Thursday, December 27, 2007

The Best and Worst of 2007: The Best

Yesterday, we offered our choices for the ten worst drug and device product liability cases of 2007.

Today, it's the other side of the coin: Our choices for the best ten decisions of the year.

May we have the envelope, please:


1. International Union of Operating Engineers Local No. 68 Welfare Fund v. Merck & Co., 929 A.2d 1076 (N.J. 2007). Number one on our list is this definitive decision by the New Jersey Supreme Court decertifying a nationwide class action of third-party payers under the New Jersey consumer fraud statute. That’s a huge win, no matter how it’s reasoned, because a potential billion-dollar lawsuit went up in smoke. But it’s the rationale that puts Operating Engineers firmly in the top spot. First, Consumer Fraud Act claims lack predominance because “ascertainable loss” individualizes the inquiry much like reliance does in the context of common-law fraud. Second, “price inflation” is a form of fraud on the market that doesn't apply to the CFA. Third, because third-party payers are large entities, a class action isn’t “superior” under the rules. Our earlier post is here.

2. Pennsylvania Employees Benefit Trust Fund v. Zeneca, Inc., 499 F.3d 239 (3d Cir. 2007). Just what the doctor ordered. With Colacicco pending in the same court, the Third Circuit finds broad implied conflict preemption (almost field preemption) of state law tort claims in a false advertising context. Implied preemption’s first win in a federal court of appeals could not have come at a better time or place. Our post is here.

3. Arons v. Jutkowitz, __ N.E.2d __, 2007 WL 4163865 (N.Y. Nov. 27, 2007). Okay, so it’s not technically a product liability case, but it has huge product liability implications. Reversing an adverse decision, New York’s highest court ruled that defense attorneys have equal rights to talk informally with physicians who treat personal injury plaintiffs. The court rejects the claim that there’s any HIPAA preemption in the litigation context. Our post is here.

4. Rowe v. Hoffman-La Roche, Inc., 917 A.2d 767 (N.J. 2007). The New Jersey Supreme Court strikes again. The court holds that the law of the state of injury, rather than the law of the state of the defendant’s incorporation (which was New Jersey) governs, in a prescription drug product liability case. That’s generally good because New Jersey substantive law is pretty liberal (the unique DTC exception to the learned intermediary rule, for one thing, and the heeding presumption for another), but it’s even better because plaintiff-specific choice of law typically defeats certification of putative multistate class actions. Our post here.

5. In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, ___ F. Supp. 2d ___, 2007 WL 4170276 (N.D. Cal. Nov. 19, 2007). Probably the best Daubert decision of the year, holding large chunks of the plaintiffs’ expert testimony to be inadmissible. Especially good on requiring epidemiology to prove “general causation” (can a drug cause a particular condition at all at a given dose?), downward extrapolation (just because something happens at a high dose, does it necessarily happen at a lower dose?) and requiring a relative risk of 2 or more (statistically, that’s how the “more likely than not” civil standard of liability is expressed). Our post is here.

6. Blunt v. Medtronic, Inc., 738 N.W.2d 143 (Wis. App. 2007). An excellent finding of broad express preemption where the FDA had specifically determined that a Class III medical device was safe and effective. It makes the list over several other similar decisions because it’s a state appellate court in a difficult jurisdiction for defendants. This decision is subject to further appeal. Our post is here.

7. Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007). The best pro-preemption decision on implied conflict preemption and the FDA Final Rule decided by a trial court in 2007. This lengthy decision is, somewhat surprisingly, decided under the Vaccine Act. It beats out several other similar decisions due to its comprehensive reasoning and detailed discussion of the Preemption Preamble to the 2006 Final Rule. Our post here.

8. Thomson v. Novartis Pharmaceuticals Corp., 2007 WL 1521138 (D.N.J. May 22, 2007). Whether it’s a harbinger or an aberration is too early to tell, but this federal district court decision that diverse cases brought in the defendant’s home state court are removable to federal court if removal is accomplished before service of process predictably (hey -- we predicted it, so it didn't take Jeanne Dixon or The Amazing Kreskin to view this crystal ball) prompted a horde of copycat removals. For 2008, we foresee a great deal more litigation on the point. Our posts here, here, here, and here.

9. In re Baycol Products Liability Litigation, 495 F. Supp.2d 977 (D. Minn. 2007). An excellent opinion on evidence. It excludes evidence of comparative safety between drugs of the same class, fraud on the FDA (due to Buckman preemption), corporate ethics, and regulatory actions outside of the United States. Our post here.

10. Prohias v. Pfizer, Inc., 490 F. Supp. 2d 1228 (S.D. Fla. 2007), and Prohias v. Pfizer, Inc., 485 F. Supp. 2d 1329 (S.D. Fla. 2007). Two decisions in the same case. Excellent on preemption, but even more important for their use of safe harbor provisions in state consumer fraud laws to dismiss claims against prescription drugs whose labeling and advertising was approved by the FDA. Our post here.

Honorable Mentions: (11) Bruesewitz v. Wyeth, Inc., 508 F. Supp. 2d 430 (E.D. Pa. 2007) (rejecting Ferrari anti-preemption rationale in Vaccine Act case); (12) Rohde v. Smiths Medical, 165 P.3d 433 (Wyo. 2007) (less than two months after Karl (the West Virginia case that was number one on our "ten worst" list yesterday), Wyoming adopts the learned intermediary rule); (13) O’Neill v. Novartis Consumer Health Inc., 55 Cal. Rptr.3d 551 (App. 2007) (relevance of FDA compliance in strict liability); (14) In re Neurontin Marketing & Sale Practices Litigation, 244 F.R.D. 89 (D. Mass. 2007) (denying class certification in an economic loss case involving off-label); (15) Ledbetter v. Merck & Co., 2007 WL 1181991 (Tex. Dist. Apr. 20, 2007) (Vioxx; fraud on the FDA preemption); (16) Beale v. Biomet, Inc., 492 F. Supp. 2d 1360 (S.D. Fla. 2007) (learned intermediary rule applies to consumer fraud claims); (17) Tucker v. SmithKline Beecham Corp., 2007 WL 2726259 (S.D. Ind. Sept. 19, 2007) (SSRI conflict preemption); (18) Nelson v. Wyeth, 2007 WL 4261046 (C.P. Philadelphia Co. Dec. 5, 2007) (HRT; warning causation); (19) Rattay v. Medtronic, Inc., 482 F. Supp. 2d 746 (N.D.W. Va. 2007) (PMA medical device preemption in circuit where law not settled); and (20) Jensen v. Bayer AG, 862 N.E.2d 1091 (Ill. App. 2007) (affirming denial of class certification in recall-economic loss case).

We never would have guessed it, but we must be optimistic guys: We had only ten choices for our ten worst list, but we have ten plus ten honorable mentions for the ten best.

Looking ahead, we already know three of our choices for the best and the worst of 2008: Riegel v. Medtronic, Warner-Lambert v. Kent, and Colacicco v. Apotex.

But we won't know for months yet on which side of the ledger -- top ten or bottom ten -- those cases will land.

2008 will tell.

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