Product Liability

September 22, 2011

DePuy Metal on Metal Hip Failure Rate

As a Texas Medical Doctor and DePuy ASR Failure Attorney, I am providing this update and commentary on a recent British database study.

According to a British database, the National Joint Registry for England and Wales, which tracks hip replacement problems, a number of recalled DePuy ASR metal hip implants are failing within six years. Data from the National Joint Registry for England and Wales indicates that 29% of patients who received the DePuy metal-on-metal hip replacement have reported that they failed after only six years of use.

DePuy Orthopaedics, a division of Johnson & Johnson, issued a DePuy ASR hip recall last year, indicating that about 12% to 13% of these hips mail fail within five years. More than 90,000 DePuy ASR XL Acetabular Systems and DePuy ASR Hip Resurfacing Systems were sold worldwide before the metal-on-metal hip implants were recalled in August 2010. About 40,000 of those were sold in the United States.

September 21, 2011

Bard Avaulta Mesh and Bard Avaulta Sling Transvaginal Mesh Update

by Dr. Shezad Malik

30 plaintiffs who have filed a vaginal mesh lawsuit against C.R. Bard, are asking the U.S. Judicial Panel on Multidistrict Litigation (JPML), to include these cases as part of the consolidated federal Bard Avaulta litigation.

In October 2010, the JPML ordered that all federal Bard Avaulta pelvic mesh lawsuits be consolidated before U.S. District Judge Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation for coordinated pretrial proceedings.

This MDL included cases filed by women who received three different types of Bard surgical mesh used for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI): the Bard Avaulta Biosynthetic, Bard Avaulta Plus and Bard Avaulta Solo mesh. These products were sold by C.R. Bard and manufactured by either Bard or subsidiaries of Covidien plc.

September 15, 2011

Trans Vaginal Mesh TVM Lawsuits: The Next Big One?

by Dr. Shezad Malik

According to the concerned women who are calling our offices; they believe that the FDA and other U.S. regulators have failed them by not requiring extensive testing before allowing Johnson & Johnson (JNJ) and other manufacturers to sell the type of surgical mesh implanted in them, to hold their pelvic organs in place. Now many these callers say that they cannot work, sleep through the night, or have sex with their partners due to endless pain.

There are about 270 lawsuits pending against J&J. In all, about 600 suits have been filed against it and other mesh makers, including C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings.

The U.S. Food and Drug Administration warned on July 13 of a fivefold increase in women suffering pain and injuries after surgeons inserted mesh through vaginal incisions. Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

September 13, 2011

Actos MDL Consolidation Over Bladder Cancer

by Dr. Shezad Malik

As a Texas medical doctor and Actos Bladder Cancer Attorney I am providing this information and commentary. The maker of the world’s best-selling diabetes drug is facing many lawsuits as adverse medical research shows that taking the pill for more than a year raises the risk of bladder cancer.

A motion was filed asking for all federal Actos bladder cancer lawsuits to be centralized before one judge for coordinated handling during pretrial proceedings as part of an MDL, or multidistrict litigation.

There are about 12 lawsuits over Actos that have been filed in federal district courts. Experts believe that hundreds of complaints that will likely be filed on behalf of individuals who claim they developed bladder cancer from side effects of Actos.

September 10, 2011

Fosamax Injuries and the FDA Part 2

by Dr. Shezad Malik

As a Texas medical doctor and Fosamax femur fracture injury Attorney, I am fielding many calls from concerned plaintiffs regarding their side effects from using Fosamax and similar drugs. We are providing the following update and commentary.

A FDA advisory committee wants the agency to limit the duration of bisphosphonate therapy for treatment of osteoporosis. This year, the FDA required that all bisphosphonates used to prevent or treat osteoporosis warn on their labels that optimal duration of use hasn’t been determined. The issue has become concerning to the FDA as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee met to discuss whether emerging reports of adverse events should cause the FDA to change the label to indicate that the drug not be used long term. The medical advisers did not press the issue as strongly as the F.D.A. staff itself did in a 45-page report issued on Wednesday. The staff report said studies “suggest no significant advantage of continuing drug therapy beyond five years.”

