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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

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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’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

Here’s an important decision that we can’t say much about because we’re involved up to our eyeballs in this litigation.  The MDL magistrate judge in the HT litigation has granted a Daubert motion excluding plaintiffs’ expert testimony that short term use (less than three years) causes ductal breast cancer.  This will affect a lot of…

It’s not exactly drugs/devices, but it’s food (which is close), and it’s preemption, and it’s the Supreme Court, so we thought we’d let you know.   There’s a pending cert. petition called National Meat Ass’n v. Brown, No. 10-224.  One of the questions presented, which attracts our attention, is:

Did the Ninth Circuit err

…

We blogged about the highly suspect decision in Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), and last month awarded it the dubious honor of our #4 worst drug/device decision of all 2010.
Well, that isn’t all we’ve done. We (well, Bexis) submitted an amicus brief in Hamilton in the Texas Supreme Court earlier this week.  Doing that required us to sit down and think about the supposed (except in New Jersey) “DTC (direct to consumer) exception” to the learned intermediary rule – more than we had before (which was relatively little). And it just so happened, that when we exercised our brains, we came up with more thoughts.
As we mentioned in the earlier post, the first problem with Hamilton was that it wasn’t even a DTC advertising case.  Instead, it was a situation where the defendant provided patient-friendly material (a videotape) to the doctors and those doctors had the final say in whether the plaintiff ever saw the material.
Our gut reaction then was that this sort of professionally-mediated information wasn’t what anybody really considered DTC advertising.  Now, having looked at that question further, we know we’re right.  Why?  Well, for one thing the FDA says so.  The Agency itself doesn’t consider a videotape (or anything else) provided to a physician for the physician use with patients (or otherwise) to be DTC advertising – or “advertising” at all.
Nope.Continue Reading Already DTC (Done Through Causation) – More Thoughts About A DTC Exception

We just saw LeFaivre v. KV Pharmaceutical Co., No. 10-1326, slip op. (8th Cir. Jan. 19, 2011), and all we can say is bad facts make bad law – sort of, anyway.  The bad facts are these:

KV stipulated as part of the Consent Decree that it had sold drugs that were “adulterated” as

…

Just a quickie post about today’s Supreme Court oral argument in Smith v. Bayer, a copy of the transcript here.  This is the case where the, once the Baycol MDL had denied class certification, the plaintiffs tried for certification of an identical class in West Virginia state court.
In the interim, as we…

The other day the Pennsylvania Superior Court (an intermediate appellate court), sitting en banc no less, decided to weigh in on Vaccine Act preemption.  See Wright v. Aventis Pasteur, Inc., 2011 Pa. Super 9, slip op. (Pa. Super Jan. 11, 2011).  Briefly, the court did the same thing as the intermediate Georgia court did…

We put up an initial post about Bausch v. Stryker Corp., ___ F.3d ___, 2010 WL 5186062 (7th Cir. Dec. 23, 2010), back in December, only four days (including Christmas) after it was decided.  But Bausch is so spectacularly bad – on more than one issue – that it deserves a more thorough bashing.  We’ve called some opinions we’ve seen “spherical error,” but with Bausch things get so bad that we’d have to add a couple of more dimensions to the sphere to have an apt comparison.
Anyway, Bausch went south on not just one, but two, major issues:   pre-market approved (“PMA”) medical device preemption and Twombly/Iqbal pleading.  With respect to preemption, Bausch created a circuit split – explicitly backing the partial dissent in Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) (we previously discussed Bryant here).  Bausch, 2010 WL 5186062, at *6.  That has the advantage of creating a direct circuit split over the extent of PMA preemption, and direct circuit splits are one thing upon which successful United States Supreme Court appeals are based.
But on TwIqbal, what Bausch is conceptually worse than just disagreeing with a decision we like.  Rather, the court essentially rebelled against the spirit and letter of Twombly and Iqbal – two controlling decisions of the Supreme Court that it was bound by the fundamental workings of our court system to follow.  Bausch’s rationale, as we will see, retreats to the “let discovery solve everything” mindset that TwIqbal overturned.  In a sense, that’s not terribly surprising, since Judge David Hamilton had previously taken the same track (if less explicitly) in his previous opinion while still on a district court judge in Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009). As we’ve previously pointed out, Hofts had been widely rejected as contrary to TwIqbal.  If you keycite Hofts on Westlaw, you’ll see that the decision has accumulated an impressive 10 adverse citations (only two of which are mere “distinguisheds”) in less than two years.  But to become the first post-TwIqbal appellate court to raise the red flag of outright rebellion, Judge Hamilton seems to have acquired some new, and somewhat disturbing, allies.
Preemption first.  In one sense Bausch is fairly narrow.  It affirmed, or else plaintiffs didn’t appeal, the dismissal of everything in a product liability suite involving a PMA device other than so-called “parallel” violation claims.  So even with Bausch there’s not a whole lot left to the suit.  Real violation claims aren’t particularly easy to plead, but they’re even harder to prove, so this is just the beginning.  The easy stuff to take to a jury – warning related claims, particularly – are out of the case.
But in another sense Bausch is shockingly broad.  The opinion doesn’t exhibit any inclination at all to police what plaintiffs claim as purported violations.  To explain properly what’s going on, we first ought to briefly (for us, anyway) recapitulate how this concept of “parallel” violation claims came to be.Continue Reading Bashing Bausch

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