1. Do Not Rely Solely on Your Regulatory Expert When Developing Your Defense Strategy on FDA Issues
Of course, a good regulatory expert can be helpful with identifying the FDA issues relevant to your case, but at bottom, the FDA’s job is to administer certain statutes and regulations. In other words, FDA issues are legal issues. This means that lawyers are best equipped to identify the FDA issues relevant to any given case. In fact, because legal training and experience are so helpful in understanding the FDA regulatory scheme, lawyers serve in many non-legal positions (including high-ranking positions) throughout the agency. Examples include those who run the FDA’s compliance programs for drugs, biologics, foods, and tobacco products.
When identifying the relevant issues, keep in mind that FDA requirements are generally not set forth in case law. Instead, they are set forth in (a) the FDCA, 21 U.S.C. §§ 301–399i; (b) the Public Health Service Act (PHSA) provisions governing the approval of biological products (e.g., vaccines), 42 U.S.C. § 262; and (c) FDA regulations, 21 C.F.R. §§ 1.1–1271.440.
The FDA also issues a number of publications that set forth the agency’s nonbinding interpretations of the statutes and regulations, as well as the ways in which the agency implements and enforces them. These publications include FDA guidance documents (a searchable database), the FDA’s Regulatory Procedures Manual, the FDA’s Investigations Operations Manual, and the FDA’s Manual of Compliance Policy Guides. All of these publications are available on the FDA’s website.
At first blush, the volume of this material may seem overwhelming. Indeed, the FDCA is around 900 pages long and the FDA regulations are about 4,000 pages long. But only certain portions of this material will be relevant to any given case, and locating the relevant material is normally not too difficult. The table of contents of the FDCA and the FDA regulations can be helpful—I suggest using the government’s online versions of the U.S. Code and the Code of Federal Regulations. FDA guidance documents can also be an excellent place to start because they often contain concise summaries of the statutory provisions and regulations relevant to a particular issue.
2. Learn Which FDA Organizations and Officials Are Relevant to the Issues in Your Case
In addition to learning about the FDA issues relevant to your case, you should learn about the organizations and officials within the FDA that are involved with those issues. This knowledge can be helpful in at least two respects when developing your defense—in identifying former FDA employees to serve as regulatory experts and in determining the significance of statements made by FDA employees about your client’s product.
First, this knowledge can be helpful in identifying former FDA employees to serve as regulatory experts in your case. For example, if the product at issue is a drug, you may want to retain someone who worked in the FDA’s Center for Drug Evaluation and Research (CDER). But be aware that FDA’s centers are not monolithic entities. Each center comprises several “super offices,” each “super office” comprises two or more “offices,” each “office” can comprise two or more “divisions,” and each “division” can comprise two or more “branches.” Every one of those organizations has specific responsibilities that are spelled out in the FDA’s Staff Manual Guide, Organizations and Functions, Volume I. In short, not every former center employee necessarily dealt on a daily basis with the issues raised by your case.
Note also that the centers do not have primary responsibility for conducting inspections of facilities that manufacture drugs or medical devices; the FDA’s Office of Regulatory Affairs (ORA) has that primary responsibility, so a former ORA employee may be a good option to serve as an expert on current good manufacturing practice (cGMP) issues. Because ORA also comprises “super offices, offices, etc., you may want to focus your initial search efforts on those who worked in an ORA organization that deals with the types of cGMP issues relevant to your case.
An important caveat here is that the FDA occasionally undergoes reorganizations. For example, the CDER division that approved the drug at issue in your case may have changed its name since the time of the approval. As a result, you may have to do some further digging on organizational issues depending on the time frame of FDA actions relevant to your case.
Second, this knowledge can be helpful when determining the significance of statements made by FDA employees about your client’s product. Not every statement by an FDA employee reflects the official position of the agency. Only the secretary of Health and Human Services has the authority to make every decision within the FDA’s jurisdiction, and the secretary has delegated much of that authority to the commissioner of Food and Drugs, who has redelegated certain authorities to other specific officials within the agency. Those delegations and redelegations are spelled out in the FDA’s Staff Manual Guide, Delegations of Authority, Volume II.
