If there’s a better place for filing Daubert motions than in the Eleventh Circuit, we don’t know of it. Of course, we’re biased – we had great success with them ourselves in the Seroquel litigation and in the Ephedra litigation before that. Building on the Eleventh Circuit’s landmark decision in McClain v. Metabolife, International, Inc., 401 F.3d 1233 (11th Cir. 2005), defendants have had a lot of success fighting “junk science” peddlers in Eleventh Circuit courts.
And so it was with yesterday’s decision in In re Denture Cream Products Liability Litigation, No. 09-2051-MD-Altonaga, slip op. (S.D. Fla. June 16, 2011). The product is (surprise) a denture cream, Fixodent. The alleged defect is failure to warn that zinc compounds allegedly reduce the amount of copper in the blood, which in turn purportedly cause something called “copper deficiency myelopathy” (called a lot of other things, too, see slip op. at 2 n.3) – which we’ll call “CDM” for short. The very existence of such a thing as CDM is controversial. The court in Denture Cream found that the claims didn’t pass Daubert scrutiny.
The Denture Cream defense team went after this MDL pretty much using the Seroquel model – that is, take the MDL plaintiffs’ best case and beat it on Daubert grounds. The test plaintiff in Denture Cream claimed numbness in her hands and feet (a description suspiciously like diabetic neuropathy) leading to loss of function in her arms and legs, along with various blood abnormalities. Slip op. at 2-3.
These symptoms appeared after the test plaintiff allegedly used Fixodent – a lot of Fixodent.
How much Fixodent?
From the Denture Cream opinion: The test plaintiff supposedly “use[d . . .] two to four 68-gram tubes of Fixodent denture adhesive every week for eight years to hold her dentures in place.” Slip op. at 3.Continue Reading Denture Cream Myelopathy Claims Found Toothless
Some Good News On SSRI Preemption
Finally, a judge with some common sense….
We’ve always thought (and the FDA did too) that the adult suicide/SSRI warning claims were the strongest possible claims for implied preemption in the prescription drug context. C’mon, the FDA looked and looked again at the suicide data for these drugs and found that there was no scientific
An Oldie But Goodie
We’ve always been interested in being allowed to have informal (sometimes called “ex parte”) interviews with treating physicians of the plaintiffs. We think they’re fact witnesses (the most important ones in many, if not most, cases) and that by filing a personal injury lawsuit a plaintiff waives any expectation of physician/patient confidentiality as to the injuries being claimed and their treatment.
Good treating physician testimony can also win a case in and of itself – on the basis of no causation of any purported warning defect under the learned intermediary rule.
We’ve been sufficiently interested in the informal interview question that in late 2008, we even prepared our own 50-state survey of what we understood the states’ law to be on the subject.
Little did we know.
Well, it pays to keep our eyes open. Just the other day the court in the Aredia/Zometa MDL released a valedictory of sorts – an order summarizing that MDL’s activity for the benefit of judges in remand cases. In re Aredia & Zometa Products Liability Litigation, 2011 WL 2182824 (M.D. Tenn. June 3, 2011). We got word of this because the court mentioned its Buckman decisions on fraud on the FDA claims. Buckman citations tend to be interesting, so we have a search that looks for them.Continue Reading An Oldie But Goodie
When It’s The Plaintiff, Not The Doctor
Earlier this week we posted about the learned intermediary aspects of Shaw v. Bayer, U.S. Dist. Lexis 57057 (S.D. Fla. May 23, 2011), which confusingly bears a completely different caption on Westlaw: In re Trasylol Products Liability Litigation, 2011 WL 2117257 (S.D. Fla. May 23, 2011). We said then that there was more to Shaw/Trasylol than just the learned intermediary rule, and promised to return to the case later.
Now is later.
The alternative holding in Shaw/Trasylol illuminates another lurking causation issue in our sandbox – what happens when the focus turns away from the prescribing physician to the plaintiff. For all the plaintiff side’s attacks on the learned intermediary rule, their clients often don’t fare much better when, for one reason or another, the rule doesn’t apply.
Shaw/Trasylol is exhibit A.Continue Reading When It’s The Plaintiff, Not The Doctor
Utah Preemption Split Deepens
We’ve blogged before about the split among Utah courts about whether Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), preempts the fraud on the FDA exception to Utah’s statutory bar (Utah Code Ann. §78B-8-203) against punitive damages where the product complies with FDA standards.
