Articles Posted in Personal Injury

As a Texas medical doctor and Yaz Side Effect Product Liability attorney, I am providing this litigation update regarding the increased discovery that has been allowed in the federal MDL.

NON-BELLWETHER CASE-SPECIFIC DISCOVERY.

The judge presiding over all federal Yaz lawsuits and Yasmin lawsuits has expanded the scope of discovery in the litigation beyond the selected bellwether cases. According to Judge Herndon’s most recent order, “… This matter is before the Court for case management. The Court is in the process of compiling a list of the the “oldest 100 non-bellwether” cases. Thus, a list identifying the 100 member actions that will be subject to core, case-specific discovery pursuant to Doc. [1866] will be forthcoming…”

In essence the Court is allowing case-specific discovery to move forward in up to 100 other cases filed on behalf of women who allege that side effects of the Bayer birth control pills caused them to suffer injuries. The Court has expanded the scope of discovery beyond the 24 cases selected last year to serve as a pool of bellwether lawsuits. Case-specific discovery, including depositions of individual plaintiffs, will also now be permitted in the oldest 100 non-bellwether cases that have been filed.

About 6,350 lawsuits are now consolidated as part of the Yasmin and Yaz litigation in the U.S. District Court for the Southern District of Illinois and the number of cases is expected to only increase as Yaz, Yasmin and Ocella lawyers file additional cases.

All of the suits involve claims that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and potentially life-threatening injuries from the birth control pills containing drospirenone, such as a stroke, heart attack, pulmonary embolism, and deep vein thrombosis. Yaz and Yasmin were the first birth control pills to contain drospirenone, a new type of progestin.

The outcome of the bellwether trials and information obtained from the additional plaintiff depositions could help facilitate an eventual Yaz settlement agreement between the parties.

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As a Yaz, Yasmin and Ocella side effect and blood clot attorney, and Texas Medical doctor I am providing this update regarding the bellwether trial status for the New Jersey State MDL litigation trial schedule.

The first trial dates for any Yaz, Yasmin or Ocella lawsuits pending in New Jersey state court will begin in the fall of 2012, with at least two cases to be selected as test cases out of hundreds of claims pending in the state.

There are about 1,000 Yaz, Yasmin and Ocella product liability lawsuits pending in New Jersey state courts involving claims that women suffered serious or deadly injuries as a result of side effects of Yaz, Yasmin or Ocella birth control, containing the fourth-generation progestin drospirenone which are all manufactured by Bayer.

All of the suits involves claims that Bayer failed to properly research their birth control pills or adequately warn about the increased risk of serious and life-threatening injuries from the birth control pills containing drospirenone, causing stroke, heart attack, pulmonary embolism, and deep vein thrombosis.

According to a case management order issued July 8 by New Jersey Superior Court Judge Martinotti, the first Yaz trial in New Jersey state court should be ready to go before a jury on September 10, 2012. A second trial date has been set for November 27, 2012.

The parties have been directed to identify a pool of 18 cases that may be selected for an early trial date, known as bellwether cases. Judge Martinotti has asked each side to select three cases involving allegations of pulmonary embolism, three involving claims of gall bladder injury and three involving allegations of venous thromboembolism, such as a deep vein thrombosis (DVT).

In addition to the cases pending in New Jersey state court, more than 6,000 other cases are pending in federal court and other state court systems. The federal Yaz litigation has been centralized as part of a multidistrict litigation (MDL) before Judge Herndon in the U.S. District Court for the Southern District of Illinois.

At least three trial trial dates are anticipated in the federal MDL, one involving a pulmonary embolism, one involving a gallbladder injury and one involving a venous thromboembolism, with the first Yaz trial in federal court expected to begin early next year.

QUICK FACTS: YAZ LAWSUITS ALLEGATIONS

Throughout the United States, a number of Yaz birth control lawsuits have been filed against Bayer Healthcare Pharmaceuticals, Inc., which was formerly known as Berlex, Inc. and Berlex Laboratories, Inc., claiming that the drug makers:

Failed to adequately warn consumers and the doctors about the potential risk of Yaz side effects.

