Proactive Preparation of Defense of Post-Recall Litigation

Most pharmaceutical and medical device recalls are voluntarily initiated by manufacturers either on their own or by FDA request. Indeed, the FDA is only authorized to order a recall and determine its scope and extent in certain situations involving medical devices, human tissue products, and infant formula. See 21 U.S.C. ” 350a(e)-(g) and 21 C.F.R. Part 107, Subpart E (governing mandatory recalls of infant formula); 21 U.S.C. ' 360h(e) and 21 C.F.R. Part 806 (governing mandatory recalls of medical devices); 42 U.S.C. ' 262 (governing mandatory recalls of human biological products). Generally, 21 C.F.R. Part 7, Subpart C provides guidelines to manufacturers on voluntary recalls and certain responsibilities following voluntary recalls. See 21 C.F.R. ” 7.40-7.59. In addition, the FDA, has issued a guidance on the conduct of recalls and responsibilities and recommendations following a recall. See Guidance for Industry: Product Recalls, Including Removals and Corrections (issued Nov. 3, 2003) found at www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm.

Post-Recall Responsibilities

After a pharmaceutical or medical device manufacturer has initiated a voluntary recall, the FDA sets out certain responsibilities and recommends certain steps a manufacturer should take in order to ensure an effective recall. These responsibilities and steps may include effectiveness checks, status reports to the FDA, root cause analysis, corrective action plans, and follow-up or updated recall communications, where necessary. It is important for in-house and outside product liability attorneys to be aware of these post-recall responsibilities and steps in order to coordinate litigation preparation effectively.

Effectiveness Checks

According to FDA regulations, “[t]he purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the [manufacturer's recall] strategy have received notification about the recall and have taken appropriate action.” 21 C.F.R. ' 7.42(3). A “consignee” is anyone who received, purchased, or used the product being recalled. 21 C.F.R. ' 7.3(n). Effectiveness checks may be done by letters, telephone calls, personal visits, or any combination of these methods. 21 C.F.R. ' 7.42(3). There are five different levels of effectiveness checks: Level A, in which “100 percent of the total number of consignees to be contacted”; Level B, in which “[s]ome percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater than 10 percent and less than 100 percent of the total number of consignees”; Level C, in which “10 percent of the total number of consignees to be contacted”; Level D, in which “2 percent of the total number of consignees to be contacted”; and Level E, in which there are no effectiveness checks. Id. Although it is generally the responsibility of the manufacturer to conduct the effectiveness checks, the FDA may assist where necessary. Id. Regardless
of the method by which a manufacturer conducts an effectiveness check, such a check includes a consignee list, a common identifier, a questionnaire, and a procedure for recording responses. Methods for Conducting Recall Effectiveness Checks, Regulatory Procedures Manual, Chap. 7 Attachment A at 7-49, FDA (March 2009). The goal of the questionnaire, whether written or oral, is to determine “whether the recall notification was received; the product involved was handled as instructed in the recall notification; the product was further distributed by the consignees before receipt of the recall notification; and, if so, were the additional consignees notified.” Id. at 7-50. If the effectiveness check is done through a letter and an enclosed questionnaire, then the letter should also state: 1) “the reason for the recall”; 2) “a complete description of the product being recalled or corrected”; 3) “instructions regarding the disposition of the recalled product”; and 4) “a request for cooperation in completing and returning the questionnaire.” Id.

Recall Status Reports

Manufacturers must submit periodic recall status reports to the appropriate FDA district office. 21 C.F.R. ' 7.53(a). FDA regulations do not state specifically how often manufacturers should submit reports. Id. Instead, the frequency of reports is determined by the FDA on a case-by-case basis depending on the urgency of the recall. Id. The FDA, however, recommends reporting between every two and four weeks. Id. Generally, recall status reports should include:

• Number of consignees notified of the recall, and date and method of notification;
• Number of consignees responding to the recall communication and quantity of products on hand at the time it was received;
• Number of consignees that did not respond (if needed, the identity of nonresponding consignees may be requested by the FDA);
• Number of products returned or corrected by each consignee contacted and the quantity of products accounted for;
• Number and results of effectiveness checks that were made; and
• Estimated time frames for completion of the recall.

