There are times that you can tell that a witness at a deposition just isn’t committed to his or her answers.  They get long-winded, creeping toward the ultimate answer, circling it, poking it, testing it, before ultimately offering it and then cautiously backing away.  It’s the reddest of red flags.  And, if it comes from a causation expert, you could be on the verge of hobbling or ending the plaintiff’s case.  Here is just that type of testimony:

Q: So, Doctor, would you be willing to testify to a jury Nexium [sic] can cause fractures?

A: You know, it would depend on the question posed to me in front of a jury. I would be honest in my interpretation of the data.  It would [sic] not take it any more than it is or less than it is.

I don’t think—if this is a question asked before a jury, I’ll be honest with them.  I don’t think that looking at all of this data any reasonable physician or scientist or even a person of the lay public reading this can say there’s absolutely no relationship between Nexium use and risk of fracture, absolutely none.

The weight of the evidence suggests otherwise,that there is a relationship, a causal relationship, can be inferred because of a number of studies that seem to point the same way.  And the evolution of those studies and that’s what I would testify that, yes, it seems from the weight of the scientific evidence we have that the long-term use of Nexium seems to be related to the risk of fractures.

In re Nexium (Esomeprazole) Prods. Liab. Litig., 2014 WL 5313871, at *2 (C.D. Cal. Sep. 30, 2014).  That answer is from a real expert in the Nexium litigation.  It’s loaded with just the type of hedging you get from an uncomfortable and uncertain witness: “it depends”; “I’ll be honest”; and “it seems from the weight of the evidence.”  That testimony would never convince a jury.

Continue Reading Anatomy of a Rule 702 Win

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.

Continue Reading Two Quick Updates – Mesh and Pain Pump

We’ve been following all this Pain Pump litigation for some time – our “Pain Pump” topic has 31 posts in it − and with some trepidation.  The trepidation has primarily derived from the Pain Pump defendants’ rather powerful state of the art defense in many of the current cases (mostly involving older surgeries).  As always, when the defendants have a solid defense, we see plaintiffs resorting to a variety of more-or-less novel and expansive causes of action in attempt to circumvent it.  In Pain Pump we’ve seen duty to test, post-sale duty to warn, off-label promotion, and “no good deed goes unpunished” FDA-related allegations that amount to private FDCA enforcement.  As to the latter, a word to the wise:  If you’ve already received a general use indication from the FDA for your device, anything you do to seek a more precise indication, especially if you aren’t successful, might be used against you by plaintiffs improperly trying to impose their peculiar view of the FDCA

Well, with the plaintiffs unsuccessful (twice) in getting a federal MDL, they haven’t all been able to pile on in one forum.  Instead, it’s been the legal equivalent of guerilla warfare in various courts – state and federal – around the country.  Some of those cases have been approaching the trial stage.  As veterans of the Baycol and Vioxx wars (among others), we know how important early trial wins can be.

Well, on February 6, 2013, the defense won a big one – in a difficult jurisdiction (California), but not in the worst parts of it (Orange County), which is where hundreds of California state Pain Pump (against all defendants) cases have been “coordinated.”  This bellwether case, the first to be tried in California, was called McKenna and the target defendant was Breg.  Previously, other Pain Pump defendants also won a trial in federal court in Oregon, and we believe another in Wyoming.

Continue Reading Getting Pumped Up

Updates are not necessarily a good thing, but we
suppose they can be necessary.  So here
are a couple.
First, some time ago we blogged about
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

Here’s another guest post from Reed Smith’s Eric Alexander, who is inching (being hauled) towards full blogger status, but who isn’t there yet – so we’re posting this for him.

**********************

We warn our readers that there will be a neck-snapping
segue later in this post.  You might want
to stretch before reading.  The segue

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,

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