Last Friday, we promised you more on the Second Circuit’s reversal of Judge Weinstein’s Zyprexa class certification decision. Well, here’s more (and the Westlaw cite to boot).
First, the background: A bunch of third-party payors (“TPP”) sued Eli Lilly and Company, claiming that Lilly had misrepresented Zyprexa’s efficacy and side effects. UFCW Local 1776 and
More Spherical Error – This Time In Pennsylvania
Last May, in our post criticizing a decision in the Gadolinium litigation, we coined the term “spherical error” to describe an opinion that we thought was wrong in so many ways that it was erroneous no matter how one viewed it. To borrow another phrase from the realm of science (Wolfgang Pauli, this
A masterly Rule 702 opinion
Every once in a great while, we read an opinion that stands out as an example of judicial craftsmanship. The facts and issues are explained in clear, lively prose. The reasoning is careful and thorough, leading inevitably to undeniable conclusions. The opinion articulates in a fresh way ideas we have often discussed, bringing to mind Alexander Pope’s definition of wit: “What oft was thought, but ne’er so well expressed.” The author treats the participants in the case with respect and has a sense of humility. Tamraz v. Lincoln Electric Co., Nos. 08-415/4016 (6th Cir. Sept. 8, 2010), available here, is such an opinion.
Jeff Tamraz worked as a welder for 25 years. After he began to suffer symptoms of parkinsonism, he and his wife sued several manufacturers of welding supplies, alleging that the fumes from their products caused his parkinsonism.
The main issue at trial was whether he had Parkinson’s Disease – the most common type of parkinsonism, which usually has an unknown cause – or manganism, a form of parkinsonism with symptoms distinct from Parkinson’s Disease, which is caused by overexposure to – guess what – manganese. Tamraz’s first treating doctor and the defense experts testified that he had Parkinson’s Disease; a hired litigation expert testified that he had manganism. Dr. Walter Carlini, one of Tamraz’s treating neurologists, took a middle ground by testifying that Tamraz did not have manganism, but something akin to Parkinson’s Disease that Dr. Carlini opined was caused by exposure to welding products containing manganese. The jury returned a whopping $20.5 million verdict for plaintiffs. Defendants appealed, contending, among other things, that the trial judge abused her discretion by admitting the opinion of Dr. Carlini about the cause of his disease.
The court started by clarifying that the precise issue was not Dr. Carlini’s diagnosis that Tamraz suffers from a form of parkinsonism, which was undisputed, but his etiology, i.e., his opinion about what caused the disorder. Although Dr. Carlini opined with a reasonable degree of medical certainty that Tamraz has manganese-induced Parkinson, the court showed by carefully parsing his reasoning that his etiology “was at most a working hypothesis, not admissible scientific ‘knowledge.’” Slip op. at 6. Dr. Carlini’s causation opinion was based on Tamraz’s development of Parkinson’s Disease after exposure to welding fumes that presumably contain manganese; the fact that manganese causes manganism and therefore might trigger Parkinson’s Disease as well; literature hypothesizing that toxins combined with genetic factors may cause Parkinson’s Disease; and other less compelling factors. Id. at 6-7.Continue Reading A masterly Rule 702 opinion
Nidek Laser Off-Label Use Thoughts
One of us had a conversation yesterday with a lawyer (who will remain nameless because we haven’t asked otherwise) about off-label use issues in a malpractice case against a doctor who used something called a Nidek Laser in eye surgery. We haven’t looked at any facts of any case or about the device. We know
Mom and the FDA Know Best
We have a weakness for holiday-themed posts, so it’s a pity the recent Vicks Vitamin C case didn’t come out around Mother’s Day. You’ll see why in a few short paragraphs.
The case, Loreto v. Procter & Gamble, No. 1:09-cv-815 (N.D. Ohio Sept. 3, 2010), was a class action claiming that Defendant misled consumers
Zyprexa – Class Action Reversed
More later, but we’ve just learned that the Second Circuit reversed the certification of a class in the Zyprexa litigation. Here’s the opinion.
The grounds for reversal are: (1) whether or not there are RICO cases that don’t require reliance, this one does. Slip op. at 24. (2) the plaintiff’s excess price theory is
What’s Up With The Third Restatement?