Failed to adequately test and research Yaz birth control before placing it on the market, which could have shown that patients would face an increased risk of heart attacks, strokes, pulmonary embolism, deep vein thrombosis and other life-threatening health problems.

Failed to issue a Yaz recall or remove the birth control pill from the market after it became apparent that it is an unreasonably dangerous drug, for which the harmful side effects outweigh any potential benefits provided over other available birth control pills.

Aggressively marketed Yaz and encouraged misuse and overuse despite the known Yaz dangers to maximize profits at the expense of patients’ health.

The drug makers had access to all the facts concerning the potential Yaz problems, and ignored the connection between their drug and deadly side effects. Yaz safety concerns were hidden and misrepresentations were made to to convince consumers and doctors to use the birth control pill instead of other available products. This increased the drug makers’ profits at the expense of women throughout the United States. Another example of corporations putting profits before people.

In complex litigation involving a large number of claims with similar underlying facts, early trials are useful in helping the parties gauge the strengths and weaknesses of their cases, and may help facilitate a possible Yaz settlement agreement that includes other lawsuits in the litigation.

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As a Vaginal Mesh Defective Product Lawsuits attorney, and Texas Medical doctor I am providing this important update.

According to a safety communication issued by the Food and Drug Administration, Women who have vaginal surgery to fix a gynecologic condition called pelvic organ prolapse may wind up with more problems than benefits if a plastic mesh is used.

The FDA said it plans to convene an advisory committee to determine whether to ban the mesh – manufactured by Mass-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies – for this procedure.

About 100,000 women with pelvic organ prolapse are treated with plastic mesh each year, but in most cases, according to the FDA, the condition can be treated successfully without mesh.

Mesh-related problems reported to the FDA include painful sexual intercourse, infections, urinary problems, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

Boston Scientific, is one of several companies that already face lawsuits over the mesh. Dozens of women who said they endured painful complications after the company’s mesh was implanted filed complaints last year in a California court, and many of the cases are now being transferred to jurisdictions across the country where the plaintiffs live.

Covidien, a company incorporated in Ireland with its corporate headquarters in Mansfield, supplies mesh to Bard, which markets it to health care providers to treat pelvic organ prolapse.

According to attorneys who represent more than 100 women in a complaint against Bard lodged in federal court in West Virginia, said the manufacturers initially designed the mesh for hernia repair. While regulators gave companies clearance to market it for pelvic organ prolapse repair, they did not look to see if, mechanically or otherwise, these products worked in the pelvis. “They should have known that they needed to check and test.’’
In 2008, the FDA announced that problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for pelvic organ prolapse repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.

Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half require additional surgeries to remove the mesh. Sometimes, the mesh becomes so intertwined with scar tissue that it cannot be removed. Furthermore, the FDA found that the mesh does not make the surgery any more effective.

According to Dr. William Maisel, the FDA’s deputy director of the Center for Devices and Radiological Health, “The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn’t be used routinely for all transvaginal prolapsed repairs.”
In 2010, 75,000 women had vaginal surgery with mesh to repair pelvic organ prolapse. That surgery was performed three times as often as abdominal surgical mesh repair, according to the FDA, since it does not require a painful incision through the skin and offers a less painful recuperation for women.

The FDA cited studies showing abdominal mesh repair for pelvic organ prolapse led to vaginal erosion in 4 percent of women within 23 months of surgery. The FDA urged patients with the condition to ask their surgeon about all treatment options, including those without mesh, before having the operation.

The reassessment of surgical mesh comes as FDA reviews its fast-track system for clearing medical devices, which has been largely unchanged since the 1970s. Like 90 percent of medical devices sold in the U.S., pelvic mesh was cleared under the FDA’s fast-track system, which grants market approval in 90 days to devices that are considered low-risk.

Medical device manufacturers have spent the last year lobbying the FDA and Congress to speed up device approvals as the government reviews the process. Safety advocates say the agency has been overusing the system and clearing high-risk devices that should be subject to more testing.

According to Dr. Diana Zuckerman, the agency should have required the studies it is now contemplating before mesh products were approved. “If they had been required to go through the more rigorous approval process, similar to that for prescription drugs, it would have been obvious years ago that surgical mesh has more risks than benefits in many types of surgery,” said Zuckerman, who directs the National Research Center for Women & Families.

