Defending the Medical Device Claim:

Transcription

1 Defending the Medical Device Claim: Strategically Approaching Your Defense Marc A. Polk Stryker Corporation 6 Pearl Court Allendale, NJ (201) marc.polk@stryker.com Amy Fiterman Faegre Baker Daniels LLP 2200 Wells Fargo Center 90 S. Seventh Street Minneapolis, MM55402 (612) Amy.fiterman@faegrebd.com

2 Marc A. Polk is senior legal counsel at Stryker Corporation, a global manufacturer of medical devices, including orthopaedic products, instruments, supplies, and services, where he heads an in-house litigation team in developing and implementing effective global litigation strategies. Before Stryker, Mr. Polk was chief litigation counsel at Covidien, a global medical products company in Massachusetts, and subsequently he was in-house at Medtronic. Before his in-house positions, he practiced in Philadelphia and Boston, where he was a partner at Nutter McClennen & Fish, LLP. Amy Fiterman is a partner in Faegre Baker Daniels LLP s product liability and environmental group. Ms. Fiterman concentrates her practice in the defense of class actions, mass torts, product liability, and consumer fraud cases focused primarily on the pharmaceutical and medical device industries. Ms. Fiterman has also played a prominent role as a member of the defense teams in nationwide class actions and multi-district litigation involving various types of products. Most recently, she has managed mass tort medical device litigation as in-house counsel on secondment to Boston Scientific Corporation.

3 Defending the Medical Device Claim: Strategically Approaching Your Defense Table of Contents I. Introduction...5 II. The Role of FDA Evidence in a Medical Device Case...5 A. What Is FDA Evidence in a Class II Medical Device Case? Premarket FDA Evidence Postmarket FDA Evidence Quality Systems Evidence...7 B. Impact of FDA Evidence on Litigation A Double-Edged Sword...7 C. Key Variables Impacting Strategic Uses of FDA Evidence...8 D. When No FDA Evidence Is Admissible...8 E. When All FDA Evidence Is Admissible...10 F. When Limited FDA Evidence Is Admissible Limitations Based on Time FDA Evidence Limited to a Jury Instruction...12 III. Manufacturing Defect...13 A. Plaintiff Claims Defending the Claim When the Device at Issue Is Available for Testing Defending the Claim When the Device at Issue Is Unavailable, Discarded, or Damaged...13 B. Defense Strategies Use Experts to Cover the Entirety of the Manufacturing Process Prepare for Manufacturing Claims to Survive Even When It Appears Proximate Cause Is Lacking...15 IV. Failure to Report Adverse Events...16 A. Making Plaintiffs Failure to Report Case...16 B. Strategies for Defending Against Failure to Report Claims Motion to Dismiss Limit the Scope of Permissible Discovery Daubert Motions Trial...23 V. Conclusion...23 Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 3

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5 Defending the Medical Device Claim: Strategically Approaching Your Defense I. Introduction Medical device manufacturers continue to design and manufacture innovative products improving lives throughout the world. As the manufacture and sale of these products grow, so do product liability claims. To support those claims, plaintiff lawyers often focus on evidence that bears no relationship to the alleged product defect but is instead offered to propagate negative corporate stereotypes to the jury. This article assesses the role of such evidence in product liability claims, and identifies strategies for medical device manufacturers to succeed against these claims. II. The Role of FDA Evidence in a Medical Device Case A. What Is FDA Evidence in a Class II Medical Device Case? The U.S. Food and Drug Administration ( FDA ) has exclusive regulatory authority over medical devices sold in the United States. In performing this function, the agency has classified approximately 1,700 different generic types of medical devices into three different classifications. See 21 U.S.C. 360c (establishing three classifications of devices Class I, Class II, and Class III). The classification assigned to each device determines the degree of regulatory oversight needed to provide a reasonable assurance of the safety and effectiveness of the device. Medical devices are classified based on intended use and the potential risk the device poses to the patient. Low risk devices (e.g., surgical gloves, dental floss, surgical instruments) are classified as Class I devices and are subject to the least regulatory controls. Moderate risk devices are Class II devices (e.g., surgical mesh, some hip and knee implants) and require greater regulatory controls compared to Class I devices, which may include performance standards, postmarket surveillance, patient registries, and the development and dissemination of guidelines. Finally, high risk devices (e.g., pacemakers, defibrillators, heart valves) are subject to the most stringent level of regulatory control and are therefore classified as Class III devices. The classification associated with a medical device determines, among other things, how a medical device is developed, reviewed, authorized for commercialization, and monitored in the postmarket setting. Class III devices are subject to the rigorous premarket approval ( PMA ) process and are therefore entitled to federal preemption. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). As such, FDA evidence is unlikely to become an issue in the case unless the plaintiff is able to assert a viable parallel claim. Id. at 330 ( State requirements are preempted under the MDA only to the extent that they are different from, or in addition to the requirements imposed by federal law. ). For this reason, the focus of this discussion will be on Class II medical devices subject to the 510(k) premarket notification process. In a product liability action involving a Class II medical device, FDA evidence can take many forms premarket evidence, postmarket evidence, and quality systems evidence and depending on the regulatory history of the device at issue, it can play an influential role in the outcome of the case. Medical device manufacturers and their counsel should prepare a strategic trial defense with an understanding of what they want and need regarding FDA evidence, how their opponent will seek to use/not use FDA evidence, and how the court will handle admissibility. Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 5

