Tuesday, December 30, 2008

Top Ten Best And Worst Prescription Drug/Medical Device Decisions of 2008 - The Best

We’re back again with our manifestly unoriginal, but still interesting, idea of top ten lists for the best and worst decisions in our niche for 2008. It’s a way of recapping our second full calendar year in the blogosphere. Sure, there’s a little bit of time left in 2008, but that isn’t stopping anybody else, didn't stop us last year, so it won’t stop us this year, either.

Last week, we offered our choices for the ten worst drug and device product liability cases of 2008.

Today, it’s the other, happier side of the coin: Our choices for the best ten decisions of the year.
Drum roll, please:

1. Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). No surprise here. In baseball, they’d call it a “no doubt about it shot” - in other words, a home run. The Supreme Court, in an 8-1 opinion, recognizes extensive express preemption in product liability litigation involving PMA approved medical devices – ending years of litigation on the point with a clear-cut defense victory. It’s a game changer for manufacturers of PMA medical devices. Some of our posts on Riegel (there were a bunch) are here, here, here, and here.

2. Sinclair v. Merck & Co., 948 A.2d 587 (N.J. 2008). This ruling takes New Jersey, one of the biggest centers of pharmaceutical mass torts, just about out of the class action business in this area. Medical monitoring is out, because all product liability actions require a physical injury. Consumer fraud is also out, as those claims are subsumed by the New Jersey product liability statute. To boot, it’s one of Bexis’ cases. Our (well, Herrmann’s) posts on Sinclair are here and here.

3. Colacicco v. Apotex, Inc., 521 F.3d 253 (3d Cir. 2008). The Colacicco decision in the district court (and Bexis’ involvement) was a catalyst for the creation of this blog, and we’ve been following this case religiously ever since. The Third Circuit’s decision was worth the wait – the first appellate recognition of implied conflict preemption in a prescription drug product liability context. Colacicco held that SSRI suicide cases, at least in adults, were precluded by the FDA’s decade-long review of this issue and rejection of any causal language in product warnings. While factually narrow, it’s a conceptually broad decision. Beyond preemption, there’s an excellent discussion of judicial notice of FDA regulatory activity as a vehicle for bringing early dispositive motions. We blogged about the Colacicco decision here, here, and here.

4. In re St. Jude Medical, Inc., 522 F.3d 836 (8th Cir. 2008). Any class certification reversal is a big deal, and this is bigger than most. The core of the St. Jude decision – that, even though a consumer fraud statute eliminates reliance as an element of the action, class certification remains inappropriate because the defendant can defend by proving lack of reliance – has already been enshrined as an illustration in the ALI’s draft Principles of the Law of Aggregate Litigation. So St. Jude is relevant to consumer fraud class actions nationwide. We found St. Jude heavenly here and here.

5. Gourdine v. Crews, 955 A.2d 769 (Md. 2008). Maryland’s highest court rejects a novel “bystander” warning liability theory that potentially exposed drug manufacturers to liability to non-users – the plaintiff had been injured in an auto wreck allegedly caused by a user of the drug. The court held that a drug manufacturer had no duty at all to warn non-users. We discussed Gourdine here.

6. Ironworkers Local Union No. 68 v. AstraZeneca Pharmaceuticals LP, ___ F. Supp.2d ___, 2008 WL 4832659 (M.D. Fla. Nov. 4, 2008). This is the rejoinder to Judge Weinstein’s adoption of non-reliance RICO in Zyprexa (see worst ten list). In another MDL involving quite similar allegations, the court holds that, even if there’s no reliance element, RICO claims based on illegal promotion fail for lack of proximate cause due to the intervening conduct of the independent learned intermediary prescriber. Our post on the decision is here.

7. Ackermann v. Wyeth Pharmaceuticals, 526 F.3d 203 (5th Cir. 2008). This is the best overall learned intermediary causation decision in a year where there were a lot of them (see here) – and a Herrmann (appellee)-Bexis (PLAC amicus) production to boot. The prescriber submitted an affidavit that the plaintiff’s proposed warning wouldn’t have changed anything he did. Summary judgment affirmed. The decision pretty much kills any heeding presumption in Texas pharma cases and will be useful elsewhere. We had to be careful what we could say, but we discussed Ackermann here and here.

8. In re: Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation,
MDL 08-1934 PSG (AGRx), slip op. (C.D. Cal. Dec. 17, 2008). Allegations that the defendant illegally promoted the off-label use of its drug aren't viable because they amount to a disguised attempt at private enforcement of FDA regulations, which the FDCA expressly prohibits. The master complaint is so shot through with prohibited allegations that the entire MDL was dismissed, with leave to replead. We blogged about Epogen here.

