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It is increasingly common in product liability cases for a plaintiff to disclose as an expert a former employee of a government agency such as the Consumer Product Safety Commission (“CPSC”) or the Food and Drug Administration (“FDA”). These witnesses frequently advertise themselves as experts in “product/drug safety” and refer to their regulatory background as their primary qualification. Frequently, however, these witnesses' responsibilities as government employees had little, if anything, to do with the subjects about which they are now testifying. Nevertheless, these witnesses are dangerous if allowed to testify to a jury, because they lend the credibility of the U.S. government to the plaintiff's case.
There are several approaches that defense counsel should consider in seeking to exclude such an expert witness. These include: 1) challenging the qualifications of the witness; 2) determining whether the proposed testimony violates the Ethics in Government Act; and 3) analyzing whether the testimony complies with Rule 702's requirement that it be expert testimony and that it “fit” the facts of the case. Defense counsel must conduct appropriate discovery and/or investigation of the expert to decide which, if any, of these approaches will offer the best opportunity to exclude the expert.
Not Qualified
The CPSC and FDA, like most government agencies, are large bureaucracies with numerous employees with different levels of responsibilities. While these agencies employ many engineers and scientists with real expertise in their fields, they also employ politicians, lawyers, and bureaucrats, who would have little, if any, expertise relevant to the facts of a particular product liability case. Moreover, given the size of these agencies, it is likely that a former employee has, at best, only limited knowledge about the agency's policies and limited responsibility for decision making. Thus, if a purported expert witness's primary qualification on his curriculum vitae is simply that he was a former employee of one of these agencies, it is worth careful scrutiny to determine if he is truly qualified to testify about anything relevant to the case at hand.
It is important, therefore, to gather as much information as possible about the purported expert's employment responsibilities with the government, starting from the moment defense counsel receives the expert witness disclosure. Information may be obtained directly from the government through federal subpoena duces tecum and requests pursuant to the Freedom of Information Act (“FOIA”), although such methods often take a substantial amount of time and effort. In addition, some agencies such as the FDA have enacted regulations purportedly allowing them to decline to produce documents pursuant to subpoena duces tecum, 21 C.F.R. '20.2; see United States ex rel. Touhy v. Ragen, 340 U.S. 462, 467-69 (1951) (holding that an agency may enact such regulations), although some courts have held that federal agencies must comply with a valid subpoena issued by a federal court. See Houston Bus. Journal v. Office of the Comptroller, 86 F.3d 1208, 1212 (D.C. Cir. 1996). Even when agencies decline to respond to direct inquiries, agency Web sites may prove useful sources of information. See www.fda.gov; www.cpsc.gov. Counsel should use all other available means of investigating the purported expert's background, including expert witness tracking services and defense groups. In cases pending in federal court, counsel should insist on an expert report that fully complies with Rule 26.
It may turn out that the purported expert has no relevant qualification other than the fact that he was once employed by a government agency. If that is the case, he should not be allowed to testify because he is simply a “hired gun,” with no particular expertise that is relevant to the product at issue in the case. See Shreve v. Sears, Roebuck & Co., 166 F. Supp. 2d 378, 393-94 n.8 (D. Md. 2001) (excluding professional expert whose resume listed close to 200 “product liability reports” he authored after finding that he had no particular expertise regarding the subject product) (citing Tyus v. Urban Search Mgmt., 102 F.3d 256, 263 (7th Cir. 1996), cert. denied 520 U.S. 1251 (1997)).
The Ethics in Government Act
A critical fact to discover early in the litigation is whether the proffered expert was actually involved with the product that is at issue in the lawsuit during his government employment. For example, in a pharmaceutical case in which the FDA took some action on the drug at issue, defense counsel must determine whether the proffered expert was involved in any capacity in the FDA's decision-making process with respect to that drug. If so, the Ethics in Government Act, 18 U.S.C. '207, may preclude the proffered expert from testifying on behalf of any person, including the plaintiff. The Ethics in Government Act provides, in relevant part:
Any person who is an officer or employee … of the executive branch of the United States … and who, after the termination of his or her service or employment with the United States … knowingly makes, with the intent to influence, any communication to or appearance before any … court … of the United States … on behalf of any other person … in connection with a particular matter '
(A) in which the United States … is a party or has a direct and substantial interest,
(B) in which the person participated personally and substantially as such officer or employee, and
(C) which involved a specific party or specific parties at the time of such participation, shall be punished as provided in section 216 of this title. 18 U.S.C. '207(a)(1) (emphasis added).
