## Vioxx...

As background, Dr. David Graham, Associate Director for Science and Medicine in the FDA's Office of Drug Safety, in 2004:

Dr. Graham's Testimony to Senate Committee on Vioxx, FDA Failures: Prior to approval of Vioxx, a study was performed by Merck named 090. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx.... In November 2000, another Merck clinical trial named VIGOR found a 5-fold increase in heart attack risk with high-dose Vioxx.... In 2002, a large epidemiologic study reported a 2-fold increase in heart attack risk with high-dose Vioxx.... About 18 months after the VIGOR results were published, FDA made a labeling change about heart attack risk with high-dose Vioxx, but did not place this in the Warnings section. Also, it did not ban the high-dose formulation and its use..... In March of 2004, another epidemiologic study reported that both high-dose and low-dose Vioxx increased the risk of heart attacks compared to Vioxx's leading competitor, Celebrex....

If you apply the risk-levels seen in the 2 Merck trials, VIGOR and APPROVe, you obtain a more realistic and likely range of estimates for the number of excess cases in the US. This estimate ranges from 88,000 to 139,000 Americans. Of these, 30-40% probably died. For the survivors, their lives were changed forever...

If you believe Dr. Graham--which I am not sure that I do--we have 30,000 excess deaths from Vioxx. A $5 billion settlement amounts to$170,000 per extra death caused, which does not seem to me to be grossly out of line on the high side as a sanction on a company whose marketing department did not want warning labels.

The usually-reliable Joseph Nocera has a different view:

Forget Fair; It’s Litigation as Usual: They had the kits ready to go. The “trial package,” they called it... the plaintiffs’ bar always develops a trial kit when a mass tort gets to a certain point; it’s one of the weapons trial lawyers use to put pressure on the company they are attacking. The big-time lawyers who bring the early cases... wind up spending $1 million to$1.5 million developing their case... expert witnesses... discovery... depositions... jury consultants.... And then they put their collective knowledge in a neat little package of documents and videotaped depositions and suggested lines of attack, so that all the other lawyers who have sued the same company can partake of their acquired scholarship, and bring their own trials — for a lot less money. “Ours would have allowed a lawyer to try a legitimate case for under $200,000,” said Mr. Herman, with no small touch of pride. He was talking, of course, about the Vioxx litigation, which the drug’s manufacturer, Merck, settled late last week for the tidy sum of$4.85 billion.

Mr. Herman has 120 of the 27,000 cases — that’s right, 27,000 — that were brought against Merck, which took Vioxx off the market three years ago after a study made it clear that the medication increased the risk of a heart attack or stroke. He was also one of the key architects of last week’s settlement. When I spoke to him a few days ago, he defended the settlement as a fair one, which, as he put it, “balances the scales between two competing parties.” He made it sound like standard business negotiation. Which it was.

But he also said something plaintiffs’ lawyers don’t often say out loud — at least not when a reporter is within hearing distance. “A corporate defendant cannot afford to defend thousands of cases where there is an alleged mass disaster at one time,” Mr. Herman said.... [A]s mass torts have evolved over the last decade, it is that it scarcely matters anymore whether the facts are on the plaintiffs’ side — not when a thousand lawyers are armed with those kits.... Is a mass tort really the right mechanism to settle disputes about product safety, or to punish corporate wrongdoing?

Vioxx was hardly Merck’s finest hour. I’ll readily concede that point. The company did things it shouldn’t have.... Vioxx... was a painkiller that was originally aimed at a pretty small group... people who suffered serious stomach problems as a result of taking aspirin regularly. But Merck spent hundreds of millions of dollars marketing Vioxx... as some kind of miracle pain reliever.... [T]here were rumblings... that Vioxx might increase the risk of heart attacks or strokes. It’s not quite right to say that Merck completely ignored those potential problems — but the company certainly tried to avert its eyes....

There are many problems with viewing product liability lawsuits as a means to right wrongs, which is how we see them in this country. They often make lawyers rich while the people who say they were hurt wind up with very little. The legal system gives corporations zero incentive to step forward if there is evidence that a drug might have a harmful side effect — because, after all, they’ll get sued as soon as they make such an admission. Third, even the smartest lawyers aren’t the Food and Drug Administration, which is charged with making decisions about which drugs should be allowed on the market and how their risks should be disclosed. Mass torts have become a rogue form of regulation, and not necessarily in the public interest. And finally, when you get right down to it, litigation is a crapshoot, and it can be cruelly unfair.

That was certainly true of Vioxx, whose potential side effect is one of the most common serious conditions known to mankind: a heart attack. It is impossible to know what causes someone to have a heart attack, just as it is impossible to know why someone develops cancer. In the Vioxx litigation, the plaintiffs’ lawyers were arguing, in effect, that the way to punish the company’s bad behavior was to make it hand their clients large sums of money, even though they couldn’t prove that the clients’ heart attack had been induced by Vioxx. Meanwhile, the company argued that it was just as likely, if not more likely, that some other risk factor was involved, like smoking or obesity — even though it had put a product on the market that increased heart attack risk.

As a result, a handful of lucky people who may well have been victims of their own bad habits — and not of Vioxx — won large sums of money. (Although they haven’t seen a penny yet: every case the plaintiffs won is on appeal.) And some people who may well have suffered because of Vioxx lost their cases and didn’t get a penny. How does such a system even approximate “justice”?...

[W]hy, then, did Merck settle? Because it had no choice. The four judges managing most of the cases had decided that the time had come to settle the litigation, and Merck was not in a position to say no to the judges.... Besides, Merck had won enough cases that it felt it could devise a settlement that it could live with. Which it did.... [T]he stock jumped when the $4.85 billion deal was announced.... As for the plaintiffs’ lawyers, they are likely to pocket around$1.5 billion of the settlement money, which means that Merck will wind up feeding the beast, just like every other company that finds itself embroiled in a mass tort. That money will go to funding the next mass tort...

A good newspaper story on this would answer three questions about these cases:

1. Is the settlement too large or too small as a sanction on Merck--as a two-by-four to the head of the CEO to make sure that he understands that his job is to curb the enthusiasm of his marketing product when he has a new product with dangerous side effects?
2. Are the lawyers' fees too large or too small--does it give lawyers too much of an incentive to crank up this mass-tort machine as a way of providing drug companies with an incentive to do the right thing?
3. Does the settlement money get to the people who were harmed--to the victims?

My answers in this case to these three questions right now are: (1) probably about right, (2) I don't know but I fear too large, and (3) somewhat but not largely.

My first beef with Joseph Nocera is that his story does nothing to help me get better answers to any of these questions. My second beef is that his story pushes a less-informed reader towards answers--too large, too large, and no--that are largely wrong. My third beef is that Joseph Nocera doesn't set out any ideas about how one might create a better system. My fourth beef is that Joseph Nocera pushes readers wrong answers by playing intellectual three-card monte--if he's going to make a big deal about how large the 27,000 case number is, he has a moral obligation to set it alongside the 30,000 net excess heart attack death number.

And my fifth beef is that Nocera knows damned well that he has a moral obligation to raise the level of the debate, and that he is ducking that obligation.

Why oh why can't we have a better press corps?