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It’s déjà vu all over again.  Taking a rather tattered page from the Bone Screw plaintiffs’ spectacularly unsuccessful playbook of a decade ago, at least some plaintiffs in the every-man-for-himself Pain Pump litigation are trying to turn truthful promotion of off-label use (which the FDA – running roughshod over the First Amendment – regards as illegal) into a tort.
It’s not, and while off-label promotion may be illegal, “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 349 n.4 (2001).  This statute (21 U.S.C. §337(a)) is “clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at 352.
We’re pleased to report that, in Healey v. I-Flow, LLC, ___ F. Supp.2d ___, 2012 WL 1185680 (D. Minn. April 10, 2012), the court squashed an FDCA-based illegal promotion claim when masquerading as a claim for punitive damages.  Basically, plaintiff argued that, because the defendants allegedly promoted an “inadequately tested” off-label use, they should be liable for punitive damages.  Id. at *2.  The inadequate testing claim was basically tautological – grounded in the FDA’s refusal to clear the device for the use in question – which is what made it an off-label use in the first place:

Plaintiff . . . seek[s] punitive damages because Defendants . . . market[ed] and promot[ed] the pain pump without researching or testing the safety of its use in intra-articular sites, by disregarding the FDA’s denial of clearance, and by failing to inform doctors and patients of the FDA’s denial.

So the alleged duties in Healey appear to be:  (1) not researching uses that aren’t cleared by the FDA and thus can’t appear on the label anyway, (2) off-label promotion of a use the FDA declined to clear, and (3) not telling everybody that the FDA declined to clear that use.Continue Reading Pain Pump Plaintiff’s Promotion-Based Punitives Precluded

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We’ve just been informed of Miller v. Stryker Instruments, No. CV 09-813-PHX-SRB, slip op. (D. Ariz. March 29, 2012), which decided both Daubert and summary judgment motions in a pain pump case.  Part of it’s good, part not so good, and part of the not so good part is a little hard to understand.  Probably the best part of Miller, at least from the broader perspective, is the court’s exclusion of – you guessed it – Suzanne Parisian.  Slip op. at 14-19.  Dr. Parisian was excluded for the usual reasons:  She offers improper regulatory opinions on legal matters that invade the province of the court.  She offers other regulatory opinions that have no discernable basis in fact.  She offers non-expert opinions that invade the province of the jury.  She has no coherent methodology.  She offers causation opinions that are incompetent.  She offers examples of “less than admirable conduct by Defendant” that are entirely irrelevant to the case.  Most of her report “state[s] facts that could be directly presented to the jury and then make[s] legal conclusions.”
Yup, that’s Dr. Parisian in a nutshell.  Miller excludes it all.
Certain challenged portions of another plaintiff expert, Dr. Busman, are also excluded.  Dr. Busman seems to be offered mostly as a medical causation expert, but he tried to stray into other areas.  The court excluded his attempted regulatory opinions – after the plaintiff fell on his sword and effectively withdrew them.  Dr. Busman was also excluded as a warnings expert.  Since some courts have allowed medical experts to opine on warnings, simply because they have medical degrees, what Miller holds in this regard is also of note:

Plaintiff does not assert that Dr. Busfield is a warnings or humans factor expert, nor does Plaintiff contend that Dr. Busfield has a special methodology for interpreting warnings.  Rather, Plaintiff argues that Dr. Busfield should be able to state “what the words of the labeling communicate to him” as a licensed, qualified orthopedic surgeon.  The Court agrees with Defendant that Dr. Busfield is not an expert on the adequacy of warnings and that only Plaintiff’s surgeon, Dr. Hofstedt’s understanding of the label is relevant.