The first case, Grange v. Mylan Laboratories, 2008 WL 4813311 (D. Utah Oct. 31, 2008), got it right. Buckman‘s rationale extends to any state-law assertion of fraud on the FDA that could bring about submission to the FDA of unnecessary and unwanted information due to fear of later tort liability.
Indeed, since punitive damages can (and often do) exceed compensatory damages in their amounts, allowing punitive damages based on fraud on the FDA is even more likely to bring about the prophylactic conduct that Buckman decried than the claim in Buckman itself – particularly since punitive damages are frankly intended to “deter” the conduct they punish – and thus create precisely what Buckman held was unacceptable.
The next case, Lake-Allen v. Johnson & Johnson, 2009 WL 2252189 (D. Utah July 27, 2009), botched the issue, for some reason asserting that Buckman involved express preemption. We criticized this patently wrong result here.Continue Reading Utah Preemption Split Deepens
Opening Salvo In New FDA Attack On Off-Label Use?
There aren’t too many other blogs that we’d characterize as “essential” to what we do, but the FDA Law Blog is one of them (SCOTUSblog is another). Yesterday’s post (emailed this morning) on the FDA Law Blog about a new draft FDA guidance concerning certain investigational in vitro diagnostic devices may seem arcane at
The Closing Of The Learned Intermediary Frontier
It was the last blank space on the legal map – the only state with no precedent whatsoever. As we mentioned earlier in the week, Rhode Island has now fallen. There now remains no state in the country totally without precedent concerning the learned intermediary rule. Granted, for now it’s only an oral ruling in a transcript, but a federal judge has predicted that Rhode Island would join the overwhelming consensus of jurisdictions and follow the learned intermediary rule:
First of all, after the learned intermediary doctrine, that has been adopted by over two dozen jurisdictions and, I think, Rhode Island would adopt it as well.
I see nothing in Rhode Island case law, including the Castrugnano [sic, should be Castrignano] case, to suggest that Rhode Island would require direct patient warning in pharmaceutical drug cases. Just because 4024 A [sic, should be 402A] of the second restatement says nothing about the learned intermediary doctrine doesn’t bother me. There are a lot of states that adopted both.
If Rhode Island doesn’t accept the doctrine in the way that most courts have, then it’s likely it’s going to look to the third restatement, which requires direct warnings when the manufacturer has reason to know that the health care provider will not be in a position to reduce the risk to the patient.
Unlike the mass inoculation vaccine scenario that the restatement mention in one of its comments, Zometa is a very serious therapy that is commenced after consultation with doctors. . . . As intended there Zometa is a type of drug learned intermediary doctrine encourages a doctor-patient dialogue.
Zometa does not fall within the exception of the restatement and I, therefore, find a direct warning to Mr. Hogan was not required.
Hogan v. Novartis Pharmaceuticals Corp., 06 CV 260, Trial Tr. (5/23/11), at 387-88 (E.D.N.Y.). The same court had discussed the learned intermediary rule with approval, but avoided a direct ruling, in Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *9 (E.D.N.Y. April 24, 2011).Continue Reading The Closing Of The Learned Intermediary Frontier
Bisphosphonate Trial Score All Knotted Up
Most defense lawyers, if given the choice, would probably pick North Carolina and Montana over New Jersey and Rhode Island as places to try cases. But as we mentioned yesterday, the bisphosphonate litigation continues chugging along in its merry, contrarian way.
In the federal litigation that’s being thrown off by the Aredia/Zometa MDL, the
Federalism And Tort Reform
On Wednesday, we discussed the relevant parts of pending tort reform legislation. Earlier in the month we updated our favorite federalist point, which is that federal courts should not issue expansive interpretations of state tort law when sitting in diversity jurisdiction.
OK, what do those two things have to do with one another.
Well,
What’s Up With Removal Before Service?
It was one of our biggest issues in the blog’s first couple of years – whether a defendant’s removal of a case before service on: ( 1) the forum defendant where an out-of-state defendant is sued in its own state’s court, or (2) anybody (including the removing defendant), would result in the unserved forum defendant