Andy Birchfield, who heads up our firm’s Mass Torts Section, provided the following information concerning activities in this Section. The lawyers and staff are currently investigating the following topics. Lawsuits have been filed and are pending in courts around the country dealing with these products. Some of them will be mentioned in more detail in this issue.

Yaz, Yasmin, or Ocella

Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol. It is marketed not only as a contraceptive pill, but as a proven treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms. Yaz is also marketed as an effective treatment for moderate acne. However, studies indicate that Yaz poses a particular health hazard because one of its two primary ingredients, drospirenone, is a diuretic, which can cause an increase in potassium levels in the blood and lead to hyperkalemia, which causes heart rhythm disturbances that can cause blood clots leading to sudden cardiac death or pulmonary embolism or strokes. Diuretics can also cause significant problems with the gallbladder, leading to gallbladder removal.

If you have taken Yaz, Yasmin or Ocella and experience any of these problems, please contact Alyce Addison, a lawyer in the section, for additional information at 800-898-2034 or by email at Alyce.Addison@beasleyallen.com.

Bard Composix Kugel Mesh Hernia Patch®

The Composix Kugel Mesh Hernia Patch, manufactured by Davol, Inc., was first introduced in 2000. The patch is used to repair ventral hernias. In some cases, a hernia can be repaired surgically. However, when the stomach muscles can’t withstand the stitching required, mesh is inserted and placed between the intestines and the stomach muscles to help contain the intestines.

Not long after the patch was introduced into the market, the FDA began to receive reports of problems with the patch. By 2005, the number of reports had greatly increased regarding the recoil ring which could easily break. When the ring breaks, patients experience bowel perforations and other serious injuries. The reports prompted the FDA to issue a recall in December 2005 of the Bard Composix Kugel Mesh hX Larage Patch. Doctors were warned to stop using that version of the Kugel Mesh Hernia Patch, and patients with this particular patch were told to seek medical attention if they experienced unexplained fever, persistent abdominal pain, or tenderness to the incision site. By February 2007, the Kugel Patch recall had been expanded twice to include several other sizes of the device.

The hernia mesh patch is inserted into the abdomen through a small incision. In order to fit through the incision, the mesh is folded in half by the surgeon. Once inside the abdomen, the mesh re-deploys as a result of a “memory recoil ring” that is embedded in the mesh. The patch was recalled by Davol after it was discovered that the “memory recoil ring,” which opens the patch, can break under the stress of surgical placement. The ring can form a sharp, hard edge which can cut into and through internal organs.

If you had hernia surgery after 2000 and have experienced similar problems, you can contact Danielle Mason, a lawyer in the Mass Tort Section, for more information at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.

Fosamax®

Fosamax®, manufactured and heavily marketed by Merck, is in a class of drugs to prevent and treat osteoporosis in post-menopausal women. The Journal of Oral and Maxillofacial Surgeons has reported a link between bisphosphonates and a serious bone disease called Osteonecrosis of the Jaw (ONJ). Osteonecrosis is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the bone. Osteonecrosis is a dreaded disease that is often accompanied by pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. Symptoms may occur spontaneously, or at the site of previous tooth extraction.

We have an upcoming trial in Montgomery, Ala. on behalf of a sweet lady who developed osteocerosis of the jaw due to Fosamax usage.

If you have taken Fosamax and experienced any of these problems, please contact either Chad Cook or Leigh O’Dell, lawyers in the Mass Torts Section, for additional information at 800-898-2034 or by email at Chad.Cook@beasleyallen.com or Leigh.Odell@beasleyallen.com.

Gardasil®

Gardasil, a vaccine manufactured and marketed by Merck and Company, is marketed as a preventative for cervical cancer. However, Gardasil has not been proven to prevent cervical cancer. In fact, it is a vaccine to prevent only four types of the sexually transmitted disease HPV (human papillomavirus) two of which are associated with cervical cancer. These two types of HPV are present in only 3.3% of the cases. Scientific data indicates that the vaccine may not last longer than five years, if that long. The drug is indicated for young women and men from the age of nine years old up to 26 years old, though the vaccine is primarily given to girls. The Vaccine Adverse Event Reporting System has received over 16,000 reports of adverse events related to the administration of this vaccine including 50 deaths. Serious adverse events include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and death. The vaccine is recommended to most young girls in their early teens. Parents should proceed with caution before allowing their daughters (and sons) to be vaccinated. Some believe this drug could be the next Vioxx due to the dangers involved.

