From the Leadership

Chair's Corner

By Gail Rodgers

Dear Friends and Colleagues –

I have started and stopped writing this column as many times as there have been closings, openings, and re-closings due to Covid.  What to convey after two years long distanced?  And in what is essentially my swan song.  My time as chair of DMD is coming to a close, so I reflect on the past two years. 

I reflect on what we all have survived in the past two years and how important my friends and colleagues of this community have been.  If you are reading this, you have survived the pandemic, you witnessed (and maybe participated in) the fight for racial justice, you weathered an unbelievable election season, and maybe you even got a pandemic puppy.  Yet there has been such profound loss.  So many of us have lost family members, friends, colleagues, or been impacted by health issues, job loss, financial strain, regular old life problems amplified by the pandemic, and the insanity of working and teaching kids simultaneously. 

Yet everyone I have connected with virtually during these crazy times has been agile, nimble, and strategic in their work.  We have discussed this before, but I am continually in awe of the amazing work of our clients and colleagues, including  developing testing, developing vaccines, ramping up supplies of critical care meds, mass producing ventilators, mass producing PPE—the list is endless.  I am also in awe of the many of you who have been on the frontlines of litigation, legislation, and policymaking to address the unique legal challenges many of our companies and clients have faced in responding to the pandemic.  Yet in each virtual meeting, you all greeted each other with smiles, laughter, virtual cocktails, favorite recipes, new hobbies, and favorite music. 

We have had some amazing virtual programming (no I am not biased at all! And you can still access it via contacting DRI or using your original Pathable link.).  And we have connected further as a community and welcomed many new members.  As I pass the baton to Sheila Boston and Erik Snapp and the rest of our fantastic team, I am so looking forward to the future of the DMD Committee. 

PS – Contact Sheila and Erik to share your ideas or get further involved in the DMD committee (sboston@kayescholer.com; erik.snapp@dechert.com)!

RodgersGail-21-webGail Rodgers is a partner in the New York City office of DLA Piper.  She concentrates her practice in pharmaceutical and medical device litigation, mass torts and government and internal investigations.  Gail represents clients on a wide variety of compliance matters, including the Foreign Corrupt Practices Act (FCPA) as well as advising and enhancing compliance programs in response to investigations.  Gail has extensive experience in a wide variety of state and federal litigation, including providing strategic advice at each stage of litigation, managing national discovery teams, and implementation of national resolution programs.  Gail is the immediate past chair of the DRI Drug and Medical Device Committee. 


From the Editors

Publication Opportunities Abound 

The articles in this issue of Rx for the Defense provide practical considerations related to both fact and expert discovery.  Whether you find yourself back in the office, working from home, or taking us with you on a fall adventure—we hope you find some key takeaways in these thoughtful pieces.  To learn more about publication opportunities in future issues of Rx for the Defense and the article selection process, please contact Heather Howard at hhoward@kslaw.com or Jenn Eppensteiner at jeppensteiner@reedsmith.com.

HowardHeather-21-webHeather Howard is counsel in the Atlanta office of King & Spalding LLP, where she is a member of the firm’s Trial & Global Disputes Practice.  She focuses her practice on the defense of pharmaceutical and medical device manufacturers in product liability suits at the trial level and on appeal.  She serves as the newsletter editor for the DRI Drug and Medical Device Committee. 

eppensteinerjaJennifer Eppensteiner is counsel in Reed Smith LLP’s Life Sciences Health Industry Group, resident in the Princeton, New Jersey office.  Jennifer advises drug and medical device manufacturers on complex product liability litigation, including federal multidistrict litigation (MDL) and consolidated state court actions.  Jennifer currently serves as the assistant newsletter editor for the DRI Drug and Medical Device Committee.

Document Production

It’s Out of My Hands … or Is It?

By C. Darcy Jalandoni and Justin J. Joyce

A number of DRI readers may have encountered the following scenario: your client, a large company with numerous subsidiaries and affiliates, is named as a defendant in a large litigation.  In the course of discovery, the plaintiffs serve requests for production of documents and materials that your client does not have—but one of its subsidiaries or affiliates does.  While it might be tempting to simply throw up your hands and say that searching for, reviewing, and producing these documents is beyond the scope of your and your client’s responsibilities, your legal obligations may well require a more critical analysis—even if it involves entangling the sister company in the litigation.  This article explores the circumstances under which companies may be obligated to locate and produce documents that are not in their client’s possession or custody, but may nonetheless be in their control. 

