Thursday, July 19, 2007

Daubert Decision in Baycol Raises Interesting Legal Points

We’re so used to adverse decisions out of the District of Minnesota – what with the defibrillator MDLs “distinguishing” Buckman into near oblivion, and the heart valve MDL persisting in certifying classes despite being told not to by the Eighth Circuit – that good news from that district is like a breath of fresh air.

That’s what we got recently in In re Baycol Products Litigation, 2007 WL 2004432 (D. Minn. July 9, 2007). Now we have irons in the Baycol fire, and thus we can’t say much about any of the product-specific arguments or facts, but we can blog about the legal points raised in the court’s comprehensive Daubert opinion, most of which we heartily endorse.

One of the main issues was comparative toxicity. Generally, in a situation where there are a number of competing prescription medical products all serving more or less the same need, courts have held that there’s no duty to warn about the attributes of competing products.

[Defendant] is under no duty to provide information on other products in the marketplace. Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies. This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product. Furthermore, such a duty would raise serious implications regarding the free flow of commerce in that industry.
Pluto v. Searle Laboratories, 690 N.E.2d 619, 621 (Ill. App. 1997). Accord Johnson v. American Cyanamid Co., 718 P.2d 1318, 1326 (Kan. 1986); Barnes v. Kerr Corp., 418 F.3d 583, 591 (6th Cir. 2005) (OTC product) (applying Tennessee law); Ackley v. Wyeth Laboratories, 919 F.2d 397, 405 (6th Cir. 1990) (applying Ohio law); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1233 n.13 (4th Cir. 1984) (applying South Carolina law); Adamson v. Ortho-McNeil Pharmaceutical, Inc., 461 F. Supp.2d 496, 504 (D.N.J. 2006); Doe v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp.2d 614, 626-27 (M.D.N.C. 2004); McConkey v. McGhan Medical Corp., 144 F. Supp.2d 958, 964 (E.D. Tenn. 2000); Smith v. Wyeth Laboratories, Inc., 1986 WL 720792, at *10 (S.D.W. Va. Aug. 21, 1986).

Likewise, in product liability cases generally, courts have declined to force manufacturers to discuss the relative safety of competing products. E.g., Rastelli v. Goodyear Tire & Rubber Co., 591 N.E.2d 222, 225-26 (N.Y. 1992); Firestone Steel Products Co. v. Barajas, 927 S.W.2d 608, 614 (Tex. 1996); Mitchell v. Sky Climber, Inc., 487 N.E.2d 1374, 1376 (Mass. 1986); Brown v. Drake-Willock International, Ltd., 530 N.W.2d 510, 515 (Mich. App. 1995); Fricke v. Owens-Corning Fiberglas Corp., 618 So.2d 473, 475 (La. App. 1993); Powell v. Standard Brands Paint Co., 212 Cal. Rptr. 395, 398 (Cal. App. 1985); Baughman v. General Motors Corp., 780 F.2d 1131, 1133 (4th Cir. 1986) (applying South Carolina law).

The FDA has also contributed its two cents worth. The Agency imposes strict limits on so-called “comparative advertising.” Unless the FDA otherwise allows, there are to be no comparative claims concerning regulated products unless supported the manufacturer can back them up with “adequate and well controlled studies.” 21 C.F.R. §201.57(c)(3)(v); see 44 Fed. Reg. 37434, 37441 (item 35), 37446 (item 58) (FDA June 28, 1979) (discussing this requirement).

Well, that's not what the Baycol court did. It only had Daubert motions before it. So instead of addressing the substantive product liability issue directly, the Baycol court accomplished the same result by excluding all of the expert opinion that purported to make safety comparisons with competing drugs. 2007 WL 2004432, at *3-9, 11, 14, 18-19, 23, 27, 31, 32-33, 36. The court held that it was improper to analyze adverse drug reports (“ADRs”) in order to compare the safety of competing drugs. We’ve already posted extensively on plaintiffs’ misuse and abuse of ADRs (also called “ADEs”), so we’re not going to repeat all that. Suffice it to say that the Baycol court held that:

[G]iven the limitations inherent in AER data, there is insufficient evidence before the Court as to the known or potential rate of error, and no evidence has been submitted to demonstrate that such an analysis is generally accepted.
2007 WL 2004432, at *7. The court observed that even the articles upon which the plaintiffs’ expert relied specifically noted that ADRs could not be used to calculate the relative frequency of adverse reactions. Id. at *7-8. We think that’s exactly right. After all, there are “lies, damn lies, and statistics.” If our clients ever engaged in the kind of statistical shennanigans that plantiffs’ experts regularly seek to pass off as science, the plaintiffs would be seeking punitive damages.

As to whether the ADRs had any other valid evidentiary purpose, such as notice, the MDL court left the decision to the various trial courts that would eventually try individual remanded cases. Id. at *9.

