Texas, like Michigan, imposes a strong presumption of non-defectiveness on drug labeling approved by the FDA. As to the Michigan statute (which has been around longer), the Sixth Circuit (where Michigan is located) ruled that an exception to the presumption for fraud on the FDA was preempted by Buckman. Garcia v. Wyeth-Ayerst Labs., 385
Over two years ago (have we really been at this so long we can say that?) we wrote a post “Docs for the Goose, Docs for the Gander,” in which we praised Weiss v. Astellas Pharma, US., Inc., 2007 WL 2137782 (E.D. Ky. June 25, 2007), for requiring an even playing field
RICO (the “Racketeering Influenced Corrupt Organizations” statute) is a square hammer that plaintiffs’ lawyers try to force into the round hole of drug and device litigation. So why are we seeing an increase in RICO cases? Well, there’s that whole treble damages and attorney’s fees aspect that makes a RICO claim lucrative, and then there’s
Not quite a year ago we noted the Daubert tour de force that the defense completed in Feusting v. Zimmer, 2009 WL 174163 (C.D. Ill. Jan. 26, 2009). Two notorious plaintiff experts – James Pugh and then Robert Rose – excluded in the same case. Well we’re pleased to report that the second exclusion
As we said last week, because it’s a Dechert case, we can’t comment directly on Clark v. Pfizer, Inc., 2010 WL 163583, slip op. (Pa. Super. Jan. 19, 2010). However, we were sufficiently inspired by what’s in the opinion that we thought this would be a good time to put in our two cents worth about one of the theories that the Clark plaintiffs pursued: “fraud on the market.”
As defense lawyers, we want to do our part in killing off this pernicious import from federal securities law. So we decided to take an in-depth look at all of the the precedent that rejects application of a “fraud on the market” reliance presumption to state-law claims.
Just to make sure that everyone’s with us, briefly “fraud on the market” is a doctrine that waters down fraud (and, plaintiffs would like to say, other liability theories based on claimed misinformation) by presuming reliance in certain limited circumstances. See Basic, Inc. v. Levinson, 485 U.S. 224 (1988) (4 justice majority of 7-justice court). It’s not a state law claim – the Supreme Court has never applied a “fraud on the market” presumption to state law even in securities cases.
The presumption arose because the Supreme Court bought a questionable proposition – that securities markets are “efficient” and “developed.” in other words, because there are so many participants in national stock markets, and those participants have such a voracious appetite for information, then anything about a particular stock is essentially instantaneously reflected in that stock’s price. Because of that (rather questionable) conclusion, any plaintiff in a securities fraud suit is “presumed” to rely on any material disinformation.
That’s the theory. In practice, however, what “fraud on the market” is really all about is class actions – reliance is ordinarily considered an individualized issue that’s kryptonite to the supposed “superman” of class actions . Without “fraud on the market,” there probably wouldn’t be very many securities class actions. Conversely, if plaintiffs could import the “fraud on the market” presumption of reliance into non-securities contexts – such as consumer fraud/common-law fraud/warranty litigation against our drug/device clients – an invasion of class actions would follow like night follows day.Continue Reading No State-Law Market For “Fraud On The Market”
The standing requirement. . . . Are you asleep yet?
Okay, few things induce yawning and cure insomnia as much as discussions about standing and jurisdiction, but in the world of no-injury lawsuits, we defense lawyers have to pay attention to such things. Standing (for the non-lawyers) is a requirement that courts impose on parties who want to sue. To have standing (at least in federal court), you need to have: (1) suffered an injury – which can be economic or not, but for our discussion today, let’s stick with an economic injury; (2) causally connected to the conduct complained of; and (3) redressable by the court.
As a practical matter, standing (generally — there are almost always exceptions to rules) means that you can’t sue a car dealer for selling a car for a false representation unless you actually bought the car. If you bought the car, you have an injury: money paid, causally connected to the false statement you complain of, and your claim is “redressable” – that is, a court can help you by ruling that you get your money refunded. But if you only thought of buying the car, or if you watched while someone else bought the car, even if you are angered by the car salesman, you have no standing to sue. (For purposes of this discussion, we’re ignoring the exception – we told you there were exceptions – that at times the law grants people standing to sue on behalf of the public.)
In federal courts, standing requirements come from the case or controversy requirement of the judicial power under Article 3 of the U.S. Constitution (“The judicial Power shall extend to all Cases, in Law and Equity, . . .–to Controversies”). Therefore, if you don’t have a real “case” or “controversy,” the courts have no authority (“jurisdiction”) to hear your gripe. States have their own versions of this constitutional grant of judicial authority; some are like the federal version, some aren’t (more exceptions) – so we’ll stick with the feds.
Now, just because you have standing does not mean you win your case, or get awarded damages. But it does get you past the first hurdle – the courthouse door – and thus into the game. And sometimes, especially class actions where the plaintiff’s goal is to pressure a defendant into settlement through the sheer size of the claim, getting into the game is the game.Continue Reading You say no injury, I say no standing
Proving they can do more than just blog, Dechert’s two longest-running bloggers, Bexis and Sean Wajert (who writes the Mass Tort Defense Blog), along with associate Vince Gallo, recently wrote a “Legal Backgrounder” for the Washington Legal Foundation analyzing the FDA’s decision to do away with the vetting of its Warning Letters by
Caveat Emptor….
That’s the take-away that we glean from the Transobturator Sling Products MDL, where the court recently granted in part and denied in part a motion to quash a subpoena served on a non-party former competitor (!!) of the device manufacturer that’s a defendant in that MDL.
Here’s the back story: the defendant in this MDL is Mentor Corporation. Mentor manufactured a medical device called “Obtape,” a sling designed to treat female stress urinary incontinence. Ethicon, Inc., a wholly-owned subsidiary of Johnson & Johnson, manufactures a competing product, “Gynecare TVT.” Mentor’s Obtape was removed from the market in 2006 amid concerns about serious complications arising from the device’s use, and … well, you can guess what happened after that.
Fast-forward three years, and plaintiffs in the Transobturator Sling Products MDL, apparently having exhausted all possible discovery against the defendant, issued a subpoena to Ethicon – the competitor. Plaintiffs asked for a number of items, including:
1) testimony and documents regarding statements Ethicon made in a TVT product pamphlet entitled “Selecting the Right Mesh: Important properties of implant materials used in urogynecological surgery” (“Pamphlet”); 2) testimony and documents regarding Mentor’s 510(k) application to the Food and Drug Administration (“FDA”), in which Mentor claimed that ObTape is the substantial equivalent of TVT; and 3) testimony and documents regarding all testing that was conducted on TVT, including published clinical trials and internal Ethicon studies.
It’s times like this that make us nostalgic for a multi-firm blog.
Yesterday, the Pennsylvania Superior Court issued a decision affirming the decertification of a putative non-personal-injury class of consumers who purchased Neurontin for alleged “off-label” uses. We can’t comment on the case because of Dechert’s involvement, but you can take a look at the
Last week’s decision in Carr v. Tillery, 2010 WL 92487 (7th Cir. Jan. 12, 2010), was not, strictly speaking, a product liability case. But it involves some key players in that field, and a very key location. And, truth be told, the case appeals to the voyeur within us.
The players are former partners