United States: "Regulatory Causation" Roundup

Last Updated: January 13 2017
Article by James Beck

Last week's Westlaw search (that's one way we find the cases we discuss in the Blog) brought a blast from the past – a case almost three years old showed up discussing – and rejecting – expert testimony about so-called "regulatory causation."  Since we'd only touched upon this type of expert opinion once, we thought we'd take a more in-depth look at this concept.

The first thing we discovered is that "regulatory causation" apparently was invented by the ubiquitous Suzanne Parisian, largely for use in the now-mostly-concluded Aredia/Zometa litigation.  That theory was an attempt to dumb down the usual common-law requirements for both causation (ordinarily "more likely than not") and expert certainty (a "reasonable degree of medical" either "certainty" or "probability" depending on the jurisdiction).

As we described in more detail, here, the FDA, being a regulatory agency, is able to intervene prophylactically, before actual harm takes place, in order to prevent such harm.  Thus, the FDA is not bound by common-law causation or expert standards in deciding when a warning should appear on the label for a drug or device.  And the Agency doesn't.  Instead, its regulations governing label changes state the new warnings should be added "as soon as there is reasonable evidence of a causal association [of a risk] with a drug; a causal relationship need not have been definitely established."  21 C.F.R. §201.57(c)(6)(i).  That's for drugs approved after mid-2001.  For some older drugs (without an update since 2001), the standard is similar, although the words vary:  "as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved." Id. §201.80(e).  See In re Incretin-Based Therapies Products Liability Litigation, 142 F. Supp.3d 1108, 1120 (S.D. Cal. 2015) (describing how these regulations work).  For medical devices, the equivalent standard is harder to locate, since the FDA's "labeling" regulations for devices does not address when to change a label.  For PMA devices a standard of sorts – "reasonable evidence of a causal association" – in the CBE provisions applicable to such devices.  21 C.F.R. §814.39(d)(2)(i).

For §510k devices, label changes of this sort appear to trigger resubmission requirements, which is getting rather far afield from the topic of this post. However, it is in connection with such a device where Parisian's "regulatory causation" terminology first appears in a decision on either Lexis or Westlaw.  While it's not much of a discussion, it is favorable – excluding the testimony:

Regarding Opinion 3 . . . that [defendant] did not conduct an adequate review of scientific and medical literature to identify potential risks . . . Plaintiff presents Dr. Parisian as a regulatory expert, not a medical expert[,] . . . stating that Dr. Parisian's opinions are offered to a degree of "regulatory certainty," not "medical certainty" and speaking of "regulatory causation" rather than "medical causation". . . . Plaintiff does not argue that Dr. Parisian has the required expertise to offer such an opinion.

Miller v. Stryker Instruments, 2012 WL 1718825, at *11 (D. Ariz. March 29, 2012). Thus, Dr. Parisian's "regulatory causation" testimony regarding a §510k medical device, whatever it might have been, was excluded because she had no expertise qualifying her to offer causation opinions.

That doesn't mean, however, that Parisian hadn't tried the same thing before. In In re Trasylol Products Liability Litigation, 709 F. Supp. 2d 1323 (S.D. Fla. 2010), the same Parisian opinions, couched solely as "causal association," were also excluded.  The opinion quoted cross-examination that described such testimony as "a back door causation opinion in the guise of talking about information available and regulatory affairs."  Id. at 1340.

Then Parisian became active as a plaintiff-side expert in Aredia/Zometa and started spewing "regulatory causation" opinions all over the place.  Courts were rightly skeptical.  The first court to encounter such an opinion in this context was "not convinced by Plaintiff's arguments distinguishing medical causation from causal association." Georges v. Novartis Pharmaceuticals Corp., 2012 WL 9064768, at *10 (C.D. Cal. Nov. 2, 2012).  Plaintiff sought to distinguish "between medical causation, which Parisian described as "the result of causally randomized clinical trials," and "regulatory causation," which was "not the standard of medical causation" at all, but rather (as we mentioned above and discussed in our earlier post), but only the amount of data that "would trigger a manufacturer to have to change their warnings due to causal association."  Id. (internal quotation marks omitted).

