Product Liability

May 1, 2011

Antidepressant SSRI Birth Defects & Cranial Malformations

As a Dallas Antidepressant SSRI Birth Defects & Cranial Malformation Attorney, I am writing about the current state of SSRI induced birth defect lawsuits.

Selective seratonin reuptake inhibitor drugs are known as SSRI antidepressants.

Serious side effects are linked to the following antidepressants when taken while pregnant:

* Prozac®, * Xanax®, * Wellbutrin®, * Paxil®

Children born with heart birth defects, lung birth defects and other congenital birth defects have been linked to the possible use of a group of antidepressant drugs classified as Selective Serotonin Re-uptake Inhibitors (SSRI) by women during pregnancy. In a medical study, infants exposed to SSRI antidepressants during the first trimester of pregnancy had a 60% higher probability of developing congenital heart defects compared to newborns whose mothers did not take SSRI antidepressants.

According to the FDA, healthcare professionals are advised to carefully weigh the potential risks and benefits of using SSRI therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients.

Additional research recently published in the New England Journal of Medicine shows that use of anti-depressant medications during the latter half of pregnancy increases the risk the newborn will develop a serious respiratory disorder known as Persistent Pulmonary Hypertension (PPHN). When a newborn suffers from Persistent Pulmonary Hypertension (PPHN), the pulmonary arteries (blood vessels in the lungs) fail to fully open, and the newborn is unable to oxygenate his/her blood. Without an adequate supply of oxygen-rich blood, the infant can suffer serious complications.

Data from this study indicate that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac®, Zoloft® and Paxil® during the second half of pregnancy may increase the risk of Persistent Pulmonary Hypertension (PPHN) by as much as six times the normal risk.

The anti-depressant drugs – known as Selective Serotonin Reuptake Inhibitors (SSRIs) include the following:

* Paxil® (paroxetine), * Zoloft® (sertraline), * Wellbutrin® (bupropion), * Celexa® (citalopram), * Cipralex® (escitalopram), * Luvox® (fluvoxamine), * Remeron® (mirtazapine), * Effexor® (venlafaxine), * Prozac® (fluoxetine)

April 30, 2011

Zimmer NexGen CR-Flex Porous Knee Litigation

by Dr. Shezad Malik

As a Dallas Zimmer NexGen CR-Flex Porous knee replacement system and lawsuit attorney, I am providing this Zimmer update.

Some Zimmer NexGen knee replacement systems have been linked to reports of pain, loosening of the implant and failure of the replacement knee leading to revision surgery. These cases are being reviewed by Zimmer NexGen knee lawyers, who are evaluating the damages for individuals who have experienced problems after a Zimmer knee replacement.

Several different components used as part of Zimmer NexGen knee replacement systems have been associated with a potential increased risk of problems, which may result in pain, limited range of motion, loosening of components or the need for additional revision surgery. In March 2010, data was presented by a group of knee surgeons that indicates nearly 9% of patients who received the Zimmer NexGen CR-Flex Porous Femoral component required revision knee surgery within two years and 36% showed signs of the replacement knee loosening.

At a conference of the American Academy of Orthopaedic Surgeons in March 2010, several prominent knee surgeons presented data on the outcomes of 108 knee replacement patients who received the Zimmer NexGen CR-Flex Porous Femoral component at Rush University Medical Center in Chicago.

After only two years, the researchers reported:

* 9 patients required knee revision surgery due to loosening and pain
* 39 patients showed evidence of radiographic loosening
It is suspected that the higher-than-expected failure rate is linked to design problems with Zimmer NexGen replacement knees, as the orthopedic surgeons concluded that they were not caused by surgical errors, problems with the techinque or the type of patient who received the knee implant.

More than 150,000 Zimmer NexGen CR and Zimmer NexGen CR-Flex Porous Femoral implants have been sold since 2003, and some doctors have reported experiencing a substantially higher-than-expected failure of the replacement knee within a few years of surgery.

The Zimmer replacement knee is a “high-flex” component, which attaches to the bottom of the thigh bone. In most knee replacement systems, a type of surgical cement is used to hold the implant in place. But, the Zimmer NextGen knee does not use a cement and this may be a design defect which increases the risk of a knee replacement loosening and needing additional surgery to revise the implant.

