2011

We can’t say much about it because of our involvement in the Hormone Therapy litigation, but the Pennsylvania Superior Court has issued its decision in Daniel v. Wyeth Pharms., 2011 Pa. Super. Lexis 27 (Pa. Super. Feb. 7, 2011). The Superior Court reversed the trial court’s decision granting Wyeth’s motion for a new trial…

We previously wrote in less than glowing terms about the New Jersey Superior Court, Appellate Division’s decision in Kendall v. Hoffman-La Roche, Inc., slip op. (N.J. Super. A.D. August 5, 2010). We explained that “the court essentially ruled that, due to the defendant’s adequate and extensive warnings about other risks (birth defects and suicide),…

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Pennsylvanians have much to be proud of, including our history, sports, food, culture, and laws. We’ve got Valley Forge and Gettysburg. We’ve got the best (okay, after last night, maybe second-best) football team, and the best baseball and hockey teams. We might end up with the best college basketball team. We’ve got cheesesteaks and Primanti…

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Worth knowing about:

What happens if the prescriber dies before being deposed and there’s no evidence on whether a different warning would have changed his/her prescribing decision.  Well, the plaintiff has the burden of proving causation, since the plaintiff is trying to take our client’s money, so the plaintiff loses:

To establish proximate causation, practical

…

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A few weeks ago a regular reader, and occasional correspondent, Prof. Ralph Hall at the University of Minnesota Law School asked us if there had been any “meaningful cases” in the drug/device field on emotional distress.  We didn’t have much to offer him, but that struck us at the time as an interesting topic for a blog post.  Unfortunately, we were jammed up with our year-end lists at the time.  Then came those appellate preemption cases….
Anyway, now we’re finally getting around to it (sorry, Ralph).  After actually taking a look, here’s what we know.
First of all, there are two broad types of emotional distress claims.  There’s “intentional infliction of emotional distress” (“IIED”), which as the name indicates, requires “outrageous” conduct intended to cause emotional distress.  This cause of action was recognized by the ALI in Restatement (Second) of Torts §46 (1965).  The second claim is for “negligent infliction of emotional distress” (“NIED”), which – duh – doesn’t require intent.  NIED is typically (but not always) limited to specific types of situations out of concern that emotional distress, since it isn’t a physical injury, could be faked.  NIED wasn’t recognized in the Second Restatement, but it could well be in the Third Restatement (which is currently under consideration).

Intentional Infliction of Emotional Distress

There aren’t all that many intentional infliction cases in the prescription drug/medical device field.  One reason is that it’s hard to muster viable claims of “outrageous” conduct because of the life-saving nature of these products:

[I]f the enormity of the outrage carries conviction that there has been severe emotional distress, bodily harm is not required.  Whether intentional conduct or reckless conduct is involved, a requisite for liability to be imposed is knowledge on the part of the actor that severe emotional distress is substantially certain to be produced by his conduct.  With these guidelines in mind . . . it is preposterous to suggest that a manufacturer of a product which is obviously intended to save lives deliberately engaged in conduct specifically calculated to cause emotional distress to some particular person.

Brinkman v. Shiley, Inc., 732 F. Supp. 33, 35 (M.D. Pa. 1989) (citation and quotation marks omitted), aff’d mem., 902 F.2d 1558 (3d Cir. 1989); accord Keath v. Shiley, Inc., 1991 WL 11242191, at *5 (N.D. Ohio Dec. 17, 1991); Lauterbach v. Shiley, Inc., 1991 WL 148137, at *4 (S.D. Tex. March 29, 1991).  IIED, after all, requires conduct “so extreme and outrageous that it exceeded all possible bounds of decency and was furthermore atrocious, and utterly intolerable in a civilized community.”  Jones v. Danek Medical, Inc., 1999 WL 1133272, at *6 (D.S.C. Oct. 12, 1999) (quoting Restatement §46; dismissing claim for failure of proof); cf. Kemp v. Pfizer, Inc., 851 F. Supp. 269, 275 (E.D. Mich. 1994) (not “outrageous’ for defendant to deny defect and causation), vacated on other grounds, 91 F.3d 143 (6th Cir. 1996); In re TMJ Implants Products Liability Litigation, 872 F. Supp. 1019, 1037 (D. Minn. 1995) (usual product liability allegations fail to establish outrageousness) (applying North Carolina law), aff’d, 97 F.3d 1050 (8th Cir. 1996).Continue Reading Emotional Distress Claims In Drug/Medical Device Cases

We confess, between the unrest in Egypt and the unremitting hype leading up to the Super Bowl, we’ve let Wisconsin’s new tort reform law sit for a few days. But it is a potentially significant development – certainly far more significant than what Packers QB Aaron Rodgers had for breakfast this week (although Packer fans may disagree) – and the plaintiffs’ bar is unhappy with the result.
The Wisconsin legislature packed a lot into this bill, but here are the highlights that we found particularly relevant in the drug/device context:
(1) Punitive damages – capped at the greater of 2x compensatories or $200,000. (There’s a specific exception to the cap that won’t apply in drug and device cases – it involves a defendant whose tortious actions included the operation of a vehicle under the influence of an intoxicant).
(2) Product liability cases – The legislature enacted a number of rules specific to products cases:
Product identification – in most cases against manufacturers, plaintiffs must prove that the defendant actually manufactured the injury-causing product. This is intended to limit the effect of Thomas v. Mallett, 701 N.W. 2d 523 (Wis. 2005) (a case Bexis unsuccessfully briefed for PLAC), where the court permitted a lead-paint case to proceed against seven manufacturers even though the plaintiff could not identify the manufacturer of the paint that caused the alleged harm.Continue Reading Cheeseheads Enact Sweeping Tort Reform