If you or one of your children have had this vaccine and experienced problems, you can contact Leigh O’Dell for more information at 800-898-2034 or by email at Leigh.ODell@beasleyallen.com.

Hormone Therapy

For years, women have taken Hormone Therapy (HT) to reduce the symptoms of menopause. Studies now show that HT medications such as Prempro and Premarin can increase the risk of breast cancer, ovarian cancer, stroke and heart disease. Our firm has several cases slated for trial this year. So far, juries have found in favor of Plaintiffs in 11 of 14 trials, and in each case the jury has awarded damages in excess of $1 million. This is not surprising given the seriousness of these injuries. A verdict in a HT case is discussed in this issue.

If you or your spouse took HT and have been diagnosed with breast cancer, you can contact Ted Meadows, a lawyer in the Mass Torts Section, for more information at 800-898-2034 or by email at Ted.Meadows@beasleyallen.com.

Pain Pumps

Pain pumps are portable and often disposable pain management devices which continuously administer local anesthetic through a catheter to a surgical wound site for several days following surgery to decrease post-operative pain and assist in earlier rehabilitation. A “Y-connector” accessory is sometimes available so that the pain pump can be used on multiple wound sites.

Recently, the use of pain pumps to administer medication directly into the glenohumeral joint space following shoulder surgery has been linked to a severe condition called Postarthroscopic Glenohumeral Chondrolysis (“Chondrolysis”), in which the cartilage of the humeral head and the glenoid space of the shoulder process has been destroyed and lost. The destruction of the shoulder cartilage can be attributed to the application of anesthetic medication directly into the joint space via the pain pump catheter. In 2003, it appears that some pain pump manufacturers may have increased the anesthetic dosing capacity of their pain pumps, which may have hastened the onset of Chondrolysis in some patients.

Chondrolysis symptoms usually present between six weeks and six months following surgery and include increased shoulder pain and stiffness, loss of cartilage, decreased range of motion, loss of shoulder joint space, crepitus in the shoulder and loss of strength. Patients suffering from Chondrolysis are usually unable to complete their post-surgical physical therapy due to pain. Whatever the patient’s condition was prior to his or her shoulder surgery, the post-operative diagnosis of Chondrolysis is typically much worse. Ultimately, complete shoulder replacement surgery (acromioarthroplasty) could become necessary in order to eliminate the painful and debilitating symptoms of Chondrolysis.

If you have experienced any of these problems, contact Frank Woodson, a lawyer in the Mass Torts Section, for additional information at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.

Reglan®

Reglan is used to treat gastrointestinal disorders such as heartburn caused by reflux. The FDA required a black box warning linking Reglan and Tardive Dyskinesia. Symptoms of tardive dyskinesia include involuntary and repetitive movements like tongue thrusting, eye blinking and head jerking as well as involuntary movements of the fingers. These symptoms are rarely reversible with no known treatment. Those at increased risk for developing Tardive Dyskinesia are the elderly, especially older women, and people who have taken the drug for a long period of time. The FDA has advised physicians to avoid long term use of Reglan and recommends treatment not exceed three months. We will write more on Reglan in this issue.

If you have taken Reglan and experienced any of these problems, please contact Danielle Mason for additional information at 800-898-2034 or by email at Danielle.Mason@beasleyallen.com.

Stevens- Johnson Syndrome

Stevens-Johnson syndrome is an immune complex hypersensitivity reaction that can be caused from an infection or immune response to drugs. It is a severe expression of a simple rash known as erythema multiforme. SJS is also known as erythema multiforme major. It affects all ages and genders including pediatric populations. The most severe form of SJS is toxic epidermal necrolysis (TENS). SJS occurs twice as often in men as in women. Most cases of SJS appear in children and young adults under age 30. Females with SJS are twice as likely as males to develop TENS, and have an even higher chance if taking a category of drugs known as NSAIDs, non-steroidal anti-inflammatory drugs.

If you have experienced any of these problems, please contact Frank Woodson for additional information at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.