Thursday, May 24, 2012

Bexis Brings Home Some Fryed Bacon

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.

Because almost every drug/device case involves the admissibility of expert testimony, Betz is also highly relevant to what we do here on the blog.  First of all, in what we consider the most important of the many good holdings in Betz, the Court rejected as "ineffectual" a lot of the usual garbage that the other side tends to offer in support of novel causation opinions:

[Plaintiff’s] efforts to invoke case reports, animal studies, and regulatory standards are also ineffectual in terms of substantial-factor causation, since the most these can do is suggest that there is underlying risk from the defendants’ products.

Betz, slip op. at 48 (emphasis added).  The Court had previously described the defense arguments on these issues in more depth.  See Id. at 32-33 (discussing the “limited role” of “anecdotal reports”; problems with “reliance on animal studies”; and the “cautionary, propylactic nature” of “regulatory standards and thresholds”).

Since most of Bexis’ PLAC brief addressed precisely these issues, it’s cause for high fives all around here.

In another critical Grady/Frye ruling, the Supreme Court affirmed the importance of dose response in cases (which would include drug cases − less so with devices) involving exposure to allegedly harmful substances.  “Simply put, one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose responsive.”  Betz, slip op. at 48.  Dose-response is important:

[The trial court] was right to be circumspect about the scientific methodology underlying the any-exposure opinion. [The court] . . . was unable to discern a coherent methodology supporting the notion that every single fiber from among, potentially, millions is substantially causative of disease. [The court] appreciated the considerable tension between the any-exposure opinion and the axiom (manifested in myriad ways both in science and daily human experience) that the dose makes the poison.

* * *

A dose-response curve shows the relationship between different exposure levels and the risk of cancer [or any other disease] associated with those exposure levels. Generally, exposure to higher levels carries with it a higher risk, and exposure to lower levels is accompanied by a reduced risk.

Id. at 44 & n.33 (citation and quotation marks omitted).

Dose-response was another major argument in Bexis’ PLAC brief.  More high fives.

Also of great general importance is the scope of Grady/Frye (the leading Pennsylvania Frye opinion is called “Grady”) challenges under Pennsylvania law − do they apply only to the most “novel” of scientific testimony, narrowly construed (the view adopted by the Pennsylvania Superior Court in Trach v. Fellin, 817 A.2d 1102, 1110 (Pa. Super. 2003), and in its now-thoroughly-reversed opinion in Betz), or are Grady/Frye challenges more broadly available whenever an expert purports to use scientific techniques, even if not “novel” in the abstract” in unusual ways.

We’re pleased to report that the Pennsylvania Supreme Court took the broader view of the Grady/Frye test’s scope.  The Court rejected various rationales given for the narrow view taken by Trach and its unfortunate Superior Court progeny.  Betz, slip op. at 43 (mentioning “increase [in] the number of challenges”; concerns over “the competency of trial judges to accept or reject scientific theories”; and “reluctance . . . to deprive litigants of their day in court”).  Instead, the Court focused on “the potential that [expert] distortions have to mislead laypersons”:

It would be naïve, in this [the “influential nature” of expert opinions] regard , to assume that the possibility for distortion is limited to the very newest realms of science. . . . We therefore agree with [defendants] that a reasonably broad meaning should be ascribed to the term “novel.” Furthermore, we conclude that a Frye hearing is warranted when a trial judge has articulable grounds to believe that an expert witness has not applied accepted scientific methodology in a conventional fashion in reaching his or her conclusions. We believe a narrower approach would unduly constrain trial courts in the appropriate exercise of their discretion in determining the admissibility of evidence.

Betz, slip op. at 43-44 (emphasis added). Bexis had been trying to get the Pennsylvania Supreme Court to take a look at Trach ever since Trach itself, and finally that happened.

Ding-dong the Trach is dead.  More high fives.

Also, although it didn’t discuss the point as much as we would have liked, the Betz court rejected the Superior Court’s expansive reading of Trach (see slip op. at 25-26, describing Superior Court decision) as allowing both upward and downward extrapolation without distinction.  Instead the Supreme Court held, “we agree with [defendants] that the breadth and character of an expert’s extrapolations are relevant to the scientific acceptance of his methodology.”  Betz, slip op. at 52.  So, while Trach extrapolation (unlike the  Trach straitjacketed scope) isn’t completely dead, at least acceptable Grady/Frye use of extrapolation doesn’t include downward extrapolation without “the requirement of sufficiently strong logic supporting the inference.”  Slip op. at 34 n.20.

