In the game of “20 Questions,” one player secretly chooses an object and the other players are allowed 20 questions to identify it. In that spirit, answering the following 20 questions may identify a defense strategy that will help win a medical device case. The goal of this game is to suggest arguments. This article provides some authority that discusses each argument but does not attempt to do any more than that. The focus here is on device cases but many of these questions will also apply to pharmaceutical cases.
Litigation Hold
1. Has the client put a litigation hold in place?
As soon as the client is notified of litigation, it needs to put in place a “litigation hold” to prevent the destruction of documents and electronic information which, if lost, might give rise to a spoliation claim.[1]
Product
2. What is the “product?”
This question sounds simple, but it is not. The usual method for proving a product design defect is to offer a safer alternative design. How the product is defined will govern what safer alternative designs should be considered. Generally, an alternative is only the same “product” if it serves the same purpose and does so with similar advantages and disadvantages. The safety of a VW bus is not to be compared to the safety of a sedan even though both provide transportation because each has its own advantages and disadvantages.[2] The safety of a bullet-proof vest is not to be compared to that of a bullet-proof jacket which allows less mobility.[3] A device that requires one kind of surgery is not to be compared to a device that requires a different kind of surgery, or surgery with no device at all.[4]
A focus on this question keeps the jury from being confronted with the insurmountable task of comparing incommensurate risks, such as whether less invasive surgery is justified by a risk of bladder puncture. A refinement of this point is that, even when the devices serve the same purpose, it is not enough for the plaintiff’s expert to say that an alternative would be safer if that alternative cannot be shown to be equally effective.[5] If they are not equally effective then the balancing of advantage and disadvantage is for the physician, not the jury.
In product liability law generally, this focus also promotes consumer choice. Consumers can only exercise choice if they have different products from which to choose.
In medicine, product diversity protects doctor choice. The law already recognizes the importance of doctor choice. For example, medical malpractice law allows doctors to choose between “two (or more) schools of thought.”[6] If there are “two schools of thought” about which type of device is best for patients, product liability law should not take choice away by decreeing that only one school is right. Limiting the jury’s consideration to different designs for the same device is a way to keep that from happening.
This question should be asked no matter what the liability standard is and should not be limited to jurisdictions that require proof of a safer alternative design. The question arose originally in product liability cases where the liability standard was unreasonable dangerousness or negligence and should logically be asked in any case where a safer alternative is proposed.
Design Defect
3. What is the defect?
The “design defect” must be a characteristic of the product’s design. It is not the adverse event that the characteristic may cause. Nor is it the corporate conduct, such as a failure to test, which resulted in the challenged design. Conduct, of course, may be relevant to negligence. But negligent conduct cannot cause injury unless it causes a defective design.[7]
4. Has a safer alternative design been tested?
The expert testimony standards set out in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), generally should exclude safer alternative designs that have not been tested. If the design has not been tested, it cannot have been the subject of peer review nor can there be any likely basis for it to be generally accepted in the scientific community or in the literature.[8] Moreover, without testing there is no way for the “reasonable medical certainty” standard for medical testimony to be met.[9]
5. Has the alternative been cleared or approved by the FDA?
If an alternative design has not been cleared or approved by the FDA, it is not available for physicians to use and whether it would ever become available is a matter of speculation. But there is more. If the alternative is not available for physicians to use, then a court decision that condemns as defective and so discourages the manufacturer from selling the device, which the physician prefers, would require the physician to substitute an existing but admittedly inferior alternative that no one contends would make the patient better off.[10]
6. Does the plaintiff’s expert rely on company documents that would not independently meet Daubert standards?
A plaintiff’s expert cannot satisfy the requirements of Daubert by relying on company documents or statements that were not themselves based on testing or otherwise sufficient to meet Daubert standards.[11]
7. Is there any independent reason why the plaintiff’s doctor would not have used the proposed alternative design?
If the implanting physician would not have used an existing alternative design for some independent reason, such as the physician’s training or the hospital’s purchasing policies, then the mere existence of that design could not have caused the plaintiff’s injuries.[12]
8. Is the device still on the market?
Logically, the only way to show defect other than a safer alternative design is to prove that the device is so dangerous that no reasonable physician would prescribe it. But if the device is still on the market and a significant number of physicians continue to use it that should defeat any such claim.[13] Some courts have reasoned that “categorical liability” should not be allowed to prevent whole categories of useful products from being taken off the market.[14]
FDA Regulation
9. How did the FDA classify the device?
This is important both on the merits and for the purpose of preemption.