For example, the commissioner has redelegated to specific officials the authority to approve new drug applications (NDAs). See id. at 1410.104. So an approval letter signed by one of those officials is an FDA determination that the drug is safe and effective when used in accordance with its labeling. Statements made by other FDA employees that appear to contradict the decision to approve the application, however, do not reflect the FDA’s view on the drug’s safety or efficacy. Cf. Serono Labs., Inc. v. Shalala, 158 F.3d 1313, 1321 n.2 (D.C. Cir. 1998) (stating that “the views of FDA staff do not bind the agency’s decisionmaker”); 21 C.F.R. § 10.85(k) (stating that, except in certain circumstances, a statement by an FDA employee “does not necessarily represent the formal position of FDA”).
3. Identify (and Have Your Regulatory Expert Testify about) All of the Actions That the FDA Could Have Taken If It Believed Your Client’s Product Was Unsafe
Plaintiffs’ lawyers try to convince juries that the FDA is a toothless tiger when it comes to product safety. But the FDCA authorizes, and in many cases requires, the FDA to take certain actions when it determines that a product presents a significant risk to patient safety.
For example, the FDCA provides that the FDA “shall” order the recall of a medical device if the agency “finds that there is a reasonable probability” that the device “would cause serious, adverse health consequences or death.” 21 U.S.C. § 360h(e)(1).
The FDCA also provides that the FDA “shall” withdraw its approval of a premarket approval application if the agency finds that the “device is unsafe or ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 360e(e)(1)(A).
The FDCA also authorizes the FDA to order a medical device manufacturer to issue a safety notification to healthcare providers and patients if the agency determines that a device “presents an unreasonable risk of substantial harm to the public health” and that such a notification “is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available” under the FDCA (other than a mandatory recall) “to eliminate such risk.” 21 U.S.C. § 360h(a).
As far as drugs go, the FDCA provides that the FDA “shall” initiate label-change proceedings when the agency “becomes aware of any new information, including any safety information or information related to reduced effectiveness,” that the agency “determines should be included in the labeling of the drug.” 21 U.S.C. § 355(o)(4)(A).
The FDCA also provides that the FDA “shall” withdraw its approval of an NDA if the agency finds “that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved.” 21 U.S.C. § 355(e).
4. Help Your Judge Understand Why Form 483s and Warning Letters Are Not Probative Evidence in a Product Liability Case
Plaintiffs’ lawyers love to point to FDA Form 483s and warning letters as evidence that drugs and medical devices are defective. A Form 483 notifies a manufacturing facility of “significant objectionable conditions” observed during an inspection of the facility. See FDA, Investigations Operations Manual at 5-20. A Form 483 is often followed by a warning letter asserting that the facility’s products are “adulterated” because they were not manufactured in compliance with the FDA’s cGMP regulations. See 21 U.S.C. § 351(a)(1), (h) (drugs and devices are “deemed to be adulterated” if manufacturing processes or facilities do not conform with “current good manufacturing practice”).
Arguments about the admissibility of these documents often revolve around whether they fall within an exception to the hearsay rule. See, e.g., Sadler v. Advanced Bionics, Inc., 2013 U.S. Dist. LEXIS 42256, at *5–6 (W.D. Ky. Mar. 26, 2013). However, you should also argue that the documents are simply irrelevant on the issue of product defect or, at a minimum, that any probative value they have on product defect is substantially outweighed by a danger of confusing the issues or misleading the jury. Fed. R. Evid. 403. A judge who understands the FDA’s processes for issuing these documents and the law underlying them may decide to exclude the documents.
Here are some of the points to include in your motion in limine:
First, observations in a Form 483 reflect only the “investigator’s judgment,” not the view of the FDA. See FDA, Investigations Operations Manual at 5-20 (2022). In fact, FDA investigators are not permitted to “report opinions, conclusions, or characterize conditions as ‘violative’” in a Form 483 because “[t]he determination of whether any condition is violative is an agency decision made after considering all circumstances, facts and evidence.” Id. at 5-24.
Second, even though some of the cGMP regulations are “intentionally vague,” Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009), and have “the vice of imprecision,” United States v. Utah Med. Prods., 404 F. Supp. 2d 1315, 1323 (D. Utah 2005), the FDA’s internal procedures do not require the agency’s lawyers to review cGMP warning letters for “legal sufficiency.” See FDA, Regulatory Procedures Manual, ch. 4 at 40 (June 2022) (stating that only “certain types of Warning Letters” must be reviewed by the Office of the Chief Counsel “for legal sufficiency” and that this does not include cGMP warning letters).
Third, there is no judicial review of warning letters for legal sufficiency because “FDA does not consider Warning Letters to be final agency action on which it can be sued.” Id., ch. 4 at 4; see, e.g., Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012) (holding that FDA warning letter was not subject to judicial review).