21 C.F.R. ' 7.53(b).

Root Cause Analysis and Corrective Action Plans

In addition to the responsibilities set out in 21 C.F.R. Part 7, Subpart C, in its Guidance for Industry: Product Recalls, Including Removals and Correction, the FDA also recommends that manufacturers take certain preventative steps. Guidance for Industry: Product Recalls, Including Removals and Corrections (issued Nov. 3, 2003) found at www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm. For example, in its Guidance, the FDA suggests that manufacturers provide the appropriate FDA district office with the root cause of the problem for which the recall was initiated, once the root cause has been established. Id. at 9. The FDA views this step as important so that appropriate preventative measures can be taken. Id. Similarly, the FDA advises manufacturers to provide the local district office with the corrective actions planned or already initiated as preventative measures. Id. at 9-10.

Follow-Up or Updated Recall Communications

After sending out their initial recall communications to its customers and users, including physicians, hospitals, patients, and/or distributors, manufacturers may need to send out follow-up or updated recall communications. Follow-up or updated recall communications may become necessary based on the results of effectiveness checks, FDA audits or requests, or additional information learned about the recalled product or potential health risks of the recalled product. Similarly, a manufacturer may need to issue an updated or additional press release, if an initial press release had been issued about the recall.

The FDA does not provide guidelines regarding additional or updated recall communications. The FDA's guidelines for initial recall communications, however, may provide some general guidance to manufacturers for updated communications. Generally, the initial recall communication should include: 1) product identification; 2) description of the problem, including any potential health hazard(s) associated with it; 3) depth of the recall; 4) instructions to customers regarding what should be done with respect to the recalled products; and 5) a means for the recipient of the communication to report to the manufacturer whether it has any of the recalled products. 21 C.F.R. ' 7.49 (c); Guidance for Industry: Product Recalls, Including Removals and Corrections. In addition, the FDA advises that the recall communication should be “brief and to the point” and “should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.” 21 C.F.R. ' 7.49(c).

In July 2007, the FDA issued a Guidance entitled, “Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs),” available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070932.htm. While this Guidance is specific to recalls of ICDs, it may also provide some considerations for manufacturers as to recall communications to physicians regarding other recalled products. For example, the FDA conducted research studies regarding sources health care professionals use for conveying risk information about medical devices. Id. at 3. Based on this research, the FDA found that the following suggestions were identified as “best practices” for communicating with health care professionals about medical device failures: 1) “present safety information in a consistent order”; 2) “format letters about safety concerns for easy readability”; 3) “notify health care professionals about safety issues through multiple channels”; 4) “make information about device failures available to health care professionals before patients hear about it in the media”; 5) “focus communications on the problem with the device and recommended actions for physicians”; and 6) “avoid promotional statements about the company.” Id. at 3-4. In addition, the FDA suggests that physician communications should be less than two pages when possible and contain short paragraphs. Id. at 4. Physician communications should also be formatted using large font size, bold type, subheadings, bullets, and tables, where appropriate. Id.

Proactive Defense of Post-Recall Litigation

Manufacturers can proactively begin preparation of a defense for post-recall litigation while carrying out their post-recall responsibilities. First, manufacturers can use their post-recall responsibilities as a means of collecting information about any potential post-recall litigation. For example, manufacturers can use effectiveness checks and recall status reports to determine the scope, extent, and likely location(s) of potential litigation. Further, effectiveness checks and recall communications can also be used to collect information on potential plaintiffs. In addition, effectiveness checks and recall communications can be used to identify key distributors, retailers, or health care providers that may become involved in any post-recall litigation.

