Exclusion of Evidence: The FDA's 510K Process

The PMA process requires the applicant to show with “reasonable assurance” that the device it wants to market is “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, (2001); 21 U.S.C. § 360e(d)(2)(A), (B).

However, Class III medical devices that were already being used prior to May 28, 1976, were not pulled from the market and required to go through the PMA process before returning, as that would have resulted in chaos for manufacturers, regulators and people dependent on access to those devices. The MDA allowed these pre-amendment devices to remain on the market until such time as the FDA decides to subject them to the full PMA process; all they needed to do was go through the less-arduous 510(k) process. Eventually, all pre-amendment devices will be required to obtain approval through the PMA process, but only when told to do so. As many of these pre-amendment products have not yet been called upon by the FDA to prove their safety and effectiveness through the PMA process, their manufacturers simply have been permitted to continue to sell them to this day, subject only to the requirement that they have been cleared through the 510(k) process.

But in order to avoid creating monopolies, pre-amendment manufacturers are not the only ones able to take advantage of the 510(k) process. When a manufacturer other than one that sold a particular device pre-amendment desires to enter into the market with a substantially similar competing product, that manufacturer's product will be subject to the same requirements as the pre-amendment device. In other words, the new product will have to go through the 510(k) process, but not the full PMA process, before it can be sold. To qualify, it must be demonstrated that the new device is at least as safe and effective as the comparable one already on the market.

The process of 510(k) approval is much less onerous than that for a PMA: It costs a fraction of the average $280,000 PMA fee — generally, less than $5,000; it requires no clinical trials; and it is completed more quickly than a PMA. So a device allowed to be marketed by the FDA under the 510(k) method comes to market more easily and cheaply. However, it has not undergone rigorous safety and effectiveness reviews. It need only be as safe as its substantial equivalent — the one on the market before 1976, which also has not undergone PMA review.

Evidence of Safety?

Like manufacturers of devices that have come to market since 1976 and have gone through the full PMA process, those whose products have been asked only to go through the 510(k) process have an interest in letting juries know that their products have been deemed safe by the FDA. But does passage through the 510(k) process mark a product with an FDA “Safe” stamp? Device manufacturers want to herald their 510(k) approvals to juries as just that, but courts are not always buying it. The case of In re C.R. Bard, Inc., MDL No. 2187, Pelvic Repair System Products Liability Litigation, 810 F.3d 913 (4th Cir. 2016), offers one example.

In Bard, plaintiff Donna Cisson, who suffered from pelvic organ prolapse and stress urinary incontinence, was implanted with C.R. Bard's Avaulta Plus transvaginal mesh medical device on May 6, 2009. She had received the proper warnings about possible complications and side-effects of the surgery and the device itself, and gave her consent. Three months after surgery, Cisson's doctor diagnosed her as having an adhesion band of scar tissue running across her vagina. This scar tissue was causing Cisson pain, so Dr. Brian Raybon, who had performed the implant surgery, resected the mesh; this required cutting out scar tissue and the mesh encased in that tissue. Dr. Raybon considered the resection to be a success and advised Cisson to return in a year. Cisson, however, was apparently not satisfied with her condition and sought a second opinion from Dr. John Miklos, who removed what he could of the Avaulta Plus from Cisson's body, though part of it could not feasibly be excised.

Cisson filed suit against Bard in March 2011, claiming that because of the implant and removal she had lost sexual feeling, and that intercourse had become painful. She asserted claims of negligent inspection, marketing, packaging and selling; manufacturing defect; breach of warranty; design defect; loss of consortium; and failure to warn. Cases similar to Cisson's had already been consolidated, and the multidistrict litigation (MDL) was transferred to the Southern District of West Virginia in 2010. Cisson's case, to which Georgia substantive law applied, was added to the MDL, and was the first of the MDL's cases to reach a jury verdict.

The district court allowed Cisson's claims — for design defect, failure to warn and loss of consortium — to go to trial. There, she presented expert evidence to back her claims that the Avaulta Plus device's anchoring mechanism caused ongoing pain and that its mesh was subject to shrinkage after implantation, which can lead to a rigid scar plate and increasing tension on internal tissues. Further, her experts testified that polypropylene in the device could be rejected by the body, causing inflammation and degradation of the mesh.