Fourth, when the FDA is actually required to prove allegations of cGMP violations in an enforcement action, courts sometimes find that the agency got it wrong. See, e.g., Utah Medical Products, 404 F. Supp. 2d at 1324 (finding against FDA after a seven-day bench trial and stating, “The fact that the road chosen by Utah Medical may be different in degree than that thought to be appropriate by [the FDA] does not mean that it is wrong, or in violation of the regulations”); see also United States v. Cal. Stem Cell Treatment Ctr., 2022 U.S. Dist. LEXIS 156714 (C.D. Cal. Aug. 30, 2022) (finding against FDA after an eight-day bench trial).
Last but not least, that a product is “deemed to be adulterated” due to a cGMP violation does not mean that there is something wrong with the product, let alone that the product is defective. This is because many cGMP regulations relate to processes and procedures rather than the condition of the finished product itself. See Utah Med. Prods., 404 F. Supp. 2d at 1324 (“Product safety is not an issue in this [cGMP] case. Processes and procedures are.”) In other words, “a drug may be pharmaceutically perfect in content but still be regarded as adulterated under the law” where “any manufacturing, packing or holding method does not conform to current good manufacturing practice.” United States v. Lit Drug Co., 333 F. Supp. 990, 998 (D.N.J. 1971) (emphasis added); see also, e.g., United States v. Undetermined Quantities of Various Articles, 800 F. Supp. 499, 502 (S.D. Tex. 1992) (“In order to prove a claim of adulteration of a device based upon noncompliance with cGMP regulations, the Government need not establish that the device is actually deficient as a result of the cGMP violation.” (emphasis in original)).
5. Develop a Strategic Plan for—and Do Not Be Afraid to Get a Court Involved in—Obtaining Documents and Testimony from the FDA
Internal FDA documents regarding your client’s product may be helpful in defending against allegations that your client did not satisfy its legal responsibilities. Congress requires the FDA to post some of its internal product-specific documents on the agency’s website. See, e.g., 21 U.S.C. § 355(l)(2) (requiring FDA to post the “action package” (review package) for an NDA drug within 30 days of approval of the NDA). But you may have to submit a Freedom of Information Act (FOIA) request to obtain other product-specific documents. Your FOIA request may turn up more than you expected. See Pfaff v. Merck & Co., 2022 WL 4121406, at *9 (E.D.N.Y. Sept. 9, 2022) (defendant “got lucky” with FDA FOIA request and obtained documents establishing “the impossibility of adding [plaintiffs’ demanded] warning under federal law”).
If you submit a FOIA request, you should narrowly tailor your request to the key issues in your case. The FDA does not have a magic button that allows it to quickly find “any and all documents relating to [drug X].” And the FDA’s FOIA regulations allow agency components “to use a multitrack system to process requests . . . based on the amount of work and/or time required for a request to be processed.” 21 C.F.R. § 20.43(a). In other words, the narrower your request, the more likely the FDA will assign your request to the fastest track. The FDA may even work with you “to limit the scope of the request in order to qualify for faster processing.” 21 C.F.R. § 20.43(e).
All that being said, the statute does place limits on how long an agency can take to respond to a FOIA request. FOIA authorizes requesting parties to sue an agency for production of the requested records if the agency does not respond to the request within 20 working days. See 5 U.S.C. § 552(a)(6)(C)(i). In such lawsuits, “the Government [has the burden to] show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request.” Id. If the government meets that burden, “the court may retain jurisdiction and allow the agency additional time to complete its review of the records.” Id. The FDA is not always able to meet that burden. See, e.g., Buc v. FDA, 2011 U.S. Dist. LEXIS 18802, at *30–31 (D.D.C. Feb. 24, 2011) (finding that FDA did not meet its burden and ordering the agency to produce the requested documents within 15 days). FDA will probably have a harder time meeting that burden if the request is a narrow one.
Once you have all of the relevant FDA documents, you may want to depose the author of one of those documents or an FDA employee mentioned in one of them. If that is the case, you should first run the person’s name through the Department of Health and Human Service’s online employee directory to see if the person still works for the FDA. Obtaining testimony from a former FDA employee is easier than obtaining testimony from a current FDA employee.
