It’s not easy getting a drug or device to market. From concept to launch, it takes years of work and the involvement of countless professionals from the engineering, medicine and regulatory disciplines. If the product becomes the focus of a product liability action, both sides of the litigation must rely on expertise from these disciplines to support or defend the case. Indeed, most cases require expert testimony to pursue a personal injury claim, and a plaintiff lacking expert testimony might see the case dismissed on summary judgment.
Traditional experts used in life science cases require heightened skills, but their expertise comes with a high price in the mass tort context, and one that may make small, “one-off” cases nearly cost-prohibitive to defend. Knowing that expert testimony is required to survive dismissal, plaintiff attorneys often save money by soliciting this expert testimony from another source—the treating physicians who are already involved in the case and have developed opinions regarding the plaintiff’s treatment.
What can life science companies do? Just like the treating physicians, pharmaceutical and medical device companies have a bench of experts with front-line, ground-level involvement with the product and who, by the nature of their positions, have spent years developing opinions about the product’s safety and efficacy. While these employee-experts, also known as non-retained experts, come with a natural loyalty and a bias to stand behind the product, they provide the ability to present opinion testimony with little additional cost. In fact, many of these same professionals may already be filling the role of the corporate 30(b)(6) representative during fact discovery, and some may be the best face for the company to sit at counsel table during trial.
Potential non-retained experts are scattered throughout the company. They can range from the patent holder or chief designer of the product to the company’s regulatory affairs employee who navigated the regulatory process to get the product to market. Although traditional retained experts can testify about the underlying studies or strategies used to support the device that they evaluated after being retained in the case, non-retained experts provide first-hand opinion testimony about what they actually did, saw or thought as the study was being performed. This front-line experience can tip the scale as much or more than any traditional retained expert.
While the bias to defend the product or company might be a line of attack for a non-retained expert, it can be countered by the passion the expert brings to defend their product. Employees are generally proud of their work, and when a product they worked on is the focus of litigation, there is natural buy-in and “skin in the game” that bolsters their passion and credibility—something that cannot be replicated by traditional experts.
What are non-retained experts?
While practitioners are familiar with the rules and roles of traditional retained experts, the same is not always true with respect to non-retained experts. Non-retained experts exist in a gray area: they are hybrid experts who have knowledge of the underlying facts but can offer opinion testimony because of their specialized knowledge. Their opinion testimony, however, is generally limited to “opinions that were formed during the course of their participation in the relevant events of the case, and only to those opinions which were properly disclosed.”
A retained expert witness is an expert who, without prior knowledge of the facts giving rise to litigation, “is recruited to provide expert opinion testimony.” In contrast, a non-retained expert witness’s testimony “arises not from his enlistment as an expert, but, rather, from his ground-level involvement in the events giving rise to the litigation.” Factors include whether the expert holds himself or herself out for hire as a purveyor of testimony, whether the expert charges for the testimony and whether the expert forms the opinion from facts supplied by others or first-hand observation.
Use of non-retained experts is subject to the disclosure requirements found in Federal Rule of Civil Procedure 26, which, among other things, requires parties to disclose the identity of any witness that may be used at trial to present expert evidence under Federal Rules of Evidence 702, 703 or 705. For witnesses who are “retained or specially employed to provide expert testimony in the case or one whose duties as the party’s employee regularly involve giving expert testimony”—i.e., traditional retained witnesses—the parties must submit a comprehensive report containing a complete statement of all opinions to be offered, the basis for the opinions, the facts or data supporting the opinions, and thorough statements regarding the witness’s qualifications, publications and compensation information. This can be expensive. The rules, however, create different disclosure requirements for experts who fall outside the “retained or specifically employed” category. For these non-retained witnesses, the disclosure requirements found in Rule 26(a)(2)(C) are much less onerous. This rule requires only (i) the subject matter on which the witness is expected to present opinion evidence; and (ii) a summary of the facts and opinions to which the witness is expected to testify.
Anyone who has worked with expert witnesses knows that these reporting requirements can drive up the costs of litigation. It takes hours to collect and analyze data and draft the report. And precision is needed because even small mistakes or omissions can lead to credibility or admissibility issues.
Although the reporting requirements differ between retained experts and non-retained experts, the same admissibility rules apply under Federal Rule of Evidence 702. This rule permits a “witness who is qualified as an expert by knowledge, skill, experience, training, or education” to give testimony only if “(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles or methods; and (d) the expert has reliably applied the principles and methods to the facts of the case.” In Daubert v. Merrell Dow Pharmaceuticals, Inc., the Supreme Court held that Rule 702 requires the district court to act as a “gatekeeper” to ensure that “any and all scientific evidence admitted is not only relevant, but reliable.” But are non-retained experts subject to Daubert challenges, too?
While cases involving Daubert and its progeny oftentimes evaluate the admissibility of a traditional expert’s opinions, courts have also applied it to Rule 26(a)(2)(B) regarding non-retained experts—particularly in cases involving treating physicians. Treating physicians are subject to challenges on causation opinions because “although a doctor may have experience diagnosing and treating [an illness] . . . that does not make him qualified to assess its genesis.” And, because any assessment by a treating physician is made during treatment and not with an eye on litigation, it may be harder to establish that a reliable methodology was used in forming the opinion.