6 1. Premarket FDA Evidence To legally market a Class II medical device in the United States, medical device manufacturers are required to submit a 510(k) premarket notification application to FDA. These submissions must demonstrate that the proposed device is substantially equivalent to a predicate device a device that is already legally marketed in the United States. See 21 U.S.C. 360(k), 360(n), 360c(f)(1), 360c(i); 21 C.F.R , (a) (3). Substantial equivalence does not mean the proposed and predicate devices must be identical; rather it means that the proposed device is at least as safe and effective as the predicate device. According to FDA [t] he 510(k) review standard is comparative, whereas the PMA standard relies on an independent demonstration of safety and effectiveness. Nonetheless, the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review. See FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], at 6 (July 28, 2014). Basic content requirements apply to all 510(k) submissions, but the data and information necessary to establish substantial equivalence will vary by device type and the differences between the proposed and predicate devices. FDA has issued device-specific guidance documents that specify the data that should be included in 510(k) applications for particular device types. The content of these applications and the FDA s determination with regard to them is potentially evidence at trial. Depending on the device-specific requirements, this may include design specifications, proposed labeling, and bench testing data. In addition to the 510(k) submission and resulting FDA clearance letter, other premarket FDA evidence will likely include FDA rules, regulations, standards, and guidance documents applicable at the time the device was developed. It may also include correspondence between the manufacturer and the FDA. Manufacturers and their counsel should consider using this evidence to show compliance with applicable regulatory and industry standards to demonstrate due care and objective reasonableness. Plaintiffs will focus their evidence on perceived shortcomings with the 510(k) process (as compared to the PMA process) and lack of premarket clinical testing required to support 510(k) clearance. They will also seek opportunities to highlight errors, omissions, and perceived false statements made to the FDA in the 510(k) application and related correspondence. 2. Postmarket FDA Evidence Once a device has been cleared by FDA, various forms of postmarket evidence typically are created. These include postmarket surveillance, medical device reports, safety alerts, Section 522 orders, advisory panels, product recalls, market withdrawals, and product reclassifications. Plaintiffs are likely to gravitate to this evidence to show: (1) that the 510(k) clearance process does not guarantee device safety and effectiveness; and (2) the existence of device-specific issues. Adverse event reporting is another type of postmarket evidence. This type of evidence will be discussed in greater detail below, but can be used by either side. Plaintiffs may argue that the defendant failed to report adverse events to the FDA, thus putting into question the safety and effectiveness of a device. They may also note inconsistencies in or underreporting of adverse events to portray the defendant as a bad actor. Defendants may use evidence of adverse event reporting to show the device in question is safe and effective, or to show compliance with FDA regulations. FDA may also mandate an advisory committee to discuss a certain medical device. FDA has 33 advisory committees, one of which is the Medical Devices Advisory Committee. The committees are established to support FDA s mission of protecting and promoting the public health, while meeting the requirements set forth in the Federal Advisory Committee Act. Committees are either mandated by statute or established at the discretion of the Department of Health and Human Services. 6 Drug and Medical Device May 2017

7 The Medical Devices Advisory Committee consists of 18 panels. With the exception of the Medical Devices Dispute Resolution Panel, the panels advise the Commissioner about issues related to the safety and effectiveness of medical devices. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers. Section 522 of the Food, Drug and Cosmetic Act ( FDCA ) also gives FDA authority to require manufacturers to conduct postmarket testing ( 522 studies ) on already-cleared devices under the following circumstances: (1) failure of the device would be reasonably likely to have a serious adverse health consequence; (2) the device is expected to have significant use in pediatric populations; (3) the device intended to be implanted in the human body for more than one year; and (4) the device intended to be a life sustaining or life-supporting device used outside of a user facility. See FDCA Section 522(a)(1)(A). Finally, the regulatory classification of a medical device type may be changed through the process of reclassification. The primary purpose of reclassification is to apply the appropriate level of regulatory controls for a device type based on the most current information regarding its safety and effectiveness. Reclassification is applied to a particular device type and not an individual device. See Sections 513(e)(f). 3. Quality Systems Evidence Manufacturers are required to implement and maintain quality systems to monitor the postmarket performance of their medical devices. FDA has authority to audit and inspect medical device manufacturers. The inspectional process is known as the Quality System Inspection Technique or SQIT, which is intended to ensure the manufacturer s quality systems are well controlled. Following an inspection, FDA may issue Form 483 findings observed conditions that may constitute violations of the FDCA (i.e., adulterated devices). These Form 483 findings are presented and discussed with the manufacturer, who is encouraged to respond in writing with a proposed corrective action plan. Importantly, FDA Form 483 findings do not constitute final determinations of violations of the FDCA or any of the applicable regulations. Rather, they are considered along with all other relevant information in determining whether further action is needed to protect the public health. When FDA finds that a manufacturer significantly violated FDA regulations, it notifies the manufacturer by issuing a warning letter that identifies the violation, demands that the manufacturer resolve the problem within a specified timeframe, and requires the manufacturer to inform the FDA of its plan to make the correction. B. Impact of FDA Evidence on Litigation A Double-Edged Sword From the jury s perspective, FDA is a neutral third party in litigation. It is a government agency whose primary mission is to promote the public health. FDA fulfills that obligation by: (1) making safe and effective medical devices available to patients in need of therapy following a premarket substantial equivalence review of device-specific information submitted by the manufacturer; (2) conducting ongoing postmarket surveillance to monitor potential safety issues; and (3) enforcing its regulatory authority to mandate postmarket action by the manufacturer, as needed. Thus, depending on the regulatory history of the device at issue, the role FDA evidence may play can be a double-edged sword for both parties. As much as evidence of FDA clearance can bolster the manufacturer and lend credibility to the safety and efficacy of the device at issue, evidence of FDA safety alerts and enforcement actions (i.e., product recalls, Section 522 orders, Form 483 findings, warning letters) just as easily destroy a manufacturer s standing in the eyes of the jury. Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 7

