July 29, 2013 Articles

The Case for Leaving the 510(k) Argument Out of a Pleading

By Prof. Jim O'Reilly

A well-written article in this issue brings a younger, fresher perspective to the defense of medical-device makers, and I encourage you to carefully consider those viewpoints. With due respect, I represent a very vanishing breed, the creators of the 1976 Medical Device Amendments, so it may be useful to have some history of the 510(k) "on the record" before this dinosaur fades from the scene.

"Medical devices" as a regulatory category had been ignored, sitting quietly in the corner of a very active regulatory field as bad drugs and foods were challenged from 1906 into the 1970s, and remained in obscurity as the Supreme Court struggled with diagnostic products in United States v. Bacto-Unidisk, 394 U.S. 784 (1969), a decision that had to stretch far to call diagnostics "drugs" for lack of any other vehicle for their regulation. By the mid-1970s, General Electric's painful experiences with bad electrical lead wires for heart pumps drew public attention to physical and mechanical objects that would not fit the "drug" world. Who would step in? The then-new (1972) consumer product safety legislation had excluded these human-use medical items, and there was reluctance in the post-Nixon era to create another federal agency. The Centers for Disease Control and Prevention, the National Institutes of Health, and the states all had some roles in the process, on issues as small as Massachusetts hearing aid rules, which gave impetus to the preemption provision of the 1976 law.

Reaching consensus on the Medical Device Amendments of 1976 was not too difficult by today's standards. General Electric, Abbott, Medtronic, and other big players were assured that the Food and Drug Administration's (FDA's) new drug approval delays would not be imposed. Hundreds of smaller medical products makers were assured that Congress would allow friendly industry-FDA committees to write Class II standards for most medical devices. As the youngest in-house lawyer at a large manufacturer that was starting a hospital-supplies sideline, I had the junior seat at the table, ready to absorb knowledge, just as my client's disposable paper drapes would be absorbing the cuttings of the surgeons—a role not dissimilar from the role of lobbying veterans who were crafting the new law in numerous rounds of drafts with FDA and House staffers.

We drafters faced a bridging problem. There was certainly going to be enough money for writing and adopting classification standards, defining what each existing set of devices would do and what their labels would say. But the FDA would not have enough engineers and scientists with time to vet all of the "me-too" competing look-alike products that would flow through its portals under section 510's registration powers. Once the classification rule had defined a device group, each new version would match up to that standard or would have to go through specific detailed approval; our benchmark was the success (as of that time) of FDA Chief Counsel Peter Hutt's 1972 genius in designing the over-the-counter (OTC) drug review. Under that system, me-too versions of aspirin or cold remedies would match the OTC standard and simply notify the FDA of their marketing and their compliant comparison with the standard.

The bridge of registration by adding (k) to section 510 was to be temporary while the classification standard was written. With all the brilliant self-promotion a young attorney can muster, I assured my client that we had arranged under new section 510(k) that our me-too versions of devices would rapidly zip through the FDA screening, with a, literally, one-page checklist comparing each newly registered item to an existing product that had been on the market as of May 28, 1976, the effective date of the bill that President Ford signed. And zip they did—few medical device firms opted for Class III premarket approval, FDA panels and scientists focused on the complex new surgical and life-sustaining items, and the 510(k) stimulated a great deal of attention. A tiny percentage were rejected, but the one-page reviews zoomed through the FDA mill.

This novel bridge was a pure "negative option"; sponsors said the device was "substantially equivalent" for safety and for effectiveness compared with older device X or Class II device Y. If the FDA said nothing in 90 days, the newly registered device was deemed cleared for market, because its predicate earlier device had been on sale before the new law was enacted. In early May 1976, a few weeks before the grandfathering date of "enactment," a truckload of my client's newest devices were shipped from Tennessee to Mississippi, making them "predicates" for future 510(k) me-too expansions. I treasured the invoice proving their actual interstate movement and became device "official correspondent" for our 510(k)s.

So the 510(k) me-too one-page checklist was launched, but the shock of domestic discretionary budget cuts on the Department of Health, Education, and Welfare aborted its plans for Class II standards writing. The OTC drug review has continued to this day, but there are not specific performance-focused standards for hundreds of medical devices in the FDA's regulations. Our 510(k), without the funds for FDA standards writing, became a bridge to nowhere. Bureaucracies faced with shortfalls make do as best they can, so the FDA slowly tightened the one-page review into some more detail. At a meeting with chief executive officers of device manufacturers  and their lawyers and new management of the FDA's device center, which I watched as a junior observer, FDA leaders began talks that showed a nascent desire for clinical trials to be done, even on me-too 510(k) products. The industry pushed back that the FDA did not have physicians to review the clinical data and that its budget would not allow for cautious doctors from the drug center to be imported as gatekeepers for device clearances. The rate of 510(k) questions slowly increased, and the Congress eventually signed off on the 1990 compromise that changed the "negative option" and required the FDA to say within 90 days whether the product was acceptable.

I was surprised when the Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), asserted that our drafting of the 1976 preemption provision meant to cover jury verdicts. No, it didn't at all; it was aimed at a Massachusetts hearing aid rule that the national lobby for hearing aid firms disliked. State "requirements" could be preempted, but the drafters did not debate jury verdicts at all.

Today, defense litigants are tempted to say to juries that a 510(k) is an FDA approval, so tort plaintiffs should lose. Creative advocacy? Yes. Accurate? No. The one-page checklists had cleared thousands of devices with silence and sometimes with "no objections," determined by one or two staffers in a matter of hours. Just as registration is easy under 510, so the claim of me-too status under 510(k) was meant to be easy, and for decades it was. I cannot reconstruct the budgeted hours assigned to this function inside the center responsible for this role, but the FDA did not spend dedicated detailed efforts on the fire-hose-like volume of registrations whose paperwork had few constraints after 1976.

Take it from one who was present at the creation: The concept offered to juries today, that the 510(k) has equaled regulatory approval, is an entertaining fantasy. After 1990, when there needed to be a formalized acceptance, the FDA did more clearance internally, but nothing like the premarket approval steps that the Supreme Court's decisions in Lohr and in Medtronic, Inc. v. Riegel, 552 U.S. 312 (2008), addressed. Be a good defense advocate with other claims, but leave the 510(k) argument out of a pleading, if you wish to be historically accurate and wish to pass the Rule 11 laugh test of creative motions.

Keywords: litigation, products liability, medical device, 510(k)

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