The Recall Lawyers

At least two petitions have been filed with the Judicial Panel on Multidistrict Litigation seeking transfer, coordination and/or consolidation of all product liability actions pending in federal courts concerning the use of intra-articular pain pumps following arthroscopic shoulder surgery. Plaintiffs seeking MDL consolidation have all developed Postarthroscopic Glenohumeral Chondrolysis (PAGCL), an extremely painful, debilitating condition resulting in a destruction of the patient's shoulder cartilage. Lawsuits are being brought against the manufacturers of the pumps and the makers of the drugs.

According to one MDL Petition, there are 13 related cases pending in federal courts throughout the United States, including Alabama, Colorado, Indiana, Kentucky, Minnesota, New York, Oregon and Utah. There are likely thousands of similar cases being investigated and being prepared for filing by attorneys around the country. The related actions seek to hold pain pump manufacturers and drug companies liable for encouraging physicians to use the devices to deliver pain medication directly into shoulder joints following arthroscopic surgery, contrary to uses approved by the Food and Drug Administration (FDA). The cases allege that both the device companies and the drug makers misled doctors into believing that the procedure posed no danger to their patients.

Postarthroscopic glenohumeral chondrolysis is a condition in which the cartilage located within the shoulder joint begins to deteriorate. This typically occurs after an individual has had surgery on the affected shoulder. The condition generally affects the glenohumeral joint, which is the joint at the end of the shoulder comprised of the socket of the shoulder blade and the ball of the arm bone. The cartilage between these two portions of the arm and shoulder is the site affected by postarthroscopic glenohumeral chondrolysis. As the cartilage begins to deteriorate due to the condition, the individual starts to experience the complications associated with the disorder.

Symptoms of PAGCL include:

Shoulder stiffness Pain when the shoulder is in motion Pain when the shoulder is at rest Clicking, popping, and/or grinding Shoulder weakness Decreased range of motion Narrowing joint space, visible on x-ray

Many time these symptoms are not seen until months after surgery.

Posted by Louisville, Kentucky lawyer: Larry Jones (larry@jonesward.com) 1-888-KYLAW22

Prescription drug Trasylol was manufactured by Bayer Pharmaceuticals and is used to reduce bleeding and blood clotting in patients during heart surgery. In the May 29, 2008 issue of the New England Journal of Medicine, a study noted a significant increase in the risk of death from kidney failure, heart attack and stroke.

The study was terminated early because of ethical concerns raised after the research showed that prescrption drug Trasylol doubled the risk of death versus the alternatives. The lead researcher Dsaid, "There was no way we could ethically enroll more patients in the trial because we had our answer."

After the initial reports were given to the FDA in November 2007, Bayer agreed to temporarily suspend sales and marketing of the prescription drug Trasylol. Bayer has now notified the FDA that it will begin removing the remaining presciption drug Trasylol stock in the U.S. Market from hospitals, warehouses and physicians' supplies.

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy.

FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure. See the FDA Healthcare Professional Information Sheet containing considerations and recommendations for clinicians prior to prescribing MMF or MPA to women of childbearing potential.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Alert and Healthcare Professional Information Sheet regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#MMF

Posted by Louisville, Kentucky lawyer: Larry Jones (larry@jonesward.com) 1-888-KYLAW22

Trasylol (aprotinin injection) Audience: Cardiovascular healthcare professionals, pharmacists, hospital surgical service managers Following publication of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study in the May 14, 2008 online issue of The New England Journal of Medicine, Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of the prescription drug Trasylol from hospital pharmacies and warehouses.

Under a limited use agreement, access to the prescription drug Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using the prescription drug Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients. Read the complete MedWatch safety summary, including links to the updated drug information page and the FDA news statement, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol

Posted by Louisville, Kentucky lawyer: Larry Jones (larry@joneswards.com) 1-888-KYLAW22

Prescription drug Digoxin is a medication used to treat congestive heart failure and abnormal heart rhythms. It is available via prescription under a number of brand names, including Digitek.

On April 25, 2008, prescription drug Digitek was subject to a nationwide recall when it was discovered that all oral strength tablets of the prescription drug Digitek contained twice the approved level of active ingredient. Before it was recalled, the double-strength Digitek tablets were reported to have caused a number of injuries, including cardiac instability and death.

Obviously, placing a product on the market with twice the approved active ingredient is going to result in lawsuits from the families of those who suffered cardiac injuries or death.

Posted by Louisville, Kentucky lawyer: Larry Jones