Premarket Approval by the FDA – why do we lose out?
Reading this recent law review article by Professor Ralph Hall, entitled “Rethinking Lohr: Does ‘SE’ Mean Safe & Effective, Substantially Equivalent, or Both?” 13 Minn. J. L. Sci. & Tech. 737 (2012). In brief, the article examines recent statutory and regulatory modifications to the “510k clearance process” that have occurred since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and concludes that it’s high time to re-examine Lohr’s restrictions on the use of preemption in non-PMA medical device litigation:
This article questions whether litigants and courts have ignored major statutory and regulatory changes in the FDA’s authority over medical devices and have too simplistically followed the Supreme Court’s decision in Medtronic, Inc. v. Lohr. We believe that this is exactly the situation and that the precedential value of Lohr is highly questionable.
13 Minn. J. L. Sci. & Tech. at 739 (footnote omitted). Professor Hall concludes, after reviewing the evolution of the 510k system in detail, that unlike the 1982 device clearance in Lohr, the FDA now (and has for some time) predicates device clearances on “safety and effectiveness” criteria:
Today, the FDA makes safety and effectiveness determinations for 510(k) medical devices in determining the classification of the new device, compared to the predicate device, and whether the new device is substantially equivalent or not substantially equivalent.
13 Minn. J. L. Sci. & Tech. at 789.
While much of Professor Hall’s article explores express preemption, we were gratified to see a discussion of the Mensing “impossibility” approach to implied preemption as applied to medical devices under the FDA’s regulations governing medical device alterations. 13 Minn. J. L. Sci. & Tech. at 768-769. We’ve had exactly the same thoughts ourselves.
Since most medical devices are not PMA approved, and preemption is the strongest legal defense there is, if you defend these sorts of products, we think you’ll find Professor Hall’s article most illuminating.
That’s the long one. Our other recommendation requires a lot less reading and (perhaps) more thinking. The other day, four life sciences industry groups sent a public letter (thanks to Fulbright and Jaworski for the link) to the Centers for Medicare and Medicaid Services asking that CMS hurry up and finalize its reporting regulations for the Physician Payments Sunshine Act.
Huh? Do you even know what that is?
You should, because it will affect your clients, and might well affect how you prepare and try your cases.
As the recent letter explains, as part of the Affordable Healthcare Act − which the Supreme Court recently upheld in large part − the health care industry is now required to report “payments to teaching hospitals, physicians, and physician ownership and investment interests.” Exactly what should be reported and how is now being sorted out. Read the letter for details.
Then think a bit.
These reports of “payments” will be public. Various financial ties between physicians − the plaintiffs’ prescribers/treaters, and both sides’ (but mostly our) experts − will soon be “transparent,” that is, generally available. Expect more learned intermediary rule challenges to physician “independence” due to financial ties − something we’ve discussed here.
Think about how this new statute is going to impact your cases; what juries will think about this type of information. There’s nothing in the legislation addressing (that is to say, precluding) admissibility of reported data in civil litigation.
Then also think about how to level the playing field.
There’s no reason not to seek discovery from plaintiffs’ experts to determine if they’ve received similar emoluments from plaintiff-side groups. It gets back to the level playing field we’ve argued for, particularly in the context if informal physician interviews. If this kind of information is discoverable/admissible as to our side, it should be equally discoverable/admissible as to entities on the other side of the “v.”
Source: Bexis to Drug and Device Law at 8/16/2012 03:55:00 PM
- Summer Reading (druganddevicelaw.blogspot.com)
- Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes (earlsview.com)
- Dems urge FDA to boost medtech recall database | MassDevice.com (earlsview.com)
- FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew (earlsview.com)
- Let’s Keep the Heat up on Smith and Nephew – Our Numbers vs. their Tactical Legal Maneuvering (earlsview.com)
- Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney (earlsview.com)
- Medical Device ” The Senate Passes Unparalleled Medical Device User Fee Act (earlsview.com)
- FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… (earlsview.com)
- FDA – Overview of Medical Device Regulation > Information about MDUFA III (earlsview.com)
- Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform (earlsview.com)