U.S. Supreme Court upholds legislation granting immunity to defective medical devices
President Bush has spent much of his two terms in office repaying favors to various industries that supported his election. One of the most substantial contributors to his election victories was the medical/pharmaceutical industry, and that industry has also been a major beneficiary of his largesse. This week the Supreme Court upheld legislation Bush's Administration sought and obtained, intended to immunize medical device manufacturers for injuries resulting from product defects, so long as the device was approved by the FDA. A similar new law, addressing drugs approved by the FDA, will be before the Court soon.
The Bush Administration went to incredible lengths to "pay back" the industries that had contributed significant cash to Bush's election. Everyone knows about his insistence that the federal government be prohibited from negotiating drug prices in the Medicare Drug Bill. His nominee to the Consumer Product Safety Commission continued to insist that the CPSC did not need funding or manpowerpower restoration, despite repeated embarrassments in CPSC enforcement. One of his appointments was withdrawn after the National Association of Manufacturers tried to "prepay" the appointee for special favors by paying him a departing six-figure bonus.
The Bush Administration plumbed the depths of cynicism by making a number of these appointments, sending numerous industry insiders to federal government positions where they could be paid by the taxpayers to avoid regulating their friends and peers. Numerous examples of these appointments and their [intended] anti-consumer consequences are discussed in other blog entries. Bush Adminsistration "paybacks" have also taken the form of special interest legislation granting various industries some form of immunity from citizen lawsuits. Bills seeking immunity for the telecommunication industry for its efforts in enabling warrantless surveillance of U.S. citizens are currently under discussion, for example.
In the arena of pharmaceuticals and medical devices, the Bush Administration sought legislation granting immunity to any devices approved by the FDA. Michigan adopted a similar immunity scheme a decade ago, and former Michigan Governor Engler apparently carried this "special favor" to Washington when he followed Bush to the District. The legislation was passed by the Republican Congress, and the U.S. Supreme Court recently upheld it. While on superficial analysis, this bill does not sound totally unreasonable: when one considers the details, however, one recognizes that it represents just another example of special favors for a big contributor.
Are the device or drug industries struggling? Goodness, no. Financially, they are the best-perfoming industry in the country, in terms of historical earnings. Do they have an unblemished record in terms of the safety of their products? For sure no; just look at our weblog's discussion of numerous defective and dangerous products. Has the FDA demonstrated the strength and independence in regulation that would justify removing from citizens their right to seek private redress? Well, no, as a matter of fact. The FDA is demonstrably short of resources and even before the Bush Administration emasculated its leadership, it had a checkered history in protecting patients. Even the approval process is flawed: often a majority of the panel of "experts" who are relied upon to confirm approval of drugs and devices suffer at least the appearance of a conflict of interest because of their employment within the industry or their reliance upon industry grant and research money. The Institute of Medicine of the National Academy of Sciences, the Government Accountability Office, and the FDA's own science board have all found serious flaws in the Agency's management, according to a February 22 editorial of the New York Times.
In 1996, the U.S. Supreme Court rejected similar claims of FDA-inspired immunity. Next week, the Court will hear another case where the Plaintiff injury victim relies on claims that the manufacturer misrepresented evidence or withheld information in obtaining FDA approval. Justice Ginsberg's dissent rejected the majority's claim that the 1976 legislation relied upon by the immunity-activists was intended to achieve this result: Ginsberg pointed out that the legislative intention was clearly to enhance patient safety, while this outcome has the opposite impact. Sadly, special favors for special interests (with cash in hand) have become a staple of modern American government.