Ask that to the other side, however, and the answer will be “only if it helps me win.” Plaintiffs are more than happy to offer evidence of FDA approval/compliance evidence – but only if it’s about non-approval/noncompliance. If the FDA pedigree of a particular product doesn’t include any sort of FDCA violation, then the same counsel who so zealously advocated the relevance of the FDA last week is quite happy the next week to disavow every word of it. That happened to us recently, hence this post.
When an application is required to sell an FDA-regulated product (including almost all such products likely to be involved in litigation), the manufacturer cannot sell it in the U.S. until and unless the FDA says ‘yes.’ Indeed, over a dozen states have statutes that, to one extent or another, presume that products passing FDA muster aren’t defective. For reasons such as these, the overwhelming majority of the caselaw recognizes the relevance of the FDA’s decisions.
Putting aside preemption (which is predicated on federal, not state, legal principles) the general state-law rule is that a product’s compliance with FDA regulations – whether they’re characterized as “minimum” or otherwise, is relevant, albeit not controlling, in product liability litigation.
[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.
Restatement (Third) of Torts, Products Liability §4(b) (1998). The supporting Reporters’ Note to §4(b) confirms:
The overwhelming majority of jurisdictions hold that compliance with product safety regulation is relevant and admissible on the question of defectiveness, but is not necessarily controlling.
Restatement (Third) of Torts, Products Liability §4, reporter’s notes to comment e (1998). Four of the six cases cited in this reporter’s note involved FDA compliance. See O’Gilvie v. International Playtex, Inc., 821 F.2d 1438, 1442 (10th Cir. 1987); Foyle v. Lederle Laboratories, 674 F.Supp. 530, 533 (E.D.N.C. 1987); Carlin v. Superior Court, 920 P.2d 1347, 1352-53 (Cal. 1996); Washington State Physicians Insurance Exchange & Ass’n v. Fisons Corp., 858 P.2d 1054, 1069 & n.45 (Wash. 1993). See also David G. Owen, M. Stuart Madden & Mary J. Davis, Products Liability §16:3 (3d ed. 2011) (“most courts have treated evidence of compliance with a statute as some evidence of due care, but not dispositive on the issue of non-defectiveness”).
As the Restatement reporter’s note indicates, this general rule has been applied repeatedly to FDA approval/compliance issues. Thus, in California, while “an FDA conclusion is not binding . . . “it deserves serious consideration.” Ramirez v. Plough, Inc., 863 P.2d 167, 178 (Cal. 1993). On state of the art issues, “FDA action or inaction, though not dispositive, may be admissible . . . to show whether a risk was known or reasonably scientifically knowable,” and in some circumstances, “the FDA’s conclusion that there was, in effect, no ‘known risk’ is controlling.” Carlin, 920 P.2d at 1352-53 (Cal. 1996). Thus, it is proper to instruct the jury that “F.D.A. action or inaction, though not dispositive, may be considered to show whether a product is safe or not safe.” O’Neill v. Novartis Consumer Health, Inc., 55 Cal. Rptr.3d 551, 557 (Cal. App. 2007). The plaintiff’s argument in O’Neill that FDA approval was “not relevant” was rejected as “not an accurate statement of the law.” Id. at 556.