How a Party May “Control” Its Affiliate for Document Production Purposes

Fed. R. Civ. P. 34(a) provides that a party must produce documents in its “possession, custody, or control.”  While possession and custody are relatively straightforward concepts, the question of when a company “controls” the documents of an affiliate is left to the discretion of the courts.  Courts generally construe control broadly, concluding that an entity controls documents of an affiliate when it can obtain the documents on demand.  See, e.g., United States v. Int’l Union of Petroleum & Indus. Workers, 870 F.2d 1450, 1452 (9th Cir. 1989) (“Control is defined as the legal right to obtain documents upon demand.”) (citing Searock v. Stripling, 736 F.2d 650, 653 (11th Cir. 1984)); Steele Software Sys. v. DataQuick Info. Sys., 237 F.R.D. 561, 564 (D. Md. 2006) (“It is well established that a district court may order the production of documents in the possession of a related nonparty entity under Rule 34(a) if those documents are under the custody or control of a party to the litigation. Control has been construed broadly by the courts as the legal right, authority, or practical ability to obtain the materials sought on demand.”) (citations omitted).

When seeking to compel the production of documents belonging to affiliated companies, the party seeking discovery must establish that the opposing party or subpoena recipient sufficiently controls the affiliate.  See Norman v. Young, 422 F.2d 470, 472–73 (10th Cir. 1970).  But how does a party make this showing?  Courts generally evaluate a number of non-determinative factors to determine if such control exists, including (1) the corporate structure of the entities; (2) how frequently the entities interact with one another in the course of business; (3) whether employees of one entity report to, or have obligations to, employees of the other entity; and (4) whether the entities are participants in, or may benefit from, the present litigation.  While some courts may emphasize certain of these factors over others, they generally consider how related companies are structured, and how they actually operate, to determine if sufficient control exists.

Structure Is Instructive, but Not Necessarily Determinative

One of the first things courts generally consider in determining whether an entity must produce documents belonging to another is the corporate relationship between the two.  For some courts this is a determinative factor, concluding that a parent corporation‘s complete ownership of a subsidiary alone establishes sufficient control to require document production.  See Atl. Specialty Ins. Co. v. M2 Motor Yachts, No. 14-62822, 2016 U.S. Dist. LEXIS 198099, at *5 (S.D. Fla. June 23, 2016) (“While a parent corporation must produce documents possessed by a subsidiary it wholly controls, the reverse is not true.”) (citing Power Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc., 233 F.R.D. 143, 144-146 (D. Del. 2005)).  Other courts have indicated that the corporate structure can be an influencing factor, and that the structure, plus the presence of one or more of the additional factors listed above, may establish sufficient control.  See Platypus Wear, Inc. v. Clarke Modet & Co., No. 06-20976-CIV, 2007 U.S. Dist. LEXIS 94327, at *14-15 (S.D. Fla. Dec. 21, 2007) (“Thus, while an intracorporate relationship and additional indicia of control . . . may be necessary for a subsidiary to reach up the corporate ladder and demand documents in its parent’s possession . . . .”).  Still others have said that the corporate relationship of the parties is not as significant as other factors, particularly because the corporate form can be abused.  See Steele, 237 F.R.D. at 565. 

The corporate form is usually the starting point for the control analysis because it provides courts with a general overview of the entities’ relationships. We generally presume that a company has less control over its sister company than it does over a wholly owned subsidiary.  But, outside of some situations, the corporate structure is not the end point of the analysis because courts recognize that the corporate structure may not correctly illustrate the relationship of multiple entities.  A company may have greater control over a sister company than a subsidiary, for example, if the sister companies are owned by the same person or entity, while the subsidiary is only partially owned by the parent.  Compare Steele, 237 F.R.D. at 555 (“Control has been found where the party and its related nonparty affiliate are owned by the same individual.”), with In re Uranium Trust Litig., 480 F. Supp. 1138, 1152 (N.D. Ill. 1979) (finding a corporate parent did not have to produce documents from 43.8 percent-owned subsidiary that conducted its corporate affairs separately).  So, while the corporate structure is a good starting point in the control analysis, it is generally not a conclusive factor.  Instead, courts will evaluate additional factors to determine if a party sufficiently controls an affiliate. 

Who’s Really in Charge?