On the merits, the classification generally expresses the FDA’s opinion as to how much risk the device poses. In fact, that FDA opinion is baked into the statutory language. 21 U.S.C. §360c(a)(1). The safer the device, the less regulation is required. This is a form of regulatory “triage.”[15]
A device in Class I is one the FDA believes does not “present an unreasonable risk of illness or injury.” §360c(a)(1)(A). No permission is needed to market it.
A device in Class II is one which, with such special controls as the FDA may impose, if any, does not “present a potential unreasonable risk of illness or injury” because, if it did, it would have to be in Class III. §360c(a)(1)(C).[16] In order to market the device, the manufacturer may have to get permission by filing a notice seeking §510(k) “clearance.” 21 U.S.C. §360(k).
A Class III device is one that may present an unreasonable risk or is for a use in supporting or sustaining human life and, because special controls are not enough to ensure its safety, can in most circumstances only be sold after the manufacturer has provided independent evidence of safety and effectiveness sufficient to gain premarket “approval.” 21 U.S.C. § 360e.
Ironically, the federal express preemption statute, 21 U.S.C. §360k, has been interpreted to provide that federal regulation for more risky devices has preemptive effect while federal regulation for less risky devices does not. The test under the statute as interpreted by the FDA is whether state law imposes “requirements” which are different from, or in addition to, any federal “requirement.” It has been held that the approval of a Class III device imposes preemptive requirements,[17] as do special controls included in an FDA regulation placing a device type in Class II, but not more general FDA requirements.[18]
There is no implied preemption for the labeling of Class I or II devices, but there should be implied preemption of safer alternative design claims for Class II devices, because changes in design affecting safety and effectiveness must be cleared by the FDA, and so require its “permission and assistance.”[19]
Finally, a claim that the defendant should stop selling a device that the FDA has cleared or approved for marketing cannot be used to avoid preemption.[20]
10. What is the post-sale regulatory history of the device?
Has the FDA taken any regulatory action? Has it issued a public health notice? Is a device subject to a §522 order requiring post-market surveillance per 21 U.S.C. §360l? Was it issued a Form 483 notice? Has a label change been required?
These actions may be useful in that they place the public on notice of potential defects and may aid in making a statute of limitations argument.
Otherwise, the question becomes whether this evidence can be excluded. Some courts might regard this as a subsequent remedial measure under Fed R. Evid. 408. A stronger argument may be that the evidence is unfairly prejudicial because the FDA applies a much lower standard of causation than the standard required by tort law. For example, the FDA can and does sometimes rely on reports that an adverse event is associated with the use of a device even if causation has not been shown. 21 U.S.C. §360i (a)(1)(A) (must report to FDA if device “may have caused or contributed to a death or serious injury”) (emphasis added)[21]
By the same token, if the FDA has applied its more consumer-friendly standard and considered adverse event reports when it cleared or classified a device for marketing, the fact that it applies a more consumer-friendly standard than the common law is an argument in favor of admitting the evidence of clearance or classification. Because a more consumer-friendly standard is applied, the plaintiff suffers no prejudice.
11. Does the case involve an off-label use?
The FDA statute contemplates that a physician may choose to use a device for a purpose which has not been cleared with or approved by the FDA. 21 U.S.C. §396. Promotion of a device for an off-label use may, however, affect the availability of preemption defenses,[22] and create a liability risk.
12. Do company documents or witnesses endorse “safety rules” that are higher than the standard for tort liability?
If so, move to exclude them. Liability is not based on compliance with a company’s own credos or codes but is instead based on the legal standards of the case. Absent evidence that the plaintiff has relied on such a standard, its probative value is outweighed by potential jury confusion.[23] For example, testimony that “safety is first” is not legally true. Patient health is “first,” and that may require some sacrifice in safety, e.g. the need to perform surgery.
Injuries
13. What are the specific injuries the plaintiff claims to have suffered?
This is the foundation for all defect and even failure to warn claims. Not only must the defect cause the injury, but the failure to warn must normally be a failure to warn of the injury the plaintiff suffered, not some other potential injury.[24]
14. Did the defect cause those injuries?
The product’s defect, and not the product itself, must cause the plaintiff’s injury.[25] An exception would be if the claim is that the device is so dangerous that no physician should ever prescribe it. However, if that is the claim, there are often ways to defeat it, such as regulatory permission to market the device, or common use, or preemption.