Other states’ law likewise holds that FDA product decisions, as a whole, are relevant but not controlling – often taking a position advocated by plaintiffs against preemption. “FDA regulations may be relevant in determining whether a manufacturer has complied with its existing common law duty.” Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 355 (Ill. 1996). “FDA regulations are pertinent in determining the nature and extent of any duty of care that should be imposed on pharmaceutical manufacturers.” Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1259 (N.J. 1999). “FDA certification of a drug is evidence but not conclusive evidence of the drug manufacturer's reasonableness; the trier of fact may assign FDA approval the weight it deserves.” Toner v. Lederle Laboratories, 732 P.2d 297, 311 n.12 (Idaho 1987). See also E.R. Squibb and Sons, Inc. v. Farnes, 697 So.2d 825, 827 (Fla. 1997) (FDA-approved label provided “an evidentiary basis for the jury verdict”); Gonzales v. Surgidev Corp., 899 P.2d 576, 591 (N.M. 1995) (“evidence of compliance with FDA regulations was properly submitted to the jury for consideration”); United Blood Services v. Quintana, 827 P.2d 509, 525 (Colo. 1992) (“[defendant’s] compliance with the Food and Drug Administration’s recommendations . . . was some evidence of due care, but was not conclusive”); Feldman v. Lederle Laboratories, 625 A.2d 1066, 1070 (N.J. 1993) (“[defendant’s] attempt to comply with existing FDA regulations still bears on the reasonableness of its conduct”); Savina v. Sterling Drug, Inc., 795 P.2d 915, 931 (Kan. 1990) (“compliance with FDA rules and regulations creates only a rebuttable presumption that the warnings are adequate”); MacDonald v. Ortho Pharmaceuticals, 475 N.E.2d 65, 70-71 (Mass. 1985) (“compliance with FDA requirements, though admissible to demonstrate lack of negligence, is not conclusive on this issue, just as violation of FDA requirements is evidence, but not conclusive”); Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984) (evidence of FDA “compliance” supported verdict for manufacturer); Bailey v. Wyeth, Inc., 37 A.3d 549, 570 (New Jersey Super. L.D. 2008) (“compliance with FDA regulations provides compelling evidence that the manufacturer satisfied its duty to warn the physician”), aff’d on opinion below, 28 A.3d 1245 (N.J. Super. A.D. 2011).
The issue of whether a company complied or did not comply with FDA requirements is relevant to many aspects of the products liability lawsuit. . . . [M]ost courts considering the issue have held that compliance with FDA regulations may be some evidence of due care. . . . Compliance with FDA requirements, therefore, often exerts a profound, yet subtle, effect on a products liability lawsuit.
Brokaw v. Davol Inc., 2009 WL 3328529 (R.I. Super. May 15, 2009); Ferrigno v. Eli Lilly & Co., 420 A.2d 1305, 1320 (N.J. Super. L.D. 1980) (“[e]vidence that the drug was marketed pursuant to FDA approval . . . may be considered by the jury on the issue of whether proper care in general, and adequate testing in particular, were exercised, but it is in no way binding”).
Likewise, in diversity cases applying the Federal Rules of Evidence, “FDA approval and industry practices may be relevant to the state duty of care.” Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 589 (6th Cir. 2013). “FDA approval is evidence which the jury may consider in reaching its verdict. The jury may weigh FDA approval as it sees fit.” Tobin v. Astra Pharmaceutical Products, Inc., 993 F.2d 528, 538 (6th Cir. 1993). “[C]ompliance with federal laws and regulations concerning a drug, though pertinent, does not in itself absolve a manufacturer of liability.” Salmon v. Parke Davis & Co., 520 F.2d 1359, 1362 (4th Cir. 1975). Thus, in In re Zyprexa Products Liability Litigation, 489 F. Supp.2d 230 (E.D.N.Y. 2007), Judge Weinstein (who literally “wrote the book” about federal evidence) held that a jury “may be guided” not only by partisan experts, but also by “the more neutral expert opinion of the FDA,” which had approved the product. Id. at 281. See, e.g., O’Gilvie, 821 F.2d at 1442 (affirming jury instruction that FDA compliance “is evidence of due” care but “not a defense”); Rader v. Teva Parental Medicines, Inc., 795 F. Supp. 2d 1143, 1149 (D. Nev. 2011) (FDA compliance “relevant and admissible” but not “a bar to recovery”); Bartlett v. Mutual Pharmaceutical Co., 760 F. Supp.2d 220, 249 (D.N.H. 2011) (instructing jury that compliance with FDA requirement relevant but “not necessarily not conclusive or controlling”), aff’d on other grounds, 678 F.3d 30 (1st Cir.), reversed on other grounds, No. 12–142, slip op. (U.S. June 24, 2013); In re Yasmin & Yaz (Drospirenone) Marketing., Sales Practices & PMF Products Liability Litigation, 2011 