Trial Magazine

Plaintiffs often use “regulatory experts”—those versed in the Federal Food, Drug, and Cosmetic Act and FDA regulations—to support negligence and products liability claims in medical device and pharmaceutical cases. These experts can bolster your liability case, but you need to be aware of the case law in your jurisdiction. There are many, sometimes disparate, admissibility decisions across the country. Here are several issues you may confront and tips for addressing them.

1 Avoid calling them, and having defendants box them in as, “regulatory experts.”

The term “regulatory experts” carries negative connotations in some courts; how these experts are presented has created unfavorable case law and misunderstandings about their role in the case. They are scientists, engineers, and physicians. They are experts in industry standards and practices. Present them this way instead, but make sure they have meaningful industry experience.¹

While having the expert emphasize industry standards and practices, home in on the iterative risk management process—the continuous identification and control of risks through testing, corrective and preventive actions, and surveillance. Manufacturers must identify risks, such as adverse reactions to a drug, by testing and monitoring marketed products. Once detected, they should remediate those problems by changing the product’s design or warning label.

If your expert takes a commonsense risk management approach instead of overemphasizing regulations and statutes, it will make him or her more jury friendly, and it avoids court concern over prohibited legal conclusions and other issues. Otherwise, when considering admissibility, courts may view the expert as novel and worthy of special scrutiny.

Also, consider hiring experts with medical training in the relevant specialty.² You may need a medical expert to lay a foundation regarding safety signals—adverse events or outcomes³ often found in scientific literature and product complaints—before the industry expert can opine about how companies should respond. This may alter your order of proof at trial. For example, a physician may need to testify first as to what specific events constitute a safety signal and why, because it may require specialized medical knowledge and incorporate causality opinions. Medical experts may need to establish the inadequacy of label warnings too.⁴ That said, you may still need an industry expert even if you have a physician expert.⁵

2 Comb through expert reports, and focus on industry standards—of which FDA regulations are a part but not the whole. Beware of legal conclusions.

There is a large body of case law about regulatory experts. What the experts say and how they say it are critical. For example, state-of-the-mind testimony remains a common issue,⁶ including when discussing the FDA⁷ and physicians.⁸ Courts often view opinions about what a defendant intended, what motivated its conduct, or what physicians think or want as inadmissible forays into others’ minds—so review expert reports for buzzwords such as “intended.” There is a line, however: Establishing knowledge through internal documents and depositions is neither speculative nor, perhaps, inferential.⁹

Some courts continue to exclude FDA-related evidence, such as FDA laws and regulations, as irrelevant.¹⁰ That sometimes favors plaintiffs.¹¹ For example, defendants may try to hide behind the FDA’s 510(k) premarket clearance process to suggest a product is safe or its labeling is adequate simply because the FDA reviewed it at some point. Leaving out FDA evidence to avoid this misleading testimony is -sometimes the best approach.

Even when courts acknowledge its probative value, FDA evidence may be subject to a Rule 403 analysis¹² and other evidentiary objections.¹³ And when defendants assert compliance as a defense, such as with state law presumptions,¹⁴ the scales should tip toward admission to prevent confusing or misleading the jurors.

When you don’t want to or cannot rely on FDA evidence, well-accepted alternative standards from organizations such as the American National Standards Institute are a good source.¹⁵ Defendants’ standard operating procedures (SOPs) are another good source; you will often find these alternative standards cited in their SOPs, making it difficult to argue against admissibility and that compliance is irrelevant.

Another common issue arises when courts construe the experts’ opinions as presenting legal conclusions. Using terms such as “violated” and “misbranded” can trigger this.¹⁶ Some courts have ruled that testimony regarding compliance with FDA regulations constitutes an inadmissible legal conclusion,¹⁷ even though noncompliance is merely evidence of negligence or a defect and not determinative of the claims.¹⁸

Another variant of a perceived legal conclusion is when experts state a defendant “breached the standard of care,” “acted negligently,” “failed to warn,” sold “defective” products, distributed “false and misleading” marketing, or had “inadequate” warnings.¹⁹ Courts exclude this testimony as questions for the jury, not the expert, and notwithstanding Rule 704.²⁰ Be wary of this, and remember that the foregoing applies to defense experts too.²¹

3 Exercise caution with causation language.

Be careful with causal language—it can be a double-edged sword. You may need proximate causation testimony, but don’t stray too far. Courts may preclude experts from opining that defendants were “on notice” or that corporate action or inaction created risks.²² For example, some courts perceive discussing whether adverse events should be reported as involving a causality analysis and consider it medical testimony.

To circumvent these issues, some attorneys have distinguished medical from regulatory causation.²³ While experts may testify about the types of evidence the FDA would consider in evaluating hazards, courts do not appear to have recognized “regulatory causation” as permissible testimony.²⁴ Be careful with your approach, and have a contingency plan—including being able to present your case without this testimony.

