Plaistow woman’s lawsuit could end up before Supreme Court
The U.S. Court of Appeals for the First Circuit recently affirmed a trial court ruling that awarded Karen Bartlett of Plaistow more than $21 million in damages after an anti-inflammatory drug left her with extreme burns and permanent near-blindness.
John Greabe, a law professor specializing in constitutional law at the University of New Hampshire School of Law, said the appeals court ruling 'sort of teed it up' for the U.S. Supreme Court.
'I can't imagine that (the Supreme Court) won't take it up, unless this gets settled beforehand,' Greabe said.
Bartlett sued Mutual Pharmaceutical Company, the manufacturer of sulidnac, a generic drug that can cause toxic epidermal necrolysis, a life-threatening disease characterized by the detachment of the top layer of skin from lower layers.
According to the ruling, Bartlett suffered the condition on about 60 to 65 percent of her body. She spent 70 days at Massachusetts General Hospital, including more than 50 in its burn unit. She cannot eat normally because of esophageal burns, is nearly blind and is seriously disfigured, according to court records.
'Bartlett's injuries were truly horrific,' the appeal court ruling said. 'Her burn surgeon described the experience as 'hell on earth.''
One of Bartlett's attorneys, Timothy Beaupre of Shaheen, Gordon and Associates, said the firm was pleased with the verdict, but that he agreed the Supreme Court will likely take up the case should Mutual petition the high court, which it has 90 days to do from the date of the appeals court verdict.
'Of course we are very pleased by the decision of the Appeals Court to affirm the verdict,' Beaupre said. 'Although we expected the decision would be affirmed, it confirms that the jury's verdict was fair and that (U.S. District Court Judge Joseph) LaPlante handled the case well from the bench. It's a credit to our client, the judge and the jury process.'
However, he said, 'I think this is fertile ground for an appeal.'
A New Hampshire federal trial ruled in Bartlett's favor and awarded her $21.06 million. Mutual appealed, arguing that the trial court misunderstood New Hampshire law on design defect claims and that the award was excessive. The company argued that the award was the largest in New Hampshire's history.
The appeals court ruled that the district court's ruling was consistent with New Hampshire law on liability for drug defects and disagreed with Mutual's claim that the award was excessive.
'In sum, the jury's award is not so clearly disproportionate to the harm suffered that a court must set it aside,' the ruling said.
But Greabe said it's not the size of the claim that likely will matter to the highest court in the country. At issue, he said, is whether manufacturers of generic drugs should be expected to 'second-guess' the Food and Drug Administration.
When drug manufacturers produce generic drugs, they are bound to use the drug's original chemical composition and cannot alter it, according to the appeals court ruling. Mutual argued that it wasn't liable for Bartlett's injuries because they could not change the drug before marketing it.
The trial and appeals courts, though, said the company had another option.
'But although Mutual cannot legally make sulindac in another composition ... it certainly can choose not to make the drug at all,' according to the appeals court ruling.
'The crux of Mrs. Bartlett's argument was that this drug shouldn't be on the market,' Beaupre said.
The issue, Greabe said, is how the Supreme Court will reconcile two earlier decisions it made regarding drug lawsuits. In the first, Wyeth vs. Levine, the court ruled that manufacturers of brand name drugs could be held liable in state courts for failing to provide adequate warnings. The drug makers in that case argued that they used labels approved by the FDA, but the Supreme Court ruled that the manufacturers of brand name drugs are not prohibited from placing additional warning labels on their drugs.
However, in a later lawsuit, PLIVA Inc. vs. Mensing, the Supreme Court carved out an exception to the Wyeth ruling for generic drug manufacturers, who cannot alter FDA-approved labels. In that case, the drug maker was not held liable for failing to provide an adequate warning because it couldn't legally change the FDA warnings.
'On balance, we conclude that the Court adopted a general no-preemption rule in Wyeth and that it is up to the Supreme Court to decide whether PLIVA's exception is to be enlarged to include design defect claims,' the appeals court wrote in its opinion.
'That virtually invites the Supreme Court to take a look at this case,' Greabe said.