Medical Device Daily Washington Editor

WASHINGTON — Lawsuits are notorious for addressing only those who have had problems in connection with a medical device, and Monday's session at the National Press Club (Washington) gave the patient's side of the story from several Americans who have benefited from medical devices. Their appearance, sponsored by the Advanced Medical Technology Association (AdvaMed; Washington) provided some faces and names to the other side of the pre-emption coin than is typically heard from.

Brett Loper, AdvaMed's director of government affairs, said at the beginning of Monday's session that the decision in Riegel v. Medtronic showed that the Supreme Court was "concerned about the impact of pre-emption on patients." He noted that the 8-1 vote in Riegel, "was not a close decision," and that the decision "did not alter the regulatory landscape." Loper also asserted that the decision "did not provide blanket immunity," but "referenced ways in which device makers would still be liable under state tort claims," including for defective devices.

The first of the patients to speak was Laura Doud of Arlington, Virginia, who remarked, "it's a great day to be a recipient of a class III medical device."

"My story begins in 2004 when I fell ill with flu-like symptoms," which a physician diagnosed as pleural effusion, a downstream result of an ejection fraction of roughly 10%.

"Anything under 14% puts you in the category of needing transplantation," Doud remarked. Before long, she said, the electrophysiological functions of her heart had begun to degrade, and she "was relegated to spending time on the couch."

Doud was diagnosed with viral cardiomyopathy but she said thanks to the Maximo implantable cardioverter defibrillator made by Medtronic (Minneapolis), she felt better shortly. "I had zero quality of life when I was ill, and without the device, I wouldn't be playing with my nephew on the weekends and I wouldn't be getting married in four weeks."

Adam Hammond of Chillicothe, Ohio, a U.S. Army paratrooper, had logged more than 1,000 jumps with the service, but the parachute "failed to open properly" during a September 2006 jump, he said, leaving him with a severed femoral artery and a damaged aorta along with multiple breaks of his spine.

Hammond was comatose for six weeks, but unexpectedly survived only to face two years of therapy. "The biggest part of my therapy was pain management," he said. "My daily life consisted of waking up, moving to the couch and sitting down." He said he had little success in dealing with the pain until he found himself in contact with a physician practicing in West Virginia who prescribed the Eon Mini, a spinal cord stimulator manufactured by St. Jude Medical (St. Paul, Minnesota). "When I turn this on, it basically scrambles the pain signals" going to his brain and "limits my pain to a one or a two" on a scale of one to 10.

Within a week, "I was walking twice as far" as before he went on the device. "I'm back in school and skydiving again," he said, but without the device "I'd still be in my wheelchair and limited to moving from my bed to my couch."

"It helped me get off my medication," Hammond stated, a regime that included but was not limited to methadone and vicodin. "After receiving the device, I could get off the medication and become a productive member of society."

Mike Roman of St. Louis said he injured his knee playing basketball in 1994, leading to a knee arthroscopy and then an infected knee. The infection persisted, though, and he had "about 26 or 27 operations" which progressively removed more tissue until his leg was gone. As is often the case, the amputation left him with profound phantom pain. "I struggled really hard to find a place to survive," he said of his ordeal. "What the pain didn't take away from me, the medication stole," he remarked.

Roman said that at one point, he was on 300 milligrams of morphine and 25 milligrams of Valium (diazepam) a day, noting that he was plagued with "suicidal thoughts."

"I felt like my whole life was slipping away," Roman said, until he encountered the Precision Plus stimulator, made by Boston Scientific (Natick, Massachusetts). He said that other electrostimulation therapies exhibited little effect on the pain, but that the Precision "turns it into a tingle."

"I think that all this technology – all the clichés – allows me to fly," he said, noting that he is pursuing his dream to become a world-class race car driver. "Today life is good," Roman said, adding that he and his wife "Susie and I have dedicated ourselves to raise awareness" of chronic pain via a web site at www.raceagainstpain.com.

Regarding the legislation, Loper said the House of Representatives is still up for grabs. "It's still early in the legislative effort," he said, adding "I think there's still an opportunity there."

Loper said the effect of the bill would add to an already dismal outlook for device start-ups. "One of our greatest concerns," he said, is that the combination of the end of pre-emption along with other factors would squash investor interest. "Without that hotbed of innovation coming from the start-up – if you change the equation by regulating through litigation – I think you'll see a stifling of interest."

Loper also pointed out that the device industry is not operating in a walled-off financial environment. "We're competing for dollars going to energy and so on," he said.

Loper declined to speak for the association's larger members on whether they would invest in start-ups in order to keep new devices coming, but he acknowledged that publicly-traded companies are more risk averse than start-ups. "I think the analogy I would use is that instead of going for the home runs, they're going to go for the safe singles and doubles," he said.