8 C. Key Variables Impacting Strategic Uses of FDA Evidence As discussed more fully below, courts vary in how they handle the admissibility of FDA evidence at trial in a medical device product liability case. Some prohibit such evidence entirely, some permit its admissibility, and others apply time and scope limitations as to how much FDA evidence the jury is permitted to hear. While the admissibility determination is usually based on state law and controlling precedent, litigants may have room to position the case favorably with respect to the use of FDA evidence. In these circumstances, manufacturers should consider the regulatory history of the device and whether the admissibility of FDA evidence would be helpful to the defense. If either party is motivated to present FDA evidence to the jury, the applicable state law (and how it is characterized) may control the result. In some states, a manufacturer s compliance with any government regulation is admissible as evidence of due care and reasonable conduct. See, e.g., Del. P.J.I. Civ (2003) ( Compliance with governmental or industry standards is some evidence of due care ); N.C. Gen. Stat. Ann. 99B-6 ( In determining whether the manufacturer acted unreasonably... the factors to be considered shall include... the extent to which the design or formulation conformed to any applicable government standard that was in effect when the product left the control of its manufacturer. ). In other states, a defendant s compliance with any government safety regulation is admissible as evidence of due care and reasonable conduct. See, e.g., Doyle v. Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518, 521 (Ga. 1997) ( Under the risk-utility test, compliance with federal standards or regulations is a factor for the jury to consider in deciding the question of reasonableness, that is, whether the product design selected was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. ). The parties are likely to disagree as to whether the 510(k) process constitutes a safety regulation (and courts largely find it is not), but as discussed more fully below, there are arguments to be made that the 510(k) process should be admissible as evidence of device safety, even if it does not amount to a finding of fact worthy of preemption. In cases where the admissibility of FDA evidence is not altogether precluded, medical device manufacturers should also consider the extent to which the judge and opposing counsel are familiar with the FDA s regulatory framework and the potential regulatory issues in the case. While plaintiffs lead counsel in an MDL or state court consolidated action may be well-informed, that may not be true in a one-off case. Manufacturers also should consider a meet-and-confer with opposing counsel to explore whether limited admissibility of FDA evidence makes sense for both parties and efficiently trying the case. D. When No FDA Evidence Is Admissible Courts precluding the admissibility of FDA evidence in cases involving medical devices cleared through the 510(k) process have done so based on the notion that the 510(k) process does not go to safety and effectiveness and does not provide any requirements on its own. Basically, it has no... operative interaction with state tort laws. In re C.R. Bard, Inc., Pelvic Repair Sys. Prod. Liab. Litig., No. 2:11-CV-00195, 2013 WL , at *7 (S.D.W. Va. July 23, 2013); see also Sanchez v. Boston Scientific Corp., 38 F. Supp. 3d 727, 744 (S.D. W.Va. 2014) (quoting Lewis v. Johnson & Johnson, 991 F. Supp. 2d 748, 754 (S.D. W.Va. 2014) ( That a device has been given clearance through the FDA s [ ] 510(k) process is not relevant to state tort law... The prejudicial value of evidence regarding the [ ] 510(k) far outweighs its probative value. )). In the pelvic mesh litigation, Judge Goodwin explained: Whether the FDA 510(k) process required testing before [or after] marketing has nothing to do with whether [defendant] satisfied any other obligation under common law to conduct testing and then to do whatever it might have been required to do under law with the results of that testing. 8 Drug and Medical Device May 2017

