Product Liability

April 20, 2011

Does Yaz, Yasmin and Ocella Cause GallBladder Disease?

As a Yaz, Yasmin, Ocella Gallbladder disease attorney, I am providing information on this latest Canadian study, which found an increase of gallbladder disease in women who took Drospirenone containing birth control pills.

Women who take Yaz and Yasmin birth control pills, which contain drospirenone, are at greater risk of gallbladder damage than women on other oral contraceptives, according to a new Canadian study. The research study involved 2.7 million women who took birth control pills for at least six months between 1997 and 2009. A total of 27,087 women in the study group underwent surgery to have their gallbladders removed. The study found that while all birth control pills put women at some risk for losing their gallbladders, women who use pills with drospirenone were at greater risk.

Drospirenone is a synthetic progestin hormone which has diuretic properties. It is used in combination with another estrogen hormone, ethinyl estradiol, in Bayer’s Yaz and Yasmin. Bayer recently released Beyaz and Safyral, two more birth control pills identical to Yaz and Yasmin, with added folate.

Bayer is fighting allegations that its popular birth control pills can put women’s lives at risk, with more than 3,000 lawsuits filed against the company from women who say they were harmed by the pills.

The new study was funded by the Fonds de la recherché en sante du Quebec, a government-financed research agency, and is in the current issue of the Canadian Medical Association Journal.

April 18, 2011

Will Yaz, Yasmin, and Ocella Be Recalled?

by Dr. Shezad Malik

As a Texas Yaz, Yasmin and Ocella Dangerous Drug Side Effect Attorney, I am providing this litigation update for current clients and potential new victims.

Many women who have suffered by side effects of Yaz and Yasmin birth control are expected to call for Bayer to issue a Yaz and Yasmin recall at an upcoming shareholder’s meeting. They claim that the popular birth control pills may be responsible for the death of more than 190 women in the United States. Bayer will hold its annual shareholder meeting on April 29 in Cologne, Germany.

Lawsuits against Bayer HealthCare Pharmaceuticals continue to be filed on behalf of women who claim to have suffered serious injuries as a result of Yaz or Yasmin (generic: Ocella) birth control pills. Consumer groups and some members of the medical community are questioning Yaz side effects and the increased risk for blood clots and strokes. Yaz, Yasmin and Ocella are considered “fourth generation” combination birth control pills. They contain a newer type of synthetic progestin called drospirenone. This contraceptive is one of the most popular contraceptives and has been heavily marketed to women throughout the United States promoting its use in treating premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD).

In the latest study of teenage girls and birth-control habits suggests the oral contraceptive Yaz is more popular with teenage girls and young adults than ever before. In the study, Yaz was named “by far” the most popular oral contraceptive for US women aged 13-18. The study was based on the behaviors of more than 3 million American women between 2002 and 2009.

The FDA has at least 190 reports of Yaz and Yasmin deaths in the United States that were linked to the use of the highly successful birth control pills. That number is likely to be a fraction of the actual number of deaths from Yasmin and Yaz, as it is acknowledged that only about 1% to 10% of all adverse events associated with the use of medications are ever reported.

Bayer’s line of drosperinone-based oral contraceptives, Yaz and Yasmin, have been found to carry an 80% increased risk of thrombosis events than older birth control pills by some studies. Thousands of women throughout the United States have filed a Yaz lawsuit or Yasmin lawsuit against Bayer, alleging that the drug maker failed to adequately research the risks associated with the medication or warn women that they may be exposed to an increased risk of serious and potentially fatal side effects when using the birth control pills. Lawsuits also allege that Bayer engaged in deceptive and misleading advertisements that were directed to consumers and the medical community.