Bolstering this argument, Cisson provided evidence that Bard knew the polypropylene used to make its product was recognized by its supplier, the Phillips Sumika Polypropylene Company, as unsuitable for long-term implantation into humans. She alleged that Phillips had warned Bard of this problem and that Bard had taken steps to hide this information.

The court did now allow Bard to present evidence that it had complied with the FDA's Section 510(k) product safety process before bringing the Avaulta Plus to market. Bard was permitted to argue to the jury that the Avaulta Plus was similar to the Avaulta Classic device, that the latter had been on the market for years and had a good safety record, and that Bard had done everything necessary to ensure the safety of the Avaulta Plus, but Bard was not allowed to cite to its compliance with the FDA's 510(k) by showing its device was substantially similar to the Avaulta Classic. The trial court based the exclusion of Bard's compliance with the 510(k) process on Federal Rule of Evidence (FRE) 402 (lack of relevance), and on FRE 403, which allows exclusion even of relevant evidence if it is substantially more prejudicial than probative.

In August 2013, the jury awarded Cisson $250,000 in compensatory damages on the design defect and failure-to-warn claims. She was also awarded $1,750,000 in punitive damages, a quarter of which was to go to the plaintiff and the remainder to the State of Georgia.

Bard appealed. One of the bases for appeal was the trial court's refusal to admit into evidence Bard's compliance with the requirements of 510(k). The U.S. Court of Appeals for the Fourth Circuit affirmed, not reaching the question of lack of relevance under FRE 402 because it could base its decision on FRE 403 alone.

First, the appeals court noted that Bard could point to nothing indicating that Georgia law requires evidence of regulatory compliance to be admitted in all cases regardless of probative value or prejudicial effect. So the court moved forward to decide whether the probative value of the evidence of 510(k) compliance was substantially outweighed by the danger of confusing the jury.

Because Cisson's claim for design defect was controlled by Georgia product liability law, the court applied Georgia's “risk-utility” test for product liability claims, which require the trial court to “evaluate design defectiveness under a test balancing the risks inherent in a product design against the utility of the product so designed.” Banks v. ICI Americas, Inc., 264 Ga. 732 (Ga. 1994). According to Banks, incorporated in this balancing test is the concept of reasonableness, so that the question in this case became whether Bard acted in a reasonable manner when choosing to design the Avaulta Plus in the way it did, given the probability and the seriousness of the risk of injury, the usefulness of the mesh device in that condition, and the burden it would have posed on Bard to eliminate the risk by using a different design. Given this standard of reasonableness, Bard argued that evidence of its compliance with the 510(k) process should have been admitted, as it showed Bard acted reasonably.

However, “Assuming without deciding that the 510(k) compliance evidence is relevant,” stated the court, “under Georgia's risk-utility test the probative value of that evidence must depend on the extent to which the regulatory framework safeguards consumer safety.” The Fourth Circuit found that the fact that the 510(k) process was completed in accordance with the law before the Avaulta Plus entered the market did not also mean that rigorous safety review had been accomplished through it. All it showed was that the Avaulta Plus device was substantially similar to one already on the market that also had never gone through a rigorous PMA review. The court explained: “While 510(k) clearance might, at least tangentially, say something about the safety of the cleared product, it does not say very much that is specific.”

In fact, the court continued, the U.S. Supreme Court has specifically held that state law product liability claims are not preempted by federal law in the case of 510(k)-compliant products because approvals under this regime do not amount to a safety regulation requiring a manufacturer to meet design standards. Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996). The issue in Medtronic had been different, but the court found the Supreme Courts analysis there to be persuasive of how the Court would have viewed the issue in Bard: that evidence of 510(k) compliance was not highly probative to the question of whether the Avaulta Plus was a safe device.

The court moved next to the risks admittance of the evidence would pose. It found that if Bard's 510(k) evidence had been admitted, the risk of confusing the jury would have been substantial, as a “mini-trial” would have ensued involving argument over the strengths and weaknesses of the 510(k) process and whether Bard had disclosed all that it should have to the FDA. The appeals court agreed with the trial court on this point, which it noted had “expressed concern that subjecting the jury to many hours, and possibly days, of complex testimony about regulatory compliance could lead jurors to erroneously conclude that regulatory compliance proved product safety. In other words, having a 'mini-trial' could easily inflate the perceived importance of compliance and distract the jury from the central question before it — whether Bard's design was unreasonable based on any dangers it posed versus the costs required to avoid them.”