9 ... This ruling is consistent with and supported by the Supreme Court s holdings in Medtronic, Inc. v. Lohr... and Riegel v. Medtronic, Inc.... In both cases, the Supreme Court held that the FDA 510(k) process does not address safety and effectiveness and therefore did not preempt the plaintiffs product liability claims, while the premarket approval process does address safety and effectiveness and therefore would preempt the plaintiffs product liability claims, subject to other preemption requirements. In re C.R. Bard, Inc., 2013 WL , at *7. Under this rationale, any state law predicating the admissibility of FDA evidence on whether it constitutes a government safety regulation will surely result in exclusion of such evidence. Whether or not evidence of compliance with 510(k) should have been admissible was appealed to the Fourth Circuit in a pelvic mesh case. The Court of Appeals stated that [w]hile some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value. In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prod. Liab. Litig., 810 F.3d 913, 920 (4th Cir. 2016). It then held that the district court did not abuse its discretion when it determined that allowing the 510(k) evidence in on the question of design defect would be substantially more prejudicial than probative. Id. at 922. When FDA evidence is inadmissible at trial, manufacturers should seek out other avenues to demonstrate compliance with objective standards in order to show reasonableness and due care in the design, development, testing, labeling, and marketing the device at issue. Most medical devices are developed pursuant to internationally-recognized industry standards, such as ASTM (American Society for Testing and Materials), ISO (International Organization for Standardization) and GHTF (Global Harmonization Task Force). These organizations can also be seen as neutral third-parties in the eyes of jurors against which the manufacturers conduct can be measured. A manufacturer should also consider offering evidence of its compliance with its own internal standard operating procedures (SOPs). Importantly, manufacturers should position their expert as an industry standards expert, as opposed to an FDA expert, to avoid exclusion of the expert s opinions on a Daubert challenge. Manufacturers should also go on the offensive and force plaintiffs (and their experts) to identify non- FDA objective standards in existence at the time that the device was developed to substantiate their litigation themes. For instance, plaintiffs may contend that the manufacturer is negligent because it did not conduct premarket clinical testing; or they may argue that the label is inadequate. To validate these positions, plaintiffs experts should be compelled to point to some non-fda objective standard to substantiate the claim. As in any medical device case, the testimony of the implanting/prescribing physician is critical. In many cases (but not all), the treating physician is also seen as a neutral third party acting in the best interests of the patient. Developing the physician s experience with the device, bolstering his/her pre-implant awareness of potential risks, and exploring all of the sources of information available to the physician before the date of implant can obviously help to build a strong defense. Manufacturers interested in presenting FDA evidence in cases where such evidence is not admissible should seek out (and remain vigilant for) opportunities to invite plaintiffs to open the door to FDA evidence. These circumstances are most likely to arise when plaintiffs contend the manufacturer acted in a manner inconsistent with reality and its interactions with FDA. Counsel should make the objection, approach the court, and either seek to offer relevant FDA evidence or the issuance of a limiting instruction to correct the issue. Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 9

10 E. When All FDA Evidence Is Admissible The opportunity to present FDA evidence at trial is most likely when the state law allows the manufacturer to introduce evidence of its compliance with government regulations. See, e.g., Del. P.J.I. Civ (2003); N.C. Gen. Stat. Ann. 99B-6. In these circumstances, however, plaintiffs may be motivated to admit FDA evidence when the device at issue has a challenging or negative regulatory history. Conversely, manufacturers should argue for the inclusion of FDA evidence when the regulatory history of the device is favorable, or if evidence of compliance with certain standards is evidence of reasonableness. When FDA evidence is admissible, manufacturers should expect plaintiffs to minimize the meaning and significance of the 510(k) clearance process as it relates to device safety and effectiveness. Plaintiffs are likely to characterize FDA as an understaffed and overburdened agency that is entirely dependent on device manufacturers to provide all product-related information for an abbreviated review. Manufacturers should therefore seek to bolster FDA s 510(k) process by showing the jury that patient safety considerations are incorporated into the framework and device evaluation process. For example, many medical devices are required to undergo specific types of testing pursuant to internationally-recognized standards, such as bench testing, chemical testing, biocompatibility testing, shelf-life testing, etc., all of which relate to patient safety. In January 2017, FDA issued a memorandum entitled Public Health Interests and First Amendment Considerations related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products. In that document, FDA reiterated its position that the 510(k) clearance process incorporates elements of device safety and effectiveness: FDA defines Premarket Review as FDA s review of scientific evidence regarding a medical product to evaluate whether it satisfies requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act... For devices, the term encompasses FDA s classification of a device type (including de novo classification) as well as review of premarket approval applications (PMA) and premarket notifications (510(k)). (Glossary at pg. 2). While there are distinctions in the review frameworks for different types of medical products, as a general matter, FDA considers the benefit-risk profile for each intended use during the premarket review process. In that process, FDA considers whether the established health benefits of the product for a particular use outweigh the identified risks of the product.... Despite the distinction in the legal frameworks and associated differences in premarket review pathways and processes, underlying them all are the goals of spurring innovation based on reliable scientific evidence of effectiveness and of ensuring the safety and effectiveness of medical products for each intended use. (pp. 2-3). FDA premarket review also assures that safety and efficacy are evaluated on a patient population level under rigorous scientific standards by independent, scientifically expert reviewers. (p. 7). In its premarket reviews, FDA evaluates, among other things, safety and efficacy data gathered and/or generated by the firm to verify whether there are adequate tests to show safety and substantial evidence of efficacy (for drugs) or a reasonable assurance of safety and effectiveness (for devices). FDA evaluates this information and makes an approval/clearance decision based on a determination of the safe and effective use of the product in the general population(s) included in the studies submitted in the application. (p. 17). The type of premarket review pathway is determined by the degree of review and regulation that FDA deems necessary to provide a reasonable assurance of safety and effectiveness for a given device type. Although the premarket submission review pathways (e.g., approval applica- 10 Drug and Medical Device May 2017