Also in the “lies, damn lies, and statistics” category, the Baycol court refused to allow a plaintiffs’ expert to “recalculate” a published study. The court was perfectly willing to permit criticism of the study’s claimed biases. Id. at *10. We have no problem with that because we recognize bias as an inherent limitation of all epidemiology. Any study’s going to have one bias or another, and that’s fair game for criticism. We’d have a field day on cross, though, comparing the magnitude of the claimed biases in the studies we like with the huge biases inherent in ADE data upon which the same expert professes to rely.

The court properly drew the line right there – at bias-related criticism – and did not permit the expert to cook the books and thus change the result:

[Plaintiffs’ expert] went beyond challenging the study, however. He also recalculated the study by making statistical adjustments; the basis of which come from adverse event data. As discussed previously, however, such data has substantial limitations that result from the inherent uncertainties in the numerator and denominator used. Accordingly, [this] recalculation. . .is not scientifically reliable.
Id. Another expert’s attempt to recalculate the same study by adding an arbitrary 40% risk factor was likewise shot down. Id. at *13. We’d like (actually we woultn’t like) to see the FDA’s reaction if a drug manufacturer (hopefully not our client) added a fudge factor of that kind of magnitude in a study submitted for agency review. It’s one of the ironies of this sort of litigation that plaintiffs’ counsel demand that a regulated manufacturer’s statistics have to be purer than Caesar’s wife, while simultaneously encouraging all manner of statistical manipulation by their own experts. Kudos to the Baycol court for recognizing these experts for what they were.

Another plaintiffs’ expert in Baycol presumed to offer expert opinions concerning “the adequacy of [the defendant’s] submissions to the FDA.” Id. at *19. We’re also quite pleased with the exclusion of this sort of second-guessing. In the particular context of submissions to federal agencies, this type of allegation is facially preempted by Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and that’s what the court held. After discussing Buckman, the court concluded:

[T]o the extent. . .testimony is offered only to show that the FDA was misled, or that information was intentionally concealed from the FDA, the testimony must be excluded.
2007 WL 2004432, at *20, see also Id. at *35. As support for the exclusion the court cited, Bouchard v. American Home Products Corp., 213 F. Supp.2d 802 (N.D. Ohio 2002). We like Bouchard plenty, but we’d hasten to add In re Prempro Products Liability Litigation, 2006 WL 3806391, at *6 (E.D. Ark. Dec. 27, 2006), and Swank v. Zimmer, Inc., 2004 WL 5254312 (D. Wyo. Apr. 20, 2004), to what we hope will be a growing list of Buckman-based evidentiary rulings.

Another laudatory aspect of the Baycol decision is it’s forthright exclusion of opinion testimony concerning the defendant’s “state of mind” and “corporate ethics.” 2007 WL 2004432, at *21. It’s become something of a fad these days for plaintiffs to hire experts and try to put them before juries for the purpose of opining that the defendant is a bad person. That strikes us as a new low in the misuse of expert testimony, and in this instance the court agreed:

Personal views on corporate ethics and morality are not expert opinions. Further, expert testimony that is merely speculation or pure conjecture based on the expert’s impressions of the physical evidence must be excluded as not based on any reliable methodology or scientific principle.
Id. See also Id. at *26 (excluding testimony about ethics in clinical trials). The court cited a couple of pharmaceutical standbys for this conclusion: In re Rezulin Products Liability Litigation, 309 F. Supp.2d 531, 544 (S.D.N.Y.2004), and In re Diet Drugs Products Liability Litigation, 2001 WL 454586 at *9 (E.D. Pa. Feb. 1, 2001).

Because we particularly abhor this type of “oath-helper” testimony about the purported moral shortcomings of our clients, we’d like to point out a number of other decisions that have reached similar results. Wayne v. Shadeowen, 15 Fed. Appx. 271, 285 (6th Cir. 2001) (expert’s “conclusory value judgments” and “subjective philosophical judgments” properly excluded); DiBella v. Hopkins, 403 F.3d 102, 121 (2d Cir. 2005) (“the real issue in the case was not whether [defendant] acted ethically”); DePaepe v. General Motors Corp., 141 F.3d 715, 720 (7th Cir. 1998) (corporate motive testimony excluded); New Mexico Savings & Loan Ass’n v. U.S. Fidelity & Guarantee Co., 454 F.2d 328, 335 (10th Cir. 1972) (state of mind “was not properly the subject of expert testimony”); In re Welding Fume Products Liability Litigation, 2006 WL 4507859, at *20 (N.D. Ohio 2006) (“jurors decide the vast majority of claims brought against corporations without help from an expert business ethicist”); Highland Capital Management, L.P. v. Schneider, 379 F. Supp.2d 461, 470, 473 (S.D.N.Y. 2005) (excluding testimony about “motivation” and claims of criminality); Bouchard v. American Home Products Corp., 2002 WL 32597992, at *6 (N.D. Ohio May 24, 2002) (excluding “corporate intent” opinion testimony as ethics opinions).