September 8, 2011

FDA To Rule On Transvaginal Mesh Injuries

by Dr. Shezad Malik

As a Texas Transvaginal Mesh Injury Lawyer and medical doctor, I am providing this update and commentary involving TV Mesh failures.

An FDA advisory panel is currently examining recent complications and failure reports associated with transvaginal mesh systems that are used to repair pelvic organ prolapse, POP.

The FDA’s Obstetrics and Gynecological Devices panel will offer recommendations to protect women from the serious debilitating problems associated with transvaginal use of surgical mesh, which medical evidence suggests may provide no actual benefit over more traditional means of treating pelvic organ prolapse.

September 7, 2011

Fosamax Side Effects And The FDA

by Dr. Shezad Malik

As a Texas medical doctor and Fosamax ONJ and femur fracture side effect Attorney, I am fielding many calls from concerned plaintiffs regarding their side effects from using Fosamax and similar drugs. We are providing the following update and commentary.

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An FDA advisory panel will meet this week to review the risks associated with long-term use of Fosamax and other bisphosphonate medications. Fosamax and other bisphosphonate medications have been linked to a potential risk of spontaneous femur fractures and osteonecrosis of the jaw (ONJ), which is a rare jaw bone condition.

A panel of medical experts will review whether the FDA should adjust the length of time Fosamax and other similar drugs are used. They may recommend that the medication users should be required to take a “drug holiday” to reduce the risk of the serious and potentially debilitating problems associated with long-term use.

September 1, 2011

FDA Transvaginal Mesh Safety Alert

by Dr. Shezad Malik

As a Texas medical doctor and Transvaginal Mesh Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted Transvaginal Mesh medical device. We are providing the following update and commentary. The FDA recommends surgical mesh be reclassified as “High Risk.”

FDA Transvaginal Mesh Safety Alert – Transvaginal Mesh Lawsuit and Class Actions being filed across the Nation. Johnson & Johnson, Boston Scientific Corp. (BSX) and other makers of surgical mesh may have to submit added safety data to regulators to keep their products on the market under a Food and Drug Administration staff recommendation.

The transvaginally implanted products fail to lead to better outcomes than non-mesh repair and should be reclassified as posing a high risk to patients, according to a FDA report. Patient advocates are demanding a recall of the devices, now classified as moderate risk.

August 28, 2011

Surgical Mesh in Pelvic Repair Procedures Should Be Recalled

by Dr. Shezad Malik

As a Texas medical doctor and Transvaginal Mesh Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted Transvaginal Mesh medical device.

According to the Public Citizen watchdog group, the surgical mesh products made by Johnson & Johnson (JNJ) and Boston Scientific Corp. (BSX) to correct falling pelvic organs in women should be immediately recalled because of painful side effects.

Public Citizen, said that mesh products made of non-absorbable synthetic material can erode and cause pain, bleeding and urinary incontinence. The mesh is implanted through incisions made in the wall of the vagina to reinforce the tissues around the pelvic organs.

August 27, 2011

Yaz MDL Court Pushing for Yasmin Lawsuit Settlements

by Dr. Shezad Malik

As a Texas medical doctor and YAZ, Yasmin and Ocella Personal Injury attorney, I am providing this litigation update, information and commentary.

Judge Herndon overseeing the federal Yaz and Yasmin MDL, has rejected the consolidation of multiple cases during the early bellwether trials. The Court plans for “meaningful” settlement negotiations after the initial trials are held. These mini trials will help decide how juries will to respond to similar evidence and testimony like other cases in the litigation.

There are more than 6,350 lawsuits that have been centralized in the U.S. District Court for the Southern District of Illinois. All of the cases allege that Bayer failed to adequately warn about the risk of serious and potentially life-threatening side effects of Yaz and Yasmin birth control, such as a stroke, pulmonary embolism, deep vein thrombosis or gallbladder disease.