11 tion (PMA), de novo, and 510(k)) differ in various ways, they all fit within the same regulatory framework that enables FDA to ensure that devices on the market are ones that have been determined by FDA to have a reasonable assurance of safety and effectiveness for each and every use for which they are intended. (Appendix A, p. 40). The 510(k) standard (substantial equivalence of a new device to a predicate device) differs from the PMA and de novo review standards. The 510(K) standard is comparative, whereas the PM and de novo review standards rely on an independent demonstration of safety and effectiveness. Nonetheless, the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review. (Appendix A, pp ). During the 510(k) review, FDA considers the device s safety and effectiveness in its substantial equivalence determination [ ] and also in its evaluation of compliance with any applicable special controls, which FDA has determined to provide a reasonable assurance of safety and effectiveness for the device type. (Appendix A, p. 44). These statements, and statements like them previously made by FDA, may be useful in opposing motions in limine or for cross-examining plaintiffs experts who may express opinions to the contrary. That being said, in an FDA evidence case, manufacturers and their counsel should resist the temptation to prove the device at issue is safe and effective if state law (and the claims at issue) only require a showing of reasonableness. Making a case that the device at issue with all of its known and accepted risks was a reasonable treatment option is much easier to do than to show that the device is in fact safe and effective. The use of FDA evidence at trial also creates the very real potential for a protracted mini-trial on FDA regulations, the manufacturers compliance with such regulations, and whether the manufacturer withheld or misled the FDA. Dueling experts discussing complex FDA rules and regulations will likely delay the trial and result in jury confusion and boredom. Simple and to-the-point facts showing reasonable conduct and compliance with applicable standards is ideal. Defendants should also be cognizant of plaintiff attempts to present improper fraud-on-the FDA evidence which should be impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) and the jury s willingness to find manufacturers liable for actual or perceived noncompliance with FDA standards regardless of whether it has a causal connection to the plaintiff s alleged injuries. In this regard, counsel should ready its objections and force plaintiffs to link their FDA themes to the facts of the case. F. When Limited FDA Evidence Is Admissible 1. Limitations Based on Time There may be instances where limited FDA evidence is the most favorable position for manufacturers whereby evidence of device clearance can be presented to the jury, but without any subsequent FDA action. In this regard, defendants might use state law to argue that evidence should be limited based on the date the device at issue was sold or implanted. As a result, all post-sale or post-implant evidence would be excluded as irrelevant. See, e.g., Shepard v. Reinoehl, 830 A.2d 1235, 1241 (Del. Super. Ct. 2002) ( the imposition of a duty must not be based upon a retrospective view of the facts, but upon the view of the [defendant] before the accident occurred ). Importantly, this evidentiary restriction would likely apply to all post-sale or post-implant evidence, not just FDA evidence. Thus, manufacturers may also self-limit their ability to present evidence of favorable clinical data generated after the date cut-off. Careful consideration of all the evidence should be made before seeking this potential option. Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 11

