Law

We hate to start the New Year by reporting on a dismal case but, as we said on Friday, the Montana Supreme Court's decision in Stevens v. Novartis Pharmaceuticals Corp., 2010 MT 282 (Montana December 30, 2010), adds to this Winter of discontent. Once a Supreme Court comes out with a decision, you're stuck with it. Smart lawyers try to make the best of such decisions, even when they are mostly bad news. Bexis is a smart lawyer, so that's what he did on Friday, emphasizing the Montana Supreme Court's reaffirmation of the learned intermediary rule.

And now we must confront the ugly bits in the opinion.

Before we do that, let's confess to a smidgen of exasperation. For a couple of weeks in a row, the Monday column has had to report bad opinions. Last week it was the horrific Bausch case from the Seventh Circuit. We're starting to feel like Stuart Scott from ESPN's Sportscenter, when he was always saddled with providing the 'highlights' for the crappiest football games of the week. This was a while ago -- back then, the worst teams were Tampa Bay, Green Bay, and Pittsburgh. (An LA Times sports columnist called the Steelers "Pitt Bay" to keep the Bay theme going when listing the Bottom 5 NFL teams). Poor Stuart Scott dutifully struggled to say something interesting about the latest interceptions heaved by the likes of Bubby Brister or Vinny Testaverde. Maybe that grim parade is what prompted Scott to resort to endless catch-phrases: "cool as the other side of the pillow," "all that and a bag of chips," and, of course, "Boo-yah."

We wish we could dismiss the Stevens case with a few catch-phrases, but it won't be so easy. The plaintiff claimed that Novartis had failed to warn that Zometa could cause osteonecrosis of the jaw (ONJ). The plaintiff had begun taking Zometa in 2002 for lymphoma. In early 2005, the plaintiff was diagnosed with ONJ and stopped taking Zometa. ONJ is a progressive disease, so the plaintiff's problems with it continued. More happily, the plaintiff's cancer "was in remission, as it has been ever since." Slip op. at 6.

In 2007, the plaintiff brought an action before the Montana Medical Legal Panel (MMLP) against her prescriber and oral surgeon alleging failure to warn of the risk of ONJ from Zometa. The prescriber responded that she had not been aware of the risks. The oral surgeon responded that it didn't matter, because there was no other feasible oral surgery option. After the MMLP proceeding concluded, the plaintiff brought a lawsuit in Montana state court against the prescriber, the prescriber's practice group, and several fictitious defendants (placeholders until the plaintiff could figure out who they were) for failure to warn. Novartis wasn't named as a defendant until January 2009 -- well after Montana's three-year statute of limitation had run out.

The plaintiff offered two ways around the statute of limitations. First, the plaintiff argued that the claim against Novartis should relate back to the filing of the case against the fictitious defendants. The problem with this position is that such relation-back usually works only if the plaintiff had to name the fictitious defendants because she didn't know about the actual defendant. That was surely not the case here with respect to Novartis. The Montana Supreme Court didn't decide this issue, because it bought the plaintiff's alternative argument: the dreaded cross-jurisdictional tolling. A Zometa class action case had been filed in the Middle District of Tennesee in September 2005 and was pending until November 2007, when the district court denied class certification.