Second, manufacturers should remember that employees and staff involved with post-recall duties and responsibilities may be potential witnesses in any recall litigation. Manufacturers should identify all key personnel with knowledge and involvement in post-recall duties. Manufacturers may want to consider conducting interviews to determine the scope and extent of involvement in the recall and post-recall duties. These interviews may also be used to aid manufacturers in identifying personnel with relevant documentation, whether in hardcopy or electronic format, regarding the recall and post-recall duties. In addition, depending on the role of the employee, manufacturers may want to involve the human resources or personnel department to determine any potential issues with these employees or to help keep track of employees if they change roles in the company or leave the company.

Third, manufacturers can take advantage of the systems and processes put into place for their recall duties to begin to collect, store, and organize documents that may become important to post-recall litigation. For example, manufacturers may want to consider electronic storage issues regarding patient information collected through recall communications and effectiveness checks. In addition, manufacturers should be sure to keep all recall status reports well-organized and should make sure that they have all communications with the FDA regarding the recall and the recalled product and that these documents are organized (probably chronologically), and probably scanned to allow for easy electronic access. Depending on the nature of the recall and the likelihood of potential post-recall litigation, manufacturers may want to consider sending out a litigation hold notice regarding relevant documents, including electronic information, to key personnel involved in the recall.

In addition, while carrying out their post-recall duties, manufacturers and their counsel should be analyzing and developing defense themes for any post-recall litigation. For example, in recall communications with physicians and health care providers, if possible and applicable, manufacturers may want to emphasize the independent role of the physician in making individual decisions for his or her patient, which could help support a learned intermediary defense. Similarly, if manufacturers send recall communications directly to patients, they could, if appropriate, include language regarding the weighing of the patient's own risks and benefits and discussions with his or her physician to correlate with defense themes based on informed consent and acknowledgement of all the risks.

Also, it is important to remember that all effectiveness checks, recall status reports, and follow-up recall communications may be discoverable and potentially used as exhibits at trial or during litigation. Manufacturers should thus consider involving in-house or outside product liability counsel in reviewing drafts of all such documents. Similarly, internal communications regarding recall and post-recall decisions and responsibilities may become discoverable and manufacturers may want to include litigation counsel on internal communications regarding post-recall duties and responsibilities, where appropriate.

Conclusion

Post-recall litigation may not be avoidable. Manufacturers, however, that take advantage of the information collected and systems in place regarding their post-recall duties and keep defense themes in the back of their minds, while carrying out their post-recall duties will be better prepared if litigation should arise. Given the potential for litigation following a recall, manufacturers should consider involving litigation counsel, as well as regulatory counsel in their post-recall responsibilities and decisions regarding their post-recall responsibilities. Likewise product liability counsel should be aware of a manufacturer's post-recall responsibilities and familiar with the specific post-recall steps carried out by the manufacturer in order to help the manufacturer prepare most effectively for post-recall litigation.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder in Greenberg Traurig, LLP's Atlanta office and is the Chair of Greenberg Traurig's Pharmaceutical and Medical Device Litigation Group. She has a national litigation practice focusing on product liability litigation and has served as both National Counsel and Regional Counsel for pharmaceutical and medical device companies and has expertise in mass tort, multidistrict and class action litigation. Christiana C. Jacxsens is an associate in the same group at the firm. Ms. Jacxsens, who has a Masters in Public Health and clinical research experience, concentrates her practice on complex medical and product liability litigation, with a focus on pharmaceutical and medical device litigation.

In the present environment, it is not surprising that a pharmaceutical or medical device recall may lead to litigation. Recalls often generate a large amount of media attention. In addition, attorneys representing plaintiffs frequently monitor the Food and Drug Administration (FDA) Web site for new recall information to solicit clients. After a pharmaceutical or medical device manufacturer initiates a recall, its duties pursuant to FDA laws and guidelines do not end there. The FDA has set out certain responsibilities and steps that a manufacturer must or should follow after initiating a recall. Pharmaceutical and medical device manufacturers, however, can effectively combine their post-recall duties and responsibilities with a proactive preparation of a defense of potential litigation.

