Product Liability

April 17, 2011

Texas Titanic About to Hit The Fosamax Iceberg?

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?
$fosamax_femur_fracture.jpg$

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.

$fosamax_femur_fracture.jpg$

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.

$fort_worth_fosamax_fracture_attorney.jpg$

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.

March 26, 2011

Topamax Seizure Drug Causes Birth Defects

by Dr. Shezad Malik

As a Texas Topamax Dangerous Drug attorney, I am providing this latest FDA warning regarding Topamax.

This latest announcement by the FDA (see below) is particularly worrisome, as it demonstrates the teratogenic side effects of Topamax and the generic versions of this commonly utilized drug.

The U.S. Food and Drug Administration (FDA) issued a warning about Topamax (topiramate), an anticonvulsant medication which is used in the prevention of migraine headaches and epileptic seizures. New medical study shows that Topamax and its generic versions increases the rate of cleft lip and cleft palate deformities if taken by women who are pregnant.

Cleft lip and cleft palate deformities are holes in the roof of the mouth that result from improper fusing of the lip and the palate during fetal development during pregnancy. The mouth birth defects can cause problems with eating and talking if not treated with surgery.

Product labeling for Topamax cautions about the risk of birth defects associated with the medication, but the warning label will now be revised to include stronger language that there is “positive evidence of human fetal risk based on human data.”

Cleft lip and palate is very treatable; however, the kind of treatment depends on the type and severity of the cleft.

Most children with a form of clefting are monitored by a cleft palate team or craniofacial team through young adulthood. Treatment procedures can vary between craniofacial teams. For example, some teams wait on jaw correction until the child is aged 10 to 12 (argument: growth is less influential as deciduous teeth are replaced by permanent teeth, thus saving the child from repeated corrective surgeries), while other teams correct the jaw earlier (argument: less speech therapy is needed than at a later age when speech therapy becomes harder).

Still prevention is better than the cure, so best avoid the use of Topamax during pregnancy or if cannot, then use contraceptive devices.

March 23, 2011

Topamax & Topiramate Usage Can Cause Birth Defects

by Dr. Shezad Malik

Dallas Topamax Cleft Palate Cleft Lip Attorney warns about the side effects of Topamax during pregnancy.

As I have previously reported, the FDA has required the makers of Topamax and generic topiramate to update their warning label regarding use of the Topamax drug during pregnancy. The usage of Topamax during pregnancy, can cause children to be born with a cleft lip or cleft palate. And shockingly enough, it appears that this particular birth defect information has been available for years and that Topamax birth defect side effects may cause malformations. Folks, the manufacturers have failed to adequately research their medication or warn consumers and doctors.

The medical journal Neurology, in July 2008, reported that pregnant women who received Topamax for epilepsy treatment, faced an increased incidence of babies with birth defects or congenital malformations. Topamax use during pregnancy was linked to babies born with cleft lip or cleft palate at a rate 11 times higher than would be expected in the general population and babies born with genital defects at a rate 14 times higher than would be expected.

Apparently this research and other post-marketing data was available to the Topamax manufacturers, and they failed to warn women about the risks of pregnancy and Topamax. If proper warnings was provided, these women could have chosen to take a different drug or taken contraception to ensure they did not become pregnant while on Topamax.

According to reports made to the North American Antiepileptic Drug Pregnancy Registry, the prevalence of oral clefts in children born to mothers who used Topamax while pregnant was 20 times higher than among women who did not take any antiepiletic drug. When compared to other epilepsy drugs, the prevalence of birth defects was still 2-3 times greater with Topamax pregnancy use.

Because of the drug makers’ decision not to disclose this important information, there are many children who have experienced birth defect problems. Compensation may be available through a Topamax cleft palate or Topamax lip lawsuit for children who were exposed to the drug before they were born.