Friday, October 14, 2011
This week on CBS's Chicago law firm drama “The Good Wife,”, Alicia (Julianna Margulies) and her suave boss are locked in a heated arbitration process with defense attorneys. The case: a patient treated with a spinal cord stimulator for pain who is experiencing adverse events is suing her doctor after she discovered, first, that the device she received was invented by the physician, who was receiving royalties on its sales, and, second, that that the product was not FDA approved. “He just implanted it in me like I was a guinea pig,” Alicia’s client claims in one deposition.
This all rang a bell to me. Replace 'spinal cord stimulator' with 'mitral valve repair device' and you have a very similar situation to the controversy that surfaced in 2008 with Edwards Lifesciences Myxo ETlogix 5100 annuloplasty ring. A patient got the Myxo device in 2006 after her cardiologist referred her to Patrick McCarthy, a cardiothoracic surgeon and Edwards consultant at Northwestern University who invented the Myxo ring and other annuloplasty devices. He was conducting a study on early experiences with the device. The patient developed an inflammatory reaction and went back to the Northwestern cardiologist who referred her, Nalini Rajamannan, for a follow up. In conjunction, the patient noticed on a warranty card she received after the procedure that her device was labeled as the “McCarthy” annuloplasty ring, which prompted her to go to FDA; she was apparently concerned that she was implanted with a prototype device invented by the surgeon without her consent. FDA’s response: we have not approved that device. It turned out Edwards had relied on a 1997 FDA guidance document to internally justify that the product was only a “minor modification” to a previously cleared ring and thus did not require a submission or notification to the agency. This is a common practice and a good way for FDA to avoid clogging up its dockets with a whole bunch of submissions for aesthetic modifications or minor wording clarifications in labeling, for example, but there has always been a gray area about where the line should be drawn. Anyway, the patient sued.
I was smitten when the term “minor modification” was a major plot turner in Sunday’s episode. It was almost enough to stop the plaintiff team in their tracks when a product manager for the manufacturer testified that the device was legitimately on the market and required no investigational status or extra informed consent because it was only a minor modification of a former device. Ah, but touché. Borrowing an argument forwarded in an ongoing real-life suit against Dr. McCarthy, Alicia’s team eventually points to the doctor’s patent for the spine stimulator in question, which describes the device as the best thing since sliced bread and clearly different from anything else before it. That was enough to get the plaintiff a multi-million dollar settlement.
Real life, as usual, is more complicated. The patient inquiry and, perhaps, follow-up communications by the patient and Dr. Rajamannan with a few senators named Obama, Durbin and Grassley, prompted FDA to looking further into the matter. Edwards removed the device from the market in 2008 and submitted a new 510(k) application. The company ultimately gained a 510(k) clearance in April 2009 for what is now called the dETlogix 5100 ring, for a more general indication than what Myxo was originally marketed for. The original patient who raised the matter dropped her lawsuit against McCarthy, Northwestern and Edwards, but a different patient who received the device during a similar period continues to pursue a suit. The controversy was one key driver in FDA’s decision to revise its 1997 guidance to companies on how to determine if they need a 510(k) for a device modifications; a new draft was issued this summer. And the matter made some headlines again this week as news came out that Dr. Rajamannan, after already being denied tenure, was dismissed from her position at Northwestern Sept. 30. The University says the dismissal is the result of her not gaining tenure based on a peer-reviewed process and is in no way retaliatory. Rajamannan disagrees.
If that was not enough for us med device policy geeks, we have the movie Puncture, which had a special screening in Washington D.C. on Wednesday night and is in limited release in New York, Los Angeles and Houston. It appears that Chris Evans, the title star of the 2011 summer action film, “Captain America: The First Avenger,” is now battling unsafe needles in a film loosely based on the real-life case of Retractable Technologies.
Underlying the challenge for the protagonists is a “corrupt arrangement between monolithic hospital purchasing cartels and a big needle maker, in which the industry giant was able to pay millions in kickbacks to the cartels to make sure its unsafe products — and only its products— were used in hospitals,” according an unofficial movie website set up by several groups to highlight the real-life issues portrayed in the movie.
This is a direct reference to the GPO safe harbor, which allows the purchasing organizations to accept fees from hospital suppliers, including device makers and others, with whom they negotiate discount contracts with for member hospitals, without running afoul of the federal anti-kickback statute. The Medical Device Manufacturers Association, which has been lobbying Congress to remove the safe harbor for years based in part on arguments that it encourages GPOs to block smaller firms from hospital customers, sponsored the D.C. screening. The group invited congressional staff and members of the press, among others.
It remains to be seen whether Puncture helps MDMA make headway on Capitol Hill. On the whole, “The Gray Sheet”'s Jessica Bylander, who attended the screening, reports: “The film was a pretty typical David and Goliath story, pitting this group of “underdogs” – the friends’ struggling law firm, the engineer who couldn’t sell his product and the nurse who contracted HIV – versus the very slick-seeming, well-oiled GPO machine whose lawyers basically tell the main characters to give up because there’s no way they can win and no way the GPO will settle. But apparently the GPOs eventually did.” For a potential lobbying tool, however, she notes, “The movie was uncomfortably R-rated at times.”
- David Filmore
By Chris Morrison at 2:53 PM