Permalink Well, I have argued more than once on these electronic pages that ERISA preemption, rather than being the whipping boy of choice for people who advocate state level health insurance mandates, should be understood as a key element in bringing about any type of effective change to the health insurance system. Because ERISA preemption forbids the states from enacting health insurance reform statues since states cannot enact them without either deliberately or unavoidably rejiggering employer provided - and thus ERISA governed - health plans, meaning that any real change from the current employer provided and voluntary health insurance system can only take place on a national level. And why is this in turn good? Because states are kidding themselves if they think that they can, financially, pull off reform of the system on their own, as this article here demonstrates yet again.
You can find those posts here and here. But before you get the wrong idea, the Third Circuit got the most important issue right — when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis.
Plaintiff suffered complications that required additional revision surgeries.
In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice.
The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds.
The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion.
To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Agreeing with the defense position, the court anchored its decision on three findings.
Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged: The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory.
But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Emphasis on the limited part.The World's most comprehensive professionally edited abbreviations and acronyms database All trademarks/service marks referenced on this site are properties of their respective owners.
Preemption Questions For Ill. Payroll Deduction IRA Plan an “employee pension benefit plan” within the meaning of ERISA or whether the program in operation may result in employers being.
Petitioner, FMC Corporation (FMC), operates the FMC Salaried Health Care Plan (Plan), an employee welfare benefit plan within the meaning of ERISA, § 3(1), 29 U.S.C. § (1), that provides health benefits to FMC employees and their dependents.
Regarding the exemption, ATA further reasons that if the federal off-duty break requirement presented a sufficient obstacle to the security plan regulations to warrant an exemption, it follows that state rules requiring off-duty breaks would constitute a similar obstacle and warrant preemption.
Arana Amicus Brief. The court further held that although the Louisiana anti-subrogation law "relates to" an employee benefit plan within the meaning of the basic preemption clause, University of Michigan Business School, Tappan Street, Ann Arbor, MI , Amicus Curiae;.
Is a multiemployer plan the same as a multiple employer plan or a multiple employer trust? No. Multiple employer plans are pension plans maintained by two or more employers for the purpose of pooling plan assets to reduce administrative costs and for advantageous investing.