12 2. FDA Evidence Limited to a Jury Instruction Recognizing the benefits and disadvantages FDA evidence has on how a medical device case is presented to the jury, some courts have limited jury exposure on the topic to a stipulated (or somewhat agreed upon) jury instruction. See Winebarger v. Boston Sci. Corp., No. 3:15CV211-RLV, 2015 WL , at *7 (W.D.N.C. Sept. 22, 2015) ( [T]he Court s preliminary ruling on Plaintiff s motion is that the 510(k) clearance process is admissible subject to a limiting instruction consistent with the terms of the instant Order. ). For example, in the pelvic mesh litigation, the Massachusetts state court read the following jury instruction: The [device] is a medical device. Sales of medical devices like the [device] are subject to the Federal Food, Drug and Cosmetic Act which is administered by the Federal Food and Drug Administration (the FDA ). The sale of such devices in the United States must be authorized by the FDA. Under the Act, there are two processes by which a manufacturer may obtain authorization from the FDA to sell a medical device in the United States on the order of a physician. One process is referred to as the 510(k) process because it is authorized by section 510(k) of the Act. Pursuant to the 510(k) process, the FDA clears a medical device for sale in the United States if it is shown to be substantially equivalent to another legally marketed medical device, that is, to another medical device that has previously been cleared by the FDA for sale in the United States, referred to as the predicate device. A device is substantially equivalent to a predicate device if it has the same intended use as the predicate device and (i) has the same technological characteristics as the predicate device, or (ii) has different technological characteristics and the information submitted demonstrates that the device is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness than the predicate device. If the FDA finds that the device is substantially equivalent to the predicate device, it clears the device for sale in the United States. The second process by which the FDA may authorize a manufacturer to sell a medical device in the United States is called the Premarket Approval process. This process requires the manufacturer to provide the FDA full reports of all information concerning investigations which have been made to show whether or not such device is safe and effective. If the FDA determines that there is a showing of reasonable assurance that the device is safe and effective for its intended use under the conditions specified in the labeling of the device, it approves the device for sale in the United States. The FDA cleared the [device] for sale in the United States pursuant to the 510(k) process. As I stated, a medical device that has been cleared for sale by the FDA may lawfully be sold in the United States on the order of a physician. Because the [device] had been cleared by the FDA, [defendant] was legally authorized to sell it in the United States. That is the only purpose for which you may consider the fact that the [device] was cleared by the FDA for sale in the United States. You may not consider it for any other purpose. You may not consider the fact that the [device] was cleared by the FDA for sale in the United States as evidence that the [device] was a safe or effective medical device. Absent device-specific considerations, limiting the use of FDA evidence to a jury instruction is likely the ideal landing spot for manufacturers. The jury is able to consider the fact that the FDA cleared the device at issue and that it was legally sold in the United States, while avoiding a long mini-trial on FDA issues that have tangential relevance to the facts of the case and potentially inject impermissible evidence of fraud-onthe-fda. 12 Drug and Medical Device May 2017

13 III. Manufacturing Defect A. Plaintiff Claims A cornerstone to most medical device product liability complaints is the manufacturing defect claim. To prevail on these claims, plaintiffs must generally show that the product at issue deviates, in its construction or quality, from the specifications or planned output in a manner that renders it unreasonably dangerous. See, e.g., In re Mentor Corp. Obtape Transobturator Sling Prod. Liab. Litig., No. 4:08-MD-2004 (CDL), 2015 WL , at *2 (M.D. Ga. Sept. 1, 2015); Restatement (Third) of Torts, Products Liability 2(a) (1998). Put another way, the theory posits that the medical device differs from the manufacturer s intended result or from other ostensibly identical units. See, e.g., Tapia v. Davol, Inc., 116 F. Supp. 3d 1149, 1157 (S.D. Cal. 2015). Plaintiff must also point to evidence linking the purported manufacturing defect as the cause of the plaintiffs alleged injuries. See id. 1. Defending the Claim When the Device at Issue Is Available for Testing In cases where the medical device at issue is available for analysis, manufacturers should retain experts to compare the device to the baseline specifications for the device. Experts are commonly needed for this purpose given that the complexities of making this determination often fall outside the common knowledge of the layperson. See, e.g., Pozefsky v. Baxter Healthcare Corp., 194 F.R.D. 438, 440 (N.D.N.Y. 2000) (expert testimony required to identify deviation of breast implant from its standard specifications). Certainly, the current condition of the device at issue will play a role in whether this type of testing can be reliably performed. When the device at issue is in the same condition as when it left the manufacturer s control, plaintiff experts must have direct evidence to speak to any deviations. He or she may be able to show physical differences from a control lot of medical devices, whether those differences be visible, tangible, or otherwise. For instance, the medical device may bear different proportions, weight, or chemical composition when tested against acceptable or expected ranges in the manufacturer s specifications. See, e.g., In re Mentor Corp. Obtape Transobturator Sling Prod. Liab. Litig., 2015 WL , at *2. Such direct evidence will aid the plaintiff in showing a deviation and thus a defect in the product. 2. Defending the Claim When the Device at Issue Is Unavailable, Discarded, or Damaged More often, the condition of a medical device following filing of a lawsuit renders it impossible to undertake the straightforward comparison mentioned above. Medical devices routinely get damaged, discarded, or otherwise spoliated by treating physicians and other third parties. But the plaintiffs still bear the burden of proof in showing the requisite deviation at the time of manufacture. If the plaintiff can prove a manufacturing defect circumstantially, expert testimony is still critical to ruling out or marginalizing other possible causes of injury. See Restatement (Third) of Torts: Prod. Liab. 3 (1998); see also Minda v. Biomet, Inc., No. 96-CV-0233 (JG), 1998 WL , at *4 (E.D.N.Y. Feb. 5, 1998) (granting summary judgment on manufacturing defect claim where implanted device was damaged post-explant and plaintiff relied on circumstantial evidence of defect); see also Cather v. Catheter Tech. Corp., 753 F. Supp. 634, 639 (S.D. Miss. 1991) (granting summary judgment on manufacturing defect claim and holding that plaintiff did not produce that minimal amount of circumstantial evidence that would allow a jury to infer a defective quality in the product. ). If a medical device is unavailable, discarded, or otherwise damaged, plaintiffs may use a variety of strategies to prove a manufacturing defect claim. Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 13

