When we last left our story, plaintiffs had lost their fight to have Pennsylvania law apply to residents of Texas ( Atkinson I) and lost a chunk of their claims as barred by the Texas statute prohibiting failure to warn claims where a drug’s label has been approved by FDA and comment k (

Recently, largely related to the dubious pleasure of home ownership, we have had multiple occasions on which we were forced to shrug our shoulders and proclaim, “Nothing’s perfect.”  To wit, we recently noticed a small wet spot on our bedroom ceiling.  The roofing company discovered that the corresponding section of the roof was too shallow

In searching for cases for this blog, we sometimes feel like its Groundhog Day.  Another preemption win in a PMA medical device case.  Another food labeling decision from California.  Another failure to plead fraud with particularity dismissal.  Another “Okay, campers, rise and shine, and don’t forget your booties ’cause it’s cooooold out there today.”  Well, that last one really only applies to Phil Connors, but you get the idea.

Faced with routine rulings, it can be difficult to be creative, to find the new hook or twist.  So, sometimes the answer is simply to not – be creative that is.  Sometimes, a decision is just what it looks like it is on its face.  Another good ruling in an already good body of law.  But that doesn’t mean it should be disregarded either.  We just need to pluck out the good sound bites and add them to top of the pile.

For instance, if faced with a claim for negligent failure to test in Pennsylvania, you can now add Houtz v. Encore Medical Corp., 2014 U.S. Dist. LEXIS 170481 (M.D. Pa. Dec. 10, 2014) to your motion to dismiss on the ground that “Pennsylvania courts have explicitly stated that negligent failure to test is not a viable cause of action.”  Id. at *7.

Continue Reading Pennsylvania Sound Bites

There are several reasons we recommend taking a look at last week’s decision in Ball v. Takeda Pharmaceuticals America, Inc., 2013 WL 4040395 (E.D. Va. Aug. 8, 2013).  One is that the case involves Stevens Johnson Syndrome, a rare but devastating idiosyncratic reaction which has become something of a litigation flavor du jour, with plaintiffs claiming that a great number of drugs cause this condition.  After showing considerable patience (plaintiff filed 5 motions to amend), the court ruled that plaintiff finally struck out.

Most significantly, Ball was super in dismissing the plaintiff’s warning claim.  The court held that the defendant’s warning about SJS/TENS was adequate as a matter of law – and dismissed the case:

The [relevant] label clearly identifies Stevens-Johnsons syndrome as a potential “adverse reaction” that could result from use of the prescription drug.  Under Virginia law, a manufacturer is obligated to give a reasonable warning, not the best possible one.  Courts have routinely held warnings adequate as a matter of law when they alert a party to the very injury for which the plaintiff seeks relief.  [Defendant] disclosed Stevens-Johnson syndrome as a possible adverse reaction to [the drug] prior to plaintiff’s ingesting the drug. . . .  The failure to disclose this risk is the sine qua non of the plaintiff’s negligence and negligence per se claims to the extent they seek to hold [defendant] responsible for plaintiff’s Stevens-Johnson syndrome.  Those claims are dismissed, with prejudice.

Ball, 2013 WL 4040395, at *5 (citations omitted).  A finding of adequacy as a matter of law is powerful, since warning claims are at the heart of prescription drug litigation.  That this determination was made at the motion to dismiss stage, with the court taking notice of the label, is obviously even better. “A manufacturer does not insure its product’s safety, and need not supply an accident-proof product,”  Id. at *6 (citation and quotation marks omitted).

Continue Reading On The Ball In The Old Dominion

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

Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will

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