January 27, 2016

Excluding or Limiting FDA Regulatory Expert Opinion

Appeared in Law360 on February 3, 2016. Originally appeared in Kaye Scholer's Product Liability Report.

by James Herschlein, Bert Slonim and David Giroux


It has become increasingly commonplace in pharmaceutical or medical device product liability litigation—particularly large, centralized mass tort litigations involving hundreds or thousands of plaintiffs—for both plaintiffs and defendants to offer competing FDA regulatory experts.  As with all other expert testimony, FDA regulatory experts are permitted to the extent that their scientific, technical, or other specialized knowledge assists the trier of fact to understand the evidence or to determine a fact in issue. 

Although FDA regulatory experts are routinely offered and permitted to testify in such cases, there are grounds for opposing such proffered opinions, in whole or in part, particularly if the expert overreaches.  In general, such experts are permitted to testify (if qualified) about the FDA regulatory framework, the contents of FDA regulations, and perhaps the defendant company’s interactions with the FDA.  Experts cross the line, and are vulnerable to being excluded when they overreach by offering legal conclusions, advocacy-based narratives of facts, or opinions about the state of mind or intent of the agency or of the defendant in a given case.

This article discusses the issues regarding admissibility of regulatory expert opinion and bases for excluding or limiting such opinion.

General Evidentiary Rule:  Expert Opinion Interpreting and Applying Domestic Law or FDA Regulations Is Inadmissible

It is a fundamental evidentiary rule that expert testimony on the meaning and applicability of law is inadmissible because it usurps the role of the judge.  In a trial setting, the judge alone instructs the jury as to what the law is and what the legal standards applicable to the case are.  As the DC Circuit held:  “Each courtroom comes equipped with a ‘legal expert,’ called a judge, and it is his or her province alone to instruct the jury on the relevant legal standards.”  Burkhart v. WMATA, 112 F.3d 1207, 1213 (D.C. Cir. 1997).  FDA regulatory experts are not permitted to testify about domestic law, i.e., the law that governs the case in which they are testifying (such as state tort law or strict products liability law) and may be precluded from offering interpretations of FDA regulations.

Courts have precluded experts, including FDA regulatory experts, from offering opinions about the standards that apply to the case and whether the defendant pharmaceutical or device manufacturer violated duties of care under applicable domestic law (such as expert opinion that a pharmaceutical manufacturer failed to fulfill its duty to warn under state law).  The court in In re:  Initial Public Offering Securities Litigation summarized the general rule that expert opinion on domestic law is inadmissible:  “The rule prohibiting experts from providing their legal opinions or conclusions is so well established that it is often deemed a basic premise or assumption of evidence law—a kind of axiomatic principle.  In fact, every circuit has explicitly held that experts may not invade the court’s province by testifying on issues of law.”  174 F. Supp. 2d 61, 64-65 (S.D.N.Y. 2001) (internal citations and quotations omitted).

In addition to being precluded from offering opinion testimony about domestic law, some cases hold that FDA regulatory experts are precluded from offering opinion testimony regarding the interpretation of FDA regulations, reasoning that such testimony amounts to legal conclusions that are to be made by the court.  These cases hold that it is the court’s role to interpret FDA regulations and then instruct the jury as to its interpretations.  For example, the court in Livingston v. Wyeth, Inc., 2006 WL 2129794, at *6 (M.D.N.C. July 28, 2006) held that “while the summaries of FDA regulatory practices” offered by a proffered FDA regulatory expert may be helpful, the expert’s “application of law to the facts of this case on an ultimate legal question is not.”  Similarly, the court in In re Rezulin Products Liability Litigation, 309 F. Supp. 2d 531, 547-50 (S.D.N.Y. 2004) precluded multiple experts from testifying about FDA procedures or from giving testimony that the defendant failed to adequately disclose material facts to the FDA.

The same holds true in medical device cases as well.  For example, the court in United States v. Caputo, 374 F. Supp. 2d 632, 646 (N.D. Ill. 2005) held that “[w]hile an expert may testify regarding industry standards and practices, he may not offer opinions that amount to legal conclusions” and precluded the expert from testifying about whether defendants complied with medical device safety reporting requirements.  The court in Steele v. Depuy Orthopaedics, Inc., 295 F. Supp. 2d 439, 446 (D.N.J. 2003) similarly precluded an FDA regulatory expert from offering such opinions.

However, some courts have permitted regulatory experts to offer opinions about FDA regulations.  For example, the court in Smith v. Wyeth-Ayerst Laboratories, Inc., 278 F. Supp. 684, 700 (W.D.N.C. 2003) permitted an expert to testify about the standard of care applicable to manufacturers under FDA regulations because his “experience with the FDA is sufficient to support opinion testimony regarding the applicable standard of care for reporting adverse drug events.”

Sometimes, parties tap former FDA employees as FDA regulatory experts.  The FDA has opposed allowing former Agency employees to testify as regulatory experts offering interpretations of Agency regulations on the grounds that it is for the court, and not the jury, to interpret FDA regulations.  For example, in Strong v. Am. Cyanamid Co., 261 S.W.3d 493 (Mo. Ct. App. 2007), the Agency submitted an amicus brief arguing that “The trial court should have interpreted the regulations itself and given guidance to the jury, with all appropriate deference to FDA’s interpretation.  It should not have allowed the jury to interpret the regulations independently.”  FDA Amicus Br. at 20.  The Agency continued:  “[T]he interpretation of a regulation is question of law; it is precisely the type of legal question that courts generally are expected to address.”  Despite FDA’s protestations, the Missouri Court of Appeals held that the testimony of plaintiff’s regulatory expert was admissible.

