A Medical Device Daily

FDA issued an update last week for its December 2007 public health notification addressing radio frequency (RF) ablation of lung tumors, informing doctors that the hazards of using RF ablation have generated "reports of death and serious injuries associated with the use of RF ablation devices in treatment of lung tumors."

The agency apparently wants to reinforce the understanding that no RF ablation devices have been cleared or approved for this specific application, noting that existing clearances and approvals cover "the general indication of soft tissue cutting, coagulation, and ablation by thermal coagulation necrosis." However, that clearance "was based only on bench testing data or animal testing performance data" and the agency states that under that broad indication, "RF ablation can be used as a tool to ablate tumors, including lung tumors."

More specific indications have included "partial or complete ablation of non-resectable liver lesions, and palliation of pain associated with metastatic lesions involving bone," but the absence of a specific lung tumor indication is due to the lack of an application that provides "clinical data ... to justify the indications by showing that the device, when used on a well-defined target population, consistently achieves the desired treatment effect."

The lack of that data leaves FDA with an uncertain picture on the actual adverse event rate, and hence "we cannot say if these deaths or injuries are occurring more frequently than with other forms of treatment for lung tumors." A number of factors are likely to be involved in any adverse events, such as "patient selection and management, technical use of the RF device, post procedural treatments, and management of complications."

Because of the dearth of data, the agency is asking doctors to be sure to report any such events to the Manufacturer and User Facility Device Experience (MAUDE) database. The Sept. 24 notice also points out that an advisory panel convened in 2003 expressed concerns about the possibility that such events are under-reported, but the notification goes into no detail on that discussion.

Medtronic says qui tam suit settled in '06

The nation's newspapers usually publish items of recent vintage, but Medtronic (Minneapolis) and the Wall Street Journal seem to have differing views on the question of what constitutes "news."

In both the electronic and print versions of last Thursday's edition (Sept. 25) of the WSJ, the newspaper's David Armstrong penned an article that dealt with a qui tam (whistleblower) lawsuit filed by former Medtronic legal counsel Ami Kelley, who alleged that the firm's executives lavished gifts on physicians, including trips to a strip club, the Platinum Plus (Memphis, Tennessee), which is where the company's spinal unit, Sofamor Danek, is located. Kelley is said to have described kickbacks as "pervasive," according to the WSJ, but no physicians were ever charged in connection with the matter, which first came to light in 2002.

According to the WSJ article, Medtronic declined to comment on the story because the case was closed under seal. Apparently the reason the story came to the surface again is that another former Medtronic employee who was part of the qui tam suit, Jacqueline Poteet, was dissatisfied with the settlement. Poteet's action may jeopardize the settlement Kelley obtained when the case was closed in 2006.

Medtronic posted a statement at its web site last Friday, stating that the firm "regrets that the Wall Street Journal chose to publish allegations the paper claims are part of a qui tam lawsuit ... which was settled in federal court in July 2006." The statement said that while the firm "cannot discuss the allegations that remain under seal by court order," it has "put more rigorous systems and processes in place to assure alignment with these standards, identify any break from standards, and address behavior that is in violation."

The statement also noted that the spinal unit "has established an electronic database to capture and manage arrangements between the business unit and its customers," which will "provide an additional level of compliance controls ... and are required by a corporate integrity agreement entered into as part of the qui tam settlement. Medtronic also noted that Sen. Chuck Grassley (R-Iowa) cited the firm in 2008 as an industry leader and said that "the company's leadership for reform in [reporting physician arrangements] is an important development in the debate" over how to keep physician/device maker relationships from sliding into an area of inappropriate behavior.

Medtronic also stated that it supports "the proposed legislation by Senators Grassley (R-Iowa) and Herb Kohl (D-Wisconsin), the Physician Payments Sunshine Act of 2008, which aims to curb inappropriate relationships or conflicts of interests between industry and physicians."

Kyl puts out new patent reform bill

Just when the 110th Congress thinks it is down to the last set of issues it will have to face before the election, a few more bills make the rounds, including a new iteration of patent reform legislation.

Sen. Jon Kyl (R-Arizona) has offered the Patent Reform Act of 2008 (S. 3600), and while the bill is not yet available from the Government Printing Office for review, two industry groups have already lauded the effort.

In a Sept. 24 statement, Stephen Ubl, president of the Advanced Medical Technology Association (AdvaMed; Washington) said the association's members "applaud Sen. Kyl and his staff for their leadership and inclusive approach to developing this legislation." Ubl also recommended "that any patent legislation be balanced in its treatment of concerns raised by stakeholders and not favor one industry model to the detriment of others." He also said the Kyl bill "offers a more balanced approach to patent reform than previous bills."

Jim Greenwood, president/CEO of the Biotechnology Industry Organization (BIO; Washington), said in a Sept. 25 statement "the Kyl legislation advances the debate on damages in a positive direction by enhancing consistent enforcement of the current law on damages and providing greater predictability for companies across all industries – but without manipulating the rules to favor infringers."

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