WL 6740391, at *17 (S.D. Ill. Dec. 22, 2011) (“[defendant] Bayer argues that it should be able to present evidence of the FDA’s approval of the [product] and that certainly is true”; “FDA approval is not dispositive”); Torkie-Tork v. Wyeth, 739 F. Supp. 2d 895, 900 (E.D. Va. 2010) (“the FDA’s continued approval of [the drug] in its current form is strong evidence of reasonableness in [its] design”); Smith v. Wyeth-Ayerst Laboratories Co., 278 F. Supp. 2d 684, 711 (W.D.N.C. 2003) (FDA “approv[al] of drug is “one factor to consider”); Erickson v. Baxter Healthcare, Inc., 151 F. Supp.2d 952, 966 (N.D. Ill. 2001) (“[e]vidence of compliance with [FDA] regulations is evidence, but not conclusive, of due care”); Brasher v. Sandoz Pharmaceuticals Corp., 2001 WL 36403362, at *13 (N.D. Ala. Sept. 21, 2001) (FDA approval is “relevant to any evaluation of [defendant’s] conduct,” but is “not dispositive”); Woodell v. Proctor & Gamble Manufacturing Co., 1999 WL 624527, at *4 (N.D. Tex. Aug. 16, 1999) (“agency approval” by the FDA is one of “many factors relevant to whether a warning is adequate”); Erony v. Alza Corp., 1996 WL 554612, at *1 (S.D.N.Y. Sept. 30, 1996) (“FDA approval . . . is not dispositive” but “may be considered, in conjunction with all the evidence, in determining whether defendants acted reasonably”); Hegna v. E.I. du Pont de Nemours & Co., 806 F. Supp. 822, 830 (D. Minn. 1992) (“FDA regulation and compliance” is “evidence, although not conclusive, of the reasonableness of a party’s actions”), aff’d without opinion, 27 F.3d 571 (8th Cir. 1994); Mazur v. Merck Co., 742 F. Supp. 239, 247 (E.D. Pa. 1990) (“compliance with an FDA regulation may establish that the manufacturer met the appropriate minimum standards of due care”); Foyle, 674 F.Supp. at 533 (“compliance with FDA regulations is evidence of due care but it is not controlling”); Martinkovic v. Wyeth Laboratories, Inc., 669 F. Supp. 212, 217 (N.D. Ill. 1987) (“compliance with FDA requirements” is “one factor for the jury to consider in deciding the reasonableness of the manufacturer's conduct”); Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1493 (D. Kan. 1987) (“FDA certification is evidence, but not conclusive evidence, of the drug manufacturer’s reasonableness”); Odgers v. Ortho Pharmaceutical Corp., 609 F. Supp. 867, 879 n.24 (E.D. Mich. 1985) (“[w]hile evidence of a manufacturer’s compliance with an applicable [FDA] safety regulation is admissible it does not have conclusive effect”) (quoting 28 ATLA L.Rep. 106 (April, 1985)); Skill v. Martinez, 91 F.R.D. 498, 508 (D. N.J. 1981) (“FDA approval” “is some evidence of adequacy” but the jury is “not compelled” to find the product adequate), aff’d, 677 F.2d 368 (3d Cir. 1982); Brick v. Barnes-Hines Pharmaceutical Co., 428 F. Supp. 496, 498 (D.D.C. 1977) (“[w]hile not conclusive, compliance with [FDA] regulations is most pertinent”).
The converse is also true. Lack of FDA approval is also not dispositive of negligence or product defect. “The mere fact that the FDA has not cleared a product for a particular use does not mean that the product is not in fact suitable for that purpose; it simply means that the FDA has not cleared it.” Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001) (quoting Holland v. Smith & Nephew Richards, Inc., 100 F. Supp.2d 53, 56 (D. Mass. 1999)), see id. (“that FDA has not approved [a product] for a particular use does not mean that it is unsafe or defective”); Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 485, 513 (E.D. Pa. 2009) (“[t]he lack of FDA approval, without more, is not enough to create an inference of a manufacturing or design defect”), rev’d on other grounds, 393 Fed. Appx. 884 (3d Cir. 2010); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 257 (E.D.N.Y. 1999) (“[t]he fact that a [product] has not been approved by the FDA for a particular use does not, however, mean that [it] is unsafe, much less that the device is defective”); Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d 1351, 1363 (N.D. Ga. 1999) (“failure to seek FDA approval does not constitute a defect”); Lester v. Danek Medical Inc., 1999 WL 1061973, at *4 (M.D.N.C. April 16, 1999) (“the status of the [product] by the FDA cannot constitute a defective product”); Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *15 n.9 (D. Neb. Aug. 16, 1999) (“the status of FDA approval does not constitute a ‘defect’ in the product”); McMurdie v. Wyeth, 71 Pa. D. & C.4th 225, 228 (Pa. C.P. 2005) (quoting and following Southard); Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *19 (Tex. Dist. June 7, 1999) (“improper FDA clearance, or even no clearance at all, does not necessarily demonstrate that a [product] is unsafe or ineffective”), aff’d mem., 2000 WL 991697 (Tex. App. July 20, 2000).