Another technical point also applicable to drug/device cases is the standard of review when a summary judgment motion (where the losing party gets the benefit of all evidentiary inferences) is based on a Grady/Frye expert exclusion (evaluated under an abuse of discretion standard).  Betz rightly held that “the appropriate appellate standard of review is the one pertaining to the underlying ruling.”  Slip op. at 45.  This is another useful ruling for defendants, who regularly win dispositive motions based upon Grady/Frye or other discretionary evidentiary rulings with dispositive effect.  Make a note of it.

The Court in Betz also didn’t allow a pathologist (a recurrent plaintiff’s asbestos causation expert named Maddox) get away with testifying about an epidemiological subject without mentioning epidemiology.  The court pointed out that the expert had “no familiarity whatsoever with [the plaintiff’s] individual circumstances.”  Slip op. at 46 (something we’ve seen in drug/device cases, too).  Therefore, the expert was necessarily treading on epidemiologic territory.  Id. (“[i]n doing so, he took it upon himself to address (and discount) the range of the scientific literature, including pertinent epidemiological studies”).  Thus, the trial court appropriately relied upon epidemiologic proof to evaluate the purported pathologist expert.  Id. at 47. “[W]here epidemiology is available, it cannot be ignored.”  Id. at 52.  That’ll also be quite useful in our cases.

The Court also pointed out how an “any exposure” causation opinion is fundamentally at odds with Pennsylvania’s longstanding “substantial factor” test for causation.

The any-exposure opinion, as applied to substantial-factor causation, does not consider the three factors [these being “potency,” “intensity,” and “duration”] which . . . need to be considered in trying to estimate the relative effects of different exposures.

* * *

The comments to the Second Restatement of Torts recognize that a proportionate evaluation may be required in a reasoned assessment of substantial-factor causation. RESTATEMENT (SECOND) OF TORTS, §433, cmt. d (1965) (“Some other event which is a contributing factor in producing the harm may have such a predominant effect in bringing it about as to make the effect of the actor’s negligence insignificant and, therefore, to prevent it from being a substantial factor.”). Notably, this Court has cited Section 433 as consistent with Pennsylvania law.
Betz, slip op. at 49 & n. 36.  Bexis hammered this issue in his PLAC brief − and just broke his arm patting himself on the back.

Thus, the Court reaffirmed − this time in the specific context of Grady/Frye − its criticism of “any exposure” causation opinions in Gregg v. V-J Auto Parts Co., 943 A.2d 216 (Pa. 2007) (the first case where Bexis briefed these issues):

[W]e do not believe that it is a viable solution to indulge in a fiction that each and every exposure to asbestos, no matter how minimal in relation to other exposures, implicates a fact issue concerning substantial-factor causation in every “direct evidence” case. The result, in our view, is to subject defendants to full joint-and-several liability for injuries and fatalities in the absence of any reasonably developed scientific reasoning that would support the conclusion that the product sold by the defendant was a substantial factor in causing the harm.

Betz, slip op. at 50 (quoting and following Gregg, 943 A.2d at 226-27).  See Id. at 51 (finding “no scientific basis for concluding that a single cigarette of the potentially half-million a person might smoke in a lifetime is substantially causative of such person’s lung cancer”).

Finally, the Betz court rejected any notion of “de minimus” exposure liability in meso cases under Tragarz v. Keene Corp., 980 F.2d 411, 421 (7th Cir. 1992) (applying Illinois law), a case the Court had unfortunately cited in Gregg.  Regardless of Illinois law, “discounting of the substantiality in exposure would be fundamentally inconsistent with Pennsylvania law.”  Betz, slip op. at 53.  This aspect of Betz will also be useful in disposing of expert testimony in “low-dose” exposure cases involving prescription drugs.

Thus, we have to conclude that Betz is the best − and Bexis' PLAC brief wasn’t bad either.