The Yaz and Yasmin lawyers at Dr Shezad Malik Law Firm represent women throughout the United States who are pursuing a lawsuit over an injury or death that may have been prevented if Bayer had recalled Yaz and Yasmin or provided adequate warnings. Potential Yaz and Yasmin recall lawsuits are being reviewed for women who have suffered an injury or death as a result of a:

* Stroke or Heart Attack
* Pulmonary Embolism
* Deep Vein Thrombosis (DVT)
* Gallbladder Disease

April 17, 2011

Texas Titanic About to Hit The Fosamax Iceberg?

by Dr. Shezad Malik

Every day, we are hearing a lot of bad news about the osteoporosis drug Fosamax. Made by Merck & Co., Fosamax has been a successful bone disease treatment on the market for over a decade. In January 2009, medical studies were released that hit the drug and its manufacturer hard. The first study links Fosamax to osteonecrosis, of the jaw, and the second, links Fosamax to esophageal cancer. Are these reports the Titantic that is about to hit the Fosamax iceberg?
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Fosamax works by attacking cells in the body responsible for bone breakdown, which can help patients dealing with osteoporosis. At the same time, if the drug is too efficient, it can cause the bone to grow too dense, which takes up inner bone space where bone marrow is found. Bone marrow is responsible for bone healing and growth, so without enough marrow, the bone will die. If you do break a bone that has been subjected to Fosamax and similar drugs it won’t heal.

Medical studies linking the drug to esophageal cancer report that many of those affected had used the drug for over two years. One thing is certain – we are only seeing the tip of the iceberg when it comes to Fosamax injuries. Currently there are over 1,000 Fosamax lawsuits in litigation, and as more studies are done to confirm the allegations against the drug, we may see even more patients coming forward.

Fosamax, when used over time, can cause dead jaw, and Fosamax femur fractures have been a major problem in some cases. When you have osteoporosis, your bones become extremely fragile, and fractures can happen even with just a bump or gentle fall. Most often, fractures happen in the hips, spine, and wrists. If you break your hip, you typically need major surgery to fix it, and even then, you may have problems walking for the rest of your life. With spinal fractures, the same is true, and patients generally have back pain and may have to deal with deformities.

Fosamax and the following drugs Actonel (risedronate sodium) tablets, Actonel with Calcium (risedronate sodium with calcium carbonate tablets), Atelvia (risedronate sodium) delayed-release tablets, Boniva (ibandronate sodium) tablets, Fosamax (alendronate sodium) tablets and oral solution, Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets, Reclast (zoledronic acid) Injections are now required to have clear warning labels regarding low-energy, or low trauma fractures of the femoral shaft (leg bone).

As a Fosamax osteoporosis attorney, I suggest discussing this drug with any elderly female friends and relatives as they may be unaware of the current crisis and the FDA’s warnings.

April 16, 2011

Fosamax Femur Fracture Lawsuits

by Dr. Shezad Malik

As a Fosamax Femur Fracture attorney, I am providing this update regarding Fosamax Femur Fractures.

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There are now many Fosamax femur fracture lawsuits filed by folks who have suffered a femur fracture or other bone fracture after taking the osteoporosis drug.The FDA added warnings about the risk of bone fractures from Fosamax and other bisphosphonate medications in October 2010, requiring drug makers to warn consumers that they should seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete fracture of the femur on Fosamax occurs.

The Fosamax bone fracture lawsuits allege that Merck failed to adequately research their medication or provide adequate warnings before they suffered a femur fracture or bone break. Merck has asked the U.S. Judicial Panel to centralize and consolidate the Fosamax bone fracture litigation in the U.S. District Court for the District of New Jersey, where most of the cases are currently pending and where the drug maker has its headquarters.

The Journal of the American Medical Association (JAMA) included publication of a major case control study relating to bisphosphonates (particularly Fosamax) and subtrochanteric femur fractures. The researchers who authored the study concluded that patients on long-term bisphosphonates for osteoporosis therapy had a 274% higher chance of subtrochanteric femur fractures than similar matched patients. (OR 2.74.) The authors concluded “these findings provide strong evidence that prolonged bisphosphonate therapy is associated with an increased risk of subtrochanteric or femoral shaft fracture.”
Bone fracture lawsuits were excluded from the prior Fosamax MDL, which was established in August 2006 for claims filed by individuals who suffered decay of the jaw bone from Fosamax.

A popular osteoporosis drug, Fosamax® and its generic form Alendronate®, is implicated to cause spontaneous fractures.Fosamax® is a drug used to strengthen bones, for many women it has worked successfully but according to medical reports, women who have taken the drug for five years are at risk of suffering spontaneous fractures.

