Medical Device Daily Washington Editor
Skeptics tend to think that most bills that surface on Capitol Hill will go quietly into the night, and a tabulation of bills might support this idea. Whether such a fate will befall a new bill that would do away with federal pre-emption of state liability law for medical devices remains to be seen, but passage would profoundly affect the medical device industry.
In response to the Supreme Court decision in the case of Riegel v. Medtronic (Medical Device Daily, Feb. 21, 2008), Sen. Ted Kennedy (D-Massachusetts) set the rhetorical tone by asserting that Kennedy added that "Congress obviously needs to correct the Court's decision" or "FDA approval will become a green light for shoddy practices by manufacturers."
Supreme Court Justice Antonin Scalia offered another view at the recent conference hosted by FDA and the Food and Drug Law Institute, stating to a luncheon audience that the Court's members "were guided by plain meaning and by intent" as expressed in MDA. He said the Court "concluded that federal law had indeed imposed federal requirements," which applied to common law as well.
In response to Riegel, Rep. Frank Pallone (D-New Jersey), the chairman of the health subcommittee of the House Energy and Commerce committee, offered a bill that would strip the pre-emption provisions of the Medical Device Amendments (MDA) of 1976 that put pre-emption in place.
Pallone's bill fills only two pages, but would amend section 521 of the MDA to read "nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State." The bill also states it will "take effect as if included in the enactment" of MDA in 1976, which suggests a grandfathering in of old liability cases. However, the bill also states that it would apply "to any civil action pending or filed on or after the date of the enactment of this act."
In a Feb. 21 statement, Pallone said the Supreme Court decision "shows why it is more necessary than ever for Congress to step in and restore the protections that patients are entitled to if they are the victim of a life-altering accident caused by a medical device."
In a statement e-mailed to Medical Device Daily, Janet Trunzo, executive VP for technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed; Washington), said AdvaMed is "still reviewing the draft language," but that "patient safety and the effectiveness and reliability of medical devices are not enhanced by patients' ability to sue device manufacturers."
Trunzo said FDA's approach "has served patients well for more than 30 years, and has prevented inconsistencies in standards and unnecessary delays in patient access to products that would occur if state regulations or multiple jury verdicts" forced additional standards.
Pallone has not introduced the bill to the subcommittee, but sources indicate that Kennedy is working on a companion bill for the Senate.
Patent reform moving in Senate?
Patent reform may finally be ready for prime time in the Senate, according to committee staffers, but the fate of S. 1145, the Patent Reform Act of 2007, is uncertain. The House passed its version last year and the Senate Judiciary Committee sent its work to the full Senate for scheduling earlier this year (MDD, Feb. 8, 2008).
Regan Lachapelle, spokeswoman for Senate majority leader Harry Reid (D-Nevada), told MDD that the bill "is not on the schedule yet, but could be debated on the floor as early as next week."
Medicare to soar to 11% of GDP
The healthcare financing fire got a dose of gasoline last month when the Board of Trustees for Medicare and Social Security published their annual report, a hefty document at 242 pages offering reams of data.
The Trustees said that more than 44 million were covered by Medicare last year, with that number split between the disabled (7.2 million) and retired beneficiaries (36.9 million). The program avoided going upside down last year, with $462 billion in tax revenues vs. $432 in outlays.
The hospital trust fund for Part A is expected to lose $326 billion by 2017, when it will have $96 billion left, "far less than the recommended minimum level of one year's expenditures," the report noted. The report said that the fund will likely tank by 2019, "the same year as in last year's report, but earlier in the year." The projected cost rate by 2082 is projected assuming a middling set of conditions to hit 11.4% of taxable payroll, and will equal 4.8% of GDP, more than triple the current 1.5%.
Part B exhibited an average growth of 9.6% in each of the last five years," the report said, and growth will run at about 6.2% for the next decade unless Congress continues to override the maligned sustainable growth rate (SGR) reductions. In that event, Part B costs would rise to an 8%-per-year clip.
The Trustees said the report is prompted by the projection that Medicare will draw more than 45% of its funding from non-dedicated sources over the term of the projection. "This is the third consecutive such finding," the report notes, which forces the White House to present a proposal to trim the cost growth of Medicare, which Congress must consider "on an expedited basis."
The Bush administration proposed a budget allowing Medicare expenditures to grow by about 5% a year over the next five years, but Congressional Democrats have blasted the proposal as a series of cuts (MDD, Feb. 7, 2008).
The report concluded that as a percentage of gross domestic product, Medicare expenditures "are projected to increase from 3.2% in 2007 to 10.8% by 2082."