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Posts tagged "sovereign immunity"

Medical Device problems continue for patients without judicial oversight

The New Englad Journal of Medicine, one of the most widely read medical journals, had two interesting artilces 1 and 2 this week on heart device failures even after Food and Drug Administration (FDA) approval.  The first  article is particularly troubling as the Supreme Court ruled that a plaintiff may not sue under state law to challenge the safety or effectiveness of a medical device to which the FDA has given "premarket approval."  Riegel v. Medtronic, Inc., 2008 WL 440744 (Feb. 20, 2008).   The premarket approval type of FDA approval--which reflects the agency's determination that the product is reasonably safe and effective for human use--establishes certain federal requirements that preempt state law remedies, including common-law claims for strict products liability, breach of warranty, and negligent design.  This decision, when it first came out in 2008, represented a significant victory for medical device manufacturers, protecting them from the risk of state court damage awards for devices that have been duly approved by the FDA. In the article, Riata and Riata ST implantable cardioverter-defibrillator (ICD) leads (St. Jude Medical), which are implanted in approximately 79,000 patients in the United States were discussed as having failure such that the leads came out of their protective coating and were only noticable upon x-ray or after study following an adverse event. The scary implication of the article is that the drug device manufactorer has little to no incentive to monitor the adverse effects post FDA approval.  In fact, the postmarketing surveillance system put in effect by the FDA is without backbone or ability to fully protect patients. As the Medtronic Sprint Fidelis lead involving 268,000 patients who received leads that had the potential to fracture, have finally been resolved via litigation, it seems that once again only through litigation will the drug device manufacturer have to protect its patients who are the most vulnerable... only the Supreme Court in Riegel v. Medtronic has hampered the ability of the attorneys who can get justice from protecting those in need.  Its time to recognize that our American system of government with the proper checks and balances, which includes an active judiciary, be given its proper due as the best system of government in the world and our Supreme Court should take into consideration that self regulation by an industry without proper judicial oversight is merely a pipedream.

Sovereign Immunity: or why I cannot sue most municipalities

One of the most bizarre and antiquated laws still existing in North Carolina is the law of sovereign immunity.  Like contributory negligence, where North Carolina is one of only a small hand-full of states with this doctrine, our sovereign immunity regulations continue despite our advances as a society.  The original reason for Sovereign immunity was to allow police and sheriff to make arrests and take other governmental actions without fear of suit for ordinary negligence.  This original logical reason has been expanded to any governmental function of a municipality.
Our Court of Appeals in one of its most recent opinions essentially sets out that the individual municipality is unfettered in taking whatever action it chooses with regard to waiver of immunity.
"As a general rule, the doctrine of governmental, or sovereign immunity bars action against, inter alia, the state, its counties, and its public officials sued in their official capacity." Herring v. Winston-Salem/Forsyth County Bd. of Educ., 137 N.C.App. 680, 683, 529 S.E.2d 458, 461 (2000) (citation omitted). The doctrine applies when the entity is being sued for the performance of a governmental function. Id. " '[S]uits against public officials are barred by the doctrine of governmental immunity where the official is performing a governmental function, such as providing police services.' " Parker v. Hyatt, 196 N.C.App. 489, 493, 675 S.E.2d 109, 111 (2009) (citation omitted). A town or municipality may waive sovereign immunity through the purchase of liability insurance. Satorre v. New Hanover Cty. Bd. of Comm'rs, 165 N.C.App. 173, 176, 598 S.E.2d 142, 144 (2004). However, " '[i]mmunity is waived only to the extent that the [municipality] is indemnified by the insurance contract from liability for acts alleged.' " Id. (quoting Combs v. Town of Belhaven, 106 N.C.App. 71, 73, 415 S.E.2d 91, 92 (1992)). "A governmental entity does not waive sovereign immunity if the action brought against them is excluded from coverage under their insurance policy." Patrick v. Wake Cty. Dep't of Human Servs., 188 N.C.App. 592, 596, 655 S.E.2d 920, 923 (2008).
Lunsford v. Lori Renn, --- N.C.App. ----, ----, 700 S.E.2d 94, 100 (2010), disc. review denied, --- N.C. ----, 707 S.E.2d 244 (2011).  Arrington v. Martinez, COA10-1204, 2011 WL 4389653 (N.C. Ct. App. Sept. 6, 2011).
In the Arrington case, the Court of Appeals set out that the City of Raleigh may set out specific rules for when it will waive immunity that includes that it will waive immunity when a case settles and may specifically agree that it never owes any pain and suffering.
'By statute, a City may, but is not required to, waive governmental immunity."  Arrington v. Martinez, COA10-1204, 2011 WL 4389653 (N.C. Ct. App. Sept. 6, 2011).
The court determined that the City of Raleigh's determination not to pay pain and suffering and to waive their immunity only upon a settlement and a release was neither "arbitrary or capricious" which would be the only waive to prove the city's waiver was invalid.
Instead the Court of Appeals found "North Carolina General Statutes § 160A-485(a) provides that a municipality may purchase insurance coverage and may waive its immunity to whatever extent it determines appropriate. It may also elect not to waive its immunity at all, in which case plaintiff would have no possibility of any recovery from the City."   Arrington v. Martinez, COA10-1204, 2011 WL 4389653 (N.C. Ct. App. Sept. 6, 2011).
Although the Court found that the waiver should be construed against the one waiving the immunity, their decision did not have much in the way of logical support for their position.  Instead the Court found that the city could just deny the claim therefore any payment they allowed was sufficient.
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