Monday, November 20, 2006
Today's NY Sun editorializes on the FDA's recent decision to permit cosmetic use of silicone gel breast implants. The editorial -- Now They Tell Us -- links breast implants to asbestos and Vioxx, suggesting that the entire mass tort litigation system is out of whack:
The Food and Drug Administration recently lifted its 14-year ban on the use of silicone breast implants for cosmetic purposes, saying that even though the devices are unlikely to last a lifetime — surgeons will need to warn patients of the likelihood of future surgeries — there is no scientific evidence that leaking silicone implants cause cancer or other serious illnesses. So where does Dow Corning go to get its $3.2 billion back?
That's the amount the erstwhile silicone implant manufacturer paid out from the jaws of bankruptcy court in 1998 to settle 170,000 lawsuits filed over its supposedly faulty implants. ...
Indeed, silicone implants join asbestos and Vioxx in the pantheon of products that have been the subject of some of the most irrational litigation in history. Women whose silicone implants had ruptured and leaked couldn't actually prove that their implants had caused the illnesses they were suffering. The majority of today's asbestos plaintiffs can't prove they're suffering any illness at all. And Vioxx's alleged victims can't point to any actual proof that the arthritis drug's cardiac risk is greater than that posed by over-the-counter painkillers. Yet overeager lawyers were happy to sue, and the courts have been only too happy to oblige. Trial lawyers are currently trying to eviscerate Merck, Vioxx's manufacturer.
Merck has elected to fight each Vioxx suit individually, and that strategy seems to be working, but it's hard to fault Dow Corning or asbestos manufacturers for settling the suits against them instead of taking them to trial. The FDA's latest announcement does, however, highlight the broader dangers of leaving the out-of-control liability system unreformed. With the benefit of hindsight it is even clearer than it was before that the only crime Dow Corning committed was selling what was then a perfectly legal product that turns out to be safe. For that transgression, the company was allowed to be eaten alive by the trial bar. Dow Corning managed to survive. Others haven't been so lucky. Congress needs to decide how many more companies will suffer Dow Corning's fate before lawmakers deliver much needed legal reforms.
It's hard to argue with the editorial's 20-20 hindsight on the breast implant litigation, but I question whether it's fair to throw asbestos and Vioxx into the same bucket. The wisdom of "much needed legal reforms" depends on what legal reforms you're talking about, which depends mightily on what problem you're trying to address.
The breast implant litigation is the most egregious example of liability in the face of strong scientific evidence casting doubt on general causation. The scientific community largely rejected the claim that silicone gel breast implants caused autoimmune disease or other systemic disorders. Bendectin and Agent Orange come to mind as other major mass torts where plaintiffs' general causation case was questionable, but neither of those reached the scale of the breast implant litigation. It's worth remembering that the settlement class action in the breast implants case came after Judge Sam Pointer, overseeing the MDL, appointed a National Science Panel to report on whether breast implants caused the alleged harms. Without the court-appointed scientific experts, the defendants' exposure surely would have been larger. Even so, there's power in the editorial's rhetorical question: "So where does Dow Corning go to get its $3.2 million back?" The problem of litigation outpacing science is a serious issue in mass torts. But the editorial gets sloppy, I think, in suggesting that the lessons of the breast implant litigation extend to mass torts generally, rather than to the particular problems of scientific evidence and general causation.
The editorial points out that much recent asbestos litigation involves uninjured plaintiffs (and could have added that the claims are against third-tier defendants rather than against the major producers of asbestos-containing products, all of whom were bankrupted by the litigation). But the problems of exposure-only plaintiffs, latent disease, and substitute defendants differ from the problems of scientific evidence and general causation. The legal reforms to address the former set of problems (e.g., pleural registries, tort law on exposure-only claims and medical monitoring, and reforms of joint-and-several liability) differ dramatically from reforms to address the latter (e.g., court-appointed experts, jury reforms, phased trials, and preemption defenses).
It's too early to judge the Vioxx litigation, but at this point it seems that the most difficult problems there involve individual causation rather than general causation. If that's correct, then again, there's a huge difference in how the legal system ought to respond. In the absence of general causation, a defendant should face zero liability. When there's proof of general causation and a basis for liability, but individual causation remains difficult to establish, then liability serves the policies of deterrence and disgorgement, and the real problems are allocation and the extent to which tort compensation must be individualized.
In other words, to criticize the breast implant litigation is easy. To lump it with asbestos and Vioxx, and to demand "much needed legal reforms" as if it were obvious what those reforms should be, is a lot harder.