Why is the head of the American Bar Association – without a vote of its members – trying to overturn an 8-1 Supreme Court decision in a way that could bankrupt the clients of a lot of ABA members?
And why should non-expert attorneys, judges and juries in the 50 states, and the District of Columbia, be asked to make highly technical judgments about the safety of medical devices that Food and Drug Administration (FDA) experts have already approved?
These questions arise in response to letters from ABA president Tommy Wells to various congressional committee chairs late last year. Wells’ Dec. 29, 2008, letters supported legislation designed to reverse the Feb. 20, 2008 decision in Riegel v. Medtronic.
The Riegel case involved an incident in which a heart catheter ruptured mid-surgery after the doctor used the catheter in a way counter to the specific rules on the device’s labeling, as approved for use by the FDA.
The victim sued, under New York state law, not the doctor and the catheter’s manufacturer. The Supreme Court ruled that Congress had expressly “pre-empted” state law by giving the FDA authority to determine the safety, and labeling requirements, of medical devices.
“On behalf of the American Bar Association and its over 400,000 members,” Wells wrote, “I write to express support for the ‘Medical Device Safety Act.’ … [The bill to counteract the Riegel decision] is consistent with ABA policy supporting the continued right of the states and territories to regulate product liability law….”
But no committee of the ABA has voted to complain about Riegel or to urge its reversal. Wells based his letter on a 1995 resolution of the ABA House of Delegates which, while opposing a specific law then before Congress, asserted generic states “rights” concerning product liability law.
But the 2008 court decision involved an entirely different law, passed in 1976 with no opposition from the ABA. The ABA never opposed the FDA’s authority to pre-empt state law.
Indeed, when one branch of the ABA proposed a resolution in 2006 to oppose federal regulatory pre-emption, the resolution proved so controversial that it was withdrawn without a vote.
It should be said that Wells is a congenial and thoughtful man. He told me Monday that while he believes the 1995 policy statement is “broad enough to cover the current statement as applied in the letters,” he had been unaware (when he wrote those letters) of the 2006 proposal, and withdrawal, of a more specific policy on the subject.
The withdrawal, he said, “would indicate that clearly there is some controversy.” With that in mind, while declining to withdraw his letters, he has announced that he will appoint a “balanced” task force to review the whole issue, with a chair who “doesn’t have a dog in the fight.”
The task force idea is wise. But Wells should withdraw his letter pending the task force review. His position badly overstates the scope of the ABA’s 1995 resolution. Clearly, the “400,000” members of the ABA do not speak with one voice in favor of Wells’ policy statement.
Now – why should you and I care about all this?
Because, in the guise of protecting patients from medical error, allowing states to pre-empt federal standards could result in patients dying on the operating table for lack of proper equipment. Securing approval for a new medical device already is an incredibly time-consuming and expensive process.
If a company must add the expense of defending jackpot-seeking lawyers in 51 jurisdictions under 51 sets of rules, it likely won’t even bother developing many of those life-saving devices in the first place.
The Supreme Court noted that “The FDA spends an average of 1,200 hours reviewing each application,” and its “experts” must consider “how many more lives will be saved by a device.” In a state court, on the other hand, “the patients who reaped those benefits are not represented in court.”
Wells’ position leaves those patients out in the cold, so even if it were an accurate statement of the ABA’s official stance, it would be morally indefensible.
Quin Hillyer is associate editorial page editor for The Washington Examiner. He can be reached at [email protected].