14 a. Unrelated Manufacturing Recalls Plaintiffs will likely highlight anything negative associated with a device to impugn the manufacturing process. See, e.g., Berman v. Stryker Corp., No. 11 C 1309, 2013 WL , at *4 (N.D. Ill. Sept. 24, 2013) (noting that plaintiff attempted to tie general FDA warning letters on insufficient controls to quality control issues with the subject product at the manufacturing plant). The defense must be prepared to combat evidence of a recall, even when the plaintiff cannot definitively show that the product at issue was subject to the particular recall. See, e.g., Rosen v. St. Jude Med. Inc., 41 F. Supp. 3d 170, 183 (N.D.N.Y. 2014). In Young v. Olympus America, Inc., the plaintiffs alleged their father contracted a bacterial infection due to a defect in the defendant s bronchoscope. No STA, 2012 WL , at *1 (W.D. Tenn. Jan. 26, 2012). After the procedure in question, the defendant issued a recall of several models of bronchoscopes. Id. The recall covered certain models of bronchoscopes, including two models identified by the hospital where the procedure took place as being in use at the time of the decedent s procedure. Id. However, it was unknown which bronchoscope was used in the procedure because the hospital no longer had records of which model bronchoscope was in use at the time. Id. at 2. The court ultimately granted summary judgment because plaintiff was required to prove that the device actually used had the purported defect. See id. at *6 (granting summary judgment on implied warranty claim akin to a manufacturing defect claim). Thus, plaintiffs must still allege facts that connect an FDA recall to the device at issue. Failure to do so opens the door for dispositive motion practice. See Bertini v. Smith & Nephew, Inc., No. 13 CIV BMC, 2013 WL , at *2 (E.D.N.Y. July 15, 2013) (granting manufacturer s motion to dismiss where plaintiff merely pled that the device was defective because it loosened, which was the performance issue underpinning the recall, but without showing that the device deviated from its intended design). b. Use of Adverse Event Data to Show Similar Failure Modes Plaintiffs may offer publically-available adverse event data from the Manufacturer and User Facility Device Experience ( MAUDE ) database as evidence that the device at issue failed in a similar manner on other occasions. MAUDE reports provide the FDA adverse event data, but they may contain inaccurate and non-validated data. Notwithstanding, plaintiffs will likely attempt to use MAUDE reports as evidence of a manufacturing defect. See, e.g., Berman, 2013 WL , at *4. In Berman, despite no other evidence of quality control issues, the plaintiff s expert cited to MAUDE reports of general FDA warning letters on insufficient controls, even though the warning letters were not related to device at issue. See id. Plaintiffs will attempt to use this publicly available adverse event data to show similar failure modes as evidence of a manufacturing defect. See Young, 2012 WL , at *4 (rejecting attempt by plaintiff s expert to suggest that because two articles traced a particular infection to a loose-port condition in a medical device, the fact that plaintiff contracted the same infection meant the product at issue had the loose-port defect). The Northern District of New York appeared to consider evidence that a manufacturer underreported a particular failure mode in its Medical Device Reporting ( MDRs ) as evidence that the product at issue had the defect in question. See Rosen, 41 F. Supp. 3d at 183. Medical device manufacturers, and those defending them, should be particularly aware of what is in adverse event data (and what is not). c. The Role of the Treating Physician s Testimony To demonstrate a deviation without the device at issue in hand, plaintiffs may rely on observations from physicians that the device was simply different in the broadest sense of the word either in the way it worked or how it physically looked and/or felt. This practice shows that plaintiffs will look for virtually any 14 Drug and Medical Device May 2017