Recalls Generally

The FDA assigns a classification to recalls of pharmaceutical and medical devices based on the relative degree of health hazard of the product being recalled: Class I, Class II, and Class III recalls, with a Class I recall having the highest degree of health hazard. See 21 C.F.R. ' 7.41(b). A Class I recall is defined as “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” 21 C.F.R. ' 7.3(m)(1). A Class II recall is defined as “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” 21 C.F.R. ' 7.3(m)(1). Finally, a Class III recall is defined as “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” 21 C.F.R. ' 7.3(m)(1).

Most pharmaceutical and medical device recalls are voluntarily initiated by manufacturers either on their own or by FDA request. Indeed, the FDA is only authorized to order a recall and determine its scope and extent in certain situations involving medical devices, human tissue products, and infant formula. See 21 U.S.C. ” 350a(e)-(g) and 21 C.F.R. Part 107, Subpart E (governing mandatory recalls of infant formula); 21 U.S.C. ' 360h(e) and 21 C.F.R. Part 806 (governing mandatory recalls of medical devices); 42 U.S.C. ' 262 (governing mandatory recalls of human biological products). Generally, 21 C.F.R. Part 7, Subpart C provides guidelines to manufacturers on voluntary recalls and certain responsibilities following voluntary recalls. See 21 C.F.R. ” 7.40-7.59. In addition, the FDA, has issued a guidance on the conduct of recalls and responsibilities and recommendations following a recall. See Guidance for Industry: Product Recalls, Including Removals and Corrections (issued Nov. 3, 2003) found at www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm.

Post-Recall Responsibilities

After a pharmaceutical or medical device manufacturer has initiated a voluntary recall, the FDA sets out certain responsibilities and recommends certain steps a manufacturer should take in order to ensure an effective recall. These responsibilities and steps may include effectiveness checks, status reports to the FDA, root cause analysis, corrective action plans, and follow-up or updated recall communications, where necessary. It is important for in-house and outside product liability attorneys to be aware of these post-recall responsibilities and steps in order to coordinate litigation preparation effectively.

Effectiveness Checks

According to FDA regulations, “[t]he purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the [manufacturer's recall] strategy have received notification about the recall and have taken appropriate action.” 21 C.F.R. ' 7.42(3). A “consignee” is anyone who received, purchased, or used the product being recalled. 21 C.F.R. ' 7.3(n). Effectiveness checks may be done by letters, telephone calls, personal visits, or any combination of these methods. 21 C.F.R. ' 7.42(3). There are five different levels of effectiveness checks: Level A, in which “100 percent of the total number of consignees to be contacted”; Level B, in which “[s]ome percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater than 10 percent and less than 100 percent of the total number of consignees”; Level C, in which “10 percent of the total number of consignees to be contacted”; Level D, in which “2 percent of the total number of consignees to be contacted”; and Level E, in which there are no effectiveness checks. Id. Although it is generally the responsibility of the manufacturer to conduct the effectiveness checks, the FDA may assist where necessary. Id. Regardless
of the method by which a manufacturer conducts an effectiveness check, such a check includes a consignee list, a common identifier, a questionnaire, and a procedure for recording responses. Methods for Conducting Recall Effectiveness Checks, Regulatory Procedures Manual, Chap. 7 Attachment A at 7-49, FDA (March 2009). The goal of the questionnaire, whether written or oral, is to determine “whether the recall notification was received; the product involved was handled as instructed in the recall notification; the product was further distributed by the consignees before receipt of the recall notification; and, if so, were the additional consignees notified.” Id. at 7-50. If the effectiveness check is done through a letter and an enclosed questionnaire, then the letter should also state: 1) “the reason for the recall”; 2) “a complete description of the product being recalled or corrected”; 3) “instructions regarding the disposition of the recalled product”; and 4) “a request for cooperation in completing and returning the questionnaire.” Id.

