Our attorneys are looking into the recent multi-state outbreak of fungal meningitis from tainted shots provided by the New England Compounding Center (NECC). The NECC has voluntarily expanded its recall to include all products currently in circulation that were compounded at and distributed from its facility in Framingham, Massachusetts. In North Carolina, three clinics have been identified as definitely receiving the recalled product: • High Point Surgery Center - High Point, North Carolina • Surgical Center of Wilson - Wilson, North Carolina • North Carolina Orthopaedic Clinic - Durham, North Carolina The FDA is currently looking into all products associated with NECC which could include up to 33 facilities in NC. The Centers for Disease Control and Prevention (CDC) has issued a Health Advisory (link), which contains updated information and guidance regarding the multi-state outbreak of meningitis and stroke associated with potentially contaminated steroid medication. As of October 26th the FDA announced serious concerns with the safety of the "clean room" of NECC and concerns about contamination going forward. FDA press release. As of 10/9/12, 13,000 people have been exposed to the steroid medication. 119 cases have been identified in 10 states, resulting in 11 deaths associated with this multi-state outbreak of fungal meningitis. In North Carolina there have been two (2) cases reported to date. Au of 10/23/2012 the associated press was reporting 308 cases with 23 deaths in 17 different states. If you have had an epidural steroid injection at one of the above facilities and have questions regarding your health, please see your doctor as recommended by the CDC. The CDC advises that "Patients have had symptoms generally starting from 1 to 4 weeks after their injection. Not all patients who received the medicine will become sick. Symptoms that should prompt patients to seek medical care include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site." Our experienced drug recall attorneys would be glad to discuss your potential claim with you from our Eastern NC or Raleigh offices or contact us through our website: O'Malley Tunstall.
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.
Pradaxa is an anti-coagulant, or blood thinner, used to prevent blood clots and strokes in people suffering from an irregular heart beat known as atrial fibrillation. With atrial fibrillation, patients have a higher risk of forming blood clots which can travel through the body and cause strokes. Pradaxa is used to lower the chance of blood clots forming.
Pradaxa is manufactured by German drugmaker Boehringer and just received FDA approval last year. Unfortunately, severe problems with the drug are already being reported as Pradaxa is proving to cause excessive internal bleeding. The FDA is currently investigating Pradaxa.
Susan O'Malley and Joe Tunstall are pleased to announce that their firm has been renamed: O'Malley Tunstall, PLLC. We have a new name for our firm; but we will continue to offer small firm service with large firm capability. Susan and Joe look at this name change as a way to move forward into 2012 in a positive way keeping our focus on client service and at the same time solidify to our clients the continued existence of this hard charging injury and disability law firm. Susan O'Malley, who is a Board Certified Social Security Disability Lawyer by the North Carolina State Bar, will continue to run our Social Security Disability Section here at O'Malley Tunstall, PLLC. Susan, whose resume as a disability attorney while extremely impressive, only touches on her true value to her clients as her experience handling Social Security claims is unmatched. Susan continues to be available for referral or consultation for other attorneys in the area of Social Security disability law. Prior to focusing her practice on Social Security and Disability law Susan successfully handled workers' compensation claims and jury trials for our injured clients, including being co-counsel on several multi-million dollar verdicts. Our automobile injury and commercial truck injury section will also continue to be lead by Joe Tunstall. Joe has extensive jury trial experience representing the injured and disabled. He has tried to verdict and judgment cases from $1 to $5,500,000.00. Joe is available for consultation or co-counsel arrangements for injury cases. In addition to our automobile and commercial truck injury section, Joe manages our personal injury litigation and workers' compensation sections. He actively associates with attorneys both within and outside of North Carolina for injury claims and handles referrals for all levels of litigation. Both Susan and Joe continue to be active handling client's appeals in the North Carolina Court of Appeals, North Carolina Supreme Court, Federal District Court and Fourth Circuit Court of Appeals. Often Susan and Joe handle client's appeals without the appeal costing the client any additional attorneys' fees. Give our office a call and one of our attorneys will explain how. Therefore, if you have an injury or disability case, take a look at our firm or give us a call as one of our knowledgeable attorneys will answer your question. O'Malley Tunstall, PLLC will continue a great tradition of client service.
Recent calls into my office have sparked my thoughts back to the non sequitur that is the recent decisions of our U.S. Supreme Court with regard to which injured plaintiffs may recover from drug manufacturer.
Bladder Cancer Risk from Actos (pioglitazone). On June 15, 2011 the U.S. Food and Drug Administration (FDA) announced that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.