We confess to having some trouble following how the court purports to distinguish Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999) – one of our prior Bone Screw wins.  See Slip op. at 15 n.11.  Miller admits that the plaintiff here “is arguing that Defendant was negligent or strictly liable at least in part because it marketed its pain pumps for [a] use when it knew this specific indication had not been cleared by the FDA.”  Slip op. at 15.  Well, that’s exactly what was going on in Talley, as off-label marketing was essentially all that the Bone Screw cases were about.  Marketing without a license is like driving without a license – an insufficient ground for arguing negligence per se.  It’s not anything to do with “quality or proper labeling.”  Since, according to Miller, the pain pump had not been cleared for the use in question, that use wasn’t on the label.  Nor is the pump alleged to have been of poor quality.  We can see a failure-to-warn claim based on off-label promotion, if some risk was left unstated, but the discussion of Talley doesn’t get into that.  Without an allegation of failure to warn, marketing without a license is just that.  Ultimately, though, it might not matter much, since the issue involved Dr. Parisian’s testimony, and all that was excluded.  We do feel protective of our Bone Screw wins, however.Continue Reading Major Pain Pump Decision

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            If you are like us you may be feeling a little sluggish this morning.  Perhaps you’re stumbling out of a candy-induced sugar coma or trying to explain to a four-year old why fairy wings were only OK for school yesterday (or both).  So, we thought we’d keep our post simple today.  Simple because you’ve

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We just spotted Placencia v. I-Flow Corp., 2011 WL 1361562 (D. Ariz. April 11, 2011), a pain pump case, in which the court threw out the plaintiff’s latest attempt to keep non-manufacturer competitors in the case.  Specifically they claimed that one pump company (DJO) conspired with another pain pump company (I-Flow) “acted as promoters of

Once a mass tort becomes widely publicized, sometimes based on a combination of a bad study, a verdict or two for plaintiffs, internet sites, and late night television ads, lots of plaintiffs come out of the woodwork, including plaintiffs with weak, late, or marginal claims. Those plaintiffs and the clever lawyers who assist them believe

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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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Ever since the JPMDL (that,s “Judicial Panel on Multi-District Litigation” for you non-lawyers), refused to create an MDLtwice – for pain pump litigation, there’s been guerilla warfare all over the country in cases involving these devices (and also for the unfortunate manufacturers of the anesthetic drug used in them).  A lot of recent pain pump decisions have involved lousy pleading, but not all of them.  A few of the more advanced pain pump cases have reached the summary judgment stage.  We’ve already written a post on one of the first, Meharg v. I-Flow Corp., 2010 WL 711317 (S.D. Ind. March 1, 2010), that granted summary judgment.
Well, now, thanks to Kim Schmid and her team at Bowman & Brooke, we’re quite pleased to report on another – this time from Ohio.  Krumpelbeck v. Breg, Inc., ___ F. Supp.2d ___, 2010 WL 5475616 (S.D. Ohio Dec. 27, 2010).  Like Meharg, plaintiff Krumpelbeck came from a state, Ohio, that’s on our master list as recognizing the state of the art defense.  Thus, a critical issue was what was known about any link between pain pumps and the plaintiff’s injury (chondrolysis) at the time of the plaintiff’s surgery on March 3, 2005.
Turns out – not much.  Even the turncoat prescriber (we hate it when that happens) had to admit that, at the time he didn’t know anything about it until two years later, and that the pump seemed to help his patients.  2010 WL 5475616, at *1-2 ¶¶4, 16.  It seems that the first public disclosure of this risk occurred on March 23, 2006.  Id. at *2 ¶12.  Nobody could find any medical literature from the 2005 era linking chondrolysis and pain pumps.  Id. at *2-3 ¶¶19-21.
Summary judgment!
Ohio, like most states doesn’t impose any duty to warn of scientifically unknown information:

There is no duty to warn of unknown and unknowable hazards.  The test focuses on the state of knowledge at the time the product left the manufacturer’s hands and at the time the product was used.

2010 WL 5475616, at *5 (citation omitted); accord id. at *6 (“Ohio law restricts the duty to warn to known or knowable risks”).Continue Reading In An Ohio State Of (The Art) Mind

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Is it still news when Medtronic wins a preemption motion for one of its PMA devices?  We think so, so we’ll tell our readers about Stengel v. Medtronic, Inc., No. CV 10-318-TUC-RCC, slip op. (N.D. Ariz. Nov. 9, 2010).
The product was a Class III pain pump that received initial PMA in 1988 and