We’ve been waiting quite a while for the FDA to modernize its positions on the truthful off-label communications by regulated manufacturers. Under current First Amendment practice, the FDA’s positions are quite likely unconstitutional as both speaker- and topic-based restrictions on the truthful communication of scientific information. However, the best we’ve seen from the Agency to
State Of The Art
Two Quick Updates – Mesh and Pain Pump
It is the Friday of Memorial Day Weekend. Barbecues are being fired up. Beach towels are being scattered on sandy dunes. Pools are opening (probably still a tad early for a dip in the Mid-Atlantic/Northeast states). Fittingly, we came across two decisions this week that warrant mentioning but don’t require much heavy lifting. Perfect blog-material for the unofficial start of summer celebration.
First, we want to report that the Eighth Circuit has affirmed summary judgment in defendant’s favor in another Pain Pump case – Mack v. Stryker, — F.3d –, 2014 WL 1876124 (9th Cir. May 12, 2014) (Minnesota law). That court joins the Sixth Circuit (Rodriguez v. Stryker Corp., 680 F.3d 568 (6th Cir.2012)) in finding that the defendant manufacturer could not be liable as a matter of law because the alleged risk was not scientifically knowable at the time of plaintiff’s surgery. Similar to Rodriguez, the Eighth Circuit reviewed 12 articles relied on by plaintiffs to establish that the risk was knowable. The court (in a 2-1 decision) concluded that these articles proved nothing about the particular device at the time in question. This state-of-the-art issue is critical in the Pain Pump litigation and this appellate decision certainly tightens the binds on plaintiffs who had earlier pain pump surgeries.
Before our detractors start yelling Krumpelbeck is the law of the Sixth Circuit, here is what the Eighth Circuit had to say about that:
A separate panel of the Sixth Circuit decided a similar case to Rodriguez less than three months later, and it reversed a district court’s decision to grant summary judgment to a pain pump manufacturer without acknowledging Rodriguez. See Krumpelbeck v. Breg, Inc., 491 F. App’x 713 (6th Cir.2012) (unpublished). Krumpelbeck and Rodriguez directly conflict. We decline to consider Krumpelbeck because it is not the law of this circuit and likely not the law of the Sixth Circuit due to Rodriguez’s prior publication. See Rutherford v. Columbia Gas, 575 F.3d 616, 619 (6th Cir.2009) (“A published prior panel decision remains controlling authority unless an inconsistent decision of the United States Supreme Court requires modification of the decision or this Court sitting en banc overrules the prior decision.” (quotation and citation omitted)). Additionally, we do not find it persuasive.
Mack, 2014 WL 1876124 at *10 n.6. Neither do we.…
No Duty to Test Claim Doesn’t Keep Out Failure to Test Evidence Entirely
Because of Reed Smith’s involvement in this litigation, this post is from the Dechert side of the blog only.
We love to bring you the slam dunks, the grand slams, the holes in one – well, at least the ones that go in defendants’ favor. And, while we dislike having to deal with the air balls, the strike outs, and the shanks into the rough, we do it. Usually with less gusto but then we’ve always been honest that this is a defense oriented blog. We examine the rulings that go against us to be forewarned, to develop new strategy, and we hope in some small way to contribute to changing the law. But, as practitioners we know that more often the course of a lawsuit is filled with small victories and minor defeats as the game inches toward completion – whether trial, settlement or dismissal.
That brings us to today’s case – mostly sweet, with a hint of a sour after taste. Cisson v. C.R. Bard, Inc., 2013 WL 3821280 (S.D. W. Va. Jul. 23, 2013) is another decision out of the Pelvic Mesh MDL and it applies Georgia law. The decision is actually clarifying the court’s earlier evidentiary ruling regarding evidence of defendant’s alleged failure to test.
First, the court makes clear that under Georgia law, there is no separate cause of action for failure to test. Id. at *4 (“there is no claim for failure to test under Georgia law”). That’s no shocker; the list of courts reaching the same conclusion is quite lengthy. But this wasn’t a motion to dismiss, rather a motion in limine. And, because the “duty to test is subsumed within the plaintiffs’ design defect and failure to warn claims,” id. at *5, the court was called upon to determine what testing evidence would be admissible at trial.…
Continue Reading No Duty to Test Claim Doesn’t Keep Out Failure to Test Evidence Entirely
suppose they can be necessary. So here
are a couple.
Degelmann v. Advanced Medical Optics, 659 F.3d 835 (9th Cir. 2011). The case even made last year’s honorable
mention list on our best of the year post
Interesting Application of State of the Art Principles
There’s a lot going on in Wendell v. Johnson & Johnson, 2012 WL 3042302 (C.D. Cal. July 25, 2012), but much of it depends on very case-specific facts about a particular prescriber’s knowledge, and some of the rest was put off essentially as premature. There is one aspect of the Wendell decision that merits…
Significant State of the Art Win
Although we aren’t familiar with all the details, we know that state of the art – that is when a particular risk was scientifically knowable – is currently a big deal in Pain Pump litigation. That litigation isn’t MDLed so it’s being fought on a case-by-case basis in courts across the country. Given this fact,…
Breaking News – Pain Pump State Of The Art Affirmed
As anyone following the Pain Pump litigation knows, the state-of-the-art issue – whether it was possible for the defendant to know of the alleged risk of its products given the state of scientific knowledge at the time of a plaintiff’s surgery – is critical. Well, today the first court of appeals to consider that question has affirmed summary judgment. Rodriguez v. Stryker Co., No. 11-5335, slip op. (6th Cir. May 21, 2012) (applying Tennessee law).
The court in Rodriguez examined some 13 articles published over the course of seven decades that the plaintiffs claimed that established a jury question on the state of the art (that is, that the risk was knowable). It concluded (as had the district court) that these articles proved nothing about this particular device at the time in question:
When all is said and done, not one of [plaintiff’s] thirteen articles shows that medical experts understood in 2004 that infusing a joint with [the drug] for two days could cause irreversible cartilage damage. [Defendant] had no duty to understand what the relevant medical literature did not.
Rodriguez likewise found that the plaintiff’s expert couldn’t make anything more out of the same 13 articles than the articles themselves:
[Plaintiff’s] theory requires two speculative leaps. It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm. And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely. Both are far too conjectural and too many steps removed from the problem that developed.
The court went on to demolish plaintiff’s regulatory theory – that because the FDA had denied §510k clearance to the device, that that somehow put the manufacturer on notice of unknowable risks.
The FDA’s action means only that no other device on the market carried that indication for use. It does not mean that the pump was (or might potentially be) dangerous to use in the joint space. The 510(k) process does not comment on safety.
Slip op. at 8. Ironically, the defendants won because of the adverse preemption decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Plaintiffs were thus prevented from having their cake and eating it, too. That is, plaintiffs who deny preemption because a §510k clearance doesn’t address safety, can’t play fast and loose by turning around and claiming that lack of §510k clearance has safety connotations.
Continue Reading Breaking News – Pain Pump State Of The Art Affirmed
The Pain Pump Litigation Pumps Out another Good Decision
In Colorado, State-Of-The-Art Defense Is Up, Duty To Test Down
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…
In An Ohio State Of (The Art) Mind
Ever since the JPMDL (that,s “Judicial Panel on Multi-District Litigation” for you non-lawyers), refused to create an MDL – twice – 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.
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