Since the corporate structure of parties usually does not fully resolve the question of whether one affiliate controls another, courts often conduct a closer analysis of the relationship between the entities to determine if sufficient control exists.  Power Integrations, 233 F.R.D. at 146 (noting that some courts go beyond examining the legal right of a party to obtain documents from another entity and inquire into their practical ability to do so).  This analysis may focus on the transaction or transactions at issue in the lawsuit, or it may expand to the parties’ general relationship.  The more frequent or important the interaction between the entities, the more likely sufficient control exists for the purpose of production.

Courts have found companies to have control over each other’s documents where they “shared responsive information and documents in the normal course of their business dealings.”  Sergeeva v. Tripleton Int’l Ltd., 834 F.3d 1194, 1201 (11th Cir. 2016). Control may also exist where the core business function of two entities necessarily requires information sharing.  In Cooper Indus., Inc. v. British Aerospace, Inc., 102 F.R.D. 918, 919–20 (S.D.N.Y. 1984), for example, the court found it “inconceivable” that a company could not seek documents from an affiliate related to planes on which the company worked on a daily basis.  Likewise, control may be found where companies that do not generally interact worked together on the transaction at the heart of the dispute.  See Camden Iron & Metal, Inc. v. Marubeni Am. Corp., 138 F.R.D. 438, 443 (D.N.J. 1991). 

In this sense, control for the purpose of discovery operates much like another familiar concept—general and specific jurisdiction.  Control may exist where a company’s business requires that it interact with a related company repeatedly and consistently.  It can also exist where the facts of the specific transaction or behavior at issue shows that the companies worked closely with one another, as this closeness suggests that materials were or could be exchanged.  Both the general and specific relationship between affiliates can inform the control analysis.

A Little Too Close for Comfort

Similarly, courts have found control where companies have common leadership and owners, or where resources are shared by the entities.  In this sense, the control analysis is akin to an alter-ego or “piercing the corporate veil” analysis.  See Camden, 138 F.R.D. at 441-42 (noting that control can be found under the “alter ego doctrine which warranted ‘piercing the corporate veil’”).  If a review of the management and operations shows that one company can effectively control the operations of an affiliate, the court may conclude that control exists for the purpose of Fed. R. Civ. P. 34. 

This analysis usually turns on the specific facts of the case.  Control can be found, for example, when one company shares managers with another or can otherwise control the other company’s operations.  See Flavel v. Svedala Indus., No. 92-C-1095, 1993 U.S. Dist. LEXIS 18730, at *13–17 (E.D. Wis. Dec. 13, 1993) (if a company shares management with another company, can make hiring or firing decisions for another company, or otherwise controls operations of an affiliate, the court may compel a party to produce the affiliate’s documents).  It may also be found where the parent company of two affiliated companies can force the companies to exchange documents. Uniden Am. Corp. v. Ericsson Inc., 181 F.R.D. 302, 307–08 (M.D.N.C. 1998) (ordering company to produce documents from a sister company because, in part, “[t]he parent company has power over both [sister] companies, including the power to make [the affiliate] provide information”).  Essentially, any evidence demonstrating that one party can influence or control the other, whether through control of management decisions or sharing of resources, can demonstrate sufficient control to require the production of documents. 

Shouldn’t You Be in This Lawsuit, Too?

A final factor courts often consider in determining control is whether the non-party corporation has a financial stake in the outcome of the litigation.  This can occur when, for example, a non-party will directly receive the benefit of an award in the action.  See Afros S.P.A. v. Krauss-Maffei Corp., 113 F.R.D. 127, 131 (D. Del. 1986).  A financial interest can also be found when a non-party could be liable for the judgment, or when the non-party’s financial interests could be otherwise affected by the outcome of the case.  Batista v. Nissan N. Am., Inc., No. 14-24728, 2015 U.S. Dist. LEXIS 177227, at *8 (S.D. Fla. Dec. 7, 2015). 

Like the other fact-intensive factors above, this factor creates significant room for debate.  Any financial interest could be potentially relevant.  In Afros, for example, the court found a non-party had a financial interest in the outcome of an action because its sales “will be enhanced” if a party to the action could no longer compete in the business space.  See Afros, 113 F.R.D at 132.  Therefore, if the affiliated non-party may be benefitted or harmed by the outcome of the litigation, this could evidence control.  