As a result of recalled Zimmer knee replacements and potential problems with the design for certain NexGen components, thousands of individuals may have been exposed to an increase risk of early failure. A number of individuals throughout the United States are pursuing compensation through a Zimmer NexGen knee replacement lawsuit as a result of the manufacturer’s failure to adequately research the artificial knee system or warn about the risk of Zimmer knee problems.

April 29, 2011

Allergan $212M Verdict in Botox Brain-Injury Lawsuit

by Dr. Shezad Malik

Botox-maker Allergan Inc. was ordered by a federal court jury to pay $212 million to a Virginia man who alleged that use of the drug left him severely disabled.

The verdict awarded Douglas Ray, 67, $12M in compensatory damages and $200M in punitive damages. Ray was injected with the drug in 2007 to treat hand tremors. Ray suffered brain damage and now requires round-the-clock care. The suit, filed a VA federal court alleged that Allergan failed to adequately warn about the potential risks of Botox for off-label use.

Even if the decision by the jury is upheld, Allergan might have to pay only a small fraction of the penalty.Allergan said that Virginia state law caps punitive damages at $350,000. In September, Allergan agreed to pay the federal government $600 million to settle civil and criminal allegations that it illegally marketed and sold the drug through 2005 for unapproved uses, such as treating headaches.

April 27, 2011

Accutane Inflammatory Bowel Disease Side Effects

by Dr. Shezad Malik

As a Texas Accutane Inflammatory Bowel Disease side effect attorney I am providing this Accutane lawsuit update regarding Accutane and the generic versions of the drug.

The Judge overseeing the New Jersey State MDL for Accutane has proposed that brand name Accutane litigation against Hoffman-LaRoche be combined with lawsuits against the manufacturers of the generic version of the drug, isotretinoin.

If granted, the additional defendants in the consolidated Accutane lawsuits would include the following manufacturers. Ranbaxy Laboratories manufactured an Accutane version called Sotret which has been withdrawn. Barr Pharmaceutical manufactured Claravis, which contains the same active agent as Accutane (isotretinoin). Claravis continues to be manufactured with similar Accutane side effects and warnings. Mylan, Inc.is a generic pharmaceutical company and distributes Amnesteem, a form of isotretinoin, which presently remains in stores.

Genpharm, ULC was the first manufacturer authorized by the FDA to produce generic versions of Accutane and manufactured Amnesteem. The manufacturing and packaging activities were delegated to Cardinal Health 409 and sold to Mylan Laboratories, who distributed it around the world. Along with Cardinal Health 409 and Mylan Inc., Genpharm could be among the generic drugmaker defendants in the consolidated Accutane lawsuits.

Judge Higbee who is overseeing the centralized New Jersey Accutane lawsuits, implemented an April 15 deadline by which parties could comment or object to the addition of the generic drug makers to the centralized Accutane litigation. No final decision has yet been announced.

Accutane is a acne medication manufactured by Hoffman LaRoche and the subject of an Accutane recall in 2009. According to scientists, Accutane has serious long term side effects including Crohn’s Disease, Ulcerative Colitis and Inflammatory Bowel Disease (IBD).

If you took Accutane to treat acne and suffer from IBD, our Accutane attorneys may be able to recover you and your family compensation by filing an Accutane Crohns lawsuit or Accutane Ulcerative Colitis lawsuit against the manufacturer of the acne medication.

April 26, 2011

Plavix Side Effect Lawsuits

by Dr. Shezad Malik

As a Texas Plavix Side Effect attorney, I am providing this update regarding the current status of Plavix injury lawsuits and a request for consolidation in New Jersey State Courts.

Bristol Myers Squibb Co. and Sanofi-Aventis pharmaceutical companies are calling for centralization of all Plavix lawsuits filed in New Jersey state court, pointing to a growing number of complaints filed by users who allege that the drug makers fraudulently promoted their popular blood thinner and failed to adequately warn about the risk of potentially life-threatening side effects of Plavix.

Plavix (clopidogrel) is a antiplatelet agent that prevents blood platelets from sticking together to form clots. It is prescribed to prevent heart attacks, strokes and blood clotting (thrombosis) when drug coated stents are used in patients with coronary arteriosclerosis.

