Medical Device Daily Washington Editor
Medtronic (Minneapolis) on Monday won a dismissal of a series of lawsuits dealing with the Sprint Fidelis lead, a legal decision in keeping with the Supreme Court ruling of last February (Medical Device Daily, Feb. 21, 2008) in the case of Riegel v. Medtronic, which confirmed FDA's regulatory pre-emption of state liability laws where PMA devices are concerned.
However, the decision is sure to light a fire under Democrats in Congress, including Rep. Frank Pallone (D-New Jersey), who penned a bill last year that would rescind pre-emption (MDD, June 30, 2008).
The Fidelis lead was reportedly used in 90% of patients getting Medtronic's electrophysiology equipment in 2007 and earned the firm $1 billion before the problems began to surface. The Fidelis was not proofed via clinical trial, but by bench testing to establish durability.
The lawsuits, which ended up in the U.S. District Court for the District of Minnesota, were filed on behalf of 850 patients and are said to be headed for appeal, according to attorney Hunter Shkolnik of Rheingold, Shkolnik & McCartney (New York). Any such appeal would be handled by the Eighth Circuit Court of Appeals.
The judge in the Minnesota district case, Richard Kyle, stated in his opinion that "at least some plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight." However, he concluded that the solution "lies with Congress."
Bill Hawkins, chairman/CEO of Medtronic, said in a statement posted at the firm's web site that the company is "pleased with the Court's decision, which is consistent with the United States Supreme Court's ruling in Riegel v. Medtronic last year," and that the ruling "supports the principle that [FDA] is the appropriate body to determine the safety and efficacy of innovative technologies."
Wanda Moebius, a spokeswoman for the Advanced Medical Technology Association (Washington), told Medical Device Daily in an e-mail exchange that "from a policy perspective we believe it is critical that the courts recognize FDA's long-established preemptive authority with respect to PMA products as the U.S. Supreme Court did last year." Moebius added that "a central, expert authority to weigh the risk-benefits of medical technologies for all Americans is key to patient access to life-saving treatments and continued innovation."
At press time, a call to Pallone's office had not been returned.
CMS opens NCA for PET as diagnostic
The Centers for Medicare & Medicaid Services (CMS) has announced it will undertake a national coverage analysis for the use of positron-emission tomography (PET) as a first-line diagnostic for suspected cases of cancer. CMS has been reimbursing for PET for such uses under the coverage with evidence development (CED) regime for several years, and the accumulation of data has prompted the agency to open the idea up for consideration for routine reimbursement.
The Jan. 7 announcement states that the proposed decision "would remove a significant part of the CED requirement for PET scans in cancer and allow coverage for one PET scan to guide the initial treatment strategy." However, the use of PET for further treatment strategies will still fall under the CED mechanism "as CMS believes that the current evidence is not adequate to provide coverage for PET scans in guiding subsequent treatment."
Acting CMS Administrator Kerry Weems, who is likely a short-timer at the agency, said in the statement that CMS is "pleased with these first results of the Coverage with Evidence Development program and look forward to patients gaining greater access to new technologies while enhancing the evidence physicians use to make treatment recommendations."
Don Ruckner, MD, chief medical officer at Siemens Medical Solutions (Malvern, Pennsylvania), told MDD that a decision to generally cover first-line diagnosis of cancer via PET "is not going to have a significant effect on sales," because most patients have already been getting the scans, albeit in a delayed fashion.
Ruckner also said it is difficult to forecast whether a positive outcome on the analysis would put more bundling into play for Medicare reimbursement. "Historically, CMS goes through phases of bundling and unbundling," he said, so there is no certain way to predict the outcome.
As for patient care, Ruckner said, "I think there will be pretty big changes" because "the biggest clinical impact [of PET] has been on surgical cures." He made the case that earlier diagnosis can "save Medicare massive amounts of money."
Ruckner said that while the decision memo deals with use in initial diagnosis and not staging, that latter function will figure more prominently in the technology's future all the same. "You'll see increased use down the road in evaluating the effect of chemotherapy," which is currently based on tumor size. With some cancers, "you can see within days whether the tumor has stopped metabolizing," which indicates some positive effect of chemotherapy.
Ilyse Schuman of the Medical Imaging and Technology Alliance (Rosslyn, Virginia) told MDD, "We're pleased that this is moving in the direction of providing patient access to minimally invasive procedures," especially for cancer. She said that "over time, this is a valuable tool in determining the most effective treatment," and that there are sure to be "cost savings associated with smarter treatment decisions."
CNN's Gupta tapped for surgeon general
A physician who serves as the chief medical reporter for cable news giant CNN (Atlanta) is the subject of rumors that he will serve as the nation's next Surgeon General.
Sanjay Gupta, MD, a neurosurgeon, is said to have been approached by the transition team for President-elect Barack Obama, and while the move may prove popular with television viewers, it will not go without dissent.
Gerard Farrell, executive director of the Commissioned Officers Association of the U.S. Public Health Service (Landover, Maryland), is on record as preferring that the incoming administration choose someone from the Public Health Services' corps. "The best way to find a good leader and to depoliticize the office is to do what the military does: you pick leaders from within the service," Farrell is quoted as having said.
Gupta would have to leave behind a thriving personal business, which includes regular work for CNN, appearances on CBS Evening News and columns in Time magazine. Gupta also is said to receive as much as $50,000 for speaking fees, according to the All American Talent and Celebrity Network (Decatur, Illinois). The salary for a surgeon general is in the range of $150,000 a year.