15 deviation from a standard allotment of the product, irrespective of its relation to a failure mode. See, e.g., Minda, 1998 WL , at *4 (noting that plaintiff used testimony of physician that medical device differed in the color of the metal in the area of the fatigue failure to suggest that a defect existed at the time of implantation). A manufacturing defect claim may be supported with as little as the treating physician s statement that this type of failure in a certain product had never happened to me before. The inference is that the product must have deviated from its specifications. After all, the implanting physician (especially one who has performed a significant number of the procedures in question) is arguably in as good a position as any to compare the device at issue to one meeting the standard specifications. But mere proof of damage following the use of a product is not sufficient to establish liability, and conclusory allegations of a difference without any link to an injury-causing defect may be good grounds for a motion for summary judgment. See, e.g., Cather, 753 F. Supp. at 639. B. Defense Strategies While summary judgment is always in the manufacturer s crosshairs, defense counsel should consider options to narrow the scope of discovery. Although a manufacturing defect claim may ultimately survive dispositive briefing, there are aspects of the claim that can be disposed of the outset. The court may be amenable to a discovery order limiting plaintiff to more focused issues. 1. Use Experts to Cover the Entirety of the Manufacturing Process Plaintiffs will inevitably seek discovery on a defendant s manufacturing processes and retain experts to substantiate their manufacturing defect theory. In turn, defendants should also secure both in-house and external experts that can speak to the manufacturing process from beginning to end. The in-house expert should be prepared to speak to the manufacturing standards at the outset of production and the controls in place for purposes of consistent, quality assurance. See Bertini, 2013 WL , at *1 (noting that plaintiff tied to a manufacturing defect claim evidence that the FDA found the facilities or controls used for the manufacture of the device not in conformity with Current Good Manufacturing Practice (CGMP) requirements). More challenging, the in-house expert has to be prepared to discuss the manufacturing process to a lay person (i.e., a juror). Objective industry standards are rarely this accessible to a lay person, so extra care should be given to crafting testimony related to the manufacturer s compliance with objective standards. It should color your witness preparation whether your expert can make the lay person feel at ease that ultimately, the manufacturing rules were followed. An outside expert should also physically track the manufacturing process on-site from start to finish, even if it may not appear particularly cost-effective. In this way, you can anticipate the plaintiff attacking your witness for opining on the consistency of a certain process without confirming in person that the process is in fact appropriate. 2. Prepare for Manufacturing Claims to Survive Even When It Appears Proximate Cause Is Lacking In Rosen v. St. Jude Med. Inc., plaintiff s physician implanted her with a medical device in 2004 designed to correct irregular heartbeat rhythms. 41 F. Supp. 3d at 183. The device was removed in 2012 bearing signs that it had fractured and its conductor coils had protruded through the insulation. Despite the device having functioned properly for eight years and a complaint almost entirely focused on the medical device generally (rather than the device at issue), the plaintiff s manufacturing defect claim survived the motion to dis- Defending the Medical Device Claim: Strategically Approaching... Polk and Fiterman 15

16 miss stage largely because the FDA issued a 2011 recall related to insulation and the extracting surgeon noted the device s coils had externalized (which could be associated with insulation issues). Id. at 182. This result for plaintiffs is significant considering the changes in the device since it left the manufacturer s control. In a Fifth Circuit opinion, the product at issue, designed to stop bleeding at a puncture site, was discarded after a procedure. Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919, 937 (5th Cir. 2006). The plaintiff claimed that a defect in the device led to nearly complete blockage in her femoral artery. The district court granted the defendant s motion for judgment as a matter of law on the manufacturing defect claim after the close of evidence at trial. The plaintiff, however, convinced the appellate court that because collagen was found in his artery, it must have come from the manufacturer s product and could only have been a result of a defect. Notably, the appellate court was not alarmed that the plaintiff showed no evidence that the collagen found inside the femoral artery was of the same type as that in the medical device. Per the appellate court, plaintiff s expert successfully excluded other possible causes of the blockage and reversed the district court s holding. See id. at 938. The Northern District of California correctly set aside the unfortunate circumstances surrounding the plaintiff s injuries and evaluated the manufacturing defect claim objectively, ultimately dismissing the claim in a recent case. Smith v. Pride Mobility Prod. Corp., No. 16-CV LHK, 2016 WL , at *1 (N.D. Cal. Oct. 28, 2016). There, a wheelchair-bound plaintiff suddenly found herself without power in her chair on a steep hill, at which point she careened downward crashing violently. The plaintiff claimed serious injuries to her neck along with serious psychological and emotional distress. Nonetheless, the Court dismissed the manufacturing defect claim because despite numerous conclusory allegations: [t]he complaint does not state how the wheelchair that [p]laintiff purchased is different from the design of the wheelchair that [d]efendant intended or from other identical models of the wheelchair. Id. at *9 (emphasis added). Likewise, in a case in the Southern District of New York, where the medical devices at issue were not tested, the court excluded the opinion of plaintiff s expert regarding a manufacturing defect. In re Mirena IUD Prod. Liab. Litig., 169 F. Supp. 3d 396 (S.D.N.Y. 2016). The witness opined that after he tested a sampling of the manufacturer s devices, a misalignment existed, which exceeded the manufacturer s specifications. But the court held that assuming the expert s tests were accurate, he failed to link this misalignment with the perforation of plaintiff s uterus where he had not tested the device at issue and offered no literature connecting a misalignment in the device to a risk of perforation. See id. Defense counsel should scrutinize closely whether any manufacturing defect theory can be linked to the plaintiff s specific device. IV. Failure to Report Adverse Events A. Making Plaintiffs Failure to Report Case Regardless of whether FDA evidence is admissible in the case, plaintiffs will invariably assert a failure to report claim premised on a theory that the manufacturer failed to properly report adverse event information to the FDA. Plaintiffs argue that adverse event reporting is critical to understanding the postmarket safety profile of a device to ensure it is safe and effective for its intended use. They contend adequate complaint monitoring and adverse event reporting practices is how manufacturers (and the FDA) know to initiate timely corrective actions if safety and/or effectiveness concerns arise. Plaintiffs argue that postmarket FDA regulatory actions and decisions are predicated on a partnership with industry. FDA relies on medical device manufacturers for accurate and timely data and information about their devices because manufacturers are in the best position to know the safety profile of their devices. From plaintiffs perspective, the FDA is not structured or funded to perform their own tests or investigations 16 Drug and Medical Device May 2017