The statute also states that such an employee who is subject to these restrictions “may not, except pursuant to court order, serve as an expert witness for any other person (except the United States) in that matter.” Id. '207(j)(6)(A).
The regulations promulgated pursuant to the Ethics in Government Act permit a former employee to “testify before any court … with respect to matters of fact within the personal knowledge of the former Government employee,” but do not permit that former employee to “testify on behalf of another as an expert witness,” except:
(1) To the extent that the former employee may testify from personal knowledge as to occurrences which are relevant to the issues in the proceeding, including those in which the former Government employee participated utilizing his or her expertise, or
(2) in any proceeding in which it is determined that another expert in the field cannot practically be obtained; that it is impractical for the facts or opinions on the same subject to be obtained by other means, and that the former Government employee's testimony is required in the interest of justice. 5 C.F.R. '2637.208(b).
The regulations promulgated pursuant to the Ethics in Government Act make it clear that a former government employee “acts on behalf of” or “represents” another person by serving as an expert witness. 5 C.F.R. '2637.201(a)(2).
Although the Ethics in Government Act is a criminal statute that does not speak to the admissibility of the former government employee's testimony, federal courts have suggested that there may be grounds for excluding the testimony of an expert witness who would be violating the statute. In United States ex rel. Watson v. Connecticut General Life Insurance, No. 98-6698, 2003 U.S. Dist. LEXIS 1344 (E.D. Pa., Jan. 30, 2003) (Yohn, J.), the defendant moved for summary judgment and attached in support of its motion the declaration of a consultant who was a former contracting officer for the Centers for Medicare and Medicaid Services (“CMS”). The plaintiff moved to exclude this declaration under the Ethics in Government Act (and on the additional ground that the declaration contained undisclosed expert opinions). The court ultimately allowed the declaration, but only after engaging in an analysis that suggested that in some circumstances the Ethics in Government Act would be grounds to exclude the testimony of a former government employee. The court noted that the proposed witness:
received no compensation from either [the defendant] or defense counsel. He performed no additional work for defendant. He did not conduct an independent evaluation of the documents in this matter. He did not review witness depositions. He did not formulate proposed testimony for the defendant. … [The witness] merely responded to questions based on his personal knowledge of certain contracts while employed by the government. There is nothing consulting-like about this arrangement. Id. at *10-11.
The court discounted the fact that the witness had 1) promoted his services as a consultant to the defendant; and 2) spent several hours with defense counsel preparing for his deposition. The court simply stated that “there is no evidence in the record that the defendant ever retained [the witness] as a consultant,” and “the deposition preparation was necessary because [the] plaintiff requested the deposition.” The court concluded that these additional facts “do not make [the witness] a consultant.” Conn. Gen. Life Ins., 2003 U.S. Dist. LEXIS 1344, at *11 n.3.
As a result, the court found that the witness was serving as neither a representative of, a consultant to, or on behalf of the defendant, nor was he acting as an expert witness. Id. at *11-12. The court's reliance on these facts, however, suggests that if the witness was retained in a more traditional “expert witness” capacity, the court may have excluded his testimony. See also Conrad v. United Instruments, Inc., 988 F. Supp. 1223 (W.D. Wis. 1997) (refusing to rule on whether former employee of the FAA would be permitted to testify as an expert witness on behalf of the plaintiff, but acknowledging that having him testify as an expert witness might subject him to liability while testifying as a fact witness would not).
