As the nation inches toward the November elections and a possible Obama White House, few groups are salivating quite like the trial lawyers lobby. Trial Lawyer Lobby Salivates at Prospect of Obama White House

As the nation inches toward the November elections and a possible Obama White House, few groups are salivating quite like the trial lawyers lobby.

Conversely, few groups are more threatened than America’s medical innovation industry. It is one of the industries in which America continues to lead the world, despite a period of ever-increasing international competition. But even it may now be in jeopardy.

As the plaintiff’s bar anticipates an Obama victory and an even friendlier Democratic Congress, it is mobilizing for open season in what one spokesman labels “war.” Should they succeed under a more lawyer-friendly Obama Administration and Pelosi/Reid Congress, America’s medical industry, and those of us who benefit from its lifesaving innovations, ultimately stand to suffer most of all. This is because new drugs and medical innovations will suddenly become more rare, more expensive and less reliable.

But that’s a small price to pay for liberals in Washington who must find a way to reward the tort bar that helps prop them up.

Under our current regulatory system, medical innovations that pass the Food and Drug Administration’s (FDA) exhaustive, excruciating and years-long approval process are generally protected against subsequent state product-liability lawsuits. According to the nationwide standard established by the 1976 Food, Drug, and Cosmetics Act (FDCA), no state may enact requirements that differ from or contradict federal standards, or that regulate the safety or effectiveness of devices governed by the FDCA.

This obviously makes sense, since medical innovations shouldn’t have to survive FDA examination only to face an onslaught of greedy lawyers who manipulate conflicting and contradictory laws across each of the 50 states. Under such a scenario, America’s medical innovation industry would grind toward a halt, because many states’ laws and regulations conflict with one another, making it impossible to satisfy every regulatory scheme.

But this is exactly what the lawyers’ lobby hopes to achieve, regardless of the costs to American consumers. They seek to dismantle our well-established federalist system, and replace it with a 50-state gauntlet of jackpot justice.

In one line of assault, the tort bar lobby has persuaded Congress to introduce the “Medical Safety Device Act.” This harmless-sounding statute would legislatively reverse the United States Supreme Court’s well-reasoned recent decision in Riegel v. Medtronic, Inc., which affirmed the FDA’s preemption over conflicting state laws.

In Riegel, the plaintiffs argued that a balloon catheter was somehow negligently designed, labeled and manufactured. The FDA, however, had already reviewed the catheter device in question and approved it after thorough analysis. On this basis, the district court dismissed the case, ruling that the plaintiffs’ claims were preempted by federal law. On appeal, the Second Circuit Court of Appeals agreed, noting that plaintiffs weren’t alleging that the particular catheter used somehow failed to comply with FDA standards, but rather that even the FDA-approved device was nevertheless defective.

The U.S. Supreme Court correctly affirmed the district court and court of appeals in an overwhelming 8-1 decision, holding that subjecting this FDA-approved innovation to state lawsuits would place it in the untenable position of simultaneously complying with federal regulations and contradictory state regulations. Thus, all three courts affirmed the logic of our well-designed federalist system.

In a similar case to be heard by the Supreme Court in November, Wyeth v. Levine, the plaintiffs are again arguing that FDA approval is no roadblock to trial lawyer attack. In that case, the plaintiff argues that the manufacturer of the anti-nausea drug Phenergan failed to warn about the drug’s dangers. But the FDA had explicitly approved the drug’s warning label, which warned physicians and the public about its potential dangers if improperly used. Accordingly, the Supreme Court should follow the logic of its Riegel decision and reject the lawyers’ attempt to undercut the FDA’s nationwide standard.

It is also important to note that people injured by medical devices that are defective or poorly-manufactured can still sue, so it’s not as though FDA approval provides manufacturers a free pass to behave negligently afterward.

But this obviously isn’t enough for trial lawyers and liberal politicians whom they support. They want nothing less than a 50-state make-work scheme for themselves, regardless of the consequences to American consumers.

Right now, a divided Congress and Bush White House renders trial lawyers unable to force that scheme upon the nation. But should Obama win the White House and liberals increase their margins in Congress in November, all bets are off.

August 14, 2008
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