In short, when a client receives a document request seeking information from an affiliate, you must conduct an in-depth analysis of the business relationship between the entities, both generally and relative to the transaction or event at issue, to determine whether your client has an obligation to search for and produce the responsive documents.  Additionally, you should make sure to review the relevant law in your jurisdiction on this issue to assess the factors most heavily weighted by the relevant court.  

Jalandoni_Darcy_2017_printC. Darcy Jalandoni is a litigation partner in the Columbus, Ohio office of Porter, Wright, Morris, & Arthur, LLP.  She focuses her practice on product liability and complex commercial litigation and is an active member of the DRI Drug and Medical Device Committee.

Joyce_Justin_2017_pdf_jpgJustin J. Joyce is a senior associate in Porter Wright’s Cincinnati office.  Justin concentrates his practice on commercial litigation, product liability, reinsurance, and advising startups and emerging businesses.  He advises clients not only before a lawsuit is filed, but also during all stages of the litigation process, including appeals.     

Ethics Update

Ethically Walking the Social Media Tightrope

By John Browning, Allison Oliver, and Larissa Eustice

With billions of users worldwide, social media is too pervasive to ignore, and attorneys often leverage such sites for a variety of reasons, both personally and professionally. The following outlines some of the issues of legality, ethics, and professional responsibility that lawyers face when their work intertwines with professional and personal social media sites.

When managed responsibly, social media can help attorneys expand their network, engage with current and potential clients, and establish thought leadership. However, when used irresponsibly, the potential to disclose privileged or confidential information, gather information unethically, misrepresent or act in a deceptive manner, or engage in ex parte communication is ever present. The challenge is assuring social media use doesn’t negatively affect reputation, violate an attorney’s responsibility to the legal system and clients, or break the law.

Areas of Concern

For improper advertising and unauthorized practices, some regulations provide guidance on what is (and is not) permissible.  Less clear are newest practices, including ‘friending’ judges, ‘false friending,’ or communicating with represented parties. While attorneys have the right and an affirmative duty to investigate social media representations in defense of their client (see ABA Ethics 20/20 Commission and Rule 1.1) many recent court rulings indicate where the affirmative duty crosses the line into unethical conduct. Disregarding confidentiality requirements, gathering information without regard to ethics or the law, or misrepresenting themselves are areas uncovered and sanctioned by the courts.

When attorneys improperly communicate, or have their representatives do so, they are likely to be found out and held accountable by opposing counsel and judges. Rulings have even been issued in cases where non-lawyer employees, either as instructed or independently, have initiated contact, ‘friended’ or communicated with jurors or the opposition. Caution must be used to assure no contact or communication is initiated because the fallout can be damaging. It’s also important to note that numerous judges around the country have varying opinions on whether counsel should or should not be researching jurors online before, during, and after trial, so it is best to discuss it with your judge before the beginning of trial.

Facebook Cleansing

Is it ever permissible and responsible to advise clients on privacy settings or to remove unseemly posts?  When does doing so violate the law (including the potential for spoliation of evidence)? Current rulings provide some guidance to help navigate the thin line between legality and ethics when it comes to the role of counsel advising clients to adopt a more benign social media presence.

Ethics opinions looking at this issue have said that it is ethically permissible to provide advice to clients on what privacy settings to implement on social media profiles, as well as to counsel them on the content they post and the potential ramifications of same. They also say it is ethically permissible to advise clients to remove or take down social media content, so long as no spoliation of evidence occurs and all evidence preservation obligations are adhered to.

It is important to note that some cases have resulted in significant sanctions, including heavy fines and impact on an attorney’s right to practice, when attorneys or their clients erase their social media presence.

Social Media Discovery

With regard to discovery, there are regulatory and litigation issues that must be considered when leveraging social media. Problems may arise when plaintiffs, current or future, use social media as a platform to raise questions or concerns about, for example, a particular product. Discovery of social media may be useful in motion practice when leveraged against statute of limitations issues, for example, or for negotiating favorable discovery limitations.

Another thing to keep in mind is the collection techniques used to capture the information. Gone are the days of flat-text screenshots. We’re seeing an increase in plaintiffs challenging the authenticity of the social media profiles and the collection methods, so it may be necessary to start producing collection reports with the captures so that you have the meta-data including the source code, digital signatures, timestamps, and hashing that is needed to authenticate the profiles. It’s also important to know that certain platforms implement their own archival setting restrictions.