Rule 702
If the expert witness was not involved during his government employment with the product that is at issue in the lawsuit, there may be other grounds to exclude his testimony. Under Fed. R. Evid. 702 (or the equivalent state rule), courts will not permit testimony that does not consist of scientific, technical, or other specialized knowledge, and will not assist the jury to understand the evidence or to determine a fact in issue. Fed. R. Evid. 702. In this sense, the testimony does not “fit” the facts of the case, pursuant to the framework set out by the Supreme Court for the admissibility of expert testimony in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
In the absence of personal experience to draw upon as a basis for his conclusions, the expert witness will necessarily have to depend on information he obtains, often from plaintiff's counsel, as a basis for his opinions. Often, this information is limited or simply wrong. The witness will likely be unaware of additional or different information that his former agency possessed, and will have to speculate as to how the agency would have reacted had it been in possession of such information. Such speculative testimony does not assist the jury. See In re Rezulin Products Liability Litigation, Master File 00 Civ. 2843, 2004 U.S. Dist. LEXIS 5197 (Mar. 15, 2004) (excluding purported expert opinions regarding ethical behavior of defendant).
Similarly, the witness may be offered by the plaintiff simply as a conduit for admitting potentially damaging government documents such as Adverse Event Reports (“AERs”) to the FDA or Epidemiological Investigation Reports (“EIRs”) to the CPSC. These reports contain information gathered by the agency about injuries and/or accidents associated with use of the product and/or pharmaceutical at issue, but they are not intended as statements of causation, although plaintiffs frequently offer them to prove causation.
Former employees of the government are sometimes simply asked to review such documents, and then present them to the jury as “support” for their purported opinions. These reports are intrinsically unreliable because they invariably contain multiple levels of hearsay, often from biased sources. See McKinnon v. Skil Corp., 638 F.2d 270 (1st Cir. 1981) (noting that CPSC reports contain double hearsay, often consisting of “a paraphrasing of versions of the victims themselves who surely cannot be regarded as disinterested observers”). For evidence of other incidents to be admitted, the plaintiff must prove through competent, admissible evidence the general foundational requirement that the other incidents were “substantially similar” to the incident at issue. See Knotts v. Black & Decker, Inc., 204 F. Supp. 2d 1029, 1041 (N.D. Ohio 2002) (excluding accounts of other incidents contained in CPSC reports); Riley v. Yamaha Motor Co., No. 85-110, 1986 U.S. Dist. LEXIS 29890, at *4-5 (E.D. Penn. Jan. 30, 1986) (statistical information regarding other accidents contained in CPSC briefing reports is inadmissible). Where appropriate, defense counsel must argue in this situation that these reports are not the type of evidence that experts in the particular field would rely on in forming their opinions, and/or that the probative value of the reports does not substantially outweigh their highly prejudicial effect. Fed. R. Evid. 703. See Fed. R. Evid. 703 (“Facts or data that are otherwise inadmissible shall not be disclosed to the jury … unless the court determines that their probative value in assisting the jury to evaluate the expert's opinion substantially outweighs their prejudicial effect.”), advisory committee's note (“If it be feared that enlargement of permissible data may tend to break down the rules of exclusion unduly, notice should be taken that the rule requires that the facts or data 'be of a type reasonably relied upon by experts in a particular field.' The language would not warrant admitting in evidence the opinion of an 'accidentologist' as to the point of impact in an automobile collision based on statements of bystanders, since this requirement is not satisfied.”). Moreover, the witness's purported “opinion” may not follow logically from the reports (eg, the witness may opine that the documented injuries and/or accidents were caused by a defect in the product) or it may be simply a matter of common sense (eg, the witness may opine that the defendant had “notice” of the claims set forth in the reports). These types of opinions are not helpful to the jury, and the real purpose of such testimony is simply to get the damaging reports before the jury. Defense counsel must argue in this situation that the witness lacks personal knowledge of any of these documents and that the real reason this witness is being offered is simply to testify as to highly prejudicial and unreliable hearsay.
The witness also may be offered by the plaintiff simply to opine that the defendant and/or its product failed to comply with rules and regulations promulgated or administered by his former agency. If so, defense counsel should argue that these opinions should be excluded as improper legal opinions. See Zepik v. Ceeco Pool & Supply, Inc., 118 F.R.D. 455, 461-62 (N.D. Ind., 1987), aff'd in part and vacated in part by Zepik v. Tidewater Midwest, Inc., 856 F.2d 936 (7th Cir. 1988) (striking purported opinions of former employee of the CPSC as to compliance with regulations on the grounds that these were legal conclusions); Payne v. A.O. Smith Corp., 627 F. Supp. 226, 228-29 (S.D. Oh. 1985) (same). The expert will likely be unable to explain the absence of any official finding by the agency to this effect.