Thus, Parisian hoped to focus the jury on the FDA "causal association" standard for label changes rather than on controlling common-law causation requirements. This, the court found, could only cause "confusion."  "Dr. Parisian's attempt to draw this distinction is confusing at best and would almost certainly confuse or mislead the jury."  Id. (relying on Brown v. Novartis Pharmaceuticals Corp., 2012 WL 9082913 (Mag. E.D.N.C. Jan. 9, 2012), adopted in pertinent part, 2012 WL 9082901 (E.D.N.C. Feb. 3, 2012)). Brown, while not using the term "regulatory causation," was discussing the same thing, and reached the same result.  Id. at *7 ("plaintiffs' attempt to distinguish causal association from medical causation [is] confusing and generally ineffective").  These cases were spot on, since the whole point of such testimony is to sow confusion – to offer a false "regulatory" standard to a common-law jury.

In the case we discussed previously, Guenther v. Novartis Pharmaceuticals Corp., 2013 WL 1278089 (M.D. Fla. March 28, 2013), the plaintiffs had stipulated that Parisian wouldn't testify "about medical causation."  Id. at 2.  Instead, plaintiffs trotted out Parisian's "regulatory causation" testimony based on the FDA's "causal relationship need not have been definitely established" regulatory language.  The Guenther court was having none of it, recognizing this dodge for what it was:

The Defendant argues that allowing Parisian to testify regarding [defendant's] compliance with that regulation is effectively the same as allowing her to testify regarding medical causation, allowing her to make an end run. . . . Plaintiffs' counsel responds that "causal association" is an FDA term, rather than a medical term, and that Parisian as an FDA compliance expert should be permitted to testify in regard to that term.  Aside from its origin, however, Plaintiffs' counsel offers nothing to meaningfully distinguish "causal association" from medical causation. . . .  Parisian will not be permitted to offer opinions regarding any alleged "causal association" between ONJ and Zometa.

Id. at at *7. A few days later, another judge in the same federal district adopted Guenther's conclusion verbatim in an other A/Z case.  Dopson-Troutt v. Novartis Pharmaceuticals Corp., 2013 WL 1344755, at *3 (M.D. Fla. April 2, 2013).  See also Kirchman v. Novartis Pharmaceuticals Corp., 2014 WL 12617778, at *5 (M.D. Fla. May 22, 2014) ("Plaintiff's regulatory causation argument in this case does not differ from the one made by the Dopson-Troutt plaintiff.  The Court adopts its Dopson-Troutt reasoning and precludes Dr. Parisian's opinions regarding regulatory causation.").

These cases set the trend.  Parisian's testimony – sometimes labeled "regulatory causation" and elsewhere called "causal association" after the language she lifted from §201.57, was excluded as disguised medical causation testimony, about which Parisian was utterly unqualified to testify, and which would also confuse the jury:

[R]egulatory causation or "causal association" is also outside Dr. Parisian's expertise and should be excluded. . . . Plaintiffs' counsel fails to meaningfully distinguish the causal association outlined in §201.57(c)(6)(i) from medical causation, and as such, testimony on this issue must be excluded.  Dr. Parisian's discussion of regulatory causation would not be beneficial to the jury's decision-making process, and is thus not permissible.

Kruszka v. Novartis Pharmaceuticals Corp., 28 F. Supp.3d 920, 934-35 (D. Minn. 2014) (citations omitted). See Gilliland v. Novartis Pharmaceuticals Corp., 2014 WL 11581411, at *1 (S.D. Iowa July 30, 2014) ("The Court finds Kruszka persuasive, and, accordingly, adopts both its reasoning and conclusions").

Parisian will not be permitted to offer causation testimony of any kind, including "regulatory causation" or "causal association" opinions related to compliance with 21 C.F.R. §201.57.  Plaintiffs have failed to sufficiently differentiate such testimony from general medical causation testimony, which [she] is not qualified to give.

Rowland v. Novartis Pharmaceuticals Corp., 9 F. Supp.3d 553, 562 (W.D. Pa. 2014).

The Court agrees with the Georges Court that "Dr. Parisian's attempt to draw [a] distinction between medical causation and causal association is confusing at best and would almost certainly confuse or mislead the jury."  Dr. Parisian is not qualified to give medical causation testimony . . . , and allowing Dr. Parisian to testify on this issue would impermissibly allow the jury to reply on Dr. Parisian's opinion regarding [causation].

Stanley v. Novartis Pharmaceuticals Corp., 2014 WL 12573393, at *4 (C.D. Cal. May 6, 2014).

