Thursday, December 24, 2009

Top Ten Best Prescription Drug/Medical Device Decisions Of 2009

Good tidings and great cheer. Merry Christmas, Happy Hanukkah, Kool Kwanzaa, Super Solstice – whatever holiday you’re celebrating. What is there to celebrate? Well, for the moment we can all celebrate our top ten favorite drug and medical device decisions of 2009. While we don’t have a Supreme Court star at the top or our tree this year (Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), isn’t drug/device), there are still quite a few well-reasoned and useful 2009 decisions for those of us on the right side (in more ways than one) of the “v.” to rely upon in the years to come.


So here are the best – those decisions that had us rushing to the keyboard during the year to bang out those congratulatory posts – the kinds we like to write most. We’ll be starting with some state supreme court decisions, and working our way down from there.

1. AstraZeneca LP v. State, ___ So.2d ___, 2009 WL 3335904 (Ala. Oct. 15, 2009). It’s not really “product liability,” but in terms of sheer impact and dollar value, this one belongs on top. For years the Alabama Attorney General has been using gullible juries and questionable “fraud” claims to extract large settlements and even larger judgments from out-of-state pharmaceutical companies. Only trouble was that the supposedly defrauded party, the Alabama Medicaid Agency, knew perfectly well what was going on, and didn’t rely upon the purported misrepresentations. In a gutsy move, because over $250 million in verdicts were involved, AZ and two other defendants appealed rather than knuckle under. While the rationales differed, eight of nine justices of the Alabama Supreme Court agreed that reliance was completely absent and that AZ and the others should receive judgment n.o.v.  As a result, Alabama will have to go back to raising revenues the old fashioned way – through legislatively imposed taxes. We (Bexis) blogged about the case here, while sitting in an airport in San Diego coming back from a PLAC meeting.

2. DePriest v. AstraZeneca Pharmaceuticals, L.P., ___ S.W.3d ___, 2009 WL 3681868 (Ark. Nov. 5, 2009). It gets tougher after number one. We’ve decided to go with DePriest in the second spot because of it’s potential long-term impact. A lot of state consumer fraud statutes have “safe harbor’ provisions that exempt activities that the government allows and regulates (exact language varies) – which means FDA-approved labels, among other things. The blog has promoted wider use of these safe harbors as a defense here (listing every state that had a “safe harbor” provision), here, and here. DePriest is the first state supreme court decision to apply one of these safe harbor provisions and hold that a consumer fraud claim attacking FDA-approved labeling cannot proceed. Your state’s law may vary, but we’re hoping that DePriest becomes the first of many. We blogged about DePriest here.

3. De Bouse v. Bayer, ___ N.E.2d ___, 2009 WL 4843362 (Ill. Dec. 17, 2009). A recent entry, but a very good one. How far off-track product liability has gotten? Well, our three top cases all involve consumer fraud/economic loss, rather than what we studied in law school as “product liability.” Anyway, Illinois is a big state with a history of questionable class action practice in “Hellhole” counties. De Bouse throws out two more dangerous class-action-friendly theories: (1) there can’t be recovery when the defendant never communicated, directly or indirectly, with the plaintiff; and (2) the mere offering for sale of a prescription drug isn't any sort of actionable “implied representation” that the product is safe for its intended use, so that any injury could give rise to a consumer fraud claim. Extreme theories, both. And both rejected. But, the scariest thing is that an intermediate appellate court gave these crazy theories credence, and the case had to go all the way to the Illinois Supreme Court before common sense prevailed. The good news, of course, is that in the end, it did, so the case ends up on the good list, rather than the bad one. We posted about De Bouse earlier this week when it came down.

4. Blunt v. Medtronic, Inc., 760 N.W.2d 396 (Wis. 2009). The Wisconsin Supreme Court, not known as overly friendly to defendants, rejected an argument that could have blown a rather large hole in PMA medical device preemption under Riegel. Instead, the court held that PMA supplements – basically every medical device improvement after the FDA’s initial PMA approval – have just as much preemptive effect as the original device approval. That’s as it should be, since PMA supplements are subject to the same stringent review standards as the initial PMA. Since most devices are upgraded regularly after approval, failure to accord preemptive weight to the supplements would have limited the scope of preemption significantly. For PMA device manufacturers, Blunt has nationwide implications. We blogged about Blunt here.