FDA’s Touhy regulation prohibits an “officer or employee” of the agency from testifying about “any function of the Food and Drug Administration” or “any information acquired in the discharge of his official duties” unless “authorized by the Commissioner of Food and Drugs” to do so. 21 C.F.R. § 20.1(a); see also Touhy v. Ragen, 340 U.S. 462, 468–70 (1951) (holding that federal agencies may place limits on production of evidence in litigation in which the government is not a party). But unlike some federal agencies’ Touhy regulations, the FDA’s regulation does not mention “former” employees. See, e.g., 38 C.F.R. § 14.802(c) (Veterans Administration’s Touhy regulation applies to “[a]ll present and former officers and employees of the VA”); see also FDA, Regulatory Procedures Manual, ch. 10 at 34 (“Requests for the testimony of former FDA employees are not covered specifically by 21 C.F.R. § 20.1.”). The FDA will therefore not lodge a wholesale objection to testimony from a former FDA employee about work the employee performed while employed at FDA. At most, the FDA may send a lawyer to the deposition to object to testimony that may reveal privileged information, another company’s trade secrets, or confidential commercial information. See 21 U.S.C. § 331(j) (prohibiting “any person” from releasing trade secrets acquired under the authority of the FDCA). (Note: A federal conflict-of-interest statute prohibits former federal employees from testifying as an expert witness regarding certain matters on which they worked while a government employee, but that statute does not prohibit them from testifying as a fact witness. See 18 U.S.C. § 207(j)(6)).
For current FDA employees, the agency’s Touhy regulation allows the commissioner or a designee to authorize the testimony if the requesting party submits a written request, under oath, that establishes the “testimony will be in the public interest and will promote the objectives of the [FDCA] and the agency.” 21 C.F.R. § 20.1(c). The commissioner has delegated the authority to approve Touhy requests to three officials in ORA. See FDA, Staff Manual Guide 1410.24. Touhy requests should be submitted to those officials through ORA’s Office of Strategic Planning and Operational Policy, Division of Information Disclosure Policy (DIDP), which “[s]erves as the ORA focal point for handling testimony requests.” Id. at 1121.632. The DIDP has employees called “Testimony Specialists” who advise those officials on Touhy requests.
While the FDA denies most Touhy requests, that fact should not prevent you from submitting such a request. The FDA is well aware that the denial of a Touhy request can be successfully challenged in court under the Administrative Procedure Act’s “arbitrary and capricious” standard and, if the underlying litigation is in federal court, under the Federal Rule of Civil Procedure 45 “undue burden” standard. See 5 U.S.C. § 706(2)(A); Fed. R. Civ. P. 45(d)(3)(A)(iv); In re Vioxx Prods. Liab. Litig., 235 F.R.D. 334, 344 (E.D. La. 2006) (“the deposition of [FDA employee] Dr. Graham must proceed because FDA has acted arbitrarily and capriciously in failing to provide Dr. Graham for a deposition and has also failed to show that the deposition of Dr. Graham will subject it to undue burden”).
Therefore, a narrow and carefully crafted request may persuade the FDA that it would be better to allow a limited deposition rather than risk an adverse court decision. For example, the request could attach specific documents you want to depose the witness about, as well as pleadings or other filings in which plaintiff’s counsel and “experts” have mischaracterized those documents. Because the FDA’s lawyers generally have no experience with product liability litigation, they are unaware of the FDA issues that you often see from plaintiffs and their experts. See, e.g., In re Fosamax Prods. Liab. Litig., 742 F. Supp. 2d 460, 481 (S.D.N.Y. 2010) (noting that in closing argument, plaintiff’s counsel “condemn[ed] the FDA’s objectivity, characterizing the agency as having an ‘incestuous’ relationship with pharmaceutical companies under which it gives cursory reviews and expedited approvals of new drug applications ‘in exchange’ for funding”). The request could also offer to take the deposition at the FDA employee’s workplace outside of business hours and include a list of cases (obtained via FOIA) in which the FDA has granted a Touhy request. See In re Vioxx, 235 F.R.D. at 345 (“This Court does not see how the deposition of one employee during non-working hours would cripple the FDA’s ability to function.”); id. (“FDA has voluntarily produced medical officers in connection with other pharmaceutical MDLs. If FDA has voluntarily produced medical officers in the past, why cannot it produce one in this litigation?”).
Finally, keep in mind that a “governmental agency” can be deposed under Federal Rule of Civil Procedure 30(b)(6). Therefore, if you have been unable to identify a specific FDA employee whom you want to depose on a particular topic, you may want to serve a subpoena and 30(b)(6) deposition notice on the FDA and leave it to the agency to designate someone to testify on that topic.