15. When did the injuries first occur?
This begins any statute of limitations analysis. Please note, if the claim is that the device should never have been implanted at all, then logically the first injury occurred on the date the device was implanted. The implantation surgery itself was an injury. Also, if the claim is that the manufacturer failed to warn of the injury, then the occurrence of an injury about which neither the doctor nor the plaintiff was warned should begin the running of the statute of limitations even if the plaintiff has no reason to suspect a defect.[26] All of this depends on state law, and in some states either statutes of repose or the terms of warranty statutes limit liability based on the time that has elapsed since the sale of the device.
Failure to Warn
16. What are the precise statements in the defendant’s warnings that the plaintiff contends are false?
Only a focus on particular language can show whether the statements are in fact true, or are opinions based on disclosed facts,[27] or may have been cleared – or even suggested – by the FDA.[28]
17. If the plaintiff claims warnings were omitted, were they about risks commonly known to physicians prescribing the device?
There is no duty to warn of risks which should be obvious to, or generally known by, the physicians who implant the device.[29] This is an objective test and is properly the subject of expert testimony. It can be shown through FDA public health notices, teaching materials, and so forth.
18. Did the prescribing physician rely on the defendant’s warnings?
Physician’s typically rely on their training and experience and not on what is in a package insert or Instructions for Use. [30]
19. Would a corrected warning have changed the physician’s decision to implant the device?
The plaintiff should be required to show that the prescribing physician would have changed his decision to use the device if the physician had received a different warning.[31] That cannot be shown if the physician testifies that additional warnings would not have changed her mind and she would still use the device today,[32] or if the prescribing physician is deceased or otherwise does not testify.[33]
Special Damages
20. What are the plaintiff’s special damages?
If they are not large, the defendant may want to introduce them into evidence. “Centering” and “anchoring” are words psychologists used to describe the tendency to pick a number based on the presence of other numbers in the case, whether or not they are directly relevant.[34] Because of this phenomenon, plaintiffs’ lawyers in some cases put no “real world” numbers before the jury because they do not want jurors thinking about the real world. Defense counsel should consider reintroducing the jury to the real world by showing the jury the actual medical expenses.
Resources
James M. Beck and Anthony Vale, Drug and Medical Device Product Liability Deskbook (2021): https://www.lawjournalpress.com/player/default.aspx?slreturn=20190213115537/&#bookid=40!
Drug and Device Law blog: https://www.druganddevicelawblog.com/
[1] Fed. R. Civ. P. 37(e) states that a party must take “reasonable steps to preserve” electronically stored information. Generally, this is done through the issuance of a litigation hold. See, e.g., Iberia Bank v. Broussard, 907 F.3d 826, 841 (5th Cir. 2018) (sending a litigation hold “protect[s] [a party’s] legitimate interests” to prevent spoliation of evidence). This is, of course, but the first step toward preventing a spoliation claim, and it must be done carefully. It is important to ensure that the notice covers the entire time period and all products included in the complaint. A new notice will be needed whenever a new complaint is filed that expands the time period or adds a product.
[2] Driesenstok v. Volkswagenwerk A.G., 489 F.2d 1066, 1074 (4th Cir. 1974) (“peculiar purposes” of bus design meant it could not be compared to passenger sedan which lacked that purpose) (applying Virginia law on negligent design)
[3] Linegar v. Armour of Am., Inc., 909 F.2d 1150, 1154 (8th Cir. 1990) (unreasonably dangerous claim)(bullet-proof vest and jacket two different products) (applying Missouri law); Restatement (Third) of Torts §2, comment f, illustrations 9,10 (following Driesentstok and Linegar).
[4] Mullins v. Ethicon, No. 2:12-CV-02952, 2017 WL 711766, at *2 (S.D.W. Va. Feb. 23, 2017) (pelvic mesh); Schmidt v. C.R. Bard, Inc., No. 2:11-CV-00978-PMP, 2013 WL 3802804, at *2 (D. Nev. July 22, 2013) (hernia mesh); Brockert v. Wyeth Pharm. Inc., 287 S.W.3d 760, 770-71 (Tex. App.—Houston 2009, no pet.) (hormone therapy drug); Theriot v. Danek Med. Inc., 168 F.3d 253, 255 (5th Cir. 1999)(pedicle screw design); Drug and Medical Device Product Liability Deskbook §3.02[3][d] & nn. 88-90.