Extensive social media discovery can create logistical and financial burdens and consequences. Further, perceptions of the general public or the jury may be impacted by social media discovery in litigation. It remains up to the attorney and firm to work diligently in defense of their client to collect relevant social media information while assuring they do not cross the line.

Platform Navigation and Changes

It’s also important to remember that social media platforms are constantly changing their layouts, filters, archives, and engagement techniques, which can affect the identification, navigation, and collection of information. Most users access Facebook on their mobile devices, e.g., they take pictures and upload them from their phones to their profiles. However, when conducting fact finding for litigation, most lawyers use a desktop computer, which provides a different layout from the mobile version. Lawyers need to be careful with navigating platforms on different devices because they can get a false sense of familiarity due to mobile use of the platforms in their personal life.

Most users are aware of the most popular features such as the “like” button, however, newer sites may offer similar-looking features that actually function differently, so it’s best to use caution. It’s also worth noting that different generations may use different platforms.

It’s also important to keep in mind how often the feature sets change, as well as functions like privacy settings and notifications of actions. Currently, you can see who likes, comments, and shares information on Facebook, but you never know when Facebook will change their settings to allow people to see who has “viewed” a video.

Lastly, be mindful that Facebook uses algorithms to make friend suggestions. If you share mutual connections, or if you continually visit someone’s site, Facebook is learning that you are interested in that person. We’re betting that the last thing you would want is to be the next recommended friend to the plaintiff!

Professionalism Online

Another area to consider is your professionalism online. The temptation to post “victory selfies” may be strong, particularly in hard-fought cases, but the courts frown on such unsportsmanlike conduct. Some lawyers have seen their licenses to practice suspended for “egregious, over the top” messages on Facebook. Improper statements or photos about clients or their injuries, disclosure of confidential mediation proceedings and other posts have garnered sanctions from the bench.

The Fallout

Ethical violations, mistrials, attorney firings—both public and private—and sanctions from the bench and bar associations can be the result of irresponsible actions on social and professional media. Private practitioners and firms have been assessed heavy fines due to their employees or their clients’ actions. It’s important to remember the internet is both a tool and a potential threat. Even an immediately deleted post may be recoverable and may have been captured to save for a later date or reposted to go viral.

Heeding the hard-earned and sometimes career-destroying lessons of other attorneys, some of whom didn’t understand their responsibility under the law, is necessary. Ultimately, it’s up to an attorney to understand their rights and responsibilities when representing their firm, their client, and their profession. A rule of thumb may be if you wouldn’t express it in open court, before a judge and jury, without fear of reprimand or recrimination, you probably shouldn’t post it online, in an email, on voice mail, or in a letter. In this realm, it is better to be safe than sorry.

John BrowningJohn Browning is a partner at Spencer Fane and a former Justice on Texas’ Fifth Court of Appeals. Prior to becoming a judge, he handled a wide variety of civil trial and appellate work in Texas and Oklahoma as a defense attorney. He is the author of several books, dozens of law review articles, and numerous other legal articles on social media and the law. An internationally recognized thought leader on technology and the law, Justice Browning’s work has been cited by courts in Texas, California, New York, Illinois, Maryland, Tennessee, Washington, D.C., and Puerto Rico, by practice guides in eleven states, and in over 400 law review articles.

Allison Oliver_Full Headshot_2019Allison Oliver is an Executive Vice President at Smith & Carson, a defense oriented private investigation firm that specializes in conducting complex fact investigations for large scale and high exposure product liability litigation. Allison provides clients with investigation recommendations to support defense themes such as alternative causation, product defense, illegitimate claims, and questionable credibility. Prior to joining Smith & Carson, Allison was a Large Law Research Consultant and Client Manager for LexisNexis. Allison graduated from the University of Georgia with a degree in International Business.

Larissa EusticeLarissa Eustice, Senior Assistant General Counsel at Bayer US LLC, manages and sets strategy in various litigation matters across all business units, specializing in legal defense of pharmaceutical, crop science and consumer health matters.  Larissa is actively engaged in all phases of the litigation life cycle, including providing counseling to business units regarding risk management.    Larissa has spent the last five years directing a successful litigation strategy in large pharmaceutical product liability mass tort MDL, including six consecutive defense verdicts in federal and state courts involving a key product. 