Fosamax and the following drugs Actonel (risedronate sodium) tablets, Actonel with Calcium (risedronate sodium with calcium carbonate tablets), Atelvia (risedronate sodium) delayed-release tablets, Boniva (ibandronate sodium) tablets, Fosamax (alendronate sodium) tablets and oral solution, Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets, Reclast (zoledronic acid) Injections are now required to have clear warning labels regarding low-energy, or low trauma fractures of the femoral shaft (leg bone).

As a Fosamax medication attorney, I suggest discussing this drug with any elderly female friends and relatives as they may be unaware of the current crisis and the FDA’s warnings.

Doctors are seeing many femurs fractured in patients who have been on the drug. If you have taken Fosamax® or its generic form Alendronate® and believe to have been injured as a result, please fill out the form below to contact a Case Manager.

April 15, 2011

Propecia Product Liability Lawsuit Filed

by Dr. Shezad Malik

As a Dallas Propecia Side Effect Litigation Attorney, I want to pose the following question-how many men do you think, would trade a head of hair for the significant possibility of permanent impotence and male breasts (gynecomastia). Did not think so.

Finasteride is a highly potent inhibitor of Type II 5-Alpha Reductase, an enzyme that converts testosterone, into dihydrotestosterone (DHT).

Propecia (1mg) was approved by the FDA in 1997 and is marketed as a treatment for male pattern hair loss (MPHL), as DHT has been implicated in the balding process. Proscar (5mg) was approved in 1992 by the FDA for treatment of Benign Prostate Hyperplasia (BPH – enlargement of the prostate).

Both Propecia and Proscar share the same active ingredient (Finasteride) which can aid in stopping hair loss.

Clinical studies of Finasteride for male pattern hair loss, including the Propecia clinical trials for the FDA, indicate that a certain percentage of men may experience negative sexual side effects from Finasteride, including decreased libido or sex drive, erectile dysfunction, and decreased ejaculate volume while on the medication.

In addition, prescribing information warns against possible physical changes to the body, including breast tenderness or enlargement (gynecomastia); hypersensitivity (allergic) reactions including rash, pruritis (itching) and urticaria (hives); swelling of the lips and face; testicular pain; ejaculation disorder; impotence; and male breast cancer. The official warning label for the drug in the U.S. says that sexual side effects — such as erectile dysfunction — occurred in less than 2 percent of men and that these side effects went away in men who stopped taking it. In a lawsuit filed in New Jersey federal court in February by two men who took Propecia claims that in the U.K., Sweden and Italy the Propecia warning label says that sexual dysfunction may be permanent.

Some men have also reported various other psychiatric, neurological and neurocognitive side effects from Propecia, including depression, sexual anhedonia, sexual anesthesia, anxiety, bipolar mood disorder, suicidal ideation, cognitive dysfunction (memory loss or difficulty with intellectual processing), slurring of speech, social withdrawal, lethargy/fatigue and listlessness, and other amotivational states.

Many men who took Propecia or Proscar for MPHL have experienced mental, physical, and sexual side effects while on the medication, then discontinued Propecia, and then fully expected to return to normal in accordance with representations made in the official prescribing information. Men worried about losing their hair may be losing far more than that if they take the popular drug Propecia.

Two new studies were published in The Journal of Sexual Medicine in March 2011. Young men are being prescribed these drugs, as hair loss treatments that may negatively impact their sexual life, possibly for a prolonged time after stopping the medication, according to Dr. Irwin Goldstein, the journal’s editor-in-chief.

A new research says 5 to 23 percent of the millions of men who take the drug may become impotent and have lowered sex drives because of the active ingredient finasteride. And the problem may linger years after they stop taking the drug.

April 12, 2011

NuvaRing Birth Control Lawsuits Moving Ahead

by Dr. Shezad Malik

Defective Drugs and Product liability attorneys have submitted a proposal for the selection of bellweather trials in the federal NuvaRing multidistrict litigation (MDL).

NuvaRing is a form of birth control that releases a combination of etonogestrel and ethinyl estradiol through a ring that is inserted into the vagina once a month.

All NuvaRing lawsuits filed in federal district courts throughout the United States have been consolidated in the U.S. District Court for the Eastern District of Missouri. These complaints all involve women who suffered the following injuries; stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT) or sudden death. The claims allege that the drug makers failed to research the birth control ring or warn about the potential increased risk of these serious problems.