4 Use methodology to your advantage.

Methodology remains an issue for regulatory experts,²⁵ although most approaches pass muster.²⁶ An expert’s failure to draft an alternative warning is one potential pitfall.²⁷ Actual drafts may not be required,²⁸ but your expert should have an answer as to what a warning or label should have said and some basis for it. Comparative analyses are also methodological land mines.²⁹

Despite the challenges, methodology can be a strength when it is presented properly.³⁰ Consider having experts explain how they arrived at their conclusions, both in their reports and during direct examination. It involves the same methods used by in-house industry professionals and by the FDA during inspections, and relating the experts’ methodology in this way bolsters their opinions.³¹

5 Trial testimony should be concise, juror friendly, and linked to jury instructions.

Successful regulatory expert testimony rests on two key principles: preparation and simplicity. Testimony must be brief. Avoid using these experts to ram into evidence a bunch of fragmented “hot documents” within a tangled web of arcane FDA citations and complex terms of art—the punchline gets lost.

Experts must explain technical evidence in basic terms. A presentation that discusses how companies identify, monitor, and control risks throughout a product’s life cycle is a simple concept that applies in everyday life. You also can relate the evidence back to the jury instructions more easily and without crossing the legal conclusions line.

Stay out of the weeds. Choose a small number of the best, unassailable exhibits, and contextualize them in terms of industry standards and practices. For example, using complaint files, explain what makes an event reportable, why failing to report leaves risks unabated, and what alternatives were readily available. Hyper-technical language waters down the defendant’s misconduct.

Narrative chronologies—such as when an expert simply reads into the record document after document from the birth of the product through the present—have appeal, and some courts allow them.³² But they also present admissibility and practical risks.³³ Organizing expert testimony according to the standards, practices, or categories within the risk management life cycle can be easier for jurors to digest.

This approach also lets you present your expert in a non-litigation context: The expert can testify as if a defendant consulted with the expert while developing the product or when it learned of certain risks. Having the expert explain how he or she would advise similarly situated clients—or what the normal course was when he or she was an FDA reviewer when presented with similar facts—allows you to weave his or her qualifications throughout the examination, while making the salient points in an easy-to-follow way.

Defendants have chipped away at plaintiffs’ use of regulatory experts for many years. Despite the uncertainty in some venues about when and how you can use them, with strategic planning and armed with relevant case law, you can avoid any defense traps.

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Justin A. Browne is a partner at Janet, Jenner & Suggs in Baltimore. He can be reached at JBrowne@JJSJustice.com.

