Product Liability

September 15, 2011

Trans Vaginal Mesh TVM Lawsuits: The Next Big One?

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.

August 26, 2011

Risks of DePuy Metallosis Following a Metal On Metal Hip

by Dr. Shezad Malik

As a Texas medical doctor and DePuy Hip Recall and Replacement Attorney, I am fielding many calls from concerned plaintiffs regarding their implanted DePuy ASR and DePuy Pinnacle Metal on Metal Hip prosthesis.

The Food and Drug Administration has received many complaints recently about failed hip replacements. The FDA has received more than 5,000 reports since January concerning metal-on-metal hips. The majority of complaints involve patients who have had an all-metal hip removed, or will soon undergo such a procedure because a device failed after only a few years. Metal-on-metal hip replacement systems are a widely used type of artificial hip, which are designed to last about 15 years. However, complaints suggest that thousands of people are experiencing early failure of the hip implants within a few years of surgery, often leading to additional surgery to replace the hip.

The complaints confirm that all-metal replacement hips are becoming the biggest and most costly medical implant problem since Medtronic recalled a widely used heart device component in 2007.

Some patients have suffered crippling injuries caused by tiny particles of cobalt and chromium that the metal devices shed as they wear. This is known as metallosis. This may result in soft tissue damage, inflammatory reactions, bone loss, genetic damage, asceptic fibrosis, local necrosis or other problems that may lead to the need for a risky hip revision surgery.

Hip replacement is one of the most common procedures in the United States and all-metal implants accounted for nearly one-third of the estimated 250,000 replacements performed each year. According to one estimate, some 500,000 patients have received an all-metal replacement hip.

One of the artificial hip devices, the A.S.R., or Articular Surface Replacement, was recalled last year by Johnson & Johnson and accounted for 75 percent of the complaints. Under F.D.A. rules, many all-metal devices were sold without testing in patients or without a requirement that producers track their performance. The F.D.A. in May ordered producers to study how frequently the devices were failing and to examine the threat to patients.

In August 2010, a DePuy ASR hip recall was issued for more than 90,000 of the metal hip implants, after it was discovered that a higher-than-expected number were failing within a few years of surgery. Similar problems have been reported in connection with other metal-on-metal hip implants sold by other companies.

In February 2011, the FDA launched a new website in February 2011, which was designed to provide information about the risks associated with metal-on-metal hip replacements.

The FDA has now asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are.

As problems and questions grow, some surgeons are abandoning the all-metal hips, saying they are unwilling to expose new patients to potential dangers when safer alternatives — mainly replacements that combine metal and plastic components — are available.

For many patients, it is too late. The number of complaints filed with the F.D.A. about a product understates a problem because while companies must file reports, doctors and patients do not have to. The filing volume for the DePuy A.S.R. and the Zimmer Durom cup probably reflects a surge of lawsuits filed against their makers.

According the recent New York Times review, there were 7,500 complaints about the A.S.R., nearly 5,000 of them coming since January. In the case of the Durom cup, about 1,600 complaints were filed with the regulator from 2007 to this June.

It is impossible to say how many adverse reports about all-metal hips have been submitted. The Times analysis found some 200 complaints about an all-metal version of another DePuy device called the Pinnacle as well as 400 additional complaints that noted metal-related problems in Pinnacle patients. But the Pinnacle is sold in several versions, so it was not clear how many of the metal-related complaints were linked to the all-metal device.

Many individuals throughout the United States have already filed metal-on-metal hip replacement lawsuits over problems allegedly caused by metallosis or metal poisoning. All DePuy ASR hip lawsuits have been consolidated in federal court as part of an MDL, or multidistrict litigation, in Northern District of Ohio. Lawsuits over DePuy Pinnacle hip metal-on-metal implant replacements, which is another has been consolidated in the Northern District of Texas in Dallas.

August 9, 2011

DePuy Pinnacle Hip MDL Hearing

by Dr. Shezad Malik

As a DePuy Pinnacle Hip Replacement attorney and Texas Medical doctor I am providing this important update, regarding the first MDL hearing held in my home town of Dallas, Texas.

Attorneys from throughout the United States who represent DePuy Pinnacle hip replacement plaintiffs, met today in the U.S. District Court for the Northern District of Texas. This hearing was held in Dallas, and was the first status conference with the judge presiding over the recently formed multi-district litigation (MDL). The meeting between the plaintiff and defense attorneys was quite cordial and the hearing with Judge Kinkeade, lasted over 2 hours. This was an informal, esssentially a meet and greet type of hearing, much different from other types of contentious hearings.

It was interesting to stand at the back of the courtroom and observe the proceedings, the court room was jam packed, standing room only.