Healthy Skepticism Library item: 13876

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Publication type: news

Rugaber CS.
Wyeth decision could set legal precedent
The Star Ledger 2008 Jun 27
http://www.nj.com/business/ledger/index.ssf?/base/business-1/121454136752510.xml&coll=1

Full text:

Musician Diana Levine won a $6.8 million judgment against drugmaker Wyeth after having part of her right arm amputated in 2000 when an anti-nausea drug was improperly injected.

But Wyeth has appealed the case to the Supreme Court, setting up a potentially landmark ruling that could make it easier for pharmaceutical and other companies to defend themselves against product liability lawsuits.

The case, along with a separate tobacco lawsuit against Altria Group, centers on whether federal regulation of products overrides state laws, including those that govern when a person or company can be held liable for another’s injury.

The court’s ruling in the Wyeth case “potentially could apply to all lawsuits against all manufacturers of prescription drugs,” said Mark Herrmann, an attorney at Jones Day in Chicago who represents drug and medical device companies. “It’s the 800-pound gorilla.”

That’s because the vast majority of lawsuits against drugmakers involve the same issue: whether the company provided sufficient notice of potential hazards in the product’s label. Pharmaceutical labels are approved by the Food and Drug Administration.

If the court issues a broad ruling in favor of Wyeth, other industries likely will follow suit, said Thomas McGarity, a professor at the University of Texas Law School.

“We’re going to see anything that any federal agency has anything to do with get pre-empted,” McGarity said.

Pre-emption refers to the constitutional principle that federal laws override state laws. Businesses increasingly have used the concept to fight consumer lawsuits. In the court’s term that ended yesterday, the justices sided with businesses in two pre-emption cases, and that bodes well for Madison-based Wyeth.

In February, the court ruled 8-1 in a case involving Medtronic the FDA’s approval of advanced medical devices bars consumer lawsuits claiming design defects or improper labeling. That decision led the Arkansas Supreme Court in April to reverse its position and throw out a lawsuit against Soundtec over a hearing aid.

But two House Democrats yesterday proposed legislation that would reverse the court’s decision in the Medtronic case and clarify that suits against medical devices aren’t pre-empted. A similar bill is expected in the Senate.

The high court also ruled unanimously in February federal regulation of transportation prohibits states from imposing their own rules on shipping companies to help block tobacco shipments to minors.

“The chances are high that the Supreme Court in Wyeth … will come out in favor of the company,” McGarity said.

Such a decision could lead the lower courts to throw out many high-profile cases against pharmaceutical companies, Herrmann said. That could include suits against Merck, Eli Lilly, GlaxoSmithKline, Pfizer and other firms that have spent billions settling claims.

In the Wyeth case, the company said the label for the anti-nausea drug used by Levine, a Vermont resident, included sufficient warnings about the risk of gangrene if the drug was improperly injected. Wyeth said it couldn’t have issued stronger warnings without FDA approval.

A Wyeth spokesman declined to comment, but the company’s lawyers contend the Vermont Supreme Court ruling that upheld a jury’s $6.8 million award to Levine put the company in an impossible position: either keep the label and risk further liability or change it and violate federal law.