We’re talking about the Restatement (Third) of Torts, Products Liability §2, to be precise. Being in Pennsylvania, for quite some time we’ve had more than a passing interest in this section of the Third Restatement and its essentially negligence (“reasonableness”)-based theory of product liability. For decades, Pennsylvania followed a “ne’er the twain shall meet” rule that strictly separated strict liability from “negligence concepts.” That approach was exemplified by Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978). But in Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003), three justices of the Pennsylvania Supreme Court opined that a quarter century had proven wanting the “strict liability” of the Azzarello sort, and that Pennsylvania law should move to the negligence-based standard of §2. 841 A.2d at 1015-16. Full disclosure – Bexis filed a brief for PLAC in Phillips on the Restatement Third issue.
While three justices aren’t a majority of Pennsylvania’s seven-member Supreme Court, in Phillips they outnumbered the court’s Azzarello supporters 3-2 (there was a vacancy and an obscure concurrence in the result). In almost seven intervening years, the court has failed to address the issue squarely, although not for want of trying. The court thought it was going to decide the issue in Straub v. Cherne Industries, 880 A.2d 561 (Pa. 2005), but instead found there had been a waiver. The court tried again in Bugosh v. I.U. North America, Inc., 971 A.2d 1228 (Pa. 2009), but dismissed the appeal as improvidently granted after it turned out that the defendant was an intermediate seller, not a true manufacturer (that makes a difference in the Third Restatement, but it’s not important here).
Finally, the Third Circuit got fed up with the issue remaining undecided, and after trying unsuccessfully to get the Pennsylvania Supreme Court to accept a certified question, took the metaphorical bull by the horns and predicted that the court would eventually adopt the Third Restatement in Berrier v. Simplicity Manufacturing, 563 F.3d 38, 57 (3d Cir. 2009). As we discussed in an earlier post, that’s led to still more squabbling among the federal district courts.
Full disclosure – Bexis filed amicus briefs for PLAC in all of those other cases on the Third Restatement issue.
So the Third Restatement question has vexed Pennsylvania product liability law for quite a few years. Well, not too long ago we (well, Bexis, obviously) was expressing his frustration with this indeterminate state of affairs with regular blog reader whom we ‘re not sure wants to be publicly identified, so we won’t, and said reader mentioned that his/her home state of Wisconsin was in somewhat of the same boat.Continue Reading What’s Up With The Third Restatement?
One, Two, Three Strikes You’re Out
We’ve written about the Actimmune off-label marketing litigation before (here and here). Hey, we even named a prior Actimmune decision Honorable Mention in our Top Cases of 2009 post. And now, it seems the Actimmune litigation has finally met its demise. You can get more detail about the backstory from our prior posts, but here’s the quick synopsis: the plaintiffs filed consumer and third-party payor (TPP) class actions against InterMune and others, alleging that the defendants illegally marketed the drug Actimmune off-label for treatment of idiopathic pulmonary fibrosis (IPF), a nasty lung disease, when Actimmune was ineffective to treat IPF. Originally, the plaintiffs raised a host of fraud-based claims, which the court blew out for failure to plead with particularity. In a bit of deja vu, the plaintiffs took another hack at stating a viable claim, but the court dismissed all fraud-based claims with prejudice.
Which brings us to take three. This time, the plaintiffs tried to state a claim under California’s Unfair Competition Law (UCL), and the TPP plaintiffs also tried to assert a claim under Missouri’s Merchandising Practices Act (MMPA). Again, the court dismissed all claims. With prejudice. See In re: Actimmune Marketing Litig., 2010 U.S. Dist. LEXIS 90480 (N.D. Cal. Sept. 1, 2010). See ya, Actimmune litigation.