5. Bruesewitz v. Wyeth, Inc., 561 F.3d 233 (3d Cir. 2009). This is the good half of a yin/yang combo concerning express preemption under the Vaccine Act. Its evil twin – a case out of Georgia called Ferrari that made last year's bottom ten – got killed off this year when the plaintiff took a non-suit (despite winning below) to avoid review by the U.S. Supreme Court.  Bruesewitz holds that Congress plainly intended the Act to preempt vaccine-related design defect claims and to impose stiffer standards on vaccine warning claims. While we think that anybody who reads the legislative history fairly would agree, since its preemption, it may take the Supreme Court to enforce what congress wanted, or it may not. Although we wouldn’t be surprised if Bruesewitz gets high court review (both sides have told the Court that certiorari should be granted, and the Court's been taking its time considering the petition), the opinion as it stands is important enough to make our list. We discussed the Bruesewitz affirmance here. Stay tuned for possible future developments.

6. In re Vioxx Class Cases, ___ Cal. Rptr.3d ___, 2009 WL 4806197 (Cal. App. Dec. 15, 2009). This is another recent edition to our list. We only posted about it the other day. What this decision demonstrats is that even in California – notoriously the home of probably the broadest consumer fraud laws in the country – a plaintiff can’t state a claim without some plausible basis for damages. Here, the plaintiffs alleged that the class would have en masse migrated to a cheaper generic had it only known the “truth.” That was garbage.  In truth, they didn’t. Thus, plaintiffs’ latest shot at a fraud-on-the-market theory of recovery in a prescription drug case came a-cropper. The case only gets a #6 ranking because, while California is a big state, it’s also a peculiar one, so impact elsewhere will be slight.

7. In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009). This is the best trial court PMA medical device preemption case of the year, bar none. It contains the best analysis of the interplay between express preemption under Riegel and fraud-on-the-FDA/faux-private-FDCA-right-of-action preemption under Buckman. Sprint Fidelis is the best place for defense counsel to start (other than this blog, which explained all six months before Sprint Fidelis was decided) when trying to figure out what’s an unpreempted “parallel violation” claim and what’s really a disguised private FDCA cause of action that won’t pass muster as a state-law claim under Buckman. How good is Sprint Fidelis? So good that plaintiffs responded by trying (unsuccessfully) to force the recusal of the judge. And so good that the judge in the state-court side of the same litigation followed it. The case is now on appeal to the Eighth Circuit. We ecstatically blogged about the Sprint Fidelis win here.

8. Guinn v. AstraZeneca, 598 F.Supp.2d 1239 (M.D. Fla. 2009). How does a defendant go about winning multi-district litigation? Well, here’s one way – let the plaintiffs pick their best triable case (under Lexecon, that will be limited to cases filed in the MDL court’s district), then let the plaintiffs pick their first-string experts, and finally, despite all that, blow out the plaintiffs’ best case and experts on Daubert grounds. That’s what happened in Guinn.  It’s the best drug/device Daubert decision of 2009. Diabetes is a disease with lots of pre-existing risk factors, and just about every plaintiff will have a slew of them. The Seroquel plaintiffs’ best case sure did, and their experts couldn’t account for those factors in their opinions. So they fell back on temporal association (also known as the post hoc ergo prompter hoc fallacy) – a big Daubert no-no. We’ll leave it at that, since it’s a Dechert case and Bexis is on that team (although he doesn’t claim any credit for this win). We (well, Herrmann) blogged about Guinn here. The case is now on appeal, and we’re hoping for a repeat performance on next year’s list.  It's also the third AZ case on this list; that's one company that had a good year, result-wise.

9. In re Neurontin Marketing, Sales Practices & Products Liability Litigation, 618 F. Supp.2d 96 (D. Mass. 2009) and In re Neurontin Marketing, Sales Practices & Products Liability Litigation, 257 F.R.D. 315 (D. Mass. 2009). There aren’t many cases that have had anything nice to say about purported class actions seeking recovery of the cost of effective off-label use just because there might also have been some illegal off-label promotion going on. However, early on in the now-quite-extended Neurontin litigation, that judge did suggest there might be some “there there.” See Neurontin (the caption's just too long), 244 F.R.D. 89, 113-14 (D. Mass. 2007). Well, in these more recent 2009 decisions, the judge carefully walked those earlier comments back, in light of the torrent of more recent precedent in the good guys’ favor, and then ended up dismissing the claims outright. There were a number of similar decisions in 2009, but we go with this one because having to change the judge’s mind increases the degree of difficulty. We blogged about the first Neurontin win here.

