Evidence of FDA’s 510(k) Clearance. Admissible or Not?


Medical devices, implants and tools are used daily by people and medical personnel all over the country and are intended to improve the overall health and quality of life in patients. These medical devices are often intended to prevent or protect against certain medical dangers or injuries during the course of performing medical treatment or surgery.

However, what happens when the medical device or implant causes an injury to the patient? Such an occurrence will likely result in the pursuit of a product liability lawsuit against the manufacturer by the injured patient. During the course of litigation, the issue of the U.S. Food and Drug Administration’s (FDA) 510(k) clearance process of the subject medical device will likely arise. The FDA’s 510(k) process is one way to introduce new medical devices or implants to the market. In pursuing the 510(k) approval route, the manufacturer will submit an application to the FDA seeking clearance under the 510(k) process. Among other items, the 510(k) application will include a description of the medical product and the intended use of the product. Further, the application will reference other similar products that are on the market being used in a substantially similar manner.

While we would like to believe that the FDA is conducting a thorough and complete analysis of each medical product that is on the market, this is not the case. The FDA was never set up in this manner and simply does not have the resources to conduct such an analysis on every product. This type of in-depth, thorough evaluation is reserved for a different class of medical devices and implants, which is known as Pre-Market Approval (PMA).

In evaluating a new device under the 510(k), the FDA simply determines if the new device is substantially equivalent to that of any predicate device or implant already on the market. Typically, the manufacturer will reference the substantially equivalent devices in the application. It is important to remember that “substantial equivalence” does not mean identical. Many times, there are meaningful design differences between these products. Nevertheless, if the FDA deems the product to be substantially equivalent to the predicate device, then the medical product is cleared and available for marketing.

Issues regarding the admissibility of a product that has undergone the 510(k) clearance process will be the basis of many disputes and motions during the litigation of any product liability case involving a medical product cleared in this manner. Plaintiff’s attorneys will argue that:

  • the evidence of the 510(k) clearance process is inadmissible.
  • such evidence is irrelevant and immaterial because the 510(k) process is tantamount to rubber stamping a new product and that the FDA does not evaluate the efficacy or the safety prior to providing clearance.
  • the evidence is misleading and that any probative value is substantially outweighed by unfair prejudice under Rule of Evidence 403. The unfair prejudice arises from the unjustified emphasis or importance that a jury might place on an FDA cleared medical product.

On the other hand, the defense attorney will argue in favor of admissibility and attempt to establish that the 510(k) process is rigorous and that the medical product is scrutinized for safety. Who’s correct?

While this issue will continue to unfold in the months and years to come, the Fourth Circuit Court of Appeals in Cisson v C.R. Bard, Inc., made the argument for the medical manufacturer a little harder when it ruled that all evidence of the FDA’s 510(k) clearance of a Class II medical device was inadmissible evidence because its prejudicial effect substantially outweighed its probative value. 810 F.3d 913, 923 (4th Cir. 2016).

One issue that will arise is whether or not the 510(k) process determines if the medical device is safe. As stated earlier, the process requires finding that the new device is substantially equivalent to a predicate device. 21 U.S.C. § 360c(i)(1A). This requires the FDA to determine that the device has the same technological characteristics of the predicate device, or there is data showing the device is as safe and effective as the predicate device. Id. The Cisson court stated that the FDA’s 510(k) process allows devices to “avoid the strict safety testing requirements” that are required by the more rigorous testing of the Medical Device Amendments to the FDCA. Cisson, 810 F.3d at 920. Furthermore, the court went on to say that the 510(k) process “operate(s) to exempt devices from rigorous safety review procedures.” Id

Similar to the defendant in Cisson, a defense attorney for a medical device manufacturer would likely argue that the evidence of the 510(k) process is admissible to show that the defendant acted reasonably in designing and manufacturing the device and was following the guidelines of the FDA, assuming the plaintiff has filed a negligence action. The defense attorney could attempt to use the reasonableness argument as a way to side step the ruling in Cisson, which held that the evidence regarding the safety of testing in the 510(k) process had a very real possibility of misleading the jury and was therefore inadmissible. Id at 923. Even if a defense attorney argued that the evidence showed that the defendant acted reasonably, and thus, increasing the probative value of the evidence, a court would likely follow the precedent established in Cisson. It is likely that a trial court would still conclude that the potential for confusing and misleading the jury outweighs the probative value of the 510(k) process evidence.

A plaintiff’s attorney is likely to persuade a judge to exclude evidence of the FDA’s 510(k) process by arguing that the evidence is inadmissible because of the danger of misleading the jury, regardless of the safety testing. Although, as stated above, a defense attorney can try to get around the safety argument, they will likely not prevail. The court in In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., was faced with deciding whether the 510(k) process was relevant without regards to the process determining the safety of the product. MDL No. 2004, 2015 WL 7863032, at *6 (M.D. Ga. Dec. 3, 2015). The court decided that the evidence may be slightly relevant, but the relevance was nonetheless substantially outweighed by the danger of unfair prejudice, as well as, the potential to mislead the jury. Id. Therefore, in a pretrial motion in limine, a judge would likely grant the plaintiff’s motion and agree that the evidence of the 510(k) process would confuse and mislead the jury.

If a medical device causes injury to a person, and that device was “cleared” through the FDA’s 510(k) process, there will likely be a dispute regarding the evidence of that process at some point during the litigation. As a result of the holding in Cisson, the plaintiff’s attorney is in a better position to have that evidence excluded. There may be a few options the defense can take to avoid this outcome, but they will likely fail. Although the evidence may be slightly relevant, it would still be substantially outweighed by the danger of misleading and confusing the jury.


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