Because the probative value of the 510(k) evidence was minimal, while the risk of confusion to the jury was great if it were admitted, the court concluded the district court did not abuse its discretion by excluding the 510(k) evidence.

Punitive Damages

Bard also argued that the 510(k) compliance evidence would have been particularly relevant to the issue of whether punitive damages were warranted, and so it should have been admitted. The gist of the company's argument on this point was that Georgia Code Annotated § 51-12-5.1(b) permits punitive damages where there is clear and convincing evidence of “willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which would raise the presumption of conscious indifference to consequences,” yet Georgia case law suggests that this high willfulness standard is not met when compliance with regulations is shown. Barger v. Garden Way, Inc., 231 Ga. App. 723 (Ga. App. 1998).

The appellate court was unconvinced, returning to the conclusion that compliance with the 510(k) process says very little about safety standards and “[t]hus, the decision to pursue 510(k) clearance was a choice to minimize the burden of compliance, potentially cutting in favor of punitive damages. See Anastasi v. Wright Med. Tech., Inc., 16 F. Supp. 3d. 1032, 1036-37 (E.D. Mo. 2014) (finding that defendant chose the FDA 510(k) process to 'avoid the safety reviews, including clinical trials, required for pre-market approval under FDA regulations').” Therefore, while the district court would have been within its rights to allow the 510(k) evidence to go before the jury for the purpose of deciding if punitive damages were warranted, it was not required to do so because the probative value of the evidence did not necessarily outweigh its tendency to confuse the issues and mislead the jury.

Bard had chosen to put itself in the position it now found itself in by avoiding the burden of undergoing the safety review of the PMA process in favor of the 510(k) process. Having done this, the trial court was not constrained to reward Bard for cutting corners by treating that type of approval as though it were tantamount to a full PMA review.

Another Basis for Denying Admission

In a more recent case, involving different plaintiffs and another vaginal mesh manufacturer that used the 510(k) process to bring its product to market, the U.S. Court of Appeals for the Eleventh Circuit came to the same conclusion that the Fourth Circuit had in Bard, holding that the trial court did not err in excluding evidence of 510(k) approval. Eghnayem v. Boston Scientific Corp., 2017 U.S. App. LEXIS 20432 (11th Cir. 10/19/17). One of the Eleventh Circuit's reasons was nearly identical to the Fourth Circuit's: that under FRE 403, the evidence could properly be excluded because its probative value did not outweigh its tendency to confuse the jury. Specifically, Boston Scientific's Pinnacle Pelvic Floor Repair Kit came to market through the 510(k) process, so it was not subjected to safety testing, and any evidence of the FDA's permission for it to be sold would likely confuse the jurors into thinking the product had been deemed safe by that agency.

But, unlike the Bard court, the Eleventh Circuit in Eghnayem also based its concurrence on FRE 402, holding that the proffered evidence was irrelevant. In doing so, it quoted the Eghnayem trial court, which had said, “If 510(k) does not go to a product's safety and efficacy — the very subjects of the plaintiffs' products liability claims — then evidence of BSC's compliance with 510(k) has no relevance to the state law claims in this case.”

Conclusion

Though not all courts have come to the same conclusion as the Fourth and Eleventh Circuits did in Bard and Eghnayem, the trend appears to be in this direction: Applicants bringing medical devices to the market under the 510(k) process will be judged to have proven almost nothing concerning their safety for use. Therefore, evidence of 510(k) approval is likely, at best, be deemed prejudicial and misleading, or it may simply be found irrelevant. In either case, the evidence probably will not get to the jury if the plaintiff objects.

*****
Janice G. Inman is Editor-in-Chief of Product Liability Law & Strategy.

In a drug or medical device injury case, one of the defense's most potent arguments often is that the product in question underwent U.S. Food and Drug Administration (FDA) approval, so the balance of its safety and efficacy has already been determined by the federal government to warrant distribution of the product. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken. Still, device makers have shown themselves anxious to present evidence of 510(k) approval to juries considering whether their products are safe for patients to use. Is the fact of 510(k) approval a relevant piece of evidence in this regard?

