Wrongful Death

June 25, 2011

Supreme Court Immunizes Generic Drug Manufacturers

As a Dangerous and Defective Drug attorney, I am writing this opinion piece, regarding the latest US Supreme Court Generic Drug Decision, which in my humble opinion is disastrous to Patient Safety. The case is PLIVA, Inc. v. Mensing.

On June 23, 2011, the United States Supreme Court ruled in a 5-4 decision that Generic Drug Manufacturers cannot be sued for failing to warn consumers of the possible side effects of their defective products, as long as they use the same warnings on the brand-name drugs. This decision is absurd on its face; this means that brand-name drug manufacturers can be held responsible for their failure to warn consumers about the dangers, but generic manufacturers are now provided an all encompassing shield that brand-name manufacturers do not have.

The seriousness and ramifications of this opinion cannot be understated. The Court’s decision now prevents millions of Americans, who have been seriously injured by generic drugs, from seeking compensation for their injuries. Generic drug manufacturers have a huge business in the United States. This opinion immunizes those drug manufacturers from liability. Another win for Big Pharma, and the consumer gets it again.

June 23, 2011

Actos Bladder Cancer Warning & Side Effects

by Dr. Shezad Malik

As an Actos Side Effects Lawsuit and Piaglitazone Bladder Cancer Lawyer, I am writing this Actos update, regarding the Actos dangerous drug cancer side effects.

Actos (pioglitazone) is a medication manufactured and sold by Takeda Pharmaceuticals for treatment of Type 2 diabetes. The drug is part of the same class of medications as Avandia (rosiglitazone), which has been linked to an increased risk of heart attacks.

What is Actos?

Actos or Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes. Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body’s sensitivity to insulin, a hormone that controls blood sugar levels. Pioglitazone is not used to treat type 1 diabetes or diabetic ketoacidosis.

Fast FDA Facts About Actos

*Sold as a single-ingredient product under the brand-name Actos. Also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact).

*Used along with diet and exercise to improve control of blood sugar in adults with type 2 diabetes mellitus.

*From January 2010 through October 2010, approximately 2.3 million patients filled a prescription for a pioglitazone-containing product from outpatient retail pharmacies.

Diabetes Drug Actos Bladder Cancer Risks

The FDA has issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone).The agency’s warning comes five days after Germany and France pulled Actos from the market.

The warning comes after a review of data from a five-year analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals.The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.

According to the FDA, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.Some medical experts believe that an Actos recall is imminent or that new warnings about the risk of bladder cancer from Actos should be added to the medication.

Research Data Summary

To address the long-term risk of bladder cancer associated with pioglitazone use, the drug manufacturer (Takeda) is conducting a ten-year, observational cohort study in patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan. Patients selected in this study had diabetes mellitus and were ≥40 years of age at study entry. The study group included 193,099 patients with diabetes.

The primary outcome of the cohort study is an incident (new) diagnosis of bladder cancer identified from the KPNC cancer registry. A planned five-year interim analysis was performed with data collected from January 1, 1997 through April 30, 2008.

The results showed that after adjusting for risk factors, there was no significant increase in the risk for bladder cancer in patients ever exposed to pioglitazone compared to patients never exposed to pioglitazone.

But, the risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk. The hazard ratio after more than 24 months of pioglitazone use was 1.4. Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use of pioglitazone.

Possible signs or symptoms of Actos bladder cancer may include:

Blood in the Urine
Pain During Urination (Dysuria)
Frequent Urination
Feeling of Need to Urinate Without Results
Although it appears that information about the risk of Actos cancer problems has been known to the manufacturer for some time, inadequate warnings were provided to consumers and medical doctors. Further, it appears that the manufacturer may have placed their desire for profits ahead of patient safety by failing to adequately warn about the potential risk of bladder cancer. As a result, consumers diagnosed with bladder cancer may be able to obtain compensation through an Actos lawsuit.

June 22, 2011

Zimmer NexGen Knee Replacement Injury

by Dr. Shezad Malik

As a TEXAS Zimmer NexGen Knee replacement attorney, I am providing this update regarding the request for consolidation of these cases in one federal court.

A motion was filed in June, calling for all Zimmer NexGen knee lawsuits filed in various federal district courts throughout the United States to be centralized before one judge for coordinated handling during pretrial proceedings as part of an MDL, or multidistrict litigation.