More than 40 people have filed a Plavix lawsuit in courts throughout the United States, including at least five in Atlantic County, New Jersey. Many cases are likely to be filed in New Jersey state court, where Sanofi-Aventis is headquartered and Bristol Myers Squibb has five facilities.

All of the complaints filed so far allege that the makers of Plavix promoted the expensive medication as a safer alternative to aspirin, although it may actually provide no benefit over taking aspirin. Plaintiffs allege that they suffered injuries as a result of their unnecessary use of Plavix, such as gastrointestinal bleeding, heart attacks, strokes and a blood disorder known as TTP, or thrombotic thrombocytopenic purpora.

Plaintiffs say that the two companies repeatedly overstated the safety and effectiveness of Plavix, and point out that the companies were repeatedly cited by the FDA for illegal, off-label promotions and for ads and campaigns that touted its benefits over aspirin.

The two companies say that the lawsuits and their claims are numerous and similar enough to warrant mass tort designation in New Jersey, and have asked that the caseload be transferred to Bergen County, due to its current low mass tort caseload.

A mass tort designation would centralize all cases filed in New Jersey state court before one judge for pretrial proceedings in order to avoid duplicate discovery and conflicting rulings. The claims would remain individual lawsuits for purposes of determining damages and each claim would be judged independently at trial.

The commonly used combination of Plavix and aspirin may expose patients to a higher risk of bleeding than previously believed, according to the findings of a new study. Researchers from the U.S. Centers for Disease Control and Prevention (CDC) have released the results of a study on the side effects of Plavix and aspirin when combined to help fight blood clots (DAT Dual Antiplatlet Therapy).

The study was published in the Archives of Internal Medicine, and determines that there is a clinically significant risk of hemorrhaging when the drugs are used together that doctors and patients need to recognize and anticipate.

CDC researchers compared the rate of incidents from acute hemorrhaging from DAT to those related to another antiplatelet drug called Warfarin. They found an estimated 7,654 emergency department visits every year for hemorrhage-related adverse events from DAT, compared to 60,575 emergency department visits from Warfarin bleeding incidents. Once the researchers adjusted for the rate of prescriptions they found that the rate of emergency department visits due to acute hemorrhages from Plavix and aspirin combined was 1.2 per 1,000 outpatient prescription visits, compared to 2.5 per 1,000 for Warfarin.

April 25, 2011

DePuy ASR Hip Recall Guide and Metallosis Risk

by Dr. Shezad Malik

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

Over 90,000 US citizens are recipients of the recalled DePuy ASR DePuy hip implant. We think only a fraction of individuals with an ASR DePuy hip implant have been identified, because they do not want to go through the tough surgical ordeal again. Our goal is that we want to get all recipients of the recalled ASR DePuy hip implant identified, so that they get meaningful legal and medical help.

The ASR DePuy implants were widely used throughout the United States from 2005, until 2010. We are recommending every recipient, or family member of a recalled ASR DePuy hip implant to call us, if they are suffering pain, problems walking, swelling of the hip, or lack of flexibility. It has already been well documented that there is an extremely high failure rate for the ASR DePuy hip implants.

Women are reporting more problems, and a higher failure rate, with the DePuy ASR XL Acetabular hip replacement system. Women are also more likely to develop some of the serious side effects of the defectively designed implant, including metallosis.

Metallosis is a build-up of cobalt and chromium ions in the soft tissue of the body, particularly around the joints. Metallosis has been noted in people with all kinds of metal-on-metal joint implants and replacement systems. The engineering of the implant is causing far more friction, which leads to metallic debris being released into the tissue surrounding the implant.

The design of the ASR XL Acetabular system was developed to provide a greater range of motion. The DePuy engineers removed the plastic liner from the inside of the hip implant and made the acetabular cup shallow so that patients could move their legs in a wider arc.

The femoral head moves constantly back and forth as the hip implant’s owner moves normally, and that puts stress on the acetabular cup. In an implant with a deeper acetabular cup than the DePuy ASR hip implant, there is more material to accommodate the strain of motion. The force is distributed over a bigger surface, which means that the implant overall can hold up to that strain better.