The FDA will hold a meeting in September to discuss studies that would identify which patients benefit most from mesh implants. The FDA will ask panelists at the meeting whether pelvic surgical mesh should be reclassified as a high-risk device.

Surgeons began using mesh to repair hernias in the 1950s, and over the next 40 years they adapted the technique for women’s health conditions. FDA cleared the first mesh for prolapse in 2002, but since it was similar to devices that had been used for decades it did not have to undergo human testing.

The mesh was approved through the FDA’s 510(k) process, which calls for companies to prove that a product is “substantially equivalent” to one already on the market — usually without clinical studies on patients. The approval process is currently being scrutinized by the Institute of Medicine on behalf of the FDA.

Among the manufacturers are Boston Scientific Corp., American Medical Systems Inc. (now part of Pennsylvania-based Endo Pharmaceuticals) and Coloplast. Other companies making the mesh include Cook Medical, Covidien PLC, C.R. Bard Inc., and Ethicon, a division of Johnson & Johnson.

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Is an Actos recall in the works? As an Actos Bladder Cancer attorney, and Texas medical doctor I am providing this Actos update.

Actos (pioglitazone) is one of the world’s widely prescribed diabetes medications. Also marketed in combination with glimepiride (Duetact) and metformin (Actoplus Met, Actoplus Met XR), Actos is used by millions of patients with Type-2 diabetes. The drug works by controlling blood glucose levels through its action with insulin.

Now, Actos has also been linked to life-threatening side effects. In June 2011, the Food and Drug Administration (FDA) issued a warning to alert patients and healthcare professionals of an increased risk of bladder cancer associated with Actos. This followed another FDA warning, issued in June 2007, with reports of liver damage and cardiovascular problems among patients taking Actos.

If you have been diagnosed with bladder cancer or another condition you feel may be linked to taking Actos, the FDA recommends that you schedule an appointment with your doctor immediately.

Bladder Cancer Risk and Actos Usage

The FDA issued its Actos bladder cancer warning after an interim analysis of a 10-year epidemiological study conducted by the drug’s manufacturer, Takeda Pharmaceuticals. The analysis showed no increased risk of bladder cancer among users as a whole. The longest-term users of Actos and those with the highest cumulative dose of the drug showed increased levels of bladder cancer.

A separate study of Actos, conducted in France, has also linked the drug to bladder cancer. The FDA is aware of these findings and has stated that it intends to conduct a thorough review of the study and its findings. The agency has also stated that it will continue monitoring data from Takeda’s ongoing study.

In the meantime, the FDA has advised patients that taking Actos for longer than a year puts them at risk. The FDA recommends that patients with active bladder cancer avoid taking Actos. Physicians should use caution when prescribing Actos to patients with a history of bladder cancer, weighing the benefits of the drug to the risk of recurrence.

The FDA has also provided the following tips for patients:

Taking Actos may increase your odds of developing bladder cancer
Go to a doctor if you notice that your urine is red in color or if you see blood; if you are experiencing an extreme urge to urinate or pain while doing so; or if you are experiencing pain in your lower abdomen or back
Do not take Actos if you are receiving bladder cancer treatment
Report any side effects you notice to the FDA MedWatch program
Read the medication guide you get with your Actos prescription, which contains detailed information on risks associated with the drug
These warnings and recommendations will appear on the Warnings and Precautions section of the drug’s label, and in the accompanying medication guide.

Actos Side Effects and Potential Injuries

The FDA’s latest Actos warning follows another warning issued in June of 2007. At that time, the agency issued a “black box warning” requiring the manufacturers of Actos and Avandia (known as thiazolidinediones) to include warnings alerting patients and their doctors of cardiovascular and liver problems linked to the drug. Black box warnings appear on the packaging of drugs and are the strongest action taken by the FDA short of a recall.

These warnings were issued after the findings of a Cleveland Clinic study showed that thiazolidinedione use increased the risk of heart attack by as much as 42 percent. The findings also showed an increased risk of hepatitis, liver inflammation, elevated liver enzymes (an indication of liver damage) and liver failure.

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