Although non-retained experts are granted some leeway in the reporting and designation requirements, their opinions can still be subject to admissibility challenges. Nevertheless, since parties challenging a non-retained expert do not have the benefit of a lengthy report, a Daubert challenge might be less likely—provided the non-retained expert offers opinions that are within the expert’s area of expertise. Accordingly, the deposition of a non-retained expert is critical for both sides. Expect non-retained experts’ qualifications and opinions to be thoroughly vetted. These witnesses should be prepared for a Daubert line of questioning, and during the deposition, consider laying the groundwork for the expert’s qualifications and opinions.
Another key distinction between traditional retained experts and non-retained experts is the level of protection given to communications between counsel and the witness. When the Federal Rules were amended in 2010, “[t]he amendment provided work product protection for drafts of expert reports or disclosures and protection for communications between the party’s attorney and any witness required to provide a report under Rule 26(a)(2)(B).” Some courts have found that this protection is not afforded to “hybrid non-reporting” experts designated under Rule 26(a)(2)(C) and “have taken the position that the designation of a witness as a non-reporting expert generally waives applicable privileges for all communications between the expert and the designating party’s attorney.” However, courts have not consistently found that disclosure creates an automatic and complete waiver. For example, the court in Sierra Pacific—the seminal case that first analyzed the issue after the 2010 amendments—declined “to hold that designating an individual as a non-reporting expert witness waives otherwise applicable privileges and protections in all cases, or even for all cases involving non-reporting employee expert witnesses.” Courts have described the reasoning behind the distinction “because of difficulties separating a hybrid witness’ sense impressions from his expert opinions and because of a concern for ‘attorney-caused bias.’” The risk of having to disclose communications to non-retained experts remains a possibility depending on particular jurisdictions. Accordingly, care should be taken when communicating with any possible non-retained experts.
Use of current and former employees as non-retained experts is not widespread, and the case-law surrounding some of the aspects is not well-developed. Nonetheless, the following are several practice points and considerations regarding litigating with non-retained experts.
- Identify them early. In every litigation, a concerted effort is made to locate and retain experts. Likewise, non-retained experts can be identified as soon as there is any indication of a pending claim. Having a bench of potential non-retained experts in the form of current and former employees can help in case planning and might limit the scope on the number of topics covered by retained experts—resulting in reduced litigation costs.
- Maintain contact. When a key employee who is well suited for testifying leaves the company, whether for another position or retirement, keep updated contact information on the employee. Not only might that employee be the ideal corporate witness, but he or she might be able to fill in evidentiary gaps that require expert testimony. Retired employees are a great resource—they have time, gray hair, first-hand experience and are often inexpensive.
- Thoroughly vet the witness. While identifying possible non-retained experts, conduct a thorough background check on the witness. Identify all documents that might be used during the deposition or trial; ensure that the witness has fully formulated their opinions at the outset; and verify their first-hand experience with the product at issue. Be sure to assess any potential bad documents that can be linked to your witness that might question the witness’s support for the product at issue.
- Complete a thorough designation. Comply with the 26(a)(2)(C) disclosures requirements. Just as plaintiff attorneys occasionally reference medical records from a treating physician as part of the physician’s designation, consider attaching or referencing any key documents or studies as part of the designation that the witness authored or reviewed. Also, since the “purpose of the expert disclosure rule is to provide opposing parties reasonable opportunity to prepare for effective cross examination and perhaps arrange for expert testimony from other witnesses[,]” consider designating a non-retained expert before the witness’s “fact witness” deposition to possibly avoid a second (expert) deposition.
- Make sure they are qualified to avoid Daubert challenges. While many employees might have opinions on the product, not every employee can offer admissible opinions. They must still be qualified, and their opinions must “have a reliable basis in the knowledge and experience of the witness’s discipline” under Daubert. To avoid challenges, make sure the witness “stays in their lane” and refrains from opining on areas outside of their expertise. Also consider a re-direct examination at the deposition that directly addresses the witness’s qualifications and prepare the witness for a potential Daubert line of questioning.
- Converting to a report-required witness. Non-retained expert opinions are generally reliable because they were formed outside the litigation and without the influence of attorneys. Accordingly, care must be taken to limit the opinions to those formed pre-litigation. Otherwise, you risk converting the witness to someone who should have furnished a comprehensive report.
- Be mindful of communications. Because discovery of communications between counsel and non-retained experts is a risk, care should be taken during exchanges with any witness who may be designated under Rule 26(a)(2)(C). Operate as if any communication is discoverable, and be mindful when sending any witness documents that were created after the witness’s involvement in the underlying product as this could taint the expert’s opinions.