[5] Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 403 (6th Cir. 1990) (alternative must be “pareto-superior”); Conklin v. Novartis Pharmaceuticals Corp., 2012 WL 4127295, at *10 (E.D. Tex. Sept. 18, 2012) (rejecting alternative design theory where expert lacked sufficient data to show that lower dose of drug he proposed would effectively fight the plaintiff’s cancer); Restatement (Third) of Torts: Product Liability §2, reporter’s note to comment f (“Thus, a plaintiff must introduce evidence from which the jury can find not only that the proposed alternative would have afforded greater safety, but also that it would not have substantially impaired the function, utility, economy, convenience, and other features that drive consumer demand for and acceptance of the product”).
[6] See Jones v. Chidester, 610 A.2d 964, 969 (Pa. 1992); Steve E. Pegalis, 1 Am. Law Med. Malp. §3:3 (2017) (“reasonably applicable alternative methods” allowed); Luther Munford, Protecting Informed Physician Choice Among Medical Device Alternatives, 56 Tort & Ins. Prac. L.J. 642, 646-650 (2021).
[7] This is why failure to test, without more, is generally not considered to be a cause of action. Oddi v. Ford Motor Co., 234 F.3d 136, 144 (3rd Cir. 2000).
[8] Polski v. Quigley Corp., 538 F.3d 836 (8th Cir. 2008) (medication spray bottle not tested); Cabrera v. Cordis Corp., 134 F.3d 1418, 1422-23 (9th Cir. 1998) (brain shunt design not tested).
[9] See Protecting Informed Physician Choice, supra n. 3 at 646 (reasonable certainty requirement).
[10] See Protecting Informed Physician Choice, supra n.3 at 654-656.
[11] In re Lipitor (Atorvastatin Calcium) Marketing, 892 F.3d 624 (4th Cir. June 12, 2018) (“admissions” found in company email, or on labels, or in an NDA or a website were not enough to defeat summary judgment). That decision followed In re Mirena IUD Prods. Liab. Litig., 202 F. Supp. 3d 304, 324-27 (S.D.N.Y. 2016) (plaintiffs could not establish causation solely through ambiguous internal documents in the absence of reliable expert testimony). See also Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434, 545 (W.D. Pa. 2003) (expert reliance on phrases picked from corporate documents does not satisfy causation).
[12] See J. Henderson & A. Twerski, Optional Safety Devices: Delegating Product Design Responsibility to the Market, 45 Ariz. St. L.J. 1399, 1417 (2013) (“delegation to learned intermediaries” defeats design liability claims); Scarangella v. Thomas Built Buses, 717 N.E.2d 679, 683 (N.Y. 1999) (manufacturer not liable where employer who could balance risks and benefits chose not to purchase safety device); Scallan v. Duriron Co., 11 F.3d 1249 (5th Cir. 1994) (same); Protecting Informed Physician Choice, supra n. 3 at 653-654.
[13] In re Alloderm, 2015 WL 5022618, at *6 (N.J. Super. Law Div. Aug. 14, 2015) (hernia graft still used by surgeons for some purposes not “egregiously dangerous”).
[14] Caterpillar v. Shears, 911 S.W. 2d 379, 385 (Tex. 1995); H. Grossman, Categorial Liability: Why the Gates Should be Kept Closed, 36 Tex. L. Rev. 385, 405 (1995).
[15] See Luther Munford, Courts v. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question, 76 Food & Drug L.J. 6, 11-15 (2021) (describing the “triage” aspect of FDA medical device classification and explaining why 510(k) classification and clearance is a safety determination)).
[16] See Talley v. Danek, 179 F.3d 154, 162 (4th Cir. 1999)(placement in Class II is indication of safety). It is theoretically possible for a device which poses an unreasonable risk to be in Class II if there are special controls which provide reasonable assurance of safety, but typically the FDA and medical panel rulings that place the device type in Class II will not invoke this exception and will justify Class II placement on the ground that the risks are not unreasonable.
[17] Riegel v. Medtronic, 552 U.S. 312 (2008).
[18] Papike v. Tambrands, 107 F.3d 737, 742-44 (9th Cir. 1977).