Yet another interesting ruling had to do with the relevance of the regulatory standards of other countries to American product liability litigation. The court held that expert testimony that, in effect, sought to put the common law at odds with FDA regulation by holding defendant to regulatory standards set by other countries was improper:

[T]he Court finds that allowing the admission of evidence of foreign regulatory actions, in a case that is governed by domestic law, would likely cause jury confusion. Given that notice is not dependent on governmental action, and to avoid jury confusion, the Court finds [expert] testimony concerning foreign regulatory actions must be excluded.
2007 WL 2004432, at *22. We haven’t really encountered this issue before, so it just goes to show that we’re never too old to learn. The court doesn’t cite any other pharmaceutical cases that excluded foreign regulatory standards, so that suggests we are not alone in this condition. Any reader knowing of similar precedent is cordially invited to contact us and save us the hassle of doing additional research. We happily take freebies.

The Baycol court also held that certain expert witnesses were “not qualified” to opine that the defendant’s labeling “complied with FDA regulations.” Id. at *32, *35. While we’re sure that was the case, to us the more definitive basis for excluding such an opinion is that a conclusion on FDA compliance violates the prohibition of expert testimony on questions of law. We agree with the view in Steele v. Depuy Orthopaedics on this point:

[W]hether the FDA’s approval of a PMA supplement imposes requirements on a particular device is a question of law to be determined by the Court, not a question of fact for the jury. Consequently, [expert] opinion regarding the nature and scope of the FDA’s [regulations] would neither assist the trier of fact to understand evidence, nor help the jury to determine a fact in issue.
295 F. Supp.2d 439, 446 (D.N.J. 2003). Sure, we have our own FDA experts who will testify that our client’s compliance history was pure as the driven snow – and they’re more qualified than the plaintiff’s experts (think we’d ever say otherwise?) – but we’d frankly prefer to save the money.

Thus, in our hearts of hearts we think that “FDA expert” testimony consisting of legal conclusions about whether there was regulatory compliance should be excluded because it’s not a proper subject of expert testimony. Accord Livingston v. Wyeth Inc., 2006 WL 2129794, at *6 (M.D.N.C. July 28, 2006); United States v. Caputo, 374 F. Supp.2d 632, 646 (N.D. Ill. 2005); Rezulin, 309 F. Supp.2d at 546-47; Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp.2d 684, 700 (W.D.N.C. 2003); Moses v. Danek Medical, Inc., 1998 WL 34024164, at *3 (D. Nev. Nov. 30, 1998); Purnell v. United States, 1987 WL 13790, at *3 (E.D. Pa. July 8, 1987).

A final point on which we are in full agreement with the Baycol opinion is it’s preclusion of expert testimony relying on animal studies.

Expert opinion testimony has been excluded when the expert fails to take into account the critical differences in animal data and human experiences, including but not limited to extrapolation in dosing. . . . The inclusion of such an opinion would only be relevant in this case if the jury were to infer from such studies that [the drug] is the most toxic in humans.
2007 WL 2004432, at *33 (citing Soldo v. Sandoz Pharmaceuticals, Inc., 244 F. Supp.2d 434, 546 (W.D.Pa.2003); Bourne v. E.I. Dupont de Nemours & Co., 189 F. Supp.2d 482, 496 (S.D.W. Va. 2002). We’d also point out that the Supreme Court affirmed exclusion of animal study-based opinions in General Electric Co. v. Joiner, 522 U.S. 136, 144-46 (1997), so the favorable animal study exclusion precedent goes right to the top. They’re a lot more cases on this point, and Bexis goes through a lot of them in chapter 10 of his book, so we’ll only add a few more cases involving prescription medical products: In re Rezulin Products Liability Litigation, 369 F. Supp.2d 398, 429-30 (S.D.N.Y. 2005); Siharath v. Sandoz Pharmaceuticals Corp., 131 F. Supp.2d 1347, 1366-69 (N.D. Ga. 2001); In re Diet Drugs Products Liability Litigation, 2001 WL 454586, *15 (E.D. Pa. Feb. 1, 2001); Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387, 1407-11 (D. Or. 1996).

The Baycol opinion makes a number of other rulings concerning the admissibility of the experts in question. However, those are more fact-based with respect to the drug itself. As we said before, we are involved in this litigation, and thus we don’t feel that we can comment on anything that implicates the facts. That’s somewhat unsatisfying, but that’s what the law business requires. We highly recommend reading the opinion, as in our book it’s one of the top Daubert decisions of the year.

2 comments:

Anonymous said...

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John said...

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