Use “key language” when designating. Open your designation with a sentence clearly stating that the witness is designated under Rule 26(a)(2)(C) and is not required to submit a report. This may prevent confusion by opposing counsel. Use clear language that mirrors the rules and gives the background into how the witness arrived at the opinions before the litigation. Also, state that the opinions will be offered to the requisite level of certainty and that the opinions are consistent with the witness’s education, training and experience.
Overall, non-retained experts can be a useful tool in defending pharmaceutical and medical device cases. The scientists, engineers and physicians involved in the development and monitoring of these products are generally highly-qualified and considered leaders in their field. Although the use of non-retained company witness experts is still somewhat novel and does not have the benefit of well-established bright line rules, it can be an effective tool for companies in defending their products while still controlling costs.
 Guarantee Tr. Life Ins. Co. v. Am. Med. & Life Ins. Co., 291 F.R.D. 234, 237 (N.D. Ill. 2013).
 Downey v. Bob’s Discount Furniture Holdings, Inc., 633 F.3d 1, 6 (1st Cir. 2011).
 Id. at 6-7.
 See FED. R. CIV. P. 26(a)(2)(B).
 FED. R. CIV. P. 26(a)(2)(C).
 Tajonera v. Black Elk Energy Offshore Operations, L.L.C., 2016 WL 3180776, at *7 (E.D. La. June 7, 2016).
 Fed.R.Evid. 702.
 Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993).
 Higgins v. Koch Dev. Corp., 794 F.3d 697 (7th Cir. 2015); see also Downey, 633 F.3d at 8 (indicating that an exterminator who inspected plaintiff’s home and found an infestation of bedbugs could be challenged under Daubert on the basis that he was unqualified to render the opinion).
 Higgins, 794 F.3d at 704-705.
 Id. at 705.
 United States ex rel. Rigsby v. State Farm Fire & Cas. Co., 2019 WL 6792774, at *2 (S.D. Miss. Dec. 12, 2019) (citing DiSalvatore v. Foretravel, Inc., 2016 WL 7742996, at *2 (E.D. Tex. May 20, 2016); United States v. Sierra Pacific Industries, 2011 WL 2119078, at *2 (E.D. Cal. May 26, 2011)).
 Ramaco Res., LLC v. Fed. Ins. Co., 2020 WL 5261320, at *3 (S.D.W. Va. Sept. 3, 2020) (citing Luminara Worldwide, LLC v. Liown Electronics Co. Ltd., 2016 WL 6914995, at *6 (D. Minn. May 18, 2016)).
 Pipeline Prods., Inc. v. Madison Companies, LLC, 2019 WL 3973955, at *7 (D. Kan. Aug. 22, 2019)
 Id. at *7 (citing Sierra Pacific, 2011 WL 2119078 at *8-*10; see also, e.g., Garcia v. Patton, 2015 WL 13613521, at *4 (D. Colo. July 9, 2015) (finding waiver “in this particular case”); PacifiCorp v. Nw. Pipeline GP, 879 F. Supp. 2d 1171, 1213 (D. Or. 2012) (observing that, in Sierra Pacific, “the Court fashioned a somewhat flexible rule about the effect of designating a non-reporting witnesses, based on policy considerations voiced during the debate over the 2010 amendments”); City of Wyoming, Minn. v. Procter & Gamble Co., 2019 WL 245607, at *5 (D. Minn. Jan. 17, 2019) (“[D]esignating an individual as Rule 26(a)(2)(C) expert may not waive any and all protections in every case and under all circumstances.”).
 Rigsby, 2019 WL 6792774, at *3 (citing City of Mankato, Minnesota v. Kimberly-Clark Corp., No. 15-2010 (JRT/TNL), 2019 WL 4897191, at *11 (D. Minn. May 28, 2019); Garcia, 2015 WL 13613521, at *4; PacifiCorp, 879 F. Supp. 2d at 1213; Sierra Pacific, 2011 WL 2119078, at *6-7, 10).
 Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care, Inc., 725 F.3d 1377, 1381 (Fed. Cir. 2013) (citation omitted).
 See Arch Specialty Ins. Co. v. BP Inv. Partners, LLC, 2020 WL 5848317, at *5 (M.D. Fla. Oct. 1, 2020) (“While a hybrid witness may not have to provide a written report to pass Rule 26 muster, to the extent that the witness seeks to offer expert testimony, he must still be deemed admissible under Daubert.”)
 Avendt v. Covidien Inc., 314 F.R.D. 547, 561 (E.D. Mich. 2016) (involving a treating physician, Rule 26(a)(2)(C) witness) (citing Gass v. Marriott Hotel Servs., Inc., 558 F.3d 419, 426 (6th Cir.2009) (noting that “a treating physician’s testimony is still subject to the requirements of Daubert”); Higgins, 794 F.3d at 704–05 (“Treating physicians are no different than any other expert for purposes of Rule 702; before proffering expert testimony [as to causation], they must withstand Daubert scrutiny like everyone else.”); In re Aredia and Zometa Prods. Liab. Litig., 483 F. App’x 182, 187 (6th Cir. 2012) (“[A] treating physician’s testimony is subject to Daubert.”).