Thus, when the admissibility of FDA approval (or non-approval) has been challenged, such evidence has generally been held relevant. “It is . . . well settled that defendant is entitled to present evidence of compliance with federal [FDA] regulations.” Malek v. Lederle Laboratories, 466 N.E.2d 1038, 1039 (Ill. App. 1984). “[E]vidence of compliance with Federal government standards is relevant in a strict tort liability case both on the issue of whether a product is defective and whether the defective condition is unreasonably dangerous.” Hatfield v. Sandoz-Wander, Inc., 464 N.E.2d 1105, 1109 (Ill. App. 1984). In Mahaney v. Novartis Pharmaceuticals Corp., 835 F. Supp.2d 299 (W.D. Ky. 2011), the court rejected a motion to exclude both FDA approval and lack of FDA sanctions for any incidents of non-compliance
[W]hen the admissibility of FDA approval (or non-approval) has been challenged, such evidence has generally been held relevant. . . . [O]ther courts have used compliance with the FDA as proof of due care by a pharmaceutical company. The Court believes this evidence is both relevant and probative.
Id. at 320-21. Similarly in Rader, the court refused to hold FDA compliance inadmissible under the “consumer expectation” variant of strict liability:
This court agrees with product defendants and the Restatement of Torts, that compliance with product safety regulations is relevant and admissible on the question of defectiveness. However, the court does not find that evidence of compliance is a bar to recovery under strict products liability. Therefore, the court in not inclined to exclude evidence of products defendants’ compliance with FDA regulations with regards to plaintiff's strict liability claim.
795 F. Supp. 2d at 1149 (citations and quotation marks omitted). See also Werner v. Upjohn Co., 628 F.2d 848, 859 (4th Cir. 1980) (“fact” of FDA approval overrode any “separate relevance” of subsequent label change); Winter v. Novartis Pharmaceuticals Corp., 2012 WL 827305, at *4 (W.D. Mo. Mar. 8, 2012) (the “role of the FDA and the pharmaceutical industry in general and regarding new drug approvals is relevant to establish a context in which to analyze the reasonableness of [defendant’s] actions”); Forman v. Novartis Pharmaceuticals Corp., 794 F. Supp. 2d 382, 385 (E.D.N.Y. 2011) (“FDA, and [defendant’s] compliance with FDA regulations are issues that are relevant to the instant litigation”); In re Levaquin Products Liability Litigation, 2011 WL 6888533, at *2 (D. Minn. Dec. 29, 2011) (defendant permitted to argue “FDA approval of its label changes”; court would instruct jury that such approval is “not conclusive or controlling”); Yasmin/Yaz, 2011 WL 6740391, at *17 (“[defendant] may present evidence of the FDA’s ‘approval’ for them to begin marketing the drugs”); Elsroth v. Johnson & Johnson, 700 F. Supp. 151, 161 (S.D.N.Y. 1988) (“[e]vidence of compliance with [FDA] regulations is, we believe, pertinent”); McQuaid v. Burlington County Memorial Hospital, 515 A.2d 796, 798 (N.J. Super. A.D. 1986) (“FDA action . . . was neither hearsay nor irrelevant”; “it was clearly relevant to the reasonableness of [defendant’s] conduct”).
In the face of all this adverse precedent some plaintiffs have tried to carve out an exception from the general rule of admissibility in the case of §510k-cleared medical devices. They do so primarily by taking language in Supreme Court decision involving device preemption completely out of context.
[T]he 510(k) process is focused on equivalence, not safety. As a result, substantial equivalence determinations provide little protection to the public. . . . [T]he design of . . . “substantially equivalent” devices has never been formally reviewed . . . for safety or efficacy.
Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996); see also Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008) (“While § 510(k) is focused on equivalence, not safety, premarket approval is focused on safety, not equivalence.”).
These preemption cases have nothing to do with the admissibility of evidence. As the discussion above has shown, courts have repeatedly reaffirmed the relevance of FDA approval/compliance evidence in cases involving prescription drugs where, after Wyeth v. Levine, 555 U.S. 555 (2009), preemption is regrettably pretty darn rare. Indeed, as already mentioned judicial rulings rejecting preemption are frequently accompanied by statements reaffirming the admissibility of FDA approval/compliance.