The already-shallow hip implant is made smaller overall to accommodate a woman’s smaller frame. Women have naturally wider hips and larger hip sockets than men do, which means that the shallow acetabular cup becomes in effect even shallower.

And the smaller the surface area of the implant, the more likely the material will break down rapidly releasing metal ions into the body. Those metal ions accumulate in the soft tissues surrounding the hip joint, causing metallosis.

Women also more likely to see the problems that develop as a result of metallosis, including metal hypersensitivity, heavy metal poisoning (which includes chromium poisoning and cobalt poisoning) and tissue and bone deterioration.

April 24, 2011

Are Defective DePuy Pinnacle Hips To Be Consolidated?

by Dr. Shezad Malik

We are DePuy ASR and DePuy Pinnacle recall attorneys and are providing this news update to the victims of Defective DePuy ASR Hips and DePuy Pinnacle Hips.

According to allegations raised in a new DePuy Pinnacle hip lawsuit filed earlier this month, the manufacturer of the implant has known for some time that it was a defective and dangerous device, and should have removed it from the market years ago.

The complaint was filed in The U.S. District Court for the District of New Jersey against DePuy Orthopaedics, Inc., Johnson & Johnson and the designer of the metal-on-metal hip replacement.

The DePuy Pinnacle hip system was introduced in 2001, with some variations containing a metal liner instead of a polyethylene liner, which can result in microscopic metal particles being shed into the body as the metal parts of the hip replacement rub against each other. This can lead to inflammation, swelling, loosening of the parts and ultimately may cause the hip replacement to fail, resulting in the need for hip revision surgery.

The companies did issue a recall for the DePuy ASR hip replacement system in August 2010, due to problems that are similar to what has been reported in connection with the Pinnacle hip. The DePuy ASR was approved by the FDA in 2005 as a “substantially equivalent” design to the DePuy Pinnacle. Post-marketing data provided at the time of that recall indicated that the DePuy ASR failure rate was about 12-13%, but some estimates suggest that nearly 50% of the recalled ASR hip replacements may lead to failure problems within six years.

In October 2010, the American Academy of Orthopaedic Surgeons (AAOS) issued a warning about potential problems with metal on-metal hip replacements, indicating that patients and the medical community should be aware that pain months after hip replacement surgery may be a sign of metal-on-metal hip cobalt toxicity. The FDA launched a new website in February to provide information about the risks associated with metal-on-metal hip replacements.

The metal ions, usually cobalt or chromium, can damage bone and tissue around the implant and joint, causing the implant to become loose or causing the patient to feel pain. The particles can have effects on the heart, nervous system and thyroid when in the bloodstream at high levels.

In the U.K., health officials recommend patients with metal-on-metal hip implants that are causing them pain be tested for metal ions in the blood, but the FDA has yet to make similar recommendations. Metal-on-metal hip implant recipients should see their orthopedic surgeon if they experience symptoms including heart pain, chest pain, shortness of breath, numbness, weakness, changes in vision or hearing, fatigue, unexplained cold, weight gain or changes in urination habits, the FDA advises.

A California lawsuit has been filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize the federal DePuy Pinnacle hip litigation in one court for coordinated pretrial proceedings, either as part of the pending DePuy ASR recall litigation or as a new multidistrict litigation (MDL). The DePuy ASR hip recall litigation is already consolidated as part of an MDL, in the U.S. District Court for the Northern District of Ohio.

The lawsuit argues that they are all related on common issues of fact, and such consolidation helps reduce duplicative discovery in different cases, eliminates inconsistent rulings from different judges and serves the convenience of the parties, lawyers and the courts. The plaintiff has requested that the Panel either designate a new court for handling of the litigation over DePuy Pinnacle hips or consolidate the DePuy ASR lawsuits and DePuy Pinnacle lawsuits in the same coordinated action.

The MDL Panel is expected to hear oral arguments on the motion at the next scheduled hearing, which will be held on May 16, 2011, at the Gene Synder United States Courthouse in Louisville, Kentucky.

While approximately 93,000 DePuy ASR hip systems were sold before it was removed from the market, more than 150,000 DePuy Pinnacle hips were manufactured according to the ;awsuit. In addition, since the August 2010 ASR recall, more than 1,300 people have filed an adverse event report with the FDA involving problems with a DePuy Pinnacle hip.

