years.
All the same, one would be well advised not to fall asleep on this issue.
This week in med-tech history: Nine years ago this week the biggest news in Medical Device Daily was Guidant’s recall of nearly 50,000 implantable defibrillators, coupled with the company’s failure to alert customers of the danger of one of the devices for nearly three years after it was aware of a problem.
On June 21, 2005 MDD reported that the Guidant recall created a serious issue for Johnson & Johnson, which at that time was planning to buy Guidant for $25.4 billion.
But of course when we fast forward a bit to January 2006, we know that deal never went through anyway, as J&J lost a two-month-long bidding war for Guidant to Boston Scientific. Boston Scientific shelled out $27.2 million for the troubled cardiac rhythm management firm, finalizing the deal in April 2006.
In the long run, J&J was surely relieved to have dodged the Guidant bullet. Boston Scientific ended up facing thousands of lawsuits related to Guidant’s problems and paying millions to settle those claims, plus an investigation with the Department of Justice that was settled in 2009 for $296 million.
[caption id="attachment_3159" align="alignleft" width="163"]Take Five? Dave Brubeck five years before recording his best-selling single[/caption]
Sometimes it's fun to revisit events in the past and see how things have changed in the meantime. Here are three stories that made the pages of Medical Device Daily five years ago.
2009’s drug balloons
Germany’s Nena sang of 99 red balloons in 1983, but TCT 2009 included a session on drug-eluting (or drug-coated) balloons. In the September 28, 2009, edition of MDD, I covered a discussion at TCT of whether the then-novel guidance for drug-eluting stents was of any value for developing drug-coated balloons (DCBs), and FDA’s position was – to put it succinctly – forget about it.
Some of the chatter at TCT that day addressed a balloon’s use as a way to deal with restenosis in an already-stented coronary artery, and there was little discussion, if any, of anything below the waist. But fast-forward to last week and you have a DCB tentatively indicated for the lower extremities, and not as a way to push back against restenosis in a stented artery.
The Lutonix DCB just aced an advisory hearing for the femoropopliteal arteries, but the label is going to say something like treatment of de novo lesion or restenosis of a previously ballooned vessel. I should point out that Lutonix has been at this since 2007, so it’s not a five-year plan from their perspective. They’ve also sold a lot more than 99 of their balloons in Europe, so…
Renegades at FDA
Most who read this blog surely remember the letters sent by members of the FDA review staff to the Obama administration (and to Congress) alleging malfeasance by senior member of the agency’s staff. I covered this story in the Jan. 12 edition that year, and this turned into a story about renegades.
“Renegades” was a word used when a now-departed member of the FDA staff described the situation to me in an off-record conversation, and events proved this FDAer right. Two of the authors of those letters, who were probably the ringleaders, found themselves without jobs when the agency declined to renew their contracts.
Managers at the agency resorted to tracking what these twerps did with their computers after it came to light that they’d sent proprietary device application data to Congress. But that was much later in the year, and the troublemakers who kept their jobs presumably have cooled their jets, all of which leads us to the third item on our agenda.
Shuren sworn in
Okay, so there’s no pomp and circumstance for getting the head honcho job at the Center for Devices and Radiological Health, but I have it on good authority that a lot of people at CDRH did not like how the agency handled the defenestration, as it were, of Dr. Dan Schultz from the CDRH director’s chair.
In comes Jeff Shuren, another MD (and a JD to boot), who formally took the job in August 2009. Shuren was at the helm when the surveillance of the renegades discussed above commenced, leading to the severing of the snake’s head from the rest of the corpus.
Since taking the job at CDRH, Shuren has suggested that European patients are guinea pigs (a comment about device lag he later retracted), and alleged that longer 510(k) review times were “all on industry,” another comment he had to walk back after Senator Richard Burr waved it in his face in a hearing on Capitol Hill.
On the other hand, Shuren has also overseen a much-needed re-engineering of operations at the Office of Device Evaluation, and pushed ODE staff to consider the possibility (gasp!) that not all patients have a low tolerance for risk. That might be a no-brainer for we the great unwashed, but it was apparently akin to a lifting of the veil for some of the Einsteins at ODE.
I have no doubt that many device makers have used swearwords in conversations about Shuren in the five years since he took the job, but he did get rid of a toxic mess at the radiological devices branch. For what it’s worth, I know for a fact there are at least a few device makers who spend a lot less time cussing as a result.
[caption id="attachment_3136" align="alignleft" width="300"]CMS's dilemma: Hear about it now, or hear about it later.[/caption]
The behind-the-scenes story of Medicare coverage of low-dose CT (LDCT) screening for lung cancer is not the kind that makes page A1 in the major daily newspapers, but maybe it should. Physicians and device makers have lobbied extensively on the issue, as is their right, but I wonder if getting Congress to weigh in on this issue is really a smart move.
