Monday, February 23, 2009

A Thought Experiment On Conte v. Wyeth

We've kicked Conte v. Wyeth, No. A116707, A117353, 2008 WL 4823066 (Cal. App. Nov. 7, 2008), three ways from Tuesday (here, here, and here, for example). Well, it's Monday -- so we're kicking again.

In Conte, the California appellate court held that the manufacturer of a name-brand drug may be liable for injuries caused by a patient's ingestion of the generic version of that product.

You read that right: If the prescribing physician relied on the innovator's product labeling, then the innovator might be tagged for damages, even if the innovator did not manufacture the product that allegedly injured the plaintiff.

Here's today's thought experiment about Conte:

Suppose you market a new, name-brand drug. When you submit your draft labeling to the FDA, include the following two sentences at the end of the labeling:

"The statements contained in this package insert apply only to the name-brand version of this drug. The statements in this insert do not apply to any generic version of this drug."

There! You would eliminate any possibility that the purchaser of a generic version of the drug could rely on the package insert! You'd be insulated from liability.

But the FDA would never allow you to include that disclaimer on your package insert. The statutes governing generic drugs require generic manufacturers to use labeling and warnings on the generic drug that are identical to those approved for the name-brand drug. See 21 U.S.C. Sec. 355(j)(2)(A). So the FDA would disapprove the disclaimer on your labeling and require you to print the labeling without the disclaimer.

Perfect!

Now you have a preemption defense! You tried to tell purchasers that the statements made in your labeling did not apply to generic versions of the drug, and the FDA prohibited you from making that statement. Surely you can't be liable when the FDA has barred you from making the very statement that would have disclaimed liability.

Moreover, that result is inevitable: There's simply no way the FDA would ever allow any manufacturer to include on the name-brand labeling the sort of disclaimer that we just proposed. Given that truth, why should the innovator have to propose the label (and have it be rejected) to obtain the benefit of preemption? Why can't the manufacturer just explain that any disclaimer of liability to purchasers of the generic drug would be forbidden under federal law, so the innovator can't be liable to a plaintiff who bought the generic?

We realize that some disclaimers are not permitted because they are, for example, unconscionable. But surely it's not unconscionable for a company to disclaim liability to purchasers of a product that the manufacturer did not sell.

And we realize that our proposed disclaimer is legal in nature ("we're not liable"), rather than scientific in nature ("our drug is [or is not] associated with an adverse reaction"), but surely there's some way around that obstacle.

Maybe we need help with our thought experiment: Maybe the proposed language would say that, "The statements contained in this package insert apply only until [the date on which the patent expires], at which time the name-brand manufacturer will stop selling the product and expressly disclaims all future representations or warranties of any kind."

Or maybe even that doesn't do the trick, and there's some other statement that would work.

We told you that this was only a thought experiment, and if you have better ideas, we're all ears.

We're just searching for a (more) vivid way to make courts recognize that name-brand manufacturers shouldn't be held liable (among many other reasons) because the law forbids them from disclaiming the liability that the court is now seeking to impose.

1 comment:

Robert B. Friedman said...

The same thought occurred to me when I was preparing an article on this case, and I even went so far as to discuss the viability of a proposed disclaimer with some former FDA employees.

As you correctly observe, a disclaimer would be rejected immediately by FDA, because (1) it frustrates the entire regulatory scheme for generic drugs and (2) the implicit assertion of such a "disclaimer" -- that the warnings on the branded drug shouldn't apply to generic drugs -- is false and could be detrimental to patients if prescribers get confused about whether generics are bioequivalent.

I don't believe that proposing such a warning and having it rejected would create a preemption defense, because claims like the one in Conte aren't premised on an argument that the branded drug's warning should have included a disclaimer. So, there doesn't seem to be a conflict between a plaintiff's argument that the branded drug should have had a different warning about a safety issue, and FDA's rejection of a label that includes a disclaimer.

The real problem with Conte is that it's the pioneer manufacturer's defense that is effectively "preempted". Because the regulatory schemes (1) require generic manufacturers to use the pioneer's warnings, and (2) allow pharmacists to substitute generics for pioneer drugs, a pioneer manufacturer can't argue that the doctor/pharmacist/patient did not reasonably rely on its warnings about its drug when they made the decision to prescribe/substitute/ingest the generic drug. And if there's "reasonable reliance," there's probably "foreseeability", and, well, you know the rest.

Keep up the good work.