April 23, 2011

Crestor Liver Failure And Heart Failure Side Effects

by Dr. Shezad Malik

As a Crestor Liver Failure, Heart Failure Side Effect Attorney, I am writing this article to warn folks of the dangers associated with Crestor.

AstraZeneca, the global pharmaceutical giant and manufacturer – marketer of the popular cholesterol drug Crestor (Rosuvastatin), is being faced with the possibility of very serious and life threatening sides effects associated its cholesterol drug. Crestor (Rosuvastatin) is currently a very popular cholesterol lowering “statin” drug. Through independent medical research studies, Crestor, is shown to have significantly higher potential risks for certain serious side effects. According to documentation, the US Food and Drug Administration (FDA) appears to have not been aware of these risks when it approved Crestor for sale in the US in 2003.

Statins were initially approved by the Food and Drug Administration (FDA) for reducing high cholesterol levels in order to prevent repeated heart attacks and strokes in at-risk patients. When used for that purpose, the drugs drive down the risk of another heart attack or stroke by lowering levels of LDL (or “bad”) cholesterol.

Heart Attack and Stroke – Having the most potent statin on the market is problematic because, though statins reduce the risk of heart attack or stroke by lowering the levels of fatty deposits circulating in the bloodstream, research suggests that statins dampen the inflammatory processes. This can lead deposits of plaque to break away from blood vessel walls and cause sudden blockages of arteries leading to the heart or brain, and therefore heart attacks and strokes.

One of the major side effects of Crestor (Rosuvastatin) is a life threatening disorder known as Rhabdomyolysis. Rhabdomyolysis – This is a degenerative muscle disease that has been found in patients taking Crestor. It is a considerable depletion of muscle tissue throughout the body. As the muscles atrophy, the patient experiences weight loss, loss in body mass and serious weakness. This Crestor side effect also affects the most important muscle in the body, the heart. In a research study conducted by the independent watchdog group, Public Citizen, prescription data for Crestor was compared to that of other statin drugs. This research study showed that Crestor caused rhabdomyolysis almost 22 times more than its lowest dose competitor and 3 times more than its highest dose competitor. These are significant results.

The reason for the study’s outcome is that the higher the dose of the active ingredient, Rosuvastatin, the higher the risk of rhabdomyolysis. AstraZeneca, promotes Crestor as being the most powerful statin on the market. This may be true, but at what cost to a patient’s health? Recent studies have shown that only 10 mg of Crestor (Rosuvastatin) has a significantly positive effect, but these positive benefits plateau and the negative side effects of rhabdomyolysis, heart failure, heart attack, stroke, liver failure, kidney failure, and potentially diabetes increase significantly at the higher prescribed and advertised dosages.

April 23, 2011

YAZ, Yazmin, Ocella Side Effects And Injury

by Dr. Shezad Malik

As a YAZ, Yasmin, and Ocella Side Effect and Injury attorney, I want to bring to the attention of my blog readers, the latest medical information regarding these 4th generation oral contraceptive pills. According to a pair of studies published this weekend in the British Medical Journal (BMJ), the most popular birth control pills used by teenagers, Yasmin and YAZ doubles the risk of blood clots compared to a older generation birth control pill. Two new studies add to the growing evidence that birth control pills containing a newer type of progestin may put some women at higher risk for blood clots.

The medical report and analyses is a major warning for the heavily-marketed Yasmin and YAZ, which are popular with young adults and women with a history of menstrual disorders.

In the first study, researchers from the Boston University School of Medicine examined women ages 15 to 44 who started taking Yasmin and YAZ, which contain a contraceptive called drospirenone, instead of the much older drug levonorgestrel, which is sold under a variety of brand names. Accodrding to researchers those women who used Yasmin and YAZ were twice as likely to hospitalized with their first deep vein thrombosis or pulmonary embolisms, known as venous thromboembolism. Thromboembolism is the medical term for a blood clot in the veins, often in the legs, that gets dislodged and can cause fatal clogging in the lung arteries.

“These findings support more recent studies that suggest that drospirenone oral contraceptives are not as safe,” wrote Susan Jick and Rohini Hernandez in the BMJ. Jick and Hernandez recommended that “in the absence of other consideration, [Yasmin and YAZ] should not be the first choice in oral contraception.”