Zimmer NexGen knee replacement lawyers expect that there may become many similar claims filed on behalf of individuals who allege that they received a defective knee implant and had to undergo revision surgery or suffered permanent and debilitating injuries as a result of a problems with a Zimmer NexGen knee.

The motion was filed on June 6 on behalf of plaintiff Fred Stone, who has proposed that the federal Zimmer NexGen knee litigation be consolidated in the U.S. District Court for the Northern District of Illinois.

At the time the motion was filed there were 28 Zimmer NexGen knee implant claims pending in 13 federal judicial districts across the country, and plaintiff attorneys indicated that there were at least 200 other potential cases that had not yet been filed.

All of the lawsuits involve problems with the Zimmer NexGen high-flex knee implants, Zimmer NexGen MIS tibial components or Zimmer NexGen LPS gender solutions. Some patients who received the Zimmer NexGen knee replacement systems complained about a number of problems, including reports of pain, loosening of the implant and failure of the replacement knee leading to revision surgery.

Plaintiffs claim to have suffered catastrophic implant failures, had permanent problems walking or had to undergo revision surgery to remove or replace the implants because they failed far in advance of their projected lifespan. Plaintiffs allege that the device maker stated that using the Zimmer NexGen knee was safe, despite knowledge of serious injuries associated with the components. Zimmer also understated the risk of Zimmer NexGen knee problems, according to allegations raised in the complaints.

In September 2010, recalls were issued for several components due to apparent manufacturing defects or design defects. A Zimmer NexGen MIS recall was issued for more than 68,000 knee components following at least 114 reports of problems that caused some individuals to experiencing loosening of the parts or the need for additional knee surgery. In addition, a Zimmer NexGen LPS recall was issued due to nonconfirming and inconsistent geometry.

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.

MDL Consolidation Pending

Consolidation of the lawsuits over Zimmer NexGen knee replacement systems before one judge as part of an MDL is designed to reduce duplicative discovery, avoid contradictory rulings from different judges and to serve the convenience of the court, witnesses and parties. While the pretrial management of the cases in an MDL is often managed similar to how a Zimmer NexGen class action lawsuit would be handled, each claim will still remain an individual lawsuit.

The U.S. Judicial Panel on Multidistrict Litigation is scheduled to consider consolidation of the cases next month at a hearing on July 28 in San Francisco, California.

June 19, 2011

Crestor Side Effects & Cardiomyopathy

by Dr. Shezad Malik

As a Crestor Side Effect attorney and cardiologist, I am writing this blog article to highlight the side effects of cardiac for patients who are taking statins, particularly Crestor to manage their high cholesterol levels.

According to new medical studies, the use of statins, especially Crestor, can be a major cause of cardiomyopathy, a heart problem caused by heart muscle weakening. Statins are prescribed to lower cholesterol levels. The drugs do this by by inhibiting the key enzyme HMG-CoA reductase, which is involved in the cholesterol synthesis pathway. But a side effect of statins leads to reduced levels of Coenzyme Q10, an important chemical required for proper muscle functioning.

A 2009 Lancet article focused on that issue and indicated that statins, like Crestor, as one cause of heart failure. (See Florkowski, S Molyneux, P George, M Lever, N-3 polyunsaturated fatty acids and statins in heart failure, Lancet 2009.)
Cardiovascular side effects from Crestor use are serious and may be life-threatening. If you or a loved one experienced cardiovascular injury or death, congestive heart failure, or immune-mediated necrotizing myopathy while taking Crestor, you may have a claim.

Crestor (generically known as Rosuvastatin), is an oral prescription drug designed to reduce the cholesterol blood levels when used together with lifestyle changes of diet and exercise. AstraZeneca, the manufacturer, designed the drug to reduce the production of cholesterol in the liver and by increasing the liver’s ability to remove “bad” LDL cholesterol. Crestor has been marketed as a “super-statin” because it claims to lower LDL cholesterol more than other statin drugs.

There are currently five statin drugs on the market in addition to Crestor: Lescol (fluvastatin), Lipitor (atorvastatin), Mevacor (lovastatin), Pravachol (pravastatin) and Zocor (simvastatin). Baycol (cerivastatin), another statin drug, was removed from the market in 2001 because of serious side effects reported