We really don’t like it when state aspiring governors (that’s what “AG” stands for, isn’t it?) come after our clients − especially when our clients were merely exercising their First Amendment rights to make truthful statements about this or that off-label use. But then, the state AGs never cared what we thought before, so why
After a Memorial Day weekend filled with picnics, barbeques and full stomachs, we have a quick post for you. We recently read the opinion in Mattos v. Eli Lilly & Co., 2012 U.S. Dist. LEXIS 71519 (D. Ka. May 23, 2012), which, much like those barbeques and picnics, had a lot of good things
Miscellaneous day today, just before Memorial Day (remember to raise a glass to the common foot soldier this holiday) and the official start of summer − courtesy of our readers.
Number one:
A tip of the cyber-cap to Mike Imbroscio at Covington and Bart Sullivan at Fox Galvin for sending us Aranda v. Walgreen Co.
Bexis doesn’t limit his product liability horizons to drugs and devices − except usually on this blog. A few years ago Bexis got involved in asbestos-related expert witness issues in a big way, and in particular has devoted almost a decade (working through the Product Liability Advisory Council (“PLAC”)) trying to stamp out so-called “any exposure” causation opinions in asbestos litigation in Pennsylvania (and more lately, elsewhere). Asbestos plaintiffs attempt to recover without having to prove individual exposure histories by routinely offering expert testimony that “each and every breath” of asbestos-contaminated air is causal, particularly in mesothelioma cases.
Those kind of opinions turn our stomachs.
Yesterday, Bexis’ effort (and that of a lot of people, including asbestos-specific amici) was successful.
A unanimous Pennsylvania Supreme Court decided Betz v. Pneumo Abex LLC, No. 38 WAP 2010, slip op. (Pa. May 23, 2012), holding that such opinions offered in meso cases violated the Pennsylvania Frye-based “generally accepted” standard for the admissibility of expert testimony. Bexis’ PLAC brief in Betz was cited in several places, and his arguments were adopted even more frequently.Continue Reading Bexis Brings Home Some Fryed Bacon
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
Sometimes we feel like pulling our hair out − those of us who still have some, anyway. One things that gets us in that mood is the other side claiming that the prescribing physician (who went to med school and typically has loads of experience with the relevant product) would have treated as gospel this
The recent decision in Mims v. Wright Medical Technology, Inc., 2012 WL 1681810 (N.D. Ga. May 11, 2012), is really neither a win nor a loss. Like Gaul, the decision contains three parts, and we have comments as to each.
Very briefly, the case involves a total hip implant constructed from titanium. After being implanted for over three years, it broke.
The first part of the opinion denied summary judgment on design defect claims. The plaintiff’s expert, as is common in such cases, alleged that instead of being made out of titanium it should have been made out of cobalt-chrome alloy (“CCA”). Mims, 2012 WL 1681810, at *2. Of course, if the defendant had used CCA, the expert would then have alleged it should have been made out of titanium − anything to claim a defect.
The defendant moved for summary judgment, arguing that merely claiming an alternative design was not enough. Id. at *3. That struck us as a little odd, since defendants are usually the foremost advocates of a strong alternative design requirement. The court held that since alternative design was essential to design defect litigation, that was enough to survive summary judgment:
One factor consistently recognized as integral to the assessment of the utility of a design is the availability of alternative designs, in that the existence and feasibility of a safer and equally efficacious design diminishes the justification for using a challenged design. The alternative safer design factor reflects the reality that it often is not possible to determine whether a safer design would have averted a particular injury without considering whether an alternative design was feasible. The essential inquiry, therefore, is whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. Alternative safe design factors include: the feasibility of an alternative design; the availability of an effective substitute for the product which meets the same need but is safer; the financial cost of the improved design; and the adverse effects from the alternative.
Id. at *2.
Frankly, we don’t mind that particular ruling too much. We could even see using this quote in one of our cases.Continue Reading Not A Win, Not A Loss