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Kaiser v. Johnson & Johnson

United States District Court, N.D. Indiana, Hammond Division

March 16, 2018




         Prior to the trial of this matter, I heard oral argument on various motions in limine filed by the Parties. At the hearing, I denied Ethicon's Motion to Admit FDA Evidence, DE 248, and granted and the Kaisers' mirror image motion to exclude FDA evidence, DE 244. I provided a detailed explanation from the bench on the reasons for those rulings, but I also told the Parties that a written opinion would follow. [DE 276 at 34-40.] This is that opinion.

         While this case was before him as part of the MDL, Judge Goodwin excluded evidence regarding the FDA's §510(k) clearance process. [See, e.g., DE 146.] Judge Goodwin explained:

I have repeatedly excluded evidence regarding the FDA's section 510(k) clearance process in these MDLs, and will continue to do so in these case[sic], a position that has been affirmed by the Fourth Circuit. In re C. R. Bard, Inc., 81 F.3d 913, 921-23 (4th Cir. 2016) (upholding the determination that the probative value of evidence related to section 510(k) was substantially outweighed by its possible prejudicial impact under Rule 403). Because the section 510(k) clearance process does not speak directly to safety and efficacy, it is of negligible probative value. See In re C. R. Bard, 81 F.3d at 920 (“[T]he clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value.”). Delving into complex and lengthy testimony about regulatory compliance could inflate the perceived importance of compliance and lead jurors “to erroneously conclude that regulatory compliance proved safety.” Id. at 922. Accordingly, expert testimony related to the section 510(k) process, including subsequent enforcement actions and discussion of the information Ethicon did or did not submit in its section 510(k) application, is EXCLUDED.


         The issue of the admissibility of FDA §510(k) evidence was reanimated before me because the Indiana Product Liability Act provides a rebuttable presumption that a product is not defective, and the manufacturer is not negligent, where the product complied with applicable codes, standards, regulations, or specification. See Ind. Code § 34-20-5-1. Ethicon argues that evidence regarding the fact that Prolift was cleared for marketing through §501(k) review was relevant to this litigation because of the IPLA's rebuttable presumption and, in fact, mandated application of the presumption to this case.

         Before I explain why I agree with Judge Goodwin, and the majority of the other courts that have addressed this issue, some background on the §510(k) process is necessary. The §510(k) review process originates from the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act. The MDA was enacted in order to “impose[ ] a regime of detailed federal oversight” of medical devices. Riegel v. Medtronic, Inc., 552 U.S. 312, 316 (2008). Under the MDA, certain devices must complete a thorough premarket approval (PMA) process with the FDA before they may be marketed, including all devices that cannot “provide reasonable assurance of [their] safety and effectiveness” under less stringent scrutiny, and that are “purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health” or “present[ ] a potential unreasonable risk of illness or injury.” Id. at 317; 21 U.S.C. § 360c(a)(1)(C). The PMA process requires the applicant to demonstrate a “reasonable assurance” that the device is both “safe and effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof.” Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344 (2001) (quoting 21 U.S.C. § 360e(d)(2)(A), (B)).

         However, an exception to the PMA requirement exists for medical devices that were already on the market prior to the MDA's enactment in 1976; these devices are allowed to remain on the market until the FDA initiates and completes PMA review for them. See 21 U.S.C. § 360e(b)(1)(A); Buckman, 531 U.S. at 345. In addition, to prevent the monopolistic power that this exception might bestow on the manufacturer of the predicate device, the MDA also allows other manufacturers to piggyback on earlier products by allowing them to market devices that are shown to be “substantially equivalent” to pre-1976 devices that are exempt from the PMA requirement. Buckman, 531 U.S. at 345; 21 U.S.C. § 360e(b)(1)(B)). The §510(k) process is the method by which a manufacturer demonstrates substantial equivalence. Id.

         While the MDA provided this initial framework, the Safe Medical Devices Act of 1990 provided firmer footing for this loosely designed process. The SMDA finally codified the definition of substantial equivalence that the FDA had developed administratively through the experience of clearing devices for the 14 years since the enactment of the MDA. See 21 U.S.C. §360c(i). In addition, the SMDA ended the legal necessity to cite a pre-MDA predicate device, so that devices cleared after the enactment of the MDA could be used as predicates without construction of a clearance chain back to a pre-MDA predicate device. See 21 U.S.C. §360c(f). While this allowed the state of the art to evolve more freely, it created a more tangential relationship between FDA clearance and the safety-focused PMA process.

         Returning to the case at hand, in September 2007, Ethicon submitted its §510(k) notice to the FDA for Prolift. [DE 248-4.] The FDA found Prolift “substantially equivalent . . . to legally marketed predicated devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act that do not require approval of a premarket approval application, ” classifying Prolift as a Class II device and clearing it to proceed to market in May 2008. [DE 248-5.] The notice explicitly stated that “FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.” [Id.]

         Ethicon argues that evidence of this clearance is relevant to this action because it entitles Ethicon to the rebuttable presumption found in Ind. Code § 34-20-5-1. I disagree. Indiana Code § 34-20-5-1 provides:

In a product liability action, there is a rebuttable presumption that the product that caused the physical harm was not defective and that the manufacturer or seller of the product was not negligent if, before the sale by the manufacturer, the product:
(1) was in conformity with the generally recognized state of the art applicable to the safety of the product at the time the product was designed, manufactured, packaged, and labeled; or
(2) complied with applicable codes, standards, regulations, or specifications established, adopted, promulgated, or approved by the United States or by Indiana, or by an ...

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