Conclusion
The proffer of a former government employee as an opposing expert witness presents a number of challenges. Although there are many potential lines of cross-examination of these witnesses, the best solution is to mount a successful attack on the expert through a motion in limine that excludes some or all of his testimony.
It is increasingly common in product liability cases for a plaintiff to disclose as an expert a former employee of a government agency such as the Consumer Product Safety Commission (“CPSC”) or the Food and Drug Administration (“FDA”). These witnesses frequently advertise themselves as experts in “product/drug safety” and refer to their regulatory background as their primary qualification. Frequently, however, these witnesses' responsibilities as government employees had little, if anything, to do with the subjects about which they are now testifying. Nevertheless, these witnesses are dangerous if allowed to testify to a jury, because they lend the credibility of the U.S. government to the plaintiff's case.
There are several approaches that defense counsel should consider in seeking to exclude such an expert witness. These include: 1) challenging the qualifications of the witness; 2) determining whether the proposed testimony violates the Ethics in Government Act; and 3) analyzing whether the testimony complies with Rule 702's requirement that it be expert testimony and that it “fit” the facts of the case. Defense counsel must conduct appropriate discovery and/or investigation of the expert to decide which, if any, of these approaches will offer the best opportunity to exclude the expert.
Not Qualified
The CPSC and FDA, like most government agencies, are large bureaucracies with numerous employees with different levels of responsibilities. While these agencies employ many engineers and scientists with real expertise in their fields, they also employ politicians, lawyers, and bureaucrats, who would have little, if any, expertise relevant to the facts of a particular product liability case. Moreover, given the size of these agencies, it is likely that a former employee has, at best, only limited knowledge about the agency's policies and limited responsibility for decision making. Thus, if a purported expert witness's primary qualification on his curriculum vitae is simply that he was a former employee of one of these agencies, it is worth careful scrutiny to determine if he is truly qualified to testify about anything relevant to the case at hand.
It is important, therefore, to gather as much information as possible about the purported expert's employment responsibilities with the government, starting from the moment defense counsel receives the expert witness disclosure. Information may be obtained directly from the government through federal subpoena duces tecum and requests pursuant to the Freedom of Information Act (“FOIA”), although such methods often take a substantial amount of time and effort. In addition, some agencies such as the FDA have enacted regulations purportedly allowing them to decline to produce documents pursuant to subpoena duces tecum, 21 C.F.R. '20.2; see
It may turn out that the purported expert has no relevant qualification other than the fact that he was once employed by a government agency. If that is the case, he should not be allowed to testify because he is simply a “hired gun,” with no particular expertise that is relevant to the product at issue in the case. See
The Ethics in Government Act
A critical fact to discover early in the litigation is whether the proffered expert was actually involved with the product that is at issue in the lawsuit during his government employment. For example, in a pharmaceutical case in which the FDA took some action on the drug at issue, defense counsel must determine whether the proffered expert was involved in any capacity in the FDA's decision-making process with respect to that drug. If so, the Ethics in Government Act, 18 U.S.C. '207, may preclude the proffered expert from testifying on behalf of any person, including the plaintiff. The Ethics in Government Act provides, in relevant part:
Any person who is an officer or employee … of the executive branch of the United States … and who, after the termination of his or her service or employment with the United States … knowingly makes, with the intent to influence, any communication to or appearance before any … court … of the United States … on behalf of any other person … in connection with a particular matter '
(A) in which the United States … is a party or has a direct and substantial interest,
(B) in which the person participated personally and substantially as such officer or employee, and
(C) which involved a specific party or specific parties at the time of such participation, shall be punished as provided in section 216 of this title. 18 U.S.C. '207(a)(1) (emphasis added).
The statute also states that such an employee who is subject to these restrictions “may not, except pursuant to court order, serve as an expert witness for any other person (except the United States) in that matter.” Id. '207(j)(6)(A).