Evidence Briefing

The Changing Landscape of Expert Admissibility

By Christian Castile

In the era of modern technology, it seems that nearly every day there is an announcement of a scientific breakthrough in one field or another.  One recent announcement worth celebrating deals not with scientific advancement, however, but rather with the law regarding who can testify to that science.  The Federal Rules of Evidence Advisory Committee has proposed an Amendment to Rule 702, and with it, hopes to clarify the standards on expert admissibility.  This article examines the contours of the law governing expert admissibility from 1923 to the present and provides a lens through which to view the proposed amendment as a tool to bolster challenges to expert testimony. 

A Brief History of Expert Admissibility

To fully understand the context of the proposed amendment, we must first briefly recap the core evolution of expert admissibility law.

The General Acceptance Test

In 1923, the District of Columbia Court of Appeals made a landmark decision, braving the “twilight zone” of experimental science in Frye v. United States to lay waste to bogus expert testimony in the courtroom.  293 Fed. 1013 (D.C. Cir. 1923).  In Frye’s trial stage, the defendant sought to defeat a second-degree murder charge by introducing testimony from a scientist who conducted testing using an early model of a lie detector.  Id. at 1014.  The District of Columbia Court intervened, rejecting the scientific validity of the polygraph test because the methodology did not have significant “general acceptance” at that time.  Id.  In so doing, the court ushered in a new standard against which to judge expert testimony.

The standard introduced in Frye is commonly referred to as the “general acceptance test,” and while it had a rocky start—the case was not cited for over ten years following the decision—it held sway in federal courts for decades and is still the prevailing standard in some states.  Essentially, the Frye test requires a court to agree that the procedures, techniques, or principles in question were generally accepted by a notable (but unspecified) portion of the scientific community before they may be deemed admissible.  In other words, the Frye court essentially held that the courtroom is not the place for scientific innovation—if a noteworthy number of experts in the field have not already accepted a particular scientific theory or technique as reliable, any expert testimony based on that theory is to be considered untrustworthy and inadmissible. 

Adoption of the Federal Rules of Evidence

In 1975, more than fifty years after the birth of Frye’s general acceptance test, the Federal Rules of Evidence were adopted in federal courts.  Included within these rules were new standards for the admissibility of expert testimony, which were generally more flexible than the Frye standard (although it was not clear whether Rule 702 superseded Frye, and the general acceptance test remained the more popular alternative). 

The first version of Rule 702 provided that an expert with “scientific, technical, or other specialized knowledge [that] will help the trier of fact to understand the evidence or to determine a fact in issue” may offer opinions at trial.  The enactment of this Rule granted judges wide discretion in determining whether to admit expert testimony and ultimately obfuscated, rather than clarified, the meaning of the Frye standard.

Daubert v. Merrell Dow Pharmaceuticals, Inc.

While the creation of Rule 702 in 1975 was intended to be a departure from the general acceptance test, Frye persisted in federal courts until 1993, when the Supreme Court held that Rule 702 displaced Frye —and that the Frye standard was no longer acceptable in federal courts.  Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 580, 597 (1993).  Instead, the Daubert court described judges as gatekeepers, tasked with critically assessing the accuracy, verifiability, and trustworthiness of expert testimony.  Id. at 597.  Unlike the general acceptance test, the Daubert standard is a flexible approach under which expert testimony is generally considered more properly addressed by “vigorous cross examination, the introduction of contrary evidence, and the court’s careful instruction regarding the burden of proof,” rather than a bright line rule of scientific consensus.

In response to the growing body of Daubert case law in the federal courts, Rule 702 was amended in 2000.  Rule 702 as it stands now reads as follows:

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise 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 and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

The Federal Rules of Evidence Advisory Committee explicitly declined to state that the Rule was simply a codified Daubert standard.  In fact, the Federal Rules of Evidence Advisory Committee noted that the amendment “clearly envision[s] a more rigorous and structured approach than some courts are currently employing.”  See Hon. Fern M. Smith, Report of the Advisory Committee on Evidence Rules (May 1, 1999) at 7, in Advisory Committee on Evidence Rules October 1999 Agenda Book (1999) at 52.  Nevertheless, the Committee affirmed “the trial court’s role as gatekeeper” and incorporated the Daubert tenets of reliability and testability into the Rule.

