April is not yet complete, but two items of interest already bear noting. One of these is perhaps the most important patent case to be heard by the Supreme Court in a long time, at least where life sciences are concerned. The other is of broader but no less intense interest to device makers. Myriad at SCOTUS Leading off is the April 15 hearing of the Myriad case at the Supreme Court, a hearing during which Justice Elena Kagan remarked that the Patent and Trademark Office is "very patent-happy." Of all the comments signaling a jurist's likely vote, this was...
Back in January a columnist for The Virginian-Pilot wrote an incredibly insensitive, misinformed, and elitist piece that had my friends with inflammatory bowel disease (IBD) losing their poop. Pun intended. The column was written in reaction to a defeated bill that would have required businesses in Virginia to allow patients with Crohn’s disease or ulcerative colitis (collectively...
Does more coverage actually equate to more care? That's the question I was posed with while writing a story about a survey from the Association of American Physicians and Surgeons (AAPS; Tuscon, Arizona) concerning the upcoming Medicaid expansion. The Patient Protection and Affordable Care Act calls for a nationwide expansion of Medicaid eligibility, set to begin in 2014. As the law was written, nearly all U.S. citizens under 65 with family incomes up to 133% of the federal poverty level (FPL) ($30,675 for a family of four in 2012) will now qualify for Medicaid. During an interview with Jane Orient,...
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...
Two things happened in January that really got the attention of a lot of people in this country - the payroll tax expired and in some cases insurance premiums went up. This cataclysmic effect sent many to Twitter and Facebook, ranting about how much money was being taken out of their monthly pay. While I could go on about the first blow, it might be more appropriate to talk about the second, being that this is a blog on the med-tech and healthcare industry. According to a report titled, "Cost of Comprehensive Health Benefits” from eHealth, the average monthly premiums...
There’s no shortage of important developments in the world of medical devices, but today, let’s discuss this matter of dogmatic adherence to biostatistics. We’ve all heard about the FDA advisory committee that recently recommended the agency approve a neurostimulation device for refractory epilepsy, and the concomitant thundering from on biostatistical high about what a corruption of the process it is to put the needs of the few gravely endangered patients ahead of numbers. What a global tragedy it is when people who are suicidal are given one last option to deal with their disease. What a moral stain on humanity...
Charles Dickens at his desk in 1858. Dickens' famous opening line from "A Tale of Two Cities" could easily be applied to the current state of the medical device industry, "It was the best of times, it was the worst of times." Here at Medical Device Daily we've become accustomed to the doom-and-gloom stories about our industry. The medical device tax provision in the Affordable Care Act and other emerging realities of healthcare reform along with worldwide economic sluggishness, regulatory and reimbursement challenges, consolidation among hospitals and an increase in hospital-employed physicians has created the perfect storm for the medical device industry....
Chilling. It isn’t often that a bit of news is a perfect fit to that one-word description, but the recent decision by a Los Angeles jury in the first case to be decided pitting Johnson & Johnson (J&J; New Brunswick, New Jersey) against what is a cast of thousands of litigants is nothing short of that. Oh sure, there’s the usual post-decision posturing by the company per appealing the $8.3 million-plus jury award, but c’mon folks, the implications of this case for the medical-products giant – and truly for all other companies trying to do business in the med-tech space...
Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of treatment options. That void is all the more frustrating because epilepsy remains a debilitating condition for reasons beyond the clinical manifestations, often resulting in chronic unemployment or underemployment, social isolation and poor socioeconomic status. It's no surprise, then, that the prospect of a new treatment for people with medically refractory epilepsy would be greeted with great enthusiasm. As an adjunct...
Are you ready? That's probably the most appropriate way to start off a blog entry concerning the soon to be implemented Physician Payment Sunshine Act. And the question isn't just for med-tech companies alone, it's for the physicians as well. A recent survey conducted by MMIS, a company that develops secure communication solutions for firms, shows that physicians still aren't completely aware of the provision- which is set to go into effect in August (a little more than 4 months away. Yikes!). In a conversation with Medical Device Daily, Michaeline Daboul president/CEO MMIS said that survey results of the more...
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