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Yesterday, our 15-year-old son looked at the falling flakes and wondered aloud whether it was ever going to stop snowing. He’s prone to complaint (future plaintiff lawyer) but, in truth, the ten-foot high snowbanks and the sheets of devilish, black ice are a bit depressing. We knew the arrival of 30 page Zyprexa opinion by Judge Weinstein, In re Zyprexa Products Liability Litigation, 2011 U.S. Dist. LEXIS 6207 (E.D.N.Y. Jan. 20, 2011), would move us along the happy-sad meter, but we didn’t know which direction.
Not to put too fine a point on it, but Zyprexa rulings are a big deal. The Zyprexa litigation involves a big-selling medicine prescribed for important psychological maladies (including schizophrenia and bipolar disorder), with allegations that the drug is contributing to the American epidemics of obesity and diabetes. It involves claims for wrongful death, personal injury, consumer fraud, and securities violations. There have been third-party claims, federal and state civil actions, and a federal criminal action. Decisions in the Zyprexa litigation made our ten-best list in 2010 (the Second Circuit’s reversal of Judge Weinstein’s certification of a RICO class action by third-party payors), our ten-best list in 2009 (“Pigs Get Fat, Mississippi Got Slaughtered“), and our ten-worst list in 2008 (Judge Weinstein’s certification of the RICO action). Zyprexa rulings have kept us rather busy. We’ve blogged about the case’s treatment of Daubert challenges, caps on attorney fees, and sanctions for disclosure of confidential documents. And much more.Continue Reading A Recent Zyprexa Ruling Lifts Our Mood

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We’re returning to the topic of implied Buckman preemption today to discuss three recent decisions, Hughes v. Boston Scientific Corp., ___ F.3d ___, 2011 WL 184554 (5th Cir. Jan. 21, 2011); LeFaivre v. KV Pharmaceutical Co., ___ F.3d ___, 2011 WL 148730 (8th Cir. Jan. 19, 2011); and Goldsmith v. Allergan, Inc., 2011 WL 147714 (C.D. Cal. Jan. 13, 2011).  But before we get to these cases, we have to reiterate some things that we said not too long ago in our Bashing Bausch post.  These have to do with the relationship between implied preemption under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and express preemption under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Specifically, defendants need to keep in mind what implied Buckman preemption can and can’t do.
Specifically, as a matter of express preemption, Lohr created – under the rationale that remedies don’t matter – an exception for largely undefined state-law claims that are “identical” to FDA regulatory standards.  “Nothing in §360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements.”  518 U.S. at 495.  We have to live with that.  The Supreme Court was unanimous on the point.  Then there’s the Riegel dictum that MDA preemption “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements.”  552 U.S. at 330.
Keep that in mind.  Express preemption allows “parallel” state law duties “premised on a violation of FDA regulations.”  If such a claim exists, it may well fail for other reasons, but it won’t be expressly preempted.
Now we turn to implied preemption.  We know now – even if we don’t like it – after Wyeth v. Levine, 129 S. Ct. 1187 (2009), and Altria Group, Inc. v. Good, 555 U.S. 70 (2008), that with implied preemption, we have a presumption against preemption to deal with.  That is, where, under Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), there isn’t.
When isn’t there a presumption?
There’s no presumption when we’re concerned with the dealings between the FDA and the manufacturer in question.  “[T]he relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law.”  531 U.S. at 348.
Keep that in mind, too.
Finally, Buckman – as a matter of implied preemption – held that preemption (akin to lack of standing) applies to bar certain types of FDCA violation claims by virtue of 21 C.F.R. §337(a), the statute’s preclusion of private enforcement.Continue Reading Buckman Preemption – The Good, The Bad, And The Ugly – And (This Just In) The Funky

We’re all curious to see what the Supreme Court does with the generic prescription drug manufacturers’ preemption defense in Actavis Elizabeth, LLC v. Mensing, which is scheduled for argument on March 30. In the meantime, the Ninth Circuit has weighed in on the issue, aligning with the Fifth Circuit and the Eighth Circuit and rejecting the generics’ preemption defense.
The case was filed by the guardians of a child who developed liver complications after taking OTC ibuprofen. See Gaeta v. Perrigo Pharms. Co., __ F.3d __, 2011 WL 198420, at *1 (9th Cir. Jan. 24, 2011). The Gaetas claimed that Perrigo should have warned of the increased risk of liver injury and renal failure when ibuprofen is taken concurrently with other hepatotoxic drugs. Id. The district court held, pre­-Wyeth v. Levine, that the conflict preemption doctrine barred failure to warn claims against Perrigo. Id. at *2. Even after Levine, the district court stuck to its guns and denied the plaintiffs’ motion for reconsideration. Id.Continue Reading While We Wait On Mensing, Another Circuit Shoots Down Generic Preemption

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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