Newly Proposed Amendment to Rule 702

Modern scientific advancements and more complex litigation have led to a scattershot application of the Daubert standard in various Federal Courts.  Even the Reporter for the Federal Rules of Evidence Advisory Committee has gone as far as to describe Daubert as a “schizophrenic opinion” with an inconsistent message.  Conference on Best Practices for Managing Daubert Questions, 88 Fordham L. Rev. 1215, 1219 (2020).  In an attempt to remedy this apparent confusion, the Advisory Committee has proposed an amendment to Rule 702.  Under the proposal, Rule 702 would be changed as follows (Italics indicate proposed new text; deletion is noted in strikethrough):

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the proponent has demonstrated by a preponderance of evidence that:

(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 and methods;

(d) the expert has reliably applied expert’s opinion reflects a reliable application of the principles and methods to the facts of the case. 

Committee on Rules of Practice and Procedure, Agenda Book June 22, 2021, at 836.  This amendment is notable for two reasons.  First, while Rule 702 was previously silent as to burden of proof, the amendment imposes a preponderance of the evidence standard.  Second, requiring courts to find that “the expert’s opinion reflects a reliable application of the principles and methods to the facts of the case,” broadens the analysis beyond a myopic view of whether an expert’s methods were reliable. Id. at 838.  Instead, the rule directs courts to assess “the opinion ultimately expressed by a testifying expert.”  Id.

Using This Amendment to Your Advantage

It is important to note the shift in focus and tone of the advisory committee as evidenced by the proposed amendment.  As intentioned, Daubert scrutiny should lead to the admission of reliable evidence, even if not yet generally accepted, while screening out evidence which relies on a scientifically accepted premise but, for one reason or another, is “bad science.”  But the Advisory Committee has found otherwise, specifically calling out courts which have “incorrectly determined” that Rule 702 is “governed by [a] more permissive . . . standard.”  Id. at 837.  For example, in Owen v. Union Pac. R.R. Co., the District of Nebraska held that “[c]ourts should exclude opinion testimony only when an expert’s opinion ‘is so fundamentally unsupported that it can offer no assistance to the jury.’”  No. 8:19CV462, 2020 WL 6684504, at *4 (D. Neb. Nov. 12, 2020).  The Owens court, in issuing such a deferential and admission-friendly ruling, relied on an Eighth Circuit opinion which was written in 1988 — over a decade before the governing version of Rule 702 was published.  Loudermill v. Dow Chem. Co., 863 F.2d 566, 570 (8th Cir. 1988).  The Advisory Committee has now made clear that this reimagining of Rule 702 based on stale case law is an abrogation of the courts’ gatekeeping obligations.  Instead, the proposed amendment seeks to refocus the courts’ attention and reject “incorrect application of Rules 702 and 104(a).”  Committee on Rules of Practice and Procedure, Agenda Book June 22, 2021, at 837.  When faced with a plaintiff seeking to introduce unreliable expert opinions under the guise of a “lenient Daubert standard,” it may be helpful to remind the court that the Federal Rules of Evidence Advisory Committee eschews such holdings.

Of course, when the proposed amendment takes effect, it is key that the preponderance of the evidence standard will be explicitly stated in the black letter of Rule 702.  This clarified standard will no doubt be useful in swatting down rogue experts seeking to stretch the bounds of their expertise or discipline.  But this textual addition is significant for one more reason – as the U.S. Court of Appeals for the Sixth Circuit recently explained, “the Federal Rules of Civil Procedure are binding upon court and parties alike, with fully the force of law because they are [p]romulgated pursuant to the Rules Enabling Act, 28 U.S.C. § 2072.”  In re Nat’l Prescription Opiate Litig., 976 F.3d 664, 671 (6th Cir. 2020) (internal quotations omitted).  Thus, even if plaintiffs are able to fend off admissibility challenges during the pendency of the amendment, their wayward experts may find an explicit textual burden more difficult to overcome.


The Federal Rules of Evidence Advisory Committee has its sights set on tightening the reins on experts seeking to offer testimony and opinions in federal courts.  As this new rule is adopted and the transition period begins, it will be crucial to remind courts of the spirit and intent of this amendment, and to use it as a tool to prune your cases of baseless expert opinions and mount the strongest defense for your client.

castille_christianChristian Castile is a member in the Life Sciences Health Industry Group at Reed Smith LLP’s Philadelphia office.  Christian’s practice involves a wide range of commercial litigation matters, including primarily state and federal products liability cases concerning medical devices and prescription and generic medications.