Narrowly Tailored FDA Regulatory Expert Testimony May Be Permitted

Although FDA regulatory testimony should be disallowed under the general rule prohibiting experts on issues of domestic law, a number of decisions have permitted at least some expert testimony about FDA regulations.  For example, many courts will permit a regulatory expert to testify about the content of FDA regulations, and perhaps even a defendant company’s interactions with the FDA.  For example, the court in In re Diet Drugs Prod. Liab. Litig., 2001 WL 454586, at *18 (E.D. Pa. Feb. 1, 2001) allowed a former FDA employee to testify regarding “how information should be communicated to the FDA and what information should be reflected in labels, as mandated by applicable regulations,” but precluded the expert from offering personal opinions regarding pharmaceutical company standards that were not set forth in FDA regulations.  Similarly, the court in In re Heparin Prod. Liab. Litig., 2011 WL 1059660, at *8 (N.D. Ohio Mar. 21, 2011) permitted an expert to testify about what FDA regulations require, but precluded the expert from offering ultimate question testimony.

Issues arise, however, when a regulatory expert overreaches by purporting to assess the motive, intent, state of mind or ethics of a company, the FDA or others; by offering legal conclusions regarding whether the pharmaceutical company complied with or violated FDA regulations; or by merely providing a narrative recitation of facts.  Courts take a dim view of such proffered testimony and may either exclude it in whole, or at least limit it.  For example, the court in In re Fosomax Products Liability Litigation, 645 F. Supp. 2d 164, 191-92 (S.D.N.Y. 2009) precluded an expert from offering a narrative history of Fosamax, permitting the expert to only comment on company documents to explain their regulatory context, define specialized terminology or draw inferences that would not be apparent without the benefit of specialized knowledge.  The Fosamax court also precluded knowledge, intent or state of mind expert testimony.  The court in In re Gadolinium-Based Contrast Agents Prod. Liab. Litig., 2010 WL 1796334, at *13 (N.D. Ohio May 4, 2010) excluded similar testimony.  For a more detailed discussion of court decisions excluding state of mind testimony, see “Excluding Expert Opinion Impugning Corporate Ethics, Motive and State of Mind” earlier in this report.

Oftentimes it is difficult to draw the line between acceptable and inadmissible FDA regulatory expert testimony, and courts often reach different conclusions regarding what topics are permissible subjects of expert testimony.  For example, the court in In re Guidant Corp. Implantable Defibrillators Prod. Liab. Litig., 2007 WL 1964337 at *5 permitted plaintiffs’ expert to testify concerning whether the defendant’s actions were “reasonable and appropriate,” while the court in Hines v. Wyeth, 2011 WL 2730908 (S.D. W. Va. July 13, 2011) excluded the proffered testimony of an FDA regulatory expert “concerning the reasonableness of defendants’ testing procedures or the intent, motives, or knowledge of defendants or their employees” and barred the expert from “simply [constructing] a factual narrative based upon recorded evidence.”  While the Guidant court permitted the expert to testify about certain discrete FDA regulatory issues, it excluded “her general opinion regarding how a responsible or ethical drug manufacturer should act.”

In the same vein, the court in In re Gadolinium-Based Contrast Agents Prod. Liab. Litig., 2010 WL 1796334 (N.D. Ohio May 4, 2010) permitted an expert (a former FDA employee) to testify about “regulatory requirements relating to the development, testing, marketing and post-marketing surveillance of prescription drugs” and the defendants “compliance therewith based only on the documents and exhibits in evidence;” the court precluded narrative history testimony and testimony related to the knowledge, intent, motivations, or purposes of the defendant or the FDA.

In other words, even courts that are inclined to permit some FDA regulatory testimony generally exclude opinions regarding the state of mind or intentions of FDA officials or projection of how the Agency would have reacted had the defendant acted differently.  For example, the court in In re Fosamax Prod. Liab. Litig., 645 F. Supp. 2d 164, 192 (S.D.N.Y. 2009) precluded such expert testimony, stating the expert “conceded at the hearing that her regulatory expertise does not give her the ability to read minds.  Nevertheless, her report is replete with such conjecture.  This is not a proper subject for expert or even lay testimony.”  Similarly, in Kruszka v. Novartis Pharm. Corp., 28 F. Supp. 3d 920, 930-36 (D. Minn. 2014), the court permitted the experts to testify about the FDA regulatory process, FDA regulations, the defendant’s interactions with the FDA and compliance with FDA regulations, but precluded the experts from giving testimony about motive, intent, corporate state of mind, industry standards, monitoring of clinical trials and ghostwriting.


FDA regulatory experts have become increasingly commonplace in pharmaceutical and medical device products liability litigation, and there is no reason to expect that their involvement in such cases will cease in the foreseeable future.  Such experts can, and sometimes do, serve a valuable purpose:  they can help a jury of laypersons understand the complicated world of FDA regulations and how industry interfaces with the Agency.  However, parties—frequently plaintiffs—proffer regulatory experts for purposes that invade the province of the judge and the jury.  Legally impermissible or problematic subjects include the knowledge, motive, intent or state of mind of a party (or, as it is often put, to offer mind-reading testimony); whether a company complied with FDA regulations; whether a company adhered to certain standards of care; the meaning of FDA regulations; whether a company complied with state tort or products liability law; or simply to provide a narrative of facts (frequently advocacy-based narrations or regurgitations of a party’s factual theories).

When proffered, such expert testimony can be quite intimidating; oftentimes it might appear that, if a jury were to buy all of such testimony, the case would be over and done with.  That said, the proposed testimony and reports of such experts must be examined with great scrutiny and a keen eye.  By identifying and challenging inappropriate opinions, parties may be able to exclude FDA regulatory expert opinions either in part or entirely.  When appropriately cabined, FDA regulatory expert opinions are manageable and can frequently be rebutted with competing expert testimony.

» Read the full article on Law360 (with subscription).


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