Jan 2, 2019
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Hoosier Daddy, Part 510(k): FDA Clearance is Admissible

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It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern District of Indiana in the Cook IVC filters litigation. Here is one we found hidden in the toe of our Christmas stocking: In re Cook Medical, Inc., IVC Filters Marketing, Sales Practices and Product Liability Litigation, 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018). It is nice enough; it is not as if we are going to drive to the mall and return it. But there are some parts to it that we don’t love so much. Those parts are like ugly socks that we deposit in the bottom of a drawer and hope never to see again.

The plaintiff moved in limine to preclude evidence of 510(k) clearance of the medical device. The primary basis for such preclusion was Federal Rule of Evidence 402 – lack of relevance because the 510(k) process does not provide a reasonable assurance of the device’s safety and efficacy. That’s the argument, anyway. Prior to the pelvic mesh litigation, that argument was a sure loser. But, sadly, a couple of the pelvic mesh courts have swallowed this bogus argument hook, line and stinker. (Then again, we know of at least one recent non-mesh decision that rejected the no-510(k) argument, and we were so pleased that we deemed that decision one of the ten best of last year.)

As we have shown in a previous walk-through of this issue, the exclusion of 510(k) clearance is based on an over- or misreading of the SCOTUS Lohr decision, where the High Court contrasted the less rigorous 510(k) process with the Pre-Market Approval process. Lohr included loose language about how 510(k) clearance was limited to substantial equivalence with a predicate, rather than an independent demonstration of safety and efficacy. But SCOTUS itself subsequently reeled in that loose language in Buckman, recognizing that substantial equivalence was, in fact, a way of establishing safety. Moreover, the FDA itself subsequently tinkered with the 510(k) process and its characterization of it so as to make clear that 510(k) clearance is about safety. It is not as if the FDA would clear products it does not believe are safe. So where are we, or where should we be, when it comes to 510(k) clearance? Such clearance might not be enough to preempt a state law tort, but it is still relevant to legitimate defenses and should, therefore, be admissible.

Where does the S.D. Indiana Cook decision fit on the spectrum? It is probably more to the good (pro-defense) side, but not quite as far as we would like. The fact of FDA 510(k) clearance comes in. That’s good. At least the jury will not be under the misimpression that the company unleashed a product on the populace willy-nilly, with no governmental oversight. But … well there’s a big but. (We knew a fellow defense hack who never missed an opportunity to use that phrase in diet drug litigation to get a cheap laugh).

Interestingly, the S.D. Indiana analysis turned on an interpretation of Georgia’s risk utility test for design defect cases, and Georgia law was also at issue in one of the very bad mesh decisions in this area (that we will not and, for reasons of our existing litigation entanglements, cannot name.) Georgia law incorporates the concept of ‘reasonableness,’ i.e., whether the manufacturer acted reasonably in choosing a particular product design. FDA clearance is relevant to such reasonableness. The S.D. Indiana court held that both the plaintiff and the defendant, through appropriate expert testimony, “will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices like IVC filters, and [Cook’s] participation in the 510(k) process and its compliance (or lack thereof) with the process.”

What do we think of this ruling? It is both good and bad. It is good (and absolutely correct) that clearance comes in. But it is bad, because it seems to welcome plaintiff ‘expert’ testimony that instructs the jury on the law. Why should an expert be able to tell the jury that the company did not comply with the FDA process? Isn’t the fact of clearance itself proof that there was compliance? Is the plaintiff arguing that the FDA erred when it cleared product? Shouldn’t that be up to the FDA? Given the extensive publicity accompanying any mass tort litigation, wouldn’t the FDA have corrected its error, if there really was error? Or is the plaintiff arguing that the FDA cleared the product only because the company hid data and hoodwinked the FDA? If we are not squarely in Buckman-land, are we not at least Buckman-adjacent? Don’t the selfsame policies of deferring to the FDA apply? In other words, isn’t plaintiff’s anti-clearance position preempted?

Thus there is a part of the S.D. Indiana’s ruling that reeks to our (admittedly oversensitive) noses. The defendant is not permitted to present evidence or argument that the FDA’s 510(k) clearance of the device constitutes a finding by the FDA that the device is safe and effective. As set forth above, that ruling is factually incorrect. By contrast, the plaintiff “may present evidence that the FDA clearance process only requires substantial equivalence to a predicate device, that 501(k) regulations are not safety regulations, that Plaintiff’s filter placement was “off label,” and the like.” Wrong, wrong, and whatever “the like” means, we’re sure that’s wrong, too. The 510(k) process does, indeed, address safety. The notion is that relying on a predicate device that was already approved or cleared is a good proxy for safety. There is plenty of regulatory history showing that by devising the 510(k) process, the FDA was not waving bye-bye to the value of safety. Meanwhile, we will all be treated to a blow-hard plaintiff regulatory expert who will take us on a tour of FDA regulations and company documents to tell a tale of a bad company and an overmatched federal government. Some fun. This expert testimony amounts to a preview of the plaintiff’s closing argument. It is so gruesome that we have heard some defense lawyers say that they would just as soon omit the regulatory story altogether. But that’s defeatism. The right result would be for the fact of 510(k) clearance to come in, and then full-stop. There is no need for expert interpretation or interpolation. So for all the trial judges out there who complain that drug and device trials go on too long, here’s an answer: shut down the expert testimony that purports to teach the jury about the regulatory process “and the like.” Always beware of “the like.” And be on guard against “etc.” and “whatnot” as well.

But let’s get back to the good bits of the S.D. Indiana Cook decision. The defendant will be allowed to offer evidence that the device was never recalled by the FDA, that the FDA never observed any violation of the company’s quality system during its inspection between 2000 and 2014, and that the FDA never took any enforcement action against the company. This evidence is relevant to the defense that the design and development decisions were reasonable and that the product is safe. At least this court had some sense of balance.

The S.D. Indiana decision also dealt with the defendant’s effort to use an expert biomedical engineer to talk about the low rate of complaints. She worked at the FDA for over twenty years in various positions and currently serves as a consultant to companies seeking to obtain FDA approval or clearance of medical devices. The expert cited evidence that the device had a fracture rate of 0.066% and perforation rate of 0.153%. The defense expert calculated the occurrence rate by dividing the total number of complaints received by the company (numerator) by the product’s total sales (the denominator).

The plaintiff challenged this expert testimony because “there is no way to know whether these numbers are accurate. Some patients/hospitals may not report adverse events, and some IVC filters may have been sold to hospitals but not used in patients.” The company responded that it did not intend to offer the complaint/occurrence rates as the actual complication rates for the product. With that limitation, the Cook court held that the defense expert’s testimony was admissible.



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510(k) Clearance · FDA

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