Recall Status Reports

Manufacturers must submit periodic recall status reports to the appropriate FDA district office. 21 C.F.R. ' 7.53(a). FDA regulations do not state specifically how often manufacturers should submit reports. Id. Instead, the frequency of reports is determined by the FDA on a case-by-case basis depending on the urgency of the recall. Id. The FDA, however, recommends reporting between every two and four weeks. Id. Generally, recall status reports should include:

• Number of consignees notified of the recall, and date and method of notification;
• Number of consignees responding to the recall communication and quantity of products on hand at the time it was received;
• Number of consignees that did not respond (if needed, the identity of nonresponding consignees may be requested by the FDA);
• Number of products returned or corrected by each consignee contacted and the quantity of products accounted for;
• Number and results of effectiveness checks that were made; and
• Estimated time frames for completion of the recall.

21 C.F.R. ' 7.53(b).

Root Cause Analysis and Corrective Action Plans

In addition to the responsibilities set out in 21 C.F.R. Part 7, Subpart C, in its Guidance for Industry: Product Recalls, Including Removals and Correction, the FDA also recommends that manufacturers take certain preventative steps. Guidance for Industry: Product Recalls, Including Removals and Corrections (issued Nov. 3, 2003) found at www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm. For example, in its Guidance, the FDA suggests that manufacturers provide the appropriate FDA district office with the root cause of the problem for which the recall was initiated, once the root cause has been established. Id. at 9. The FDA views this step as important so that appropriate preventative measures can be taken. Id. Similarly, the FDA advises manufacturers to provide the local district office with the corrective actions planned or already initiated as preventative measures. Id. at 9-10.

Follow-Up or Updated Recall Communications

After sending out their initial recall communications to its customers and users, including physicians, hospitals, patients, and/or distributors, manufacturers may need to send out follow-up or updated recall communications. Follow-up or updated recall communications may become necessary based on the results of effectiveness checks, FDA audits or requests, or additional information learned about the recalled product or potential health risks of the recalled product. Similarly, a manufacturer may need to issue an updated or additional press release, if an initial press release had been issued about the recall.

The FDA does not provide guidelines regarding additional or updated recall communications. The FDA's guidelines for initial recall communications, however, may provide some general guidance to manufacturers for updated communications. Generally, the initial recall communication should include: 1) product identification; 2) description of the problem, including any potential health hazard(s) associated with it; 3) depth of the recall; 4) instructions to customers regarding what should be done with respect to the recalled products; and 5) a means for the recipient of the communication to report to the manufacturer whether it has any of the recalled products. 21 C.F.R. ' 7.49 (c); Guidance for Industry: Product Recalls, Including Removals and Corrections. In addition, the FDA advises that the recall communication should be “brief and to the point” and “should not contain irrelevant qualifications, promotional materials, or any other statement that may detract from the message.” 21 C.F.R. ' 7.49(c).

In July 2007, the FDA issued a Guidance entitled, “Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs),” available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070932.htm. While this Guidance is specific to recalls of ICDs, it may also provide some considerations for manufacturers as to recall communications to physicians regarding other recalled products. For example, the FDA conducted research studies regarding sources health care professionals use for conveying risk information about medical devices. Id. at 3. Based on this research, the FDA found that the following suggestions were identified as “best practices” for communicating with health care professionals about medical device failures: 1) “present safety information in a consistent order”; 2) “format letters about safety concerns for easy readability”; 3) “notify health care professionals about safety issues through multiple channels”; 4) “make information about device failures available to health care professionals before patients hear about it in the media”; 5) “focus communications on the problem with the device and recommended actions for physicians”; and 6) “avoid promotional statements about the company.” Id. at 3-4. In addition, the FDA suggests that physician communications should be less than two pages when possible and contain short paragraphs. Id. at 4. Physician communications should also be formatted using large font size, bold type, subheadings, bullets, and tables, where appropriate. Id.