10. In re Zyprexa Products Liability Litigation, ___ F. Supp.2d ___, 2009 WL 4260857 (E.D.N.Y. Dec. 1, 2009). What? Judge Weinstein on our good list – after making our bad list last year with another decision in the same MDL? Yup, that’s right. He’s a judge, and a smart one, thus he could see the handwriting on the wall with the increasingly widespread rejection of statistical shortcuts in class action/mass action litigation concerning supposedly “defective” products. This case is where all that precedent finally caught up. As is Judge Weinstein’s wont, he wrote a cogent and thorough opinion explaining the development of what he calls the “individualized proof rule.” And that’s not all. This was another overreaching attorney general action (see Alabama, above) compounded by contingent-fee, outside counsel making exorbitant demands. Thus, Judge Weinstein let the state have it for pursuing “slash-and-burn-style of litigation” that didn’t serve the best interests of the participants (the off-label uses helped their medical conditions) of the very healthcare plans on whose behalf the state purported to be suing. We might have ranked this decision higher, but for the obvious reluctance Judge Weinstein showed in having to follow precedent at odds with his personal preferences. Still, preferences or no, he ended up doing the right thing. We blogged about the decision here.

But we can’t stop at this point. Judicial Santas put so many shiny new gifts under our tree in 2009 that we can’t keep ourselves from opening a few more. Thus, here are another ten honorable mentions:

Honorable mentions: (11) Kovach v. Caligor Midwest, 913 N.E.2d 193 (Ind. 2009) (the Indiana Supreme Court reverses a really bad device design defect ruling on precisely the grounds that we suggested in our own commentary); (12) In re Actimmune Marketing Litigation, 614 F. Supp.2d 1037 (N.D. Cal. 2009)/In re Actimmune Marketing Litigation, 2009 WL 3740648 (N.D. Cal. Nov. 6, 2009) (excellent one-two punch demolishing another off-label promotion class action – where the company had been prosecuted; see our posts here and here); (13) Ashley County, Ark. v. Pfizer, Inc., 552 F.3d 659 (8th Cir. 2009) (the 8th Circuit puts a decisive end to the first attempt at bringing public nuisance claims in prescription drug litigation; we discussed it here) (14) Riley v. Cordis Corp., 625 F. Supp.2d 769 (D. Minn. 2009) (another really well-reasoned device preemption case, and the first one involving a combination device; we discussed it extensively here); (15) Longs v. Wyeth, 621 F. Supp.2d 504 (N.D. Ohio 2009) (there hasn’t been a whole lot to cheer about since Levine on the drug preemption side, but Longs was a bright spot; it didn’t hurt that the plaintiff’s argument was that an FDA-approved drug was too dangerous under state law ever to have been marketed at all; see our coverage here); (16) Hughes v. Boston Scientific Corp., ___ F. Supp.2d ___, 2009 WL 3817586 (S.D. Miss. Nov. 12, 2009) (this is a good device preemption case - and an outstanding fraud-on-the-FDA preemption case; we covered it here); (17) Iacangelo v. Georgetown University, 595 F. Supp.2d 87 (D.D.C. 2009) (the plaintiff’s purported “state” claims were really disguised FDCA violation claims; the court threw them out in an excellent decision; we were all over it, here), (18) Southern Illinois Laborers’ & Employers Health & Welfare Fund v. Pfizer Inc., 2009 WL 3151807 (S.D.N.Y. Sept. 30, 2009)/In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604 (D.N.J. July 10, 2009) (you pick ‘em; two good decisions blowing out third-party payer economic loss class actions; we covered them here, here, and (together) here); (19) Frey v. Novartis Pharmaceuticals Corp., 642 F. Supp.2d 787 (N.D. Ohio 2009) (Twombly/Iqbal really came to our neighborhood in this case; we think it's the best application of Rule 8 to a drug/device personal injury case in 2009; we sang its praises here); (20) Mensing v. Wyeth, Inc., ___ F.3d ___, 2009 WL 4111209 (8th Cir. Nov. 27, 2009) (you saw right – the same opinion simultaneously makes both our top and bottom ten lists; Mensing appears here because it’s the first appellate to consider and reject the infamous Conte decision on brand-name drug liability in a generic case; Mensing essentially held, “give me a break,” and followed the majority rule; we covered it all, the good, bad, and ugly, here).

Looking ahead to next year, the Supreme Court could take the Bruesewitz appeal – setting up yet another FDCA-related preemption smackdown – or it could take the Abdullahi foreign tort claims case that made our worst decisions list. Also on the preemption front, we’ve got a trio of post-Levine SSRI suicide implied preemption appeals that should be decided in the coming year by the federal courts of appeals. Those will give us a better idea whether Levine did much damage to implied preemption in cases where there are really good administrative records. One of them (Dobbs) was Herrmann’s case, although he won’t be around to argue it. There are also cases teed up in the Pennsylvania and California Supreme Courts challenging state hiring of outside contingent fee counsel to sue our clients. Bexis has been involved in amicus efforts in both of these. Finally, there are pending appeals in (at least) Zyprexa (2008 worst decisions list), Guinan (2009 worst decisions list), Oxycontin II (ditto), Sprint Fidelis, Guinn, Riley, and Longs. All of these are good candidates for repeat-player status in 2010.

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