Kaiser et al v. Johnson & Johnson et al
Filing
407
OPINION AND ORDER: Ethicons Motion to Admit FDA Evidence DE 248 is DENIED and the Kaisers Motion in Limine to Exclude FDA §510(k) evidence DE 244 is GRANTED. Signed by Judge Philip P Simon on 3/16/18. (nal)
UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF INDIANA
HAMMOND DIVISION
BARBARA KAISER and
ANTON KAISER,
Plaintiffs,
v.
JOHNSON & JOHNSON and
ETHICON INC.,
Defendants.
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CAUSE NO. 2:17-CV-114-PPS
OPINION AND ORDER
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.
[Id.]
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
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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.
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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.]
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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 agency of the
United States or Indiana.
This presumption has been interpreted narrowly. While it is clear from its wording that
the first part of the presumption relates to safety of the product, the Indiana Court of
Appeals has explicitly found that in order “for evidence of compliance with
governmental standards to be relevant, the standard itself must relate to the risk or
product defect at issue.” Wade v. Terex-Telect. Inc., 966 N.E.2d 186, 194 (Ind. Ct. App.
2012); see also Rogers ex rel. Rogers v. Cosco, Inc., 737 N.E.2d 1158, 1163 (Ind. Ct. App.
2000) (finding that compliance a Federal Motor Vehicle Safety Standard warranted the
application of the presumption, which the plaintiff then needed to rebut to succeed on
her claims under the IPLA). This makes sense, logically, given that whether a product
is defective under the IPLA turns on whether it is “unreasonably dangerous” to any
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user or consumer. See Ind. Code 34-20-2-1. As such, for the presumption to apply in
this case, Ethicon would have to show that the standard with which it conformed or
complied—the §510(k) process—spoke to safety. The problem for Ethicon, as shown
below, is that the §510(k) process speaks to equivalency, not safety.
While it may seem counterintuitive that this aspect of the FDA’s clearance
process does not speak to the safety of the device, that is the generally accepted
interpretation of the §510(k) process by courts in this country. This includes those
courts handling cases in states with rebuttable presumptions. See, e.g., Eghnayem v.
Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017) (applying Florida law); Tingey v.
Radionics, No. 04-4216, 193 Fed. App’x 747, 755, 2006 WL 2258872, at *6 (10th Cir. Aug. 8,
2006) (applying Utah law); Adams et al. v. Boston Scientific Corp., 177 F. Supp. 3d 959 (S.D.
W. Va. 2016) (applying Texas law); Williams v. Boston Scientific Corp., No. 2:12-CV-02052,
2016 WL 1448860, at *3 (S.D. W. Va. Apr. 12, 2016) (applying Wisconsin law); Lewis v.
Johnson & Johnson, 991 F. Supp. 2d 748, 761 (S.D. W. Va. 2014) (applying Texas law).
It all starts with Meditronic, Inc. v. Lohr, 518 U.S. 470, 492 (1996), where the United
States Supreme Court explained that “the §510(k) process is focused on equivalence, not
safety” and the design of the device “has never been formally reviewed under the
MDA for safety or efficacy.” Id. at 493. As the Court explained, “substantial
equivalence determinations provide little protection to the public. These
determinations simply compare a post–1976 device to a pre–1976 device to ascertain
whether the later device is no more dangerous and no less effective than the earlier
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device. If the earlier device poses a severe risk or is ineffective, then the later device
may also be risky or ineffective.” Id.
The §510(k) process is a cursory one when compared to the strenuous PMA
review. To illustrate this point, in Lohr, the Supreme Court noted that “[i]n contrast to
the 1,200 hours necessary to complete a PMA review, the §510(k) review is completed in
an average of only 20 hours. As one commentator noted: ‘The attraction of substantial
equivalence to manufacturers is clear. Section 510(k) notification requires little
information, rarely elicits a negative response from the FDA, and gets processed very
quickly.’” Id. at 479 (quoting Adler, The 1976 Medical Device Amendments: A Step in
the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L.J.
511, 516 (1988)).
In Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the Supreme Court expanded on
its analysis in Lohr. The Court explained that the PMA process “is federal safety
review,” as opposed to §510(k) review, which is a test for substantial equivalence. Id. at
323. As the Court explained, “[w]hile §510(k) is focused on equivalence, not safety,
premarket approval is focused on safety, not equivalence.” Id. (quotations marks and
citations omitted).
This is a distinction with a difference as it relates to this case because, as I
discussed above, for the IPLA presumption to apply, the standard with which Prolift
conformed or complied must speak to safety. Because §510(k) is focused on
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equivalency and not safety, it is not relevant to the application of the presumption in
this case and does not mandate its application.
Furthermore, under Federal Rule of Evidence 403, a court may “exclude relevant
evidence if its probative value is substantially outweighed” by the danger of, among
other things, confusing the issues, misleading the jury, and wasting time. I agree with
Judge Goodwin that the §510(k) evidence does not speak directly to safety and efficacy
and, therefore, is of very little probative value. I believe that introduction of evidence
regarding the §510(k) process potentially would have confused the jurors regarding the
meaning and importance of §510(k) clearance, possibly resulting in the jurors
erroneously concluding that §510(k) clearance proved safety.
What’s more, the trial would have been completely sidetracked with the
introduction of the FDA evidence. If the evidence regarding Prolift’s §510(k) clearance
had been admitted into evidence, almost assuredly, Prolift’s whole FDA story would
have been told to the jury, including evidence that after the Prolift device was
marketed, it later received FDA scrutiny and was subsequently removed from the
market after a series of exchanges with the FDA regarding its safety. This would
require the introduction of additional evidence and testimony from regulatory experts
and Ethicon employees. When balancing the probative value of the evidence against
these dangers and the needless consumption of time, I find that excluding the evidence
is appropriate.
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Conclusion
For the reasons discussed above, and at the hearing held on November 28, 2017,
Ethicon’s Motion to Admit FDA Evidence, DE 248, is DENIED and the Kaisers’ Motion
in Limine to Exclude FDA §510(k) evidence, DE 244, is GRANTED.
SO ORDERED.
ENTERED: March 16, 2018.
_s/ Philip P. Simon__________
PHILIP P. SIMON, JUDGE
UNITED STATES DISTRICT COURT
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