Tuesday, March 5, 2013
AMERICAN MEDICAL SYSTEMS: NOT ENOUGH INSURANCE MONEY TO COVER ALL TRANSVAGINAL MESH LAWSUITS?
MILLIONS OF DOLLARS IN FINANCIAL LOSSES FOR SELLING BAD MEDICAL DEVICES DOES NOT COMPARE TO THE DESTRUCTION AND DEVASTATION OF THOSE MEN AND WOMEN LIVING WITH SYNTHETIC SURGICAL MESH IMPLANTED INSIDE THEM.
THE PEOPLE AT AMERICAN MEDICAL SYSTEMS GET TO GO HOME AND FORGET ABOUT MESH AT THE END OF THE DAY DESPITE A $640 MILLION DOLLAR LOSS.
MESH INJURED PATIENTS LIVE A 24/7 NIGHTMARE NO ONE SHOULD EVER HAVE TO ENDURE!
Below under "VAGINAL MESH CASES" you will read an excerpt from the legal proceedings section of Endo Health Solution's third-quarter 2012 financial report to the Securities and Exchange Commission.
Endo apparently made a really bad buy when they acquired American Medical Systems (AMS) for $2.9 billion dollars in April 2011. The FDA's July 13, 2011 warning that complications are NOT RARE with all pelvic organ prolapse (POP) surgical mesh kits used to repair POP, including AMS 28 pelvic mesh products, precipitated the flood of transvaginal mesh lawsuits against AMS and many other surgical mesh manufacturers.
I am very proud of the results of the leadership of myself and Truth in Medicine in getting the FDA warnings issued. Without the dedication and perseverance of many mesh injured patients giving their testimony and telling their stories at CDRH Town Hall Meetings, the IOM FDA 510(k) workshops, Truth in Medicine's Capitol Hill Briefing on May 17, 2011, the Truth in Medicine Conference in Washington, D.C. in September 2010, this would not have happened.
WE ALL MADE A DIFFERENCE!!!
I WANT TO RECOGNIZE AND THANK THOSE MEN AND WOMEN WHO TRAVELED UNDER VERY DIFFICULT CIRCUMSTANTCES...WE ALL LIVE IN CONSTANT PAIN AND OUR LIVES HAVE BEEN SEVERELY IMPACTED BY A GARBAGE PIECE OF PETROLEUM WASTE, SYNTHETIC SURGICAL MESH.
AND MANY, MANY MORE WHO ARE, AND HAVE BEEN, OUT THERE SPEAKING OUT TO STOP THE INSANITY OF MESH!!!
The following is a cut and paste from page 40 on the SEC filing you will find in this link:
Vaginal Mesh Cases
On October 20, 2008, the FDA issued a Public Health Notification regarding potential complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The notification provides recommendations and encourages physicians to seek specialized training in mesh procedures, to advise their patients about the risks associated with these procedures and to be diligent in diagnosing and reporting complications.
In July 2011, FDA issued an update to the October 2008 Public Health Notification regarding mesh to further advise the public and the medical community of the potential complications associated with transvaginal placement of surgical mesh to treat POP and SUI. In this July 2011 update, the FDA maintained that adverse events are not rare, as previously reported, and questioned the relative effectiveness of transvaginal mesh as a treatment for POP as compared to non-mesh surgical repair. The July 2011 notification continued to encourage physicians to seek specialized training in mesh procedures, to consider and to advise their patients about the risks associated with these procedures and to be diligent in diagnosing and reporting complications. FDA also convened an advisory panel which met on September 8-9, 2011 to further address the safety and effectiveness of transvaginal surgical mesh used to treat POP and SUI. At the conclusion of the meetings, the advisory panel recommended reclassifying transvaginal mesh products used to treat POP to Class III devices (premarket approval) and recommended that manufacturers of these products be required to conduct additional post-market surveillance studies. The advisory panel recommended that transvaginal surgical mesh products used to treat SUI remain as Class II devices. Regarding retropubic and transobturator (TOT) slings, the advisory panel recommended that no additional post-market surveillance studies are necessary. Regarding mini-slings, the advisory panel recommended premarket study for new devices and additional post-market surveillance studies. The advisory panel’s recommendations are now under consideration by FDA.
On January 3, 2012, the FDA ordered manufacturers of transvaginal surgical mesh used for pelvic organ prolapse and of single incision mini-slings for urinary incontinence, such as AMS, to conduct post-market safety studies and to monitor adverse event rates relating to the use of these products. These class-wide post-market study orders apply to eighteen AMS pelvic floor repair and mini-sling products. AMS is in the process of complying with these orders. In these orders, the FDA also noted that it is still considering the recommendation of the September 9, 2011 advisory committee that urogynecological surgical mesh for transvaginal repair of pelvic organ prolapse be reclassified from Class II to Class III.
Since 2008, AMS, and more recently, in certain cases the company or certain of its subsidiaries, have been named as defendants in multiple lawsuits in various federal and state courts, as well as in Canada, alleging personal injury resulting from use of transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence. Plaintiffs in these suits allege various personal injuries including chronic pain, incontinence and inability to control bowel function, and permanent deformities. On February 7, 2012, a multidistrict litigation (MDL) was formed, and cases pending in federal courts are now consolidated in the Southern District of West Virginia as part of MDL No. 2325. Similar cases in various state courts around the country are also currently pending. More specifically, as of October 30, 2012, approximately 2,960 mesh cases are currently pending against AMS and/or the Company or certain of its subsidiaries. Litigation similar to that described above may also be brought by other plaintiffs in various jurisdictions. The majority of the currently pending cases are in the MDL.
In addition, we have been contacted regarding a civil investigation that has been initiated by a number of state attorneys general into mesh products, including transvaginal surgical mesh products designed to treat pelvic organ prolapse and stress urinary incontinence. We have not yet received a subpoena relating to this investigation, and at this time, we cannot predict or determine the outcome of this investigation or reasonably estimate the amount or range of amounts of fines or penalties, if any, that might result from a settlement or an adverse outcome from this investigation.
AMS and the Company intend to vigorously contest all currently pending cases and any future cases that may be brought, if any, and to explore other options as appropriate in the best interests of AMS and the Company.
Nevertheless, we believe it is reasonably possible that the outcomes of such cases could result in losses in excess of insurance reimbursement levels that could have a material adverse effect on our business, financial condition, results of operations and cash flows. However, we are unable to estimate an amount of possible loss or range of possible loss in excess of the insurance reimbursement levels.
THE ONLY GOOD NEWS HERE FOR MESH INJURED PATIENTS WHO HAVE SUED AMERICAN MEDICAL SYSTEMS IS, ENDO HEALTH SOLUTIONS BOUGHT THEM IN 2011 AND WILL HOPEFULLY HAVE THE MONEY TO COVER WHAT THEIR INSURANCE DOES NOT.