To start at the beginning, more or less, the Centers for Medicare & Medicaid Services recently opened a coverage analysis for LDCT, and the agency gave itself 12 months to sort through things. That might seem like a long time given that CMS needed only nine months to get through the hepatitis C screening analysis, but there’s no reason CMS should need the exact same amount of time to conduct two very different analyses.
Still, that didn’t stop physicians and industry from lobbying Capitol Hill on the issue. They were quite effective, prompting more than 40 Senators and nearly 140 members of the House to ink letters to CMS essentially urging CMS to drop the 12-month plan and hurry up and cover the USPSTF recommendations for high-risk beneficiaries.
I get that there is a public health issue at work here, but that can be said of just about anything CMS covers or declines to cover. So there’s nothing new about that. If you want to talk about public health, why not ask how many Americans are six feet under because CMS has been behind the times on coverage of implantable defibrillators?
I’d remind the reader that heart disease still kills more Americans over the age of 40 than what, the three deadliest cancers combined? So if you want to talk about public health, let’s talk about heart disease, shall we? Or Alzheimer’s? This is yet another indication that the cancer lobby has absolutely no sense of proportion, and indeed seems to have an entitlement air about it.
The dilemma CMS faces now is that if it speeds up the review, it sends a signal that it will succumb to congressional micromanagement if the cancer (or some other) lobby can create enough noise on Capitol Hill. That’s really a horrible message to send, so CMS really cannot – or at the very least really should not – deviate from the timeline it laid out earlier this year. Another problem with speeding things up is this: Which tasks at CMS will now take a back seat to this review?
Wait, you mean it might require that CMS take longer to review another life-saving technology? Doctors, device makers and public health advocates might say “sure,” and argue it’s a zero-sum game or better, so what’s the harm?
There’s a lot of harm when CMS has to blindly overrule an advisory conclusion that maybe the task force recommendation has holes in it, that’s what.
And just watch and see what happens if LDCT is overused for this indication as a consequence of the wished-for rush job. Do you genuinely believe docs and device makers will stand up and say mea culpa should such a situation emerge? Do you think anyone on Capitol Hill will take the hit?
If you do, you are the most hopelessly naïve person on Earth.
Again, I get that there are lives at stake, but I also think that subverting a process that has worked reasonably well up to now for a single outcome is amazingly short-sighted. Argue all you want that this is a one-time thing, but we all know that this will not be the last time someone lobbies Congress to mess with CMS on a coverage analysis if the agency caves.
This is a terrible idea, but the cancer lobby has never, ever, wanted for hubris. Let’s hope this fails and everyone involved learns a lesson in the process, but it might not be smart to hold one’s breath.
[caption id="attachment_3112" align="alignleft" width="320"]Cute, but is this little guy the next victim of the war on quack?[/caption]
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.
[caption id="attachment_3102" align="alignleft" width="283"] A DDW attendee stands in an inflatable colon tunnel on the exhibit floor in May.[/caption]
When I was first diagnosed with ulcerative colitis 15 years ago my instinct was to learn everything I could about the disease. Unfortunately, my doctor at that time discouraged me from educating myself. He handed me a pathetic little brochure that didn’t answer any of my questions and told me to stay away from the Internet. It seemed that to him, an uninformed patient was an ideal patient.
I never knew if that doctor was afraid my wee little layperson’s brain wouldn’t comprehend medical jargon, or if he just thought I would naively stumble upon misinformation. He also told me I was too young to have Crohn’s or colitis, collectively called inflammatory bowel disease (IBD), so perhaps he was the one who was misinformed.
Thankfully, times have changed. Patients today, regardless of the health condition they are faced with, are better informed than ever before. A plethora of consumer-targeted websites and mobile apps have launched in the name of patient education. Smart patients are taking responsibility for their own health and are actively seeking information to better manage their condition.
I witnessed a fantastic example of this trend last month during the annual Digestive Disease Week meeting in Chicago. I was impressed to see several IBD patients engaging with experts during DDW Twitter chats. The average patient doesn’t have the money or the credentials to attend medical meetings like DDW. But through Twitter, patients had front row access to experts and to the latest IBD research.
I’m certain the dialogue was equally beneficial for the doctors and researchers. Not only could these experts glean knowledge from each other, they were surely reminded of the impact their work has on actual patients.
In addition to IBD, the DDW Twitter chats explored trends in colorectal cancer screening, the role of the microbiomes in digestive diseases and the hepatitis C epidemic.