By the standards of the web, this is old news -- the decision came down on January 29.
And, by our recent standards, it's unimportant news -- we've been wallowing in Supreme Court cases, and now it's back to the trial courts.
But we really liked what a federal trial court did in Ebel v. Eli Lilly and Company, No. B-04-194, slip op. (S.D. Tex. Jan. 29, 2008) (copy here) (now reported at 536 F. Supp.2d 767), so we're reporting on it here.
We've seen a lot of Zyprexa cases, and you know the story about Paxil-suicide cases, but Ebel's a two-fer: The patient was ingesting both Zyprexa and Paxil when he committed suicide in November 2002. Because we're reporting on this, the plaintiff of course blamed the medications, rather than the underlying disease, for the decedent's death. Plaintiff pleaded the typical strict liability, negligence, misrepresentation, and breach of warranty claims.
Our only quibble with the trial court is in its discussion of the burden of proof under the learned intermediary doctrine. The court suggests (at page 4 of the slip opinion) that the defendant "has the initial burden of proving . . . that the warning Defendant provided to the prescribing physician was adequate [or] that the prescribing physician was aware of all of the drug's risks that would have been mentioned in an adequate warning."
The court cited no authority for that proposition, and we think it's wrong. The plaintiff always bears the burden of proving causation, and the only way to link ingestion of a drug through a warning to an injury is to show that a different warning would have prevented the injury. We think that the plaintiff bears the burden of proving causation, even in the learned intermediary context.
There was a reason, however, for this federal court to be insensitive to this issue. Under Texas state law, "there is a rebuttable presumption that the defendant . . . manufacturer . . . [is] not liable . . . if (1) the warnings or information that accompanied the product in its distribution were those approved by the United State Food and Drug Administration." Tex. Civ. Prac. & Rem. Code Sec. 82.007(a). Ebel read this provision to create "a rebuttable presumption that the approved warning is adequate" (slip op. at 6), which amounts to the same thing as placing the burden of proof on the plaintiff from the start.
Still, we would have liked the court to get to that correct result through the correct reasoning.
Beyond that, the opinion is all good news for those on our side of the "v."
Plaintiff insisted that the Texas statute (and the resulting presumption of adequacy of the warning) did not apply, because Ebel was a "no warning" case rather than an "inadequate warning" case.
The court held, however, that the label mentioned both alleged risks -- akathisia and suicide -- several times. Slip op. at 6. "Therefore, this is not a 'no warning' case." Id. at 7.
Plaintiff relied on McNeil v. Wyeth, 462 F.3d 364 (5th Cir. 2006) -- a case that wins no awards from the Drug and Device Law Blog -- for the purported proposition that a defendant manufacturer can be liable if it understates the risk of a side effect in product labeling.
But "Plaintiff did not raise such a challenge to the 2002 label for Zyprexa." Slip op. at 7.
There are five exceptions by which plaintiffs can avoid the presumption of no liability established by Tex. Civ. Prac. & Rem. Code Sec. 82.007(a). In Ebel, "Plaintiff has provided no evidence of fraud on the FDA or that Defendant withheld information from the FDA." Id. at 8 n.3. That exception thus dropped off the table.
Plaintiff pursued the "overpromotion" exception to Section 82.007(a). Her evidence of overpromotion, however, was inadmissible: an article from The New York Times and a document pulled from a website. Slip op. at 9. Even if admissible, the internal document showed only speculation about possible promotion of off-label uses, not a marketing plan for illegal promotion that Lilly actually adopted.
We don't know what game we're playing any more, but we sure like it:
Even if there had been an overpromotion marketing scheme, plaintiff provided no evidence that overpromotion ever reached (and influenced the prescribing decision of) the treating physician. Id. at 11.
Plaintiff asserted that the Texas courts should apply a presumption that, if a drug manufacturer had given an adequate warning, the physician would have read and heeded it. "This Court is persuaded by the reasoning of Koenig and shall not apply the read and heed presumption" in the learned intermediary context. Id. at 12.
Finaly, the treating physician's testimony showed that he was independently aware of the risks of Zyprexa, whether or not the package insert was adequate. Id. at 14. A changed warning therefore would not have made any difference, and the manufacturer could not be liable.
We wish this were a game with ten or twelve strikes, because we really feel like we're just getting warmed up here.
Sadly, Ebel is only a seven-strike game.
But read it, and cite it, for all that it's worth.