Taking apart the UCL claim, the court noted that the plaintiffs had one more shot to plead a non-fraud UCL claim, under the UCL’s “unlawful” and “unfair” prongs. Id. at *16. But the plaintiffs failed to plead such a claim consistent with their TwIqbal obligations. The plaintiffs pointed to alleged off-label marketing as “evidence” that the defendants’ conduct was “unlawful” under the UCL. Id. at *17. Unfortunately for the plaintiffs, they forgot that it is not enough to allege unlawful conduct “in the air” – you also have to establish that the alleged violation caused harm. Id. at *18 (statute requires showing of injury “as a result of” the alleged violation). And here’s the best part: the UCL’s causation element requires proof of “actual reliance.” Id. at *24-25. In other words, “the ‘as a result of’ language places the burden on plaintiffs to establish that they actually relied upon the representations delivered through defendants’ off-label marketing.” Id. at *23.Continue Reading One, Two, Three Strikes You’re Out
Another parallel violation claim is blocked by § 337(a)
We have been saying for a long time that parallel violation claims that avoid preemption under 21 U.S.C. § 360k pursuant to Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), may nonetheless be preempted by 21 U.S.C. § 337(a)’s ban on private actions to enforce the FDCA. It took the judiciary a little time
Barbecued Buckman
It’s Labor Day, the unofficial end to what has been a long, hot Summer. (Shakespeare wrote that “thy eternal summer shall not fade,” but this sweltering season has us saying, ‘please, please, fade away.’) We’re getting ready for the family BBQ and suspect that, as is often the case, the appetizers (salmon pinwheels, buffalo mozzarella) will outshine the more pedestrian main course.
The same thing happened in the case of Yocham v. Novartis Pharmaceuticals Corp., 2010 U.S. Dist. LEXIS 90005 (D. N.J. August 31, 2010). We like the minor rulings. But the main ruling on preemption makes us gag.
The plaintiff was a Texas resident who alleged that she developed Stevens-Johnson Syndrome from Lamisil. Her complaint asserted claims of negligence, strict liability, express and implied warranty, misrepresentation, unjust enrichment, and violations of the New Jersey Product Liability Act and the New Jersey Consumer Fraud Act.
Let’s start with the good bits. Plaintiff sought application of the law of New Jersey, where Defendant was located. Plaintiff lived in Texas, took the Lamisil in Texas, and sustained the injury in Texas. But Texas “does not permit design defect claims for prescription drugs with otherwise adequate warnings.” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 13. So it’s no surprise that the Texas plaintiff shunned Texas law. Following the “most significant relationship” test, the Court didn’t have much difficulty choosing Texas law. Plaintiff put up a struggle, contending that the location of the injury was “fortuitous.” Id. at * 13-14. That’s sort of silly. It reminds us of people who misuse certain words, “fortuitous” often one of them. It’s almost as irritating as the misplaced “hopefully,” lodging “only” next to the wrong adjective or verb, or writing “alot” as one word.
One’s choice of residence is not “fortuitous.” The late, great comedian Bob Schimmel said it would be weird to show up at somebody’s house and claim it was “fortuitous” to find them there. The Restatement’s “example of fortuitous place of injury involves the purchase of an airline ticket to fly from one state to another part, which route happens to overfly a second state, that state has no relationship to the parties, and the only relationship to the occurrence is mere chance.” Id. at * 14. Bottom line: “It was not fortuitous that Plaintiff was injured in Texas, her state of residence.” Id.
We also like the way the Court dealt with the express warranty claim. The Court pushed the eject button because Plaintiff “has not adduced evidence of reliance.” Id. at * 39. Rather, Plaintiff “relied exclusively on the advice of her physician in deciding to use Lamisil.” Id. at * 40.
Now for the main course, which gave us indigestion. Under Texas law, there is a statutory defense to failure-to-warn claims aimed at FDA-approved warnings. The only exception to the defense requires a showing that the defendant misled the FDA. Is that exception preempted by federal law? Do you really need to ask?
In Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), the Supreme Court “held that a state cause of action for injuries caused by misrepresentations made to the FDA was impliedly preempted by the [FDCA].” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 22. Since Buckman was decided, the battleground has been state statutes, like that in Texas, providing a defense that is called off only if there was fraud on the FDA. That battle has largely turned out to be a debate between the pro-preemption position set forth by the Sixth Circuit in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), and the anti-preemption position set forth by the Second Circuit in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We’ve written at length on this debate before and before and before that, so we won’t repeat ourselves here (at least not too much). Let’s leave it at this: the Garcia line of cases (which, thankfully, seems to be winning) is a straightforward application of Buckman, while the Desiano line tortures logic and policy.Continue Reading Barbecued Buckman