Now as you know from our cross-jurisdictional tolling scorecard, most courts don't like it. But the Montana Supreme Court departs from the majority view on the basis of shakey reasoning. The Montana Supreme Court discounts the federal precedents on the theory that the federal judges were simply refusing to predict whether the state courts would adopt cross-jurisdictional tolling. That's not entirely fair. Some of those federal judges actually thought (and wrote) about law and policy. But it doesn't matter, because the Montana Supreme Court didn't buy the law or policy anyway. Other courts realized that cross-jurisidictional tolling shouldn't apply to mass tort cases where the nature of the alleged injuries varies widely from plaintiff to plaintiff, so it cannot be said that the pending class action put the defendant on fair notice of all the other potential lawsuits hiding out there. Further, other courts realized that cross-jurisidictional tolling hangs out a huge Welcome sign for plaintiff lawyers. Obviously, they will file their cases in the court system that allows tolling. None of this troubles the Montana Supreme Court, because … geepers, we wish we could convey the reasoning behind this crazy decision. To our jaundiced eyes, it seems to amount to the Montana Constitution's statement that "[c]ourts of justice shall be open to every person" (slip op. at 22), and that the court can revisit its position if Montana litigation does end up increasing (slip op. at 23). Oh, and all of this is "limited to situations in which defendants are fairly put on notice of the substantive claims against them." Id. at 24. So, instead of analysis, we get a platitude, a Mulligan, and a vague, empty balancing test that allows result-driven judges to do whatever they want to do. Not a whole lot of guidance under that Big Sky, is there? The notice test guarantees the Montana court system the worst of all possible outcomes. The lack of clarity means that (1) late-filing plaintiffs will scurry to Montana, and (2) plaintiffs who actually are attuned to the litigation early-on will still have an incentive to make "protective" filings in Montana, because there is no way to predict what the court will eventually decide on the notice point.

The learned intermediary issue is more of a mixed bag. Novartis argued that controlling Montana learned intermediary precedent extended the duty to warn only to the prescriber. The Montana Supreme Court disagreed, concluded that "the greater body of common law offers a fuller, more perspicacious perspective" [wow - if alliteration counted more than analysis we might actually like this opinion] on the doctrine, and held that the court could instruct the jury to consider whether other treaters, such as nurses, had been adequately warned. Slip op. at 26. The court embarks on a discussion about how "[t]he realities of modern medicine increasingly conflict with the learned intermediary doctrine's underlying premises." Id. at 30. Big yawn. It's certainly true that the old Norman Rockwell painting of the kindly GP making a house-call is purely quaint. It's also true that anyone staying in a hospital will spend a lot more time interacting with nurses and not so much time getting the ear of the lead doctor. But when a lawsuit basically says a certain drug should not have been prescribed, shouldn't we look to who did the prescribing (whether writing the original prescription or refills)? That might -- in fact, often does -- involve more than one doctor or nurse practitioner. But to force an inquiry into the state of knowledge of every member of the "treating professional staff" (slip op. at 31) seems outlandish. Moreover, as with the cross-jurisdictional tolling, the Montana Supreme Court seems uneasy with its conclusion. It ends up observing that the "error complained of - an overbroad scope of the duty to warn - is only implicated with regard to" one part of a two-alternative-part jury instruction. Since it's possible the jury didn't even consider the portion in question, the defendant cannot demonstrate prejudicial error. Yikes. That's incredibly unfair. And how far does such reasoning go? What if there were ten alternate bases for finding liability in a particular count, and nine were phrased erroneously in the jury instructions? Given the 1-in-10 chance the jury was unaffected by error, would the case still get affirmed?

That's all bad enough. But the Montana Supreme Court also slings out other regrettable rulings on more minor matters, such as whether the defendant should have been permitted to add an apportionment defense. (The court keeps saying the issue is whether the district court correctly denied "Novartis permission to amend its complaint." Slip op. at 32-33.) The court also blesses the district court's exclusion of the plaintiff's statement in her original complaint, before Novartis was added, that the prescriber "was aware of the risks associated with Zometa and was negligent in failing to communicate those risks." Id. at 36. Such a statement would have been wholly supportive of the Novartis defense. For some reasonable jurors, it might even have been dispositive. But according to the Montana Supreme Court, it was not a statement of fact.

And at that point we had to put the opinion down and look for some Holiday cheer.

As we said at the beginning, we regret commencing the year with such a stinker. But the Stevens case came out in 2010. You know how every New Year's Eve people toast the New Year with a fervent wish that it will be better than the last? (People do that pretty much every year. Was there ever a year when people said, "Sheesh, let's just hope next year can match what we just had"? Not even after the Berlin Wall came down? Or after the Phillies won the World Series in 2008? Or after NBC finally canceled BJ and the Bear?) Well, we're still optimistic about 2011. We'd like to think of Bausch and Stevens as aberrations. As in that song by The Kinks, we're looking for "Better Things."

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Posted By Steve McConnell to Drug and Device Law at 1/03/2011 08:49:00 AM

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