Proactive Defense of Post-Recall Litigation

Manufacturers can proactively begin preparation of a defense for post-recall litigation while carrying out their post-recall responsibilities. First, manufacturers can use their post-recall responsibilities as a means of collecting information about any potential post-recall litigation. For example, manufacturers can use effectiveness checks and recall status reports to determine the scope, extent, and likely location(s) of potential litigation. Further, effectiveness checks and recall communications can also be used to collect information on potential plaintiffs. In addition, effectiveness checks and recall communications can be used to identify key distributors, retailers, or health care providers that may become involved in any post-recall litigation.

Second, manufacturers should remember that employees and staff involved with post-recall duties and responsibilities may be potential witnesses in any recall litigation. Manufacturers should identify all key personnel with knowledge and involvement in post-recall duties. Manufacturers may want to consider conducting interviews to determine the scope and extent of involvement in the recall and post-recall duties. These interviews may also be used to aid manufacturers in identifying personnel with relevant documentation, whether in hardcopy or electronic format, regarding the recall and post-recall duties. In addition, depending on the role of the employee, manufacturers may want to involve the human resources or personnel department to determine any potential issues with these employees or to help keep track of employees if they change roles in the company or leave the company.

Third, manufacturers can take advantage of the systems and processes put into place for their recall duties to begin to collect, store, and organize documents that may become important to post-recall litigation. For example, manufacturers may want to consider electronic storage issues regarding patient information collected through recall communications and effectiveness checks. In addition, manufacturers should be sure to keep all recall status reports well-organized and should make sure that they have all communications with the FDA regarding the recall and the recalled product and that these documents are organized (probably chronologically), and probably scanned to allow for easy electronic access. Depending on the nature of the recall and the likelihood of potential post-recall litigation, manufacturers may want to consider sending out a litigation hold notice regarding relevant documents, including electronic information, to key personnel involved in the recall.

In addition, while carrying out their post-recall duties, manufacturers and their counsel should be analyzing and developing defense themes for any post-recall litigation. For example, in recall communications with physicians and health care providers, if possible and applicable, manufacturers may want to emphasize the independent role of the physician in making individual decisions for his or her patient, which could help support a learned intermediary defense. Similarly, if manufacturers send recall communications directly to patients, they could, if appropriate, include language regarding the weighing of the patient's own risks and benefits and discussions with his or her physician to correlate with defense themes based on informed consent and acknowledgement of all the risks.

Also, it is important to remember that all effectiveness checks, recall status reports, and follow-up recall communications may be discoverable and potentially used as exhibits at trial or during litigation. Manufacturers should thus consider involving in-house or outside product liability counsel in reviewing drafts of all such documents. Similarly, internal communications regarding recall and post-recall decisions and responsibilities may become discoverable and manufacturers may want to include litigation counsel on internal communications regarding post-recall duties and responsibilities, where appropriate.

Conclusion

Post-recall litigation may not be avoidable. Manufacturers, however, that take advantage of the information collected and systems in place regarding their post-recall duties and keep defense themes in the back of their minds, while carrying out their post-recall duties will be better prepared if litigation should arise. Given the potential for litigation following a recall, manufacturers should consider involving litigation counsel, as well as regulatory counsel in their post-recall responsibilities and decisions regarding their post-recall responsibilities. Likewise product liability counsel should be aware of a manufacturer's post-recall responsibilities and familiar with the specific post-recall steps carried out by the manufacturer in order to help the manufacturer prepare most effectively for post-recall litigation.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder in Greenberg Traurig, LLP's Atlanta office and is the Chair of Greenberg Traurig's Pharmaceutical and Medical Device Litigation Group. She has a national litigation practice focusing on product liability litigation and has served as both National Counsel and Regional Counsel for pharmaceutical and medical device companies and has expertise in mass tort, multidistrict and class action litigation. Christiana C. Jacxsens is an associate in the same group at the firm. Ms. Jacxsens, who has a Masters in Public Health and clinical research experience, concentrates her practice on complex medical and product liability litigation, with a focus on pharmaceutical and medical device litigation.