[19] PLIVA v. Mensing, 564 U.S. 604, 620-21 (2011).
[20] Mutual Pharmaceutical v. Bartlett, 570 U.S. 472, 489 (2013).
[21] Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1201 (11th Cir. 2002) (district court did not abuse its discretion in holding that FDA’s withdrawal of approval of a use was insufficient to support expert’s opinion that use caused harm: the FDA’s “risk-utility analysis involves a much lower standard than that which is demanded by a court of law.”). See 21 U.S.C. § 360i(b)(3) (“No [medical device] report . . . shall be admissible into evidence or otherwise used in any civil action involving private parties . . . .”); see also In re Medtronic, Inc., 184 F.3d 807, 811-12 (8th Cir. 1999) (deeming any order directing the production of reports to FDA invalid because use of information from such reports in civil litigation was precluded by 21 U.S.C. § 360i(b)(3)).
[22] See Brief for the United States Food and Drug Administration, Shuker v. Smith & Nephew, Inc., 2017 WL 4151264 (3rd Cir. Sept. 14, 2017); Shuker v. Smith & Nephew, 885 F.3d 760 (3rd Cir. 2018) (marketing for off-label use was actionable state law violation). See James M. Beck and Anthony Vale, Drug and Medical Device Product Liability Deskbook §6.05[4] (2021).
[23] In re Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liab. Litig., No. 2436, 2016 WL 807377, at *8 n.22 (E.D. Pa. March 2, 2016), citing Johnson v. Mountainside Hospital, 239 N.J. Super. 312, 323 (App. Div. 1990); 65 C.J.S. Negligence § 66 (June 2017) (higher standard not admissible absent showing of detrimental reliance by plaintiff).
[24] Novak v. Unites States, 865 F.2d 718, 726 (6th Cir. 1989) (failure to warn about viral encephalitis did not proximately cause plaintiff’s injuries where “[i]t was not proven that [plaintiff] had actually suffered from viral encephalitis.”); In re Fosamax Prods. Liab. Litig., No. 1:06-MD-1789-JFK, 2010 WL 1257299, at *5 (S.D.N.Y. 2010) (“[P]laintiff cannot establish proximate cause without evidence that [the defendant] fail[ed] to warn of the specific risk that allegedly materialized. . . .”).
[25] Johnson & Johnson v. Batiste, 2015 WL 6751063 *7, n.10 (Tex. App.—Dallas 2015, pet. dism.) (insufficient evidence to show mechanical cutting, weight, pore size, or degradation that caused injury).
[26] Brawn v. Oral Surgery Associates, P.A., 893 A.2d 1011 (Me. 2006)(“once a patient discovers the risks associated with the implants, the surgeon’s duty to warn expires” and limitations period begins to run).
[27] Pizza Hut, Inc. v. Papa John’s Intern., Inc., 227 F.3d 489, 495-496 (5th Cir. 2000) (general statements of opinion such as puffing or general claims of superiority cannot form the basis for liability for false advertising); Restatement (Second) of Torts §566 (defining pure opinion as opinion based on disclosed facts).
[28] McQuaid v. Burlington Cty. Mem. Hosp., 212 N.J. Super. 472 (App. Div. 1986) (FDA participation in drafting of warning).
[29] Brooks v. Medtronic, Inc., 750 F.2d 1227, 1230 (4th Cir. 1984) (applying South Carolina law); 21 C.F.R. §801.109(c) (no duty to warn if risk “commonly known by practitioner’s licensed by law to use the device”). See Drug and Medical Device Product Liability Deskbook §2.04[2] n.89 (collecting cases by jurisdiction).
[30] Lewis v. Johnson & Johnson, 601 F. App’x 205, 208 (4th Cir. 2015) (“When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device’s warning, the warning is not the cause of the patient’s injury.”)
[31] Higgins v, Ethicon, Inc, 2017 WL 2813144 (S.D. W.Va. Mar. 30, 2017) (Texas law).
[32] Hammett v. Ethicon, Inc., 2017 WL 1015848 (S.D. W.Va. Mar. 15, 2017) (Texas law).
[33] Sauls v. Wyeth Pharms, Inc, 846 F. Supp. 2d 499, 502-504 (D.S.C. 2012).
[34] https://en.wikipedia.org/wiki/Heuristic#Well_known (searched 2/6/2019).
Finis
