Two appeals courts, one in Texas, the other in New Jersey, have sided with the Sheriff of Nottingham against Robin Hood, and the US Supreme Court is considering a case that would give the sheriff a get out of gaol free card forever and always. It’s not quite that simple, but it’s close — Goliath gets to wear his armor and David has to shoot ping-pong balls.
In the two cases that went to appeals, the Texas court ruled that the plaintiff had failed to prove that Merck’s Vioxx, a cyclooxygenase-2 inhibitor that was supposed to be safer than traditional non-steroidal anti-inflammatory drugs had caused the death of Robert Ernst, who had died after using the drug. In New Jersey, the appeals court ruled that the jury had been improperly allowed to award punitive damages to the plaintiff and to find that Merck had committed consumer fraud. A relatively small award for damages was allowed to stand.
Non-steroidal anti-inflammatory drugs, such as ibuprofen, naproxene and others, relieve pain, but they can also cause ulcers. Cyclooxygenase-2 inhibitors were supposed to relieve pain without the risk of ulcers. That was true as far as it went, In 2003, Vioxx sales came to over $22 billion, and accounted for 11% of Merck’s total sales. Then, in 2004, it was reported that in long term studies, patients taking Vioxx had a higher rate of heart attacks than those taking the older analgesics. Merck had to drop the product, agreed to pay $4.85 billion in a group settlement with people who had sued, and separately agreed to pay $58 million as a settlement for having produced misleading television ads for the product. Pennsylvania’s attorney general, Tom Corbett said that because of misleading television ads, consumers had asked their physicians to prescribe Vioxx before the physicians had sufficient opportunity to evaluate the drug.
There are a lot of questions about the whole sorry episode. On one side, Merck seems to have, if not hidden the bad news about the product, at least done all they could to avoid knowing. On the other, lawyers have been lining up like hyenas for a share of left-over zebra. On the whole, Merck seems to have more to be ashamed of, since a Food & Drugs Administration report estimated that Vioxx may have contributed to almost 28,000 heart attacks and strokes that could have been avoided had the patients taken a competitor’s product. The hazards of Vioxx were initially unclear because Merck hadn’t performed the sorts of long-term studies needed to show the adverse effects.
The New Jersey case isn’t terrible, but the Texas case might be, and the Supreme Court case could turn out to be a disaster for everyone. The New Jersey case was essentially a matter of law—what decisions should be left to the jury and which shouldn’t—the basic structure of the right to sue remains intact. The Texas ruling, at least as reported in the press, seems to put the burden of proof on the plaintiff. While Vioxx seems to have contributed to a large number of heart attacks and strokes, it’s also possible that some people taking the drug had heart attacks and strokes that were simply coincidental. If lawyers for injured parties have to prove that a drug was the direct cause of injury, it may become impossible to sue. Since the risk of litigation has been a check on corporate misbehavior, the results could lead to increased risk for consumers.
But the Supreme Court is hearing a case which might conclude that the Food & Drug Administration’s approval is all the consumer protection anybody should ever need, and if somebody is injured as a result of taking an FDA approved drug, there is no right to sue the manufacturer. If the Court decides that way, it’s hard to say what effect it would have. It might mean that no responsible physician would prescribe a new drug until there has been lots of experience—which would harm new product development. Alternately, it could give the companies freedom to design studies that would get approval without showing the risks associated with longer periods of use—which is essentially what happened in the Vioxx case. With a politicized executive branch that’s more concerned with being business friendly than protecting consumers, this could be the greatest hazard to public health since Cortez brought smallpox to Mexico.
The current system, which turns lawyers into bounty hunters, is flawed—but at least it guarantees that corporations have somebody looking over their shoulder. If there’s nobody watching the regulatory agencies, then nobody is watching at all.
Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.
From The Progressive Populist, July 1-15, 2008
Subscribe to The Progressive Populist