The tragedy of Diana Levine

"[T]ragic facts make bad law." So wrote Justice Samuel Alito in his dissent from the Supreme Court's recent decision in Wyeth vs.

[HMG]

Mark Hermann is a good guy and a smart lawyer. But I think his comments on the Levine case are miseleading.

As the Supreme Court rulings on both sides made clear, the issue has nothing to do with how many warnings are, or are not, on a drug's label. Rather, the issue is how thorough was the FDA's _review_ of whatever is on the label.

The overwarning issue is thus a red herring. The preemption issue is not about what warnings do or do not appear. It is about the adequacy of FDA's review.

That is only logical. If FDA is to claim preemptive authority, than they need to demonstrate that they have earned it.

Adding warnings that are not supported by FDA review will help a company not a whit. And so they won't.

[John Vail]

"Levine had already obtained compensation for her injury—her $700,000 malpractice settlement—from her health-care providers. She needed no more from a second lawsuit."

Profits per partner at the author's law firm were $785,000 in 2007, the last year a public report is available. See http://www.law.com/jsp/article.jsp... . I'll trust a jury of flinty Vermonters over a high-dollar corporate lawyer any day to tell me how much the value of a musician;s life is diminished by the loss of an arm.

[Jim Hastings]

What the author fails to mention is that drug companies draft the labels to be approved by the FDA, and that the drug companies leave out important information that may require a stronger label or warnings because stronger warnings = fewer prescriptions = less sales for the company.

What Wyeth was seeking was TOTAL immunity from failure to warn lawsuits under the theory of pre-emption... Wyeth, who destroyed ADE files related to Pondimin/Redux and fought against stronger labels for their blockbuster diet drug cashcows. Drug companies have been able to defend themselves successfully using the "learned intermediary" defense (placing the onus on the doctor to do a risk-benefit analysis before prescribing, thereby relieving the drug company of its duty to warn the public) but with Levine, Wyeth was hoping to close the door on drug lawsuits forever.

The FDA is not the final arbiter for drug warnings, nor should they be. They aren't qualified and they are too closely tied to the drug companies. Thank goodness that the Roberts court got this one right.

[Axiomatic]

Boiling down legalese requires some understanding of the total issue and not just focusing on the portions that benefit one side. This case is about Dianne Levine of course but even she will tell you it is much more than that. It’s about how the pharmaceutical industry wants to re-engineer the relationship between the corporation and the consumer.

Here’s the boiled down version of this case. It’s all about one word – preemption.
Side 1 – Corporate Lawyers say the FDA’s ruling on a drug’s safety is the last and only word. It shall not be challenged. After all if we let consumers (juries) make a case against a drug there will be mass confusion about the label. We will have to “over-warn” about the safety of our products and no one will use them.
Side 2 – Consumers say that they have a right to question public companies about the products that they buy, if they feel they have been harmed by those products. They even have the right to bring companies to a courthouse and prove that their product is safe in front of a judge and jury. The damages should be determined and agreed upon.

So who is right?
Side one has what seems to be a valid concern about label confusion and over-warning but it has never been proven to be fact, even in the 70 years that product liability law suits and the FDA have allowed litigation. Side one’s solution to this problem is quite simple – disallow product liability law suits. This solves their problems with over warning very easily and quickly.
Side two and the Supreme Court of course are not so easily convinced that this is the proper solution. The consumer feels that placing an industry above the law so to speak is not right. An industry should have to answer to complaints about its products.

Whatever problems the industry has about the affect of product liability litigation; the solution to that problem needs to be something other than a padlock on the courthouse door. The ability to question a company’s management practices that affect the safety of their product by the one that consumes that product must remain in tact. All other issues about the product, about how litigation works, about corporate profitability and the use of the product by others need to be solved with other means. The easy answer is not often the best answer.