[Parisian's] opinion relates to "causal association" under 21 C.F.R. §201.57. This regulation requires that a product's "labeling must be revised to include a warning about a clinically significant hazard as soon as there is reasonable evidence of a causal association with a drug."  The Court finds that Plaintiff has failed to establish how this opinion significantly differs from medical causation.  Additionally, Plaintiff has not demonstrated that Dr. Parisian is qualified to identify when a "causal association" with a drug emerges which necessitates a labeling change.

Taylor v. Novartis Pharmaceuticals Corp., 2013 WL 5118945, at *9 (S.D. Fla. Apr. 22, 2013) (citation omitted).

Defendant maintains that Dr. Parisian will testify about regulatory causation.  Specifically, Dr. Parisian will testify about the types of evidence that the FDA would consider in determining the "association of a serious hazard with a drug."  However, regulatory causation is not recognized as a legitimate form of causation.  In fact, Dr. Parisian does not even address regulatory causation in her report.  Accordingly, Dr. Parisian is precluded from testifying about regulatory causation.

Monroe v. Novartis Pharmaceuticals Corp., 2014 WL 12586426, at *3 (S.D. Ohio Sept. 15, 2014) (footnotes omitted).

[Courts] have not allowed Dr. Parisian to testify at all with respect to causation, finding her unqualified. . . .  Because Dr. Parisian was not qualified to diagnose [the condition], neither was she qualified to offer an opinion concerning the propriety of [defendant's] actions.  The Court finds this reasoning persuasive.  Accordingly, Dr. Parisian will not be permitted to testify about "regulatory causation" or a "causal association" between bisphosphonate drugs and ONJ.

Mathews v. Novartis Pharmaceuticals Corp., 2013 WL 5780415, at *24 (S.D. Ohio Oct. 25, 2013) (citations omitted).

Defendant raises legitimate concerns about the risk of unfairly prejudicial or confusing testimony.  It is not the role of Dr. Parisian to offer legal conclusions on any topic. . . .  Dr. Parisian is not permitted to testify to things outside of her expertise.  This includes testimony that may be couched as regulatory causation but in actuality speaks to medical causation.

Stambolian v. Novartis Pharmaceuticals Corp., 2013 WL 6345566, at *9 (C.D. Cal. Dec. 6, 2013).

Thus, from the opinions available on Westlaw (and Lexis), it appears that, in the Aredia/Zometa litigation, Parisian was never allowed to attempt to bamboozle juries with a standard for "regulatory" causation that was lower, and more plaintiff-friendly, than the common-law causation burden of proof in tort cases.  One problem may have been that she submitted the same "boilerplate" report in "all" cases.  Monroe, 2014 WL 12586426, at *3 n.6.

However, Parisian's singular lack of success doesn't seem to have deterred her (or counsel retaining her), since the she popped up to offer the same opinions – with the same exclusionary result − in more recent Mirena IUD litigation.  In the same epic opinion (making our 2016 top ten) that threw out all of the plaintiffs' causation experts in the Mirena MDL, the court also rejected Parisian's "regulatory causation" retread.

Parisian's testimony related to "causal association" − as this term is used pursuant to 21 C.F.R. §201.57(c)(6)(i) − is also inadmissible because Plaintiffs have not "sufficiently differentiate[d]" testimony related to causal association from general medical causation. . . .  Defendants' motion with respect to testimony relating to medical causation or regulatory causation is granted.

In re Mirena IUD Products Liability Litigation, 169 F. Supp.3d 396, 476 (S.D.N.Y. 2016) (citing Rowland and Dopson-Troutt) (footnote omitted).  The same opinion yielded the same result.  "Parisian will not be permitted to testify that the [drug's] label should have been changed to warn of [the risk], because she is not qualified to say either that that risk was clinically significant or that there was reasonable evidence of causal association."  Id. at 476 n.76.

So, if you encounter Parisian, or any other P-side expert, seeking to offer opinions about "causation," in a warning case involving label-change allegations, and the opinions are couched in FDA regulatory language rather than the more stringent common-law causation standard, don't hesitate to come down on those opinions like a ton of bricks.  Such opinions are a transparent attempt to confuse the jury into ignoring applicable law – so transparent that no opinion we've been able to find has allowed such opinions to be heard by a jury.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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James Beck
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