9. Ratliff v. Mentor Corp., 569 F.Supp.2d 926 (W.D. Mo. 2008). Even though Missouri has adopted medical monitoring, the court predicts that, for various jurisprudential and practical reasons, medical monitoring would be limited to environmental torts and not be extended to prescription drug product liability litigation. The court’s rationale is applicable to medical monitoring in any state. We discussed Ratliff here.

10. Perry v. Novartis Pharmaceuticals Corp., 564 F.Supp.2d 452 (E.D. Pa. 2008). This opinion wins the best-of-year prize in the Daubert category for drug/device cases. It offers excellent analysis of the flaws in a plaintiff’s expert's differential diagnosis, and a stellar discussion of why courts don’t let “early” cases go forward in the absence of clear scientific data. Our post on Perry is here.

Honorable Mentions: (11) Merck & Co. v. Ernst, ___ S.W.3d ___, 2008 WL 2201769 (Tex. App. May 29, 2008) (it's quite fact specific, or else it would have ranked higher; when a $250 million+ verdict ends up getting reversed outright for failure to prove the most basic thing of all – that the drug caused plaintiff’s injury – well, that’s a case that belongs on this list); (12) O’Neal v. Smithkline Beecham Corp., 551 F.Supp.2d 993 (E.D. Cal. 2008) (probably the best of quite a few good federal district court drug preemption decisions in 2008); (13) Bausch v. Stryker Corp., 2008 WL 5157940 (N.D. Ill. Dec. 9, 2008) (best so far of post-Riegel PMA preemptions decisions; notably narrow construction of “parallel” violation exception); (14) Devore v. Pfizer Inc., 867 N.Y.S.2d 425 (N.Y.A.D. 2008) (state appellate holding that plaintiff’s home state controls on choice of law; similar to, but much better than, Desiano); (15) Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kan. 2008) (really good causation decision, both on medical (general and specific) and learned intermediary proximate cause; heeding presumption overcome; plaintiff’s treater's “might have monitored more” testimony did not create a triable causation issue); (16) Longs v. Wyeth, 536 F. Supp.2d 843 (N.D. Ohio 2008) (good on a couple of less common preemption points (black box & too dangerous to be sold); also adequacy as a matter of law under Ohio statute); (17) Bailey v. Wyeth, Inc., 2008 WL 5196846 (N.J. Super. Law Div. July 11, 2008) (it's only a state trial decision, but good on several issues: statutory presumption of adequacy, off-label use, CBE regulation limited to new information, ghostwriting, and exclusion of FDA experts); (18) Colville v. Pharmacia & Upjohn Co., 565 F. Supp.2d 1314 (N.D. Fla. 2008) (double-barreled decision: one, no physical injury was established, and two, even if there were, the prescriber didn’t think the risk was worth warning about); (19) Mensing v. Wyeth, 562 F. Supp.2d 1056 (D. Minn. 2008) (well-reasoned published decision finding generic drug preemption; if you represent generics, you gotta love this case; we on the pioneer side, after Conte, have mixed feelings); (20 (tie)) In re Human Tissue Products Liability Litigation, ___ F. Supp.2d ___, 2008 WL 4665765 (D.N.J. Oct. 22, 2008) (excellent Daubert opinion excluding several experts for lack of scientific basis and bogus extrapolation; great ruling in high-profile case), and Mills v. Warner-Lambert Co., ___ F. Supp.2d ___, 2008 WL 4488308 (E.D. Tex. Sept. 30, 2008) (economic loss claims involving OTC drugs subject to preemption because they aren’t “product liability” actions; first reported case on this point outside of California).

We’re being optimists again. We only listed ten choices for our ten worst list, but as before we’ve included the ten (actually 11) honorable mentions for the ten best.

Looking ahead, we already know what the number one case of 2009 will be – Wyeth v. Levine. We just don’t know yet whether it’ll show up on the top ten best or top ten worst. Either way, though, you can bet we’ll have lots to say about it.

And another case we’re looking forward to, but that won’t make this list, is the California Supreme Court’s review of the challenge to the ability of governmental units to hire outside counsel on contingent fee in the Santa Clara lead paint case.

We hope that reading about all these wins will help our readers have a HAPPY NEW YEAR. Barring something cataclysmic, we’re off until next year.

1 comment:

Anonymous said...

Congress omitted the Prescription drug/medical device in 1962. Congress placed a shield on the prescription drug companies and left the public at risk. No Federal Law or State Law. Congress preempted the law. This has opened the door for "White Collar Crime" and Domestic Terror.