Medico-Legal News

October 17, 2011

CooperVision Contact Lens Recall Class 1 Status

According to the FDA, silicone oil is the cause of problems with Aviara contact lenses sold by CooperVision, which were removed from the market in August after a number of consumers suffered torn corneas, hazy vision and other potentially serious complications. Nearly two months after problems were first announced, contact lens giant CooperVision Inc. and federal health regulators have amped up public warnings about nearly 780,000 recalled contact lenses, urging users to return the potentially defective products and to seek medical care if they show symptoms of harm.

The FDA announced on Friday that it was classifying the CooperVision Aviara contact lens recall as a Class 1 medical device recall, which is the most serious category the agency can use to label a recall. The class 1 designation means that the FDA believes that use of a device carries a reasonable probability of serious adverse health consequences or death.

More than 778,000 CooperVision Aviara contact lenses were impacted by the recall, which was not widely publicized until the FDA criticized the company last week for failing to take sufficient steps to make sure consumers were aware of the contact lens problems.

October 17, 2011

Yaz Birth Control Coma and Blindness

by Dr. Shezad Malik

As a Yaz Birth Control Coma and Blindness Injury attorney and Texas medical doctor I am providing this YAZ, Yasmin and Ocella update.

ABC’s chief law and justice correspondent, Chris Cuomo, interviews Carissa Ubersox, a former pediatric nurse who started taking Bayer’s Yaz birth control pills when she wanted to look her best for her wedding and “saw commercials suggesting help with bloating and acne.” Two months after Ubersox started to take Yaz birth control pills, she developed massive blood clots in both lungs and fell into a coma that lasted for two weeks. When she woke up, she was blind.

All birth control pills come with some risk of developing blood clots, and Bayer “cites its own studies as proof that Yaz is just as safe as other birth control pills.” However, Dr. Susan Jick of the Boston University School of Medicine has authored an independent study involving a million women that finds Yaz’s risk to be two to three times higher than other birth control pills. ABC reports that two Bayer-sponsored studies find no difference in risk, while four independent studies all find increased risk.

October 14, 2011

Medtronic Infuse Side Effects and Lawsuits

by Dr. Shezad Malik

As a Dallas Medtronic Infuse Lawsuit and side effect attorney and medical doctor I am providing this update regarding the problems associated withe Medtronic Infuse medical product.

Medtronic, a medical device company is in the news regarding reports about its synthetic bone growth product Infuse. In 2008, the U.S. Department of Justice began investigating whether Medtronic had been illegally promoting “off-label” use of Infuse.

The Spine Journal reported in its June 2011 edition concerns about Infuse and Medtronic’s research. In 2004, a small group of doctors wrote some research papers stating that Infuse did not cause any harm to patients. The doctors who wrote the article would eventually receive millions of dollars from Medtronic.

October 7, 2011

DePuy Pinnacle Hip Replacement MDL Lawsuits

by Dr. Shezad Malik

Visit msnbc.com for breaking news, world news, and news about the economy

As a DePuy ASR and DePuy Pinnacle litigation attorney, I am providing this timely update.

More than 500 lawsuits have been filed in Northern District of Texas federal court over DePuy Pinnacle hip replacements problems. The plaintiffs have alleged that DePuy hips, caused individuals to experience severe pain and early failure of their artificial hip implant.

October 6, 2011

DePuy ASR MOM Hips in the News

by Dr. Shezad Malik

As a DePuy ASR Hip Recall attorney I am providing this update. There is a problem with metal on metal artificial hip implant devices, as highlighted on the NBC Nightly News on October 4th 2011.

According to medical experts and bio-engineers, the DePuy ASR, and DePuy Pinnacle hip implants are failing, or have failed at an unacceptably high rate. In August of 2010, there was a recall on DePuy ASR hip implant device. The ASR DePuy hip implants were surgically implanted on tens of thousands of US citizens between 2005 and early 2010.

Symptoms of a recalled ASR DePuy hip implant failure include pain in the hip region, problems walking, swelling of the hip, or lack of flexibility in the area of the hip. NBC Nightly News with anchor Brian Williams, called attention to the DePuy hip implant recall, and the issues with metal on metal hip implants on Tuesday October 4th 2011 news segment.

October 3, 2011

Merck Wins Another Federal Bellwether Trial Regarding FOSAMAX

by Dr. Shezad Malik

Merck said today that a federal court jury in New York found in its favor in the Secrest v. Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her FOSAMAX use.

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Chilton Varner of King & Spalding LLP, outside counsel for Merck said, “Unfortunately, the plaintiff had medical problems that cause people to develop the jaw and dental problems that the plaintiff has, regardless of whether they were taking FOSAMAX. She has a long history of invasive dental procedures and suffers from medical conditions that inhibit the body’s ability to heal.”

Today’s verdict marks the fourth time a jury has found in Merck’s favor on a plaintiff’s product liability claim in the litigation regarding FOSAMAX. The plaintiff in this case alleged she used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions and failed dental implants.

October 3, 2011

Actos Bladder Cancer Litigation to be Consolidated

by Dr. Shezad Malik

As an Actos Bladder Cancer Product Liability attorney and Texas medical doctor, I am providing this update regarding the status of a MDL consolidation request.

Takeda Pharmaceuticals the manufacturer of Actos and their defense attorneys have indicated that the drug maker supports a request to have all federal Actos bladder cancer lawsuits consolidated for pretrial litigation. But Takeda disagrees about where the defective product liability claims should be centralized.

On September 29, Takeda Actos lawyers filed a response with the U.S. Judicial Panel on Multidistrict Litigation, indicating that they agree with plaintiffs that an MDL, or multidistrict litigation, should be formed, but requested that the cases be transferred to either Northern District of Illinois or Western District of Louisiana.

October 1, 2011

DePuy Metal on Metal Hip and Metallosis

by Dr. Shezad Malik

As a DePuy ASR and Pinnacle Replacement and Recall attorney I am providing this blog update.

As readers to my blog will note, I am a licensed Texas medical doctor as well as a product liability attorney. We are currently fielding many phone calls from concerned hip replacement patients and the biggest concern for them is residual hip pain post procedure.”Is that normal?” they ask. “How do we know if we are suffering from metallosis?” “My doctor is not concerned but I still feel that something is wrong?”

The answers to these questions remain elusive for several reasons. Firstly and foremost is the lack of research, disclosure and transparency from the hip manufacturers who knew or should have known about these problems and concerns.

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.