Then there’s the Supreme Court’s clarification in Buckman, 531 U.S. 341, which like Lohr involved a §510(k) product. The Court pointed out that pre-market approval and §510(k) clearance are both intended “to ensure . . . that medical devices are reasonably safe and effective.” Id. at 349-50. Further, while it might not be as “rigorous” as PMA, §510(k) is also a “comprehensive scheme” that “imposes upon applicants a variety of requirements” and necessitates submission of a wide variety of information. Id. at 348-50.
What the Court said in Buckman in 2001 is only more apt now. The §510(k) process has undergone a good deal of toughening since the 1982 clearance at issue in Lohr and the 1984 clearance at issue in Buckman. The current version of “substantial equivalence” is found at 21 U.S.C. §360c(i). Unlike those earlier versions, currently §510(k) submissions must include “an adequate summary of any information respecting safety and effectiveness.” 21 U.S.C. §360c(i)(3)(A). If the FDA so requires, the 510k submission must also include “information, including appropriate clinical or scientific data . . . that demonstrates that the device is as safe and effective as a legally marketed device” and “does not raise different questions of safety and effectiveness.” 21 U.S.C. §360c(i)(1)(A). See also 21 C.F.R. §807.100(B)(2)(ii) (regulation paralleling the statute).
According to the FDA, these statutory changes mean that §510(k) is now explicitly concerned with safety and effectiveness:
[T]he 510(k) program has changed significantly since its inception. The MDA established the premarket notification process as a simple check to assure proper device classification. Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitateinnovation in the medical device industry.
FDA, CDRH Preliminary Internal Evaluations – Volume I, 510(k) Working Group Preliminary Report and Recommendations, at 34 (Aug. 2010) (§4.4 “The Current 510(k) Program”) (available online here).
Because devices are classified according to the level of regulatory control necessary to provide a reasonable assurance of safety and effectiveness, classification of a new device through the 510(k) process requires FDA to determine the issues of safety and effectiveness presented by the new device, and the regulatory controls necessary to address those issues.
FDA, Draft Guidance for Industry and FDA Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], at Part II(B) (2011) (available online here). Thus “the principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review.” Id. at Part IV(A)(1). To the extent that plaintiffs attempt to argue that §510(k) clearance should be excluded because it doesn’t involve “safety and effectiveness,” they simply don’t know what they’re talking about.
A plaintiff’s attempt to draw such a false distinction was rejected in a case we blogged about before not too long ago, Musgrave v. Breg, Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011). The court rejected the proposition that a §510k FDA clearance was somehow irrelevant:
Plaintiffs may argue about what it means, but they cannot keep the jury from hearing the fact that the FDA cleared a general indication for use for the [product]. . . . The Court concludes that the probative value of this evidence is not substantially outweighed by the danger of confusion of the issues or misleading the jury.
Id. at *3.
Like Musgrave, other courts asked to draw a distinction, for admissibility purposes, between §510(k) clearance and other FDA approval processes have declined to do so. Block v. Woo Young Medical Co., ___ F. Supp.2d ___, 2013 WL 1314449, at *14 (D. Minn. March 28, 2013) (“finding admissible testimony as to “the general nature of the FDA's approval and regulatory process” and “the FDA’s general expectations” regarding a §510(k)-cleared product); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012) (FDA compliance held “relevant” to “determin[e] the appropriate standard of care”); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012) (“whether Defendant complied with federal regulations is relevant”); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. Mar. 29, 2012) (refusing to find “federal regulatory law” was “irrelevant”); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007) (finding admissible testimony as “as to the general nature of the approval and regulatory process including compliance with FDA regulations and guidelines, the FDA's general expectations with respect to testing and marketing of new products”); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995) (FDA approval status of §510k medical device is “relevant and probative”; denying exclusion under F.R. Evid. 403); Strum v. Depuy Orthopaedics, Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013) (denying plaintiff's motion to exclude FDA §510(k) clearance).
FDA §510(k) device clearance is thus clearly relevant in product liability litigation. Don’t stand by and let courts be fooled by an untenable distinction based upon the anachronistic description in Lohr of what it takes for the FDA to find a device to be “substantially equivalent.”