Monday, October 26, 2009

Why Drug Companies Should Beware Of Doing Business In West Virginia

A federal trial court has held that West Virginia public policy forbids applying the learned intermediary doctrine even to patients treated outside of West Virginia.

Thus: An Alabama physician prescribes a drug to an Alabama resident. The resident uses the drug in Alabama and is allegedly injured by the drug there. Alabama law recognizes the learned intermediary doctrine, for its own sound policy reasons. But the plaintiff sues in West Virginia, which is the only state that rejects the learned intermediary doctrine. A recent case says that the drug company does not get the benefit of the learned intermediary doctrine because the doctrine is repugnant to West Virginia public policy.

Hence the title of this post: Why Drug Companies Should Beware Of Doing Business In West Virginia.

The rest of this post is not for laymen.

(Mom: You can stop reading now.)

The facts that we described above are from Woodcock v. Mylan, No. 2:09-cv-00507, 2009 U.S. Dist. LEXIS 95403 (S.D.W. Va. Oct. 14, 2009). The case came up on Mylan's motion to dismiss. Chief Judge Joseph Goodwin held that Alabama law governed the substantive issues in this case, except for the failure-to-warn claim: "Because West Virginia has rejected the learned-intermediary doctrine on public-policy [we disagree with the judge's hyphenation in addition to his legal conclusion] grounds and applying Alabama law to the marketing defect claims would violate that public policy, West Virginia law applies to that claim." Id. at *16.

As we've noted before, West Virginia stands basically alone among the states in rejecting the learned intermediary doctrine. So drug companies don't want to get sued in West Virginia.

But if you do business there, you can arguably be sued there.

There's only one solution: Drug companies shouldn't do business in West Virginia.

We lied!

There are actually several other possible solutions.

Our first alternative would take a while to work its way through the courts. Even if West Virginia "public policy" rejects the learned intermediary doctrine as to West Virginians treated in West Virginia, it's not clear that West Virginia public policy would have the same interest in governing the relationship between an Alabama resident treated in Alabama by an Alabama doctor.

We haven't researched this issue, so take our speculation for what it's worth, but we suspect there's an argument that West Virginia has very little public policy interest in regulating the relationship between Alabamans and their doctors. (Mylan made this argument in Woodcock, but the judge was not impressed.)

Another alternative would be to take the "reverse-comity" approach. Instead of imposing West Virginia's public policy on relationships that occurred in other states, how about recognizing that other states have an interest in governing relationships centered in those other states? We've previously discussed at length the public policy concerns that give rise to the learned intermediary rule. Why should the public policies of 49 other states all become subordinate to the public policy of West Virginia?

We have a third alternative, but we're beginning to make ourselves nervous: Intrepid lawyers might look at the various constitutional issues that arguably arise from choice-of-law rules that unilaterally favor the forum over every other state in the country. One place to start is Phillips Petroleum Co. v. Shutts, 472 U.S. 797, 822-23 (1985). Other constitutional problems arise when states try to regulate out-of-state conduct. We discussed some of those issues before with reference to punitive damages, but these sort of federalist/territorial considerations aren't limited to that context. We think that there must be -- or at least there should be -- constitutional implications to having choice of law rules as forum-favorable as the one adopted in Woodcock.

Or perhaps a solution here lies in the meaning of the words "public policy" in choice of law determinations. Almost every major common-law doctrine has "public policy" implications. Can a North Carolina plaintiff sue outside the state (which doesn't recognize strict liability) to recover under some other state's "strict liabilty" doctrine as a matter of public policy? How about a Michigan or Texas plaintiff trying to escape those state's FDA-approval presumptions? We're struggling to put our finger on it right now, but what the Woodcock court did can't possibly be right. "Public policy" must mean more than just the justifications given by a court for a common-law decision. Perhaps declarations of "public policy" must involve, at minimum, determinations concurred in by the other branches of government.

We're going to think about this much, much harder.

For the time being, all we know for sure is that Woodcock is nasty news and that drug companies should beware of West Virginia.

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