The bellweather process is common in complex litigation involving a number of claims that raise similar allegations. By selecting a small group of cases for an early trial, the parties are able to get an idea how a jury is likely to respond to evidence and testimony. The outcome of these trials shapes the litigation and may lead to an agreement to settle NuvaRing birth control lawsuits by the drug maker.

To reduce the number of cases that must go through expert discovery, the parties have proposed that nine cases constitute the final trial pool. Expert discovery would then be limited to the nine cases in the final trial pool, which will occur over 2012.

As of the end of 2010, more than 730 victims had filed a NuvaRing lawsuit and the number of cases is expected to increase over the next year. The vast majority of the pending NuvaRing cases filed throughout the country are included in the MDL, but additional lawsuits are pending in New Jersey state court and other state courts throughout the United States.

April 10, 2011

Propecia Use Can Lead to Permanent Sexual Dysfunction

by Dr. Shezad Malik

A lawsuit has been filed against Merck, in the U.S. District Court for the District of New Jersey. The complaint alleges that the drug manufacturer warned European users that the drug Propecia may cause sexual problems in men, but did not provide American users the same warning.

According to the complaint, plaintiffs were prescribed Propecia to combat male pattern hair loss, and they suffered serious sexual dysfunction.

The lawsuit alleges that the warnings about the risk of sexual problems from Propecia differed significantly in Europe from the label warnings to users of Propecia in the U.S.

In Europe, Propecia labels stating that erectile dysfunction problems may persist after the patient discontinues use treatment with Propecia were added in 2008.

Propecia (finasteride) was approved in 1992 for the treatment of benign prostatic hyperplasia, and also is approved to treat male pattern baldness.

Last month researchers from the U.S. published a study in the Journal of Sexual Medicine that found side effects of Propecia were linked to sexual problems in men. Researchers indicated that the class of drugs known as 5-alpha-reductase inhibitors can cause loss of libido, depression erectile dysfunction, reduced semen production and growth of male breast tissue.

The lawsuit over Propecia charges Merck with negligence, failure to warn, strict product liability, and breach of warranty.

March 30, 2011

Mesothelioma And Asbestos Update

by Dr. Shezad Malik

Lung Cancer, Mesothelioma and Asbestos Exposure

This article is one in a series of articles that I am writing as a Dallas Mesothelioma Attorney to educate folks about the man made toxins in the environment. Mesothelioma is called a “signature” disease—which indicates that the person was exposed to the causative agent. If someone has mesothelioma, they were almost certainly exposed to asbestos.

Mesothelioma rates continue to climb and by some estimates is set to peak around 2012-2015. Asbestos has been placed in many buildings as a fire retardant and insulator and now because of the long latency period, many contractors, pipe fitters and plumbers are coming down with the disease, some including folks who had exposure as long as 30-40 years ago. What a national tragedy.

Lung cancer, is a multi-factorial disease—Environmental factors are important in lung cancer causation. Lung cancer is cancer that starts in the lungs.

There are two main types of lung cancer:

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer.

Small cell lung cancer makes up about 20% of all lung cancer cases. If the lung cancer is made up of both types, it is called mixed small cell/large cell cancer.

If the cancer started somewhere else in the body and spread to the lungs, it is called metastatic cancer to the lung.

The most important environmental factor is smoking. Asbestos exposure is important risk for development of lung cancer. Exposure to asbestos increases your risk of developing cancer—by an average of five times the risk of a non-smoker who was not exposed to asbestos.

Smoking makes a person ten times more likely to develop lung cancer. But for someone who smokes and was also exposed to asbestos, the risk of developing lung cancer is 50 times higher.

The National Cancer Institute (NCI) has included construction workers (including plumbers, electricians, painters and other construction-related trades), demolition workers, shipyard workers, firefighters and automobile mechanics among those at risk for dangerous asbestos exposures.

See NCI Asbestos Fact Sheet.

March 30, 2011

Fosamax Femur Fracture MDL Lawsuits

by Dr. Shezad Malik

As a Fosamax Femur Fracture attorney, I am providing this update regarding Merck’s application for an MDL.