A second study published in the BMJ only examined UK patients and found an even higher risk; three times the chance of blood clots compared to the older drug.

German pharmaceutical giant Bayer, which manufactures Yasmin and YAZ, in a statement, said that the side effects were “an uncommon event” and noted that pregnancy would increase the deadly risks even more. Pregnancy actually puts women at higher risk for blood clots than birth control pills, a blood clot occurs in one pregnant woman for every 1,000 to 1,500 pregnant women, while one in 3,000 women who take birth control pills experience some form of blood clot, according to the National Blood Clot Alliance. This is a flawed argument, Bayer should compare non pill users wiith women taking YAZ, Yasmin.

In March 2010, Bayer put additional risk warnings on the European product label for the Yasmin pill but said at the time that the overall benefit-risk profile remained unchanged.Bayer said in its 2010 annual report that there were about 6,850 lawsuits pending in the United States with plaintiffs claiming they had suffered injuries from Bayer’s Yasmin and Yaz pills or generic copies sold by Teva’s Barr Laboratories.

So what does it all mean? The increased risk suggested by these studies is about two to three times those from older pills, and that any woman taking the newer medicines will get a blood clot is higher than other types of birth control. And the whole idea of medication is that the cure is less risky than the disease; here the data coupled with other research, unequivocally demonstrates that there are safer oral contraceptives than YAZ and Yasmin and that the company is putting profits over people safety. Remember physicians, the Hippocratic Oath, “first do no harm.”

Read my earlier blog, questioning whether YAZ, Yasmin would be recalled.

April 20, 2011

Can I Get Compensation For a DePuy Hip Replacement Lawsuit?

by Dr. Shezad Malik

As a Depuy ASR XL and ASR resurfacing hip recall attorney, I am trying to provide answers for my clients and potentials victims of the DePuy debacle.

If you are a victim of an ASR XL Acetabular System or an ASR Hip Resurfacing System, both of which were recalled by DePuy/Johnson & Johnson, you should expect financial compensation. In determining the amount of compensation you may be entitled to, you need to consider the following: the types of damages that available to people injured by defective products, and the recent results of a Sulzer hip implant lawsuit.

DePuy has promised, that it “…intends to cover reasonable and customary costs of treatment if you need services associated with the recall of ASR, including revision surgery if it is necessary.” DePuy names specific out-of-pocket expenses that it considers “reasonable,” including lost work time and travel expenses.

DePuy not provided any details on how, it intends to compensate you for the pain and suffering your DePuy hip replacement may have caused. To protect your legal rights, you should not call DePuy or sign any document the company provides without first speaking with a DePuy hip replacement attorney.

In a product liability case, a victim can recover economic damages (medical bills and lost wages) and non-economic damages (such as pain and suffering).

In 2000, Sulzer Orthopedics, Inc. recalled approximately 30,000 of its Inter-Op Acetabular Shell units. Because of a defective product, many recipients of this hip device required revision surgery, like with the DePuy hip recall. In 2002, Sulzer agreed to settle its class action and the company paid $1 billion to settle all the lawsuits. Those patients who required revision surgery were paid more than $200,000 each, and those who received faulty implants but did not undergo revision surgery received roughly $1,000 each. So time will tell regarding what DePuy will do and if history is going to be a guide.

We at this time do not know how the hundreds of DePuy ASR lawsuits will end up either through settlement or litigation. The fact is that taking legal action may be your only chance to recover financial compensation from DePuy. One thing is for certain, in mass tort cases, the companies usually settle, because it makes economic sense to do so and not because of any moral imperative or ethical considerations. It finally boils down to dollars and cents, like everything in life.

I have a client who is to undergo a double DePuy extraction next week, for cobaltism, metalosis and severe pain in both hips. She takes care of an elderly mother and her husband has chronic medical problems. She has been the main care giver to her family. Now with a double hip replacement, she will be the one who will require significant care and rehabilitation and she will need to make sure her family is taken cared of during her recovery, which could take as long as 6 months. The question she asks, will DePuy take care of her family diuring her rehabilitation? We have to wait and see.