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Lawyers Mark Zamora and Rob Bunch are investigating these claims, and you can reach them at 404-451-7781 and 888422-2882.

Here is the information on the recalled Lots:

Adverse Event Reporting is done here:

www.fda.gov/Safety/MedWatch/default.htm

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From the AAJ:

EMERGENCY MEDICARE SET ASIDE INFORMATION

Dear Colleague:

       In cases involving Medicare beneficiaries, attorneys for both the plaintiff and defendant are required to report certain information to the Centers for Medicare and Medicaid Services (CMS).  In addition, any case settlement or judgment must reimburse Medicare where the Trust Fund has made conditional payments for medical costs.  Under the Medicare Secondary Payer Act, attorneys have been settling cases involving liability claims without completing a Medicare Set Aside (MSAs) to account for future medical costs.  However, attorneys representing claimants in workers' compensation cases have been preparing MSAs on a case-by-case basis.

       It has come to our attention that some defense firms and insurance providers are now claiming that CMS requires MSAs in liability cases pursuant to Section 111 reporting requirements included in the Medicare, Medicaid & SCHIP Act of 2007 (MMSEA), Public Law No. 110-173.  This is false.  Section 111 contains reporting requirements for responsible reporting entities(1)  (RREs) only.  Section 111 does not impact or change the requirements for plaintiffs' attorneys.

       Moreover, statements from CMS, and other federal entities, make clear that the agency does not require set-asides for liability claims.  Since the MMSEA's passage, CMS has held several Town Hall teleconferences to discuss the Section 111 requirements.  During the March 24, 2009 call, Barbara Wright, CMS' Acting Director of the Division of Medicare Debt Management, made several statements reiterating that Section 111 has no impact on liability MSAs.(2)   For example:

• In response to a question as to whether liability set-asides will be required under Section 111, she said "the point is the set-aside process is totally separate from the Section 111 reporting process.  As we've said in more than one call we don't anticipate changing our routine recovery process."  (Transcript, pg. 24)
   
• When explaining that worker's compensation agreements use a formal review process which makes set-asides recommended, she said that was in contrast to liability agreements.  Liability "does not have the same formal review process although our regional offices will consider review of proposed liability set-aside amounts depending on their particular work load and whether or not they believe significant dollars are at issue." 
  (Transcript, pg. 24).

       In addition, CMS also has released several Alerts explaining Section 111, which do not indicate any intent to require MSAs for liability claims.  For example:

• "Unless you are a business entity which qualifies as [a required reporting entity (RRE)] for purposes of Section 111, you do not need to initiate any specific actions in connection with Section 111."  (CMS Alert, 2/23/09).(3)
   
• "The new Section 111 requirements do not change or eliminate any existing obligations under the MSP statutory provisions or regulations."  (CMS Alert, 2/23/09).

       Moreover, the Congressional Research Service (CRS) provided Congress with an "objective and non-partisan analysis" analysis of the MMSEA.  As there was no legislative history regarding the bill, the CRS research report is the most reliable analysis of the MMSEA, including the Section 111 reporting requirements.

       CRS' analysis of the Section 111 reiterates that it is a reporting requirement, and makes no mention of the need for set-asides in liability cases.  The Section 111 analysis states, in part:

This provision requires an insurer or third-party administrator for a group health plan (and in the case of a group health plan that is self-insured and self-administered, a plan administrator or fiduciary) to (1) secure from the plan sponsor and participants information required by the Secretary for the purpose of identifying situations where the group health plan is or has been a primary plan to Medicare, and (2) submit information specified by the Secretary.  If an insurer or third-party administrator for a group health plan fails to comply, then a $1,000 per day civil monetary penalty will be imposed for each individual for which information should have been submitted.(4)

If CRS believed that the legislative language implies any Congressional endorsement of liability set-asides, it would have been included in this analysis.

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Pretty well done, in my opinion. www.mydeniedclaim.com

Attorney Joey James and I have worked together and he's a courtroom litigator. His most recent verdict was in a case involving Dollar General.

The website  is one that sets out what to do when a claim has been denied. These include disability claims involving UNUM, as well as:

• UNUM Life Insurance Company of America
• Paul Revere Life Insurance Company
• First Unum Life Insurance Company
• Provident Life and Accident Insurance Company
• Provident Life and Casualty Insurance Company

I'll be watching the site, and perhaps assisting folks in MD, VA, DC and the Atlantic States.

Joey James filed a retaliatory discharge claim against an employer. The former employee was allegedly fired from Dollar General after she reported an injury. The former Dollar General employee hurt her hand on the cash drawer. It then became infected and her arm had to be amputated. Dollar General denied her worker's compensation claim three days after her arm was amputated.
The jury deliberated less than three hours before reaching the $2,298,000 verdict.

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The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

 AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

Toxic Anterior Segment Syndrome (TASS) is an acute, sterile inflammation following generally uneventful cataract and anterior segment surgery.

One of the main factors in differentiating TASS from an infectious other condition is the rapid onset. Most patients with TASS will develop symptoms within 12 to 24 hours of the surgery. . Patients may show signs of diffuse corneal edema  and they may also show signs of iris atrophy  with pupillary abnormalities and eventual increased intraocular pressure.

The degree of damage caused by TASS depends on many factors, including the type and amount of substance introduced into the eye, the duration of exposure, and how quickly treatment begins. An especially acute form of TASS, called toxic endothelial cell destruction syndrome, predominantly affects the corneal endothelium,⁷ whereas toxic endophthalmitis or sterile endophthalmitis significantly affects the posterior segment.

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