Law

We're pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover.  On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick – going three for three on summary judgments in New Jersey hernia mesh litigation.  The three decisions are:  Goodson v. C.R. Bard, Inc., 2016 WL 743478 (N.J. Super. L.D. Feb. 19, 2016); Utech v. C.R. Bard, Inc., 2016 WL 743477 (N.J. Super. L.D. Feb. 19, 2016); and Yakich v. C.R. Bard, Inc., 2016 WL 743476 (N.J. Super. L.D. Feb. 19, 2016).

A bit of background.  These three are not mass tort cases.  They are examples of what happens when there is indiscriminate plaintiff-side advertising.  People call up these 800 numbers because they had "mesh" implanted.  They don't have the targeted product but – what the hey? – it's mesh and some of the raw materials are the same, so rather than turn away a potential plaintiff, the same attorneys file one-off cases against virtually every mesh product that exists, even if (as is true here) the particular product has been the medical standard of care for the relevant surgical procedure for decades.

As one might expect with pattern litigation, these three lawsuits, and thus these three opinions, look a lot alike.  So we'll concentrate on the Goodson opinion – if for no other reason than alphabetical order.

Plaintiff Goodson was from Georgia.  What business he has suing in New Jersey is negligible (the defendant is located there), since his prescription, treatment and injuries all occurred in the Peach State, but Joisey is where his counsel filed the suit.  The mesh was for inguinal use – not any of the uses of mesh that plaintiffs have targeted for mass torts.  As is common, the surgeon already knew about the risks and did not need to read the manufacturer's warnings:

[Plaintiffs'], surgery was performed by [his surgeon]. [The surgeon], by his own testimony, was aware of the risks and benefits of using synthetic mesh for hernia repair, including the risk of chronic debilitating pain, infertility, and the possibility of nerve ingrowth.  [The surgeon] discussed the risks of numbness and chronic debilitating pain with Plaintiff.  [The surgeon] testified that he did not read the Instructions for Use ("IFU") that accompanied the product.

Goodson, 2016 WL 743478, at *1.  Using this product for this surgery was the medical "standard of care."  Id. at *2.  Testimony like this is why we love the learned intermediary rule so much – it utterly defeats causation in a warning case.

The explanting surgeon didn't help plaintiff's case either.   He testified that "nobody can say with a reasonable degree of medical certainty what was causing Plaintiff's . . . pain" and "would not say that had a different hernia repair product" would have prevented that pain.  Id.

Plaintiff's experts (two hernia surgeons and a pathologist) weren't much better for him.  The first had "no opinions as to [this product] specifically" but only offered general opinions about "whether Defendants complied with industry standards applicable to medical devices or whether the [product] was appropriately marketed to physicians."  Id.  He didn't have a design opinion at all, but did criticize the product label's risk information.  Id.  The second expert (the pathologist) disclaimed any opinions about product "design," "what information should have been provided," or "clinical outcomes."  Id. at *3.  He simply "criticizes the use of [this] mesh in general."  Id.  The third expert testified about medical causation and criticized the warnings, but admitted "that the medical community considers [this] mesh the 'gold standard' for inguinal hernia repair, but that he personally disagrees with that statement" – in other words that he disagrees with the consensus of his profession.  Id.

This is what happens when a plaintiff tries to litigate a one-off case with two experts loathe really to criticize standard-of-care medicine and another expert recycled from a mass tort involving some other, albeit vaguely related, product.

The court, applying Georgia law, granted summary judgment as to all claims.  Continuing to litigate the case on the cheap, plaintiff's papers were "devoid of any application of Georgia law to the facts of Plaintiff's case."  Id. at *9.  For a design defect claim, plaintiff needed an alternative design, but didn't have one.  An expert's "briefly mention[ing]" a different kind of mesh didn't come close to being an evaluation of competing risks and utilities.  Id. ("The Court will not unilaterally delve into matters of science not supported by evidence presented by counsel").  Other than that, the plaintiff's three experts didn't have anything to offer about design defect, which was fatal to the claim.  Id.   Nor, in the absence of any opinion that use of an alternative would have led to a better outcome, was causation established.  Id. at *10.

Plaintiff's various informationally-related claims likewise got the bum's rush.  "Plaintiff has not pointed to any specific representations made by the Defendants to Plaintiff or his doctor, who does not even recall reading the IFU."  Id.  Negligence claims failed for lack of any standard of care testimony, and warranty claims for lack of privity under Georgia law.  Id.

The other two decisions, Utech and Yakich, were generally similar.  Plaintiffs used the same trio of experts, who offered the same utterly inadequate opinions.  Both plaintiffs were also litigation tourists.  Utech was from Minnesota, while Yakich was from Wisconsin. The implanting surgeon in Utech gave similar testimony defeating warning causation:

[The surgeon], by his own testimony, was aware of the risks of numbness, tingling, and pain associated with the use of mesh for inguinal hernia mesh repair, and [he] knew that such symptoms could persist long-term. He also testified that he did not review the Instructions for Use which accompanied the [product].

Utech, 2016 WL 743477, at *1.  Likewise in Yakich:

[The surgeon] testified that she was aware of the risks of "chronic debilitating pain," "shrinkage and contracture," "pain so severe that removal would be recommended," and "chronic pain persisting after mesh removal."  [The surgeon] testified that she discusses risks, including the risk of pain, with her patients prior to hernia repair surgery, but that she did not remember her specific risk discussions with Plaintiff.

Yakich, 2016 WL 743476, at *1.

Thus, the design defect claims failed for the same reasons as in Goodson.  None of plaintiffs' experts opined about either alternative design or risk/utility generally.  Utech, 2016 WL 743477, at *9-10; Yakich, 2016 WL 743476, at *10-11. Expert "testimony, about hernia mesh in general, and the impression of surgeons, generally speaking, does not create a genuine issue of material fact."  Utech, 2016 WL 743477, at *10; Yakich, 2016 WL 743476, at *11.

The warning claims in these cases also failed.  In Utech, "Plaintiffs contentions are belied by the testimony that [the surgeon] did not read the IFU and that Plaintiff never had any contact with Defendants prior to his surgery."  Utech, 2016 WL 743477, at *11.  Yakich warrants a bit more discussion, because the court's holding that "Wisconsin applies the learned intermediary doctrine in prescription drug and device cases" is notable.  Yakich, 2016 WL 743476, at *9.  Yakich is thus one of the few Wisconsin law cases (Menges v. Depuy, 61 F. Supp.2d 817, 830 (N.D. Ind. 1999), being another that comes to mind) granting summary judgment on warning causation issues:

Plaintiff cannot sustain a failure to warn claim where his implanting surgeon . . . testified that she was aware of the risks Plaintiff has alleged led to his injury at the time of surgery and she would still use the [product] if presented with Plaintiff today.  Without a showing that the learned intermediary['s] . . . conduct would have been altered by what Plaintiff alleges would be an adequate warning, the failure to warn claim must fail.

Yakich, 2016 WL 743476, at *11.

Finally, other claims, particular warranty, fell for various state-specific reasons.  Utech, 2016 WL 743477, at *11; Yakich, 2016 WL 743476, at *11-12.

What really happened here?  The basic problem is that medicine isn't perfect and, consequently, even so-called "gold standard" treatment is no guarantee of a cure.  These products were well–established and their use the medical standard of care.  Surgical complications, particularly those consisting largely of subjective complaints of pain, as here, are not torts.  These cases are yet another example of needless litigation generated by the other side's constant solicitation of plaintiffs and their unwillingness to turn anyone away, even when they aren't those who the solicitation was after.