The regulations promulgated pursuant to the Ethics in Government Act permit a former employee to “testify before any court … with respect to matters of fact within the personal knowledge of the former Government employee,” but do not permit that former employee to “testify on behalf of another as an expert witness,” except:
(1) To the extent that the former employee may testify from personal knowledge as to occurrences which are relevant to the issues in the proceeding, including those in which the former Government employee participated utilizing his or her expertise, or
(2) in any proceeding in which it is determined that another expert in the field cannot practically be obtained; that it is impractical for the facts or opinions on the same subject to be obtained by other means, and that the former Government employee's testimony is required in the interest of justice. 5 C.F.R. '2637.208(b).
The regulations promulgated pursuant to the Ethics in Government Act make it clear that a former government employee “acts on behalf of” or “represents” another person by serving as an expert witness. 5 C.F.R. '2637.201(a)(2).
Although the Ethics in Government Act is a criminal statute that does not speak to the admissibility of the former government employee's testimony, federal courts have suggested that there may be grounds for excluding the testimony of an expert witness who would be violating the statute. In United States ex rel. Watson v.
received no compensation from either [the defendant] or defense counsel. He performed no additional work for defendant. He did not conduct an independent evaluation of the documents in this matter. He did not review witness depositions. He did not formulate proposed testimony for the defendant. … [The witness] merely responded to questions based on his personal knowledge of certain contracts while employed by the government. There is nothing consulting-like about this arrangement. Id. at *10-11.
The court discounted the fact that the witness had 1) promoted his services as a consultant to the defendant; and 2) spent several hours with defense counsel preparing for his deposition. The court simply stated that “there is no evidence in the record that the defendant ever retained [the witness] as a consultant,” and “the deposition preparation was necessary because [the] plaintiff requested the deposition.” The court concluded that these additional facts “do not make [the witness] a consultant.” Conn. Gen. Life Ins., 2003 U.S. Dist. LEXIS 1344, at *11 n.3.
As a result, the court found that the witness was serving as neither a representative of, a consultant to, or on behalf of the defendant, nor was he acting as an expert witness. Id. at *11-12. The court's reliance on these facts, however, suggests that if the witness was retained in a more traditional “expert witness” capacity, the court may have excluded his testimony. See also
Rule 702
If the expert witness was not involved during his government employment with the product that is at issue in the lawsuit, there may be other grounds to exclude his testimony. Under Fed. R. Evid. 702 (or the equivalent state rule), courts will not permit testimony that does not consist of scientific, technical, or other specialized knowledge, and will not assist the jury to understand the evidence or to determine a fact in issue. Fed. R. Evid. 702. In this sense, the testimony does not “fit” the facts of the case, pursuant to the framework set out by the Supreme Court for the admissibility of expert testimony in
In the absence of personal experience to draw upon as a basis for his conclusions, the expert witness will necessarily have to depend on information he obtains, often from plaintiff's counsel, as a basis for his opinions. Often, this information is limited or simply wrong. The witness will likely be unaware of additional or different information that his former agency possessed, and will have to speculate as to how the agency would have reacted had it been in possession of such information. Such speculative testimony does not assist the jury. See In re Rezulin Products Liability Litigation, Master File 00 Civ. 2843, 2004 U.S. Dist. LEXIS 5197 (Mar. 15, 2004) (excluding purported expert opinions regarding ethical behavior of defendant).
Similarly, the witness may be offered by the plaintiff simply as a conduit for admitting potentially damaging government documents such as Adverse Event Reports (“AERs”) to the FDA or Epidemiological Investigation Reports (“EIRs”) to the CPSC. These reports contain information gathered by the agency about injuries and/or accidents associated with use of the product and/or pharmaceutical at issue, but they are not intended as statements of causation, although plaintiffs frequently offer them to prove causation.
Former employees of the government are sometimes simply asked to review such documents, and then present them to the jury as “support” for their purported opinions. These reports are intrinsically unreliable because they invariably contain multiple levels of hearsay, often from biased sources. See
The witness also may be offered by the plaintiff simply to opine that the defendant and/or its product failed to comply with rules and regulations promulgated or administered by his former agency. If so, defense counsel should argue that these opinions should be excluded as improper legal opinions. See
Conclusion
The proffer of a former government employee as an opposing expert witness presents a number of challenges. Although there are many potential lines of cross-examination of these witnesses, the best solution is to mount a successful attack on the expert through a motion in limine that excludes some or all of his testimony.
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