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Notes

1. See, e.g., Tillman v. C.R. Bard, Inc., 96 F. Supp. 3d 1307, 1328–29 (M.D. Fla. 2015) (lacking related labeling experience); Kruszka v. Novartis Pharm. Corp., 28 F. Supp. 3d 920, 935 (D. Minn. 2014) (FDA expert not an industry expert); Deutsch v. Novartis Pharm. Corp., 768 F. Supp. 2d 420, 468 (E.D.N.Y. 2011) (expert never worked at or with a pharmaceutical company outside her interactions with companies involved with the FDA).
2. See, e.g., In re Mirena IUD Prods. Liab. Litig., 169 F. Supp. 3d 396, 475–76 (S.D.N.Y. 2016).
3. See U.S. Food & Drug Admin., Guidance, Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, at 4 (Mar. 2005).
4. See, e.g., Anderson v. Janssen Pharm., Inc., 2015 WL 3539602, at *5 (Pa. Ct. Com. Pl. May 4, 2015) (excluding testimony that warnings were inadequate).
5. See, e.g., Rheinfrank v. Abbott Labs., Inc., 2017 WL 680349, at *10 (6th Cir. Feb. 21, 2017) (precluding physician from opining about what should have been communicated to the FDA).
6. See, e.g., In re Tylenol Mktg., Sales Practices, & Prods. Liab. Litig., MDL No. 2436, 2016 WL 4039286, at *10–11 (E.D. Pa. July 28, 2016) (expert could not opine about defendants’ intent or interpret documents jury could interpret); see also Cason v. C.R. Bard, Inc., 2015 WL 9913809, at *12–13 (N.D. Ga. Feb. 9, 2015).
7. See, e.g., In re C.R. Bard, Inc., 948 F. Supp. 2d 589 (S.D. W. Va. 2013) (FDA’s supposed intent or motives inadmissible).
8. See, e.g., Anderson, 2015 WL 3539602, at *5 (referring to prior ruling precluding nonphysician testimony about physicians’ product knowledge).
9. See, e.g., In re Tylenol Mktg., Sales Practices, & Prods. Liab. Litig., MDL No. 2436, 2016 WL 4039329, at *5–6 (E.D. Pa. July 28, 2016).
10. See, e.g., Monroe v. Novartis Pharm. Corp., 2014 WL 12586426, at *3 (S.D. Ohio Sept. 15, 2014).
11. In re Fresenius GranuFlo/NaturaLyte Prods. Liab. Litig., No. 1:13-md-02428, Tr. at 2-54-58 (D. Mass. Feb. 9, 2016) (precluding discussion of FDA clearance as proof of non-defectiveness).
12. See, e.g., Mathison v. Boston Sci. Corp., 2015 WL 2124991, at *17 (S.D. W. Va. May 6, 2015); see also In re Zimmer NexGen Knee Implant Prods. Liab. Litig., 2017 WL 36406, at *12 (N.D. Ill. Jan. 3, 2017).
13. Cason, 2015 WL 9913809, at *13.
14. See, e.g., Colo. Rev. Stat. §13-21-403(1)(b) (2017); N.J. Stat. Ann. §2A:58C-4 (2017); Wis. Stat. §895.047(3)(b) (2017).
15. See, e.g., Mathison, 2015 WL 2124991, at *15–16; Hogan v. Novartis Pharm. Corp., 2011 WL 1533467, at *3 (E.D.N.Y. Apr. 24, 2011) (expert testimony about pharma-covigilance practices may help the jury understand how companies anticipate and prevent adverse events).
16. See, e.g., Kruszka, 28 F. Supp. 3d at 934; see also In re Ethicon, Inc., Pelvic Repair System Prods. Liab. Litig., MDL No. 2327, 2014 WL 186872 (S.D. W. Va. Jan. 15, 2014).
17. See, e.g., Mathison, 2015 WL 2124991, at *17; see also In re Tylenol Mktg., Sales Practices, & Prods. Liab. Litig., MDL No. 2436, 2016 WL 4039324, at *4 (E.D. Pa. July 27, 2016).
18. See, e.g., Banks v. ICI Americas, Inc., 450 S.E.2d 671, 675 n.6 (Ga. 1994) (compliance and defectiveness are distinct).
19. See, e.g., In re Tylenol Mktg., 2016 WL 4039286, at *10–11; see also Anderson, 2015 WL 3539602, at *5.
20. See Mathison, 2015 WL 2124991.
21. See, e.g., In re Fresenius GranuFlo/NaturaLyte, Tr. at 2-54-58; see also In re Tylenol Mktg., Sales Practices, & Prods. Liab. Litig., MDL No. 2436, 2016 WL 4538621, at *7 (E.D. Pa. Aug. 31, 2016) (excluding the defense expert’s opinions as misleading and confusing where they conflicted with law).
22. See, e.g., Jones v. Novartis Pharm. Corp., 2017 WL 372246, at *8–10 (N.D. Ala. Jan. 26, 2017).
23. See Deutsch, 768 F. Supp. 2d at 469 (defined as information physicians need for patient care); see also Stanley v. Novartis Pharm. Corp., 2014 WL 12573393, at *4 (C.D. Cal. May 6, 2014) (as evidence of an association of a hazard with a product).
24. See, e.g., Stanley, 2014 WL 12573393, at *4; see also Rowland v. Novartis Pharm. Corp., 9 F. Supp. 3d 553, 562 (W.D. Pa. 2014); Monroe, 2014 WL 12586426, at *3; Mathews v. Novartis Pharm. Corp., 2013 WL 5780415, at *24 (S.D. Ohio Oct. 25, 2013).
25. See, e.g., Tillman, 96 F. Supp. 3d at 1330 (excluding design, testing, and labeling opinions where the expert did not test or examine product, assess risks versus benefits, assess availability and safety profiles of other products or viability of safer alternative); see also Cason, 2015 WL 9913809, at *11–12.
26. See, e.g., In re Tylenol Mktg., 2016 WL 4039286, at *5–6; see also  Wolfe v. McNeil-PPC, Inc., 881 F. Supp. 2d 650, 660 (E.D. Pa. 2012).
27. See, e.g., Tillman, 96 F. Supp. 3d at 1328–29; see also In re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323, 1347 (S.D. Fla. 2010).
28. See, e.g., Mathews, 2013 WL 5780415, at *25.
29. See, e.g., In re Viagra Prods. Liab. Litig., 658 F. Supp. 2d 950, 961–63 (D. Minn. 2009) (excluding expert testimony comparing adverse event reporting rates across therapeutic areas).
30. In re Tylenol Mktg., 2016 WL 4039286, at *6.
31. Id.
32. See, e.g., In re Welding Fume Prods. Liab. Litig., MDL No. 1535, 2005 WL 1868046, at *17 (N.D. Ohio Aug. 8, 2005).
33. See, e.g., Baldonado v. Wyeth, 2012 WL 1802066, at *4 (N.D. Ill. May 17, 2012); In re Fosamax Prods. Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009).