510(k) Approval

Manufacturers of medical devices that are intended for human use must obtain FDA approval before distributing them in the marketplace. They generally do so through compliance with the Medical Device Amendments of 1976 (MDA) to the Federal Food Drug and Cosmetics Act (FD&C Act), which became law on May 28, 1976, and which were enacted in order to “impose[ ] a regime of detailed federal oversight” over medical devices. Riegel v. Medtronic, Inc. , 552 U.S. 312 (2008). In accordance with the MDA, medical devices are sorted into three categories — Class I, II, or III. Devices in Class I (such as dental floss) are the least dangerous and invasive types of devices, and receive the least federal scrutiny before they can be sold. Those in Class III are the most important for supporting life or preventing illness, and/or are those that pose the most risk. Therefore, Class III medical devices receive the most government scrutiny prior to approval — any such device entering the market after May 28, 1976, must go through the premarket approval (PMA) process.

The PMA process requires the applicant to show with “reasonable assurance” that the device it wants to market is “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, (2001); 21 U.S.C. § 360e(d)(2)(A), (B).

However, Class III medical devices that were already being used prior to May 28, 1976, were not pulled from the market and required to go through the PMA process before returning, as that would have resulted in chaos for manufacturers, regulators and people dependent on access to those devices. The MDA allowed these pre-amendment devices to remain on the market until such time as the FDA decides to subject them to the full PMA process; all they needed to do was go through the less-arduous 510(k) process. Eventually, all pre-amendment devices will be required to obtain approval through the PMA process, but only when told to do so. As many of these pre-amendment products have not yet been called upon by the FDA to prove their safety and effectiveness through the PMA process, their manufacturers simply have been permitted to continue to sell them to this day, subject only to the requirement that they have been cleared through the 510(k) process.

But in order to avoid creating monopolies, pre-amendment manufacturers are not the only ones able to take advantage of the 510(k) process. When a manufacturer other than one that sold a particular device pre-amendment desires to enter into the market with a substantially similar competing product, that manufacturer's product will be subject to the same requirements as the pre-amendment device. In other words, the new product will have to go through the 510(k) process, but not the full PMA process, before it can be sold. To qualify, it must be demonstrated that the new device is at least as safe and effective as the comparable one already on the market.

The process of 510(k) approval is much less onerous than that for a PMA: It costs a fraction of the average $280,000 PMA fee — generally, less than $5,000; it requires no clinical trials; and it is completed more quickly than a PMA. So a device allowed to be marketed by the FDA under the 510(k) method comes to market more easily and cheaply. However, it has not undergone rigorous safety and effectiveness reviews. It need only be as safe as its substantial equivalent — the one on the market before 1976, which also has not undergone PMA review.

Evidence of Safety?

Like manufacturers of devices that have come to market since 1976 and have gone through the full PMA process, those whose products have been asked only to go through the 510(k) process have an interest in letting juries know that their products have been deemed safe by the FDA. But does passage through the 510(k) process mark a product with an FDA “Safe” stamp? Device manufacturers want to herald their 510(k) approvals to juries as just that, but courts are not always buying it. The case of In re C.R. Bard, Inc. , MDL No. 2187, Pelvic Repair System Products Liability Litigation , 810 F.3d 913 (4th Cir. 2016), offers one example.

In Bard, plaintiff Donna Cisson, who suffered from pelvic organ prolapse and stress urinary incontinence, was implanted with C.R. Bard's Avaulta Plus transvaginal mesh medical device on May 6, 2009. She had received the proper warnings about possible complications and side-effects of the surgery and the device itself, and gave her consent. Three months after surgery, Cisson's doctor diagnosed her as having an adhesion band of scar tissue running across her vagina. This scar tissue was causing Cisson pain, so Dr. Brian Raybon, who had performed the implant surgery, resected the mesh; this required cutting out scar tissue and the mesh encased in that tissue. Dr. Raybon considered the resection to be a success and advised Cisson to return in a year. Cisson, however, was apparently not satisfied with her condition and sought a second opinion from Dr. John Miklos, who removed what he could of the Avaulta Plus from Cisson's body, though part of it could not feasibly be excised.

Cisson filed suit against Bard in March 2011, claiming that because of the implant and removal she had lost sexual feeling, and that intercourse had become painful. She asserted claims of negligent inspection, marketing, packaging and selling; manufacturing defect; breach of warranty; design defect; loss of consortium; and failure to warn. Cases similar to Cisson's had already been consolidated, and the multidistrict litigation (MDL) was transferred to the Southern District of West Virginia in 2010. Cisson's case, to which Georgia substantive law applied, was added to the MDL, and was the first of the MDL's cases to reach a jury verdict.

