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Articles from 2007 In September

Rethinking Risk Communication

Bill George, former CEO of Medtronic, Susan Alpert, MD, PhD, chair of the RAPS board, and Bogdan Dziurzynski, president of RAPS, agreed that the way risks and benefits are communicated to patients must be rethought, and that postmarket monitoring and communication efforts need to be greatly expanded. The question is, how to pay for that. Alpert suggested that premarket clearance be rethought of as a "learner's permit" rather than a stamp of approval. It would enable products to come to market quickly in limited applications, and then expand to other applications once more extensive postmarket testing was done and no red flags were raised. However, she said, "regulators are not going to want to give up premarket [authority] in order to do more postmarket."

MDUFMA II Becomes Law

Transforming FDA LogoPresident Bush today signed the FDA Amendments Act of 2007, which includes the new version of the Medical Device User Fee and Modernization Act, according to a release just sent out by AdvaMed. The law, among other things, extends the user-fee program for another five years (with significant changes in the user-fee structure) and provides incentives for device makers to conduct pediatric studies. This means there will be no disruption of FDA's work. Had the law not been signed before Oct. 1, all FDA staff whose salaries come from the user-fee budget would have had to be laid off.

5 Ortho Firms Settle with Feds

The five are Biomet, Johnson & Johnson's Depuy Orthopedics, Smith & Nephew, Stryker, and Zimmer. Four of the firms, excluding Stryker, will pay a combined $311 million to settle the claims, reports the Star-Ledger of Newark, NJ. Zimmer will make the largest payment, $169.5 million. All five will pay to have a federal monitor oversee their practices for 18 months. All but Stryker must submit to additional monitoring by the Office of Inspector General for five years. According to the government, surgeons accepted lavish gifts, vacations, and "consulting fees" as high as $200,000 from the firms in return for recommending their products. The government got involved because it decided the practices constituted the defrauding of Medicare. The five firms control nearly 95% of the U.S. market for reconstructive implants. Stryker was spared a fine and the OIG monitoring requirement because it was the first to cooperate. Other fines: $84.7 million for DePuy, $28.9 million for Smith & Nephew, and $26.9 for Biomet. Oddly, DePuy, Biomet and Zimmer are all based in the same town, Warsaw, IN. All firms except Stryker had criminal complaints filed against them, but each of the four signed a "deferred prosecution agreement" that will allow for the criminal complaints to be dropped should they reform their practices to the government's satisfaction. Stryker signed a "non prosecution agreement." Copies of the full complaints and agreements can be found on the DOJ Web site. The government did not identify or charge any surgeons, nor disclose how exactly the schemes worked. Friday morning's Ledger quotes an unidentified attorney from one settlling firm who voiced displeasure at Stryker getting no fine, because the firms believed that all were receiving the same deal. He speculated that the public could come to believe that Stryker did nothing wrong because it paid no fine. It sounds like the practice had become so pervasive in the hip- and knee-replacement markets that the firms felt they had to engage in it in order to compete. That will now end. Hopefully it never got that far in other device markets, but if any has, hopefully this settlement will be enough incentive for the players to cease and desist.

Medtronic Ensnared in Stolen Body-Part Lawsuit

The two men named individually, Michael Mastromarino, owner of one of the tissue-processing companies, and Joseph Nicelli, a funeral parlor owner, also face criminal charges related to the alleged activity. Mastromarino is accused by New York authorities of making deals with funeral directors to remove bones, tendons, and heart valves from cadavers without screening for disease or notifying the families of the deceased. Medtronic issued a recall after it was made aware of the results of the investigation. Livingston found out about his tainted implant after the Fort Worth, TX hospital where he had the operation notified him of the recall. Other patients have also filed suit, according to Livingston's lawyer.

Health Official Warning Over Pump Recall

Is J&J Losing Patent Dispute?

According to the article, Judge Sue Robinson made the final verdicts yesterday, and both companies will be moving forward to appeal the verdicts against them to the U.S. Court of Appeals in Washington, DC.

Artificial Lungs Offer More Hope

One professor at the University of Michigan received a $5 million grant to develop an artificial lung that would take over lung function and use the heart to serve as the pump. Although these devices will need extensive research and clinical trials (if they even make it to that point), the technologies show significant promise for patients who can't take breathing for granted.

Canon Launches New Midwest Tradeshow

According to the company's senior vice president of events, Kevin O'Keefe, the fives states surrounding the show make up a $20 billion marketplace for medical device manufacturing. MD&M Midwest will be held in September 2008. The show, which will also include a conference lineup, is expected to draw 300 exhibiting companies and 4000 medical design and manufacturing professionals.

House Passes Bill to Forestall FDA Layoffs

Transforming FDA LogoThe House yesterday passed a House-Senate compromise version of a sweeping FDA reform bill that includes the new version of the Medical Device User Fee and Modernization Act, reports the New York Times. The Senate is expected to pass the bill today, and President Bush is expected to sign it quickly, to forestall dismissal notices from going out to about 2000 agency employees on Friday. Without the user fees in place by Oct. 1, the agency would not have the funds to keep much of the staff it has hired as a result of the fees. In addition to the MDUFMA-related provisions, the bill contains changes in the approval process for pediatric devices, and limits the number of conflict-of-interest waivers the agency can grant for members of its advisory committees. UPDATE: As expected, the Senate passed the bill on Thursday.

Former J&J Execs Say Firm Ignored Concerns About Contraceptive Safety

But court documents now reveal a second whistleblower, a former vice president who resigned rather than sign off on a "benefit and risk safety evaluation" he disagreed with. The patch has been linked to blood clots -- possibly from great estrogen exposure -- and the plantiffs allege that J&J knew it had greater risks than birth-control pills (which have as much as 60% less estrogen than the patch), but marketed it agressively, underplaying the dangers. Postmarket studies are ongoing, and results so far have been contradictory. They could ultimately decide the fate of the lawsuits. In the meantime, J&J has a very messy situation on its hands.