Medical devices – FDA 510(k) clearance does not create a rebuttable presumption of non-defectiveness.

Today’s case, Johnson v. C.R. Bard, Inc. (7th Cir., No. 22-2610, 8/11/2023) involves injuries caused by an interior vena cava (IVC) filter.  It caught my eye because in 2021 I referred three experts – a vascular surgeon, a biomedical engineer, and an FDA medical device regulation expert – for an IVC filter case against a different manufacturer.  Both Johnson and my case were removed to the federal MDLs for cases against the respective manufacturers.  My case settled, presumably after one or more bellwether trials (see  Johnson didn’t settle and was remanded to its home base, the U.S. District Court for the Western District of Wisconsin, for trial. 

The opinion begins with a concise and cogent summary of the facts:

Hoping to minimize her risk of suffering serious complications from future blood clots, plaintiff Natalie Johnson underwent surgery to implant a retrievable intravascular filter.  Intravascular filters are medical devices that are placed in the inferior vena cava (the major lower vein that carries blood to the heart) to prevent blood clots that develop in the lower body from flowing into the heart and lungs.  Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removeable.  It was not.  Instead, Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere.  Her surgeon was unable to remove the device safely and fully.  She now faces an ongoing risk of infection, pain, and other complications as a result of the broken filter.

The plaintiff presented four theories of liability:  negligent defective design, strict liability defective design, negligent failure to warn, and strict liability failure to warn.  The jury found for the defense on the first three theories but returned a $3.3 million verdict for the plaintiff on the strict liability failure to warn theory.  “Bard moved for a new trial on a host of issues, but the district court denied the motion in its entirety.  On appeal, Bard renews three of its post-trial arguments.”  The first two arguments involved objections to testimony by the plaintiff’s treating physician and by one of her experts.  The circumstances surrounding the objected-to testimony were fact-specific and therefore not of broad interest, and the Seventh Circuit held that the district judge did not abuse her discretion in allowing the testimony.  Its disposition of the third argument is the reason for this post, as it is of interest to all trial lawyers, both plaintiff and defense, who handle medical device product liability cases.  Although Wisconsin law applied in this diversity jurisdiction case, I have no doubt that other states have similar laws – indeed, the opinion cites one of the Seventh Circuit’s own cases that involved an analogous Indiana statute.

Wisconsin law considers a manufacturer to be strictly liable for a product that is defective because of inadequate instructions or warnings.… If, however, there is evidence that the product, at the time of sale, complied in material respects with relevant standards, conditions, or specifications adopted or approved by a federal or state law or agency, then the manufacturer is entitled to a rebuttable presumption that the product is not defective.… Bard argues that the fact that the Meridian filter received 510(k) clearance from the FDA means that the filter complied…with relevant standards…adopted or approved by a federal…agency, and thus as a matter of state law it is presumed not to be defective.  But Bard overstates the impact of 510(k) clearance for present purposes.

The FDA categorizes medical devices as Class I, Class II, or Class III.  New devices are considered Class III devices by default and therefore must go through a rigorous regime of premarket approval.  One exception, however, is key.  A new device need not undergo premarket approval if it is “substantially equivalent” to a Class I or Class II device already on the market….

There are two ways to show substantial equivalence if the new device has the same intended use as the predicate device.  The new device may have the same technological characteristics as the predicate device, or be as safe and effective as the predicate and not raise different questions of safety and effectiveness.  (Emphasis in original.)  Critically for our purposes, this means that a device can receive 510(k) clearance based on its technological similarity to another device without an inquiry into the safety of the new device.  (Emphasis added.)  In addition, the statutory scheme authorizes “piggybacking” – i.e., clearing a device based on its substantial equivalence to a predicate device that itself received clearance through substantial equivalence….

The district court in the present case concluded that the line of substantial-equivalence findings that Bard’s filter depended on did not demonstrate compliance with relevant federal safety standards.  We agree with this reasoning.  Bard did not show that the 510(k) clearance of its Meridian filter was based on the FDA’s determination that it complied with any specific safety standards, rather than its similarity to previously approved devices….

We conclude that the district court did not err in holding that the evidence that Bard proffered regarding its 510(k) clearance was insufficient to show that it materially complied with relevant federal safety standards.  Therefore, the district court did not err by refusing to instruct the jury that there was a rebuttable presumption that the Meridian filter was not defective for failure to warn.  (Citations and internal quotation marks omitted.)

It is theoretically possible that a manufacturer might choose to establish substantial equivalence by showing that a new device is as safe and effective as the predicate device.  I presume that would take more time and effort than showing technological similarity to the predicate device, which the pernicious practice of piggybacking encourages.  Still, I think it would be a wise move, because a showing of compliance with relevant federal safety standards would entitle the device to the rebuttable presumption of non-defectiveness provided by Wisconsin, Indiana, and no doubt many other states.  Plaintiff and defense counsel need to be equally aware of the important distinction between technological similarity substantial equivalence on the one hand, and safety/effectiveness substantial equivalence on the other, in the event one of the latter ever shows up.


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