Merck has filed a petition for MDL (multidistrict litigation) to consolidate and centralize all federal Fosamax bone fracture lawsuits for handling during pretrial litigation.

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More than 900 Fosamax lawsuits against Merck have already been consolidated as part of an MDL in the U.S. District Court for the Southern District of New York; those involved claims that Fosamax caused jaw injury, known as osteonecrosis. There are now Fosamax suits filed by folks who have suffered a femur fracture or other bone fracture after taking the osteoporosis drug.

On March 23, Merck asked the U.S. Judicial Panel on Multidistrict Litigation (JPML) to create a new MDL for this type of injuries caused by Fosamax, where plaintiffs claim that long-term use of Fosamax increases the risk of low-trauma or no-trauma fractures, involving the femur or thigh bone.

The FDA added warnings about the risk of bone fractures from Fosamax and other bisphosphonate medications in October 2010, requiring drug makers to warn consumers that they should seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete fracture of the femur on Fosamax occurs.

More than 100 people have filed a Fosamax bone fracture lawsuit, alleging that Merck failed to adequately research their medication or provide adequate warnings before they suffered a femur fracture or bone break. The claims are contained in 36 complaints that have been filed in at least 8 different federal district courts throughout the United States.

Merck has asked the U.S. Judicial Panel to centralize and consolidate the Fosamax bone fracture litigation in the U.S. District Court for the District of New Jersey, where most of the cases are currently pending and where the drug maker has its headquarters. In the alternative, Merck requested that the Panel transfer the cases to the U.S. District for the Western District of Louisiana.

Bone fracture lawsuits were excluded from the prior Fosamax MDL, which was established in August 2006 for claims filed by individuals who suffered decay of the jaw bone from Fosamax.

A popular osteoporosis drug, Fosamax® and its generic form Alendronate®, is implicated to cause spontaneous fractures.

Fosamax® is a drug used to strengthen bones, for many women it has worked successfully but according to medical reports, women who have taken the drug for five years are at risk of suffering spontaneous fractures.

Doctors are seeing many femurs fractured in patients who have been on the drug. If you have taken Fosamax® or its generic form Alendronate® and believe to have been injured as a result, please fill out the form below to contact a Case Manager.

March 27, 2011

Darvocet, Darvon, and Propoxyphene Wrongful Death Consolidation

by Dr. Shezad Malik

As a Texas Darvocet and Darvon Recall Attorney, I am providing this update regarding the request for consolidation of the litigation in federal court.

This week, a panel of federal judges will hear arguments to consolidate a growing number of Darvocet and Darvon lawsuits that have been filed over cardiac sudden death problems allegedly caused by these medications.

Plaintiffs first requested the consolidation in December, now some Darvocet lawyers expect that thousands are cases are likely to be filed by victims diagnosed with a heart arrythmia or sudden heart-related death from side effects of the medication.

In December, plaintiff Kristine Esposito, filed a Motion with the U.S. Judicial Panel on Multidistrict Litigation seeking to have the Darvon and Darvocet litigation centralized in the U.S. District Court for the Eastern District of New York. Other plaintiffs have filed documents known as briefs, requesting that the cases be consolidated in either the Eastern District of Louisiana or Western District of Louisiana.

The plaintiffs want to have the cases consolidated in one court, since all of the Darvon and Darvocet suits contain similar allegations that the manufacturer failed to adequately research the side effects of Darvocet and Darvon and failed to warn doctors and patients that propoxyphene-based drugs caused heart rhythm problems.

These type of consolidation is similar to class actions, and are known as an MDL, or multidistrict litigation.This type of centralization is usual in complex product liability claims involving a large number of lawsuits over injuries associated with a particular product. The process is designed to avoid duplicative discovery, prevent inconsistent rulings by different judges and to promote the efficient litigation, both in time and cost.

Xanodyne Pharmaceuticals, the manufacturer of the name-brand versions of Darvon and Darvocet, has opposed consolidation of the litigation.

If the MDL Panel grants consolidation and determines that is appropriate in the litigation over Darvocet and Darvon, Xanodyne will argue that the cases should be centralized in the Eastern District of Kentucky. Xanodyne, the drug maker is headquartered in Kentucky.