The district court allowed Cisson's claims — for design defect, failure to warn and loss of consortium — to go to trial. There, she presented expert evidence to back her claims that the Avaulta Plus device's anchoring mechanism caused ongoing pain and that its mesh was subject to shrinkage after implantation, which can lead to a rigid scar plate and increasing tension on internal tissues. Further, her experts testified that polypropylene in the device could be rejected by the body, causing inflammation and degradation of the mesh.

Bolstering this argument, Cisson provided evidence that Bard knew the polypropylene used to make its product was recognized by its supplier, the Phillips Sumika Polypropylene Company, as unsuitable for long-term implantation into humans. She alleged that Phillips had warned Bard of this problem and that Bard had taken steps to hide this information.

The court did now allow Bard to present evidence that it had complied with the FDA's Section 510(k) product safety process before bringing the Avaulta Plus to market. Bard was permitted to argue to the jury that the Avaulta Plus was similar to the Avaulta Classic device, that the latter had been on the market for years and had a good safety record, and that Bard had done everything necessary to ensure the safety of the Avaulta Plus, but Bard was not allowed to cite to its compliance with the FDA's 510(k) by showing its device was substantially similar to the Avaulta Classic. The trial court based the exclusion of Bard's compliance with the 510(k) process on Federal Rule of Evidence (FRE) 402 (lack of relevance), and on FRE 403, which allows exclusion even of relevant evidence if it is substantially more prejudicial than probative.

In August 2013, the jury awarded Cisson $250,000 in compensatory damages on the design defect and failure-to-warn claims. She was also awarded $1,750,000 in punitive damages, a quarter of which was to go to the plaintiff and the remainder to the State of Georgia.

Bard appealed. One of the bases for appeal was the trial court's refusal to admit into evidence Bard's compliance with the requirements of 510(k). The U.S. Court of Appeals for the Fourth Circuit affirmed, not reaching the question of lack of relevance under FRE 402 because it could base its decision on FRE 403 alone.

First, the appeals court noted that Bard could point to nothing indicating that Georgia law requires evidence of regulatory compliance to be admitted in all cases regardless of probative value or prejudicial effect. So the court moved forward to decide whether the probative value of the evidence of 510(k) compliance was substantially outweighed by the danger of confusing the jury.

Because Cisson's claim for design defect was controlled by Georgia product liability law, the court applied Georgia's “risk-utility” test for product liability claims, which require the trial court to “evaluate design defectiveness under a test balancing the risks inherent in a product design against the utility of the product so designed.” Banks v. ICI Americas, Inc. , 264 Ga. 732 (Ga. 1994). According to Banks, incorporated in this balancing test is the concept of reasonableness, so that the question in this case became whether Bard acted in a reasonable manner when choosing to design the Avaulta Plus in the way it did, given the probability and the seriousness of the risk of injury, the usefulness of the mesh device in that condition, and the burden it would have posed on Bard to eliminate the risk by using a different design. Given this standard of reasonableness, Bard argued that evidence of its compliance with the 510(k) process should have been admitted, as it showed Bard acted reasonably.

However, “Assuming without deciding that the 510(k) compliance evidence is relevant,” stated the court, “under Georgia's risk-utility test the probative value of that evidence must depend on the extent to which the regulatory framework safeguards consumer safety.” The Fourth Circuit found that the fact that the 510(k) process was completed in accordance with the law before the Avaulta Plus entered the market did not also mean that rigorous safety review had been accomplished through it. All it showed was that the Avaulta Plus device was substantially similar to one already on the market that also had never gone through a rigorous PMA review. The court explained: “While 510(k) clearance might, at least tangentially, say something about the safety of the cleared product, it does not say very much that is specific.”

In fact, the court continued, the U.S. Supreme Court has specifically held that state law product liability claims are not preempted by federal law in the case of 510(k)-compliant products because approvals under this regime do not amount to a safety regulation requiring a manufacturer to meet design standards. Medtronic, Inc. v. Lohr , 518 U.S. 470, 493 (1996). The issue in Medtronic had been different, but the court found the Supreme Courts analysis there to be persuasive of how the Court would have viewed the issue in Bard: that evidence of 510(k) compliance was not highly probative to the question of whether the Avaulta Plus was a safe device.

The court moved next to the risks admittance of the evidence would pose. It found that if Bard's 510(k) evidence had been admitted, the risk of confusing the jury would have been substantial, as a “mini-trial” would have ensued involving argument over the strengths and weaknesses of the 510(k) process and whether Bard had disclosed all that it should have to the FDA. The appeals court agreed with the trial court on this point, which it noted had “expressed concern that subjecting the jury to many hours, and possibly days, of complex testimony about regulatory compliance could lead jurors to erroneously conclude that regulatory compliance proved product safety. In other words, having a 'mini-trial' could easily inflate the perceived importance of compliance and distract the jury from the central question before it — whether Bard's design was unreasonable based on any dangers it posed versus the costs required to avoid them.”

Because the probative value of the 510(k) evidence was minimal, while the risk of confusion to the jury was great if it were admitted, the court concluded the district court did not abuse its discretion by excluding the 510(k) evidence.

Punitive Damages

Bard also argued that the 510(k) compliance evidence would have been particularly relevant to the issue of whether punitive damages were warranted, and so it should have been admitted. The gist of the company's argument on this point was that Georgia Code Annotated § 51-12-5.1(b) permits punitive damages where there is clear and convincing evidence of “willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which would raise the presumption of conscious indifference to consequences,” yet Georgia case law suggests that this high willfulness standard is not met when compliance with regulations is shown. Barger v. Garden Way, Inc. , 231 Ga. App. 723 (Ga. App. 1998).

The appellate court was unconvinced, returning to the conclusion that compliance with the 510(k) process says very little about safety standards and “[t]hus, the decision to pursue 510(k) clearance was a choice to minimize the burden of compliance, potentially cutting in favor of punitive damages. See Anastasi v. Wright Med. Tech. , Inc. , 16 F. Supp. 3d. 1032, 1036-37 (E.D. Mo. 2014) (finding that defendant chose the FDA 510(k) process to 'avoid the safety reviews, including clinical trials, required for pre-market approval under FDA regulations').” Therefore, while the district court would have been within its rights to allow the 510(k) evidence to go before the jury for the purpose of deciding if punitive damages were warranted, it was not required to do so because the probative value of the evidence did not necessarily outweigh its tendency to confuse the issues and mislead the jury.

Bard had chosen to put itself in the position it now found itself in by avoiding the burden of undergoing the safety review of the PMA process in favor of the 510(k) process. Having done this, the trial court was not constrained to reward Bard for cutting corners by treating that type of approval as though it were tantamount to a full PMA review.

Another Basis for Denying Admission

In a more recent case, involving different plaintiffs and another vaginal mesh manufacturer that used the 510(k) process to bring its product to market, the U.S. Court of Appeals for the Eleventh Circuit came to the same conclusion that the Fourth Circuit had in Bard, holding that the trial court did not err in excluding evidence of 510(k) approval. Eghnayem v. Boston Scientific Corp., 2017 U.S. App. LEXIS 20432 (11th Cir. 10/19/17). One of the Eleventh Circuit's reasons was nearly identical to the Fourth Circuit's: that under FRE 403, the evidence could properly be excluded because its probative value did not outweigh its tendency to confuse the jury. Specifically, Boston Scientific's Pinnacle Pelvic Floor Repair Kit came to market through the 510(k) process, so it was not subjected to safety testing, and any evidence of the FDA's permission for it to be sold would likely confuse the jurors into thinking the product had been deemed safe by that agency.

But, unlike the Bard court, the Eleventh Circuit in Eghnayem also based its concurrence on FRE 402, holding that the proffered evidence was irrelevant. In doing so, it quoted the Eghnayem trial court, which had said, “If 510(k) does not go to a product's safety and efficacy — the very subjects of the plaintiffs' products liability claims — then evidence of BSC's compliance with 510(k) has no relevance to the state law claims in this case.”

Conclusion

Though not all courts have come to the same conclusion as the Fourth and Eleventh Circuits did in Bard and Eghnayem, the trend appears to be in this direction: Applicants bringing medical devices to the market under the 510(k) process will be judged to have proven almost nothing concerning their safety for use. Therefore, evidence of 510(k) approval is likely, at best, be deemed prejudicial and misleading, or it may simply be found irrelevant. In either case, the evidence probably will not get to the jury if the plaintiff objects.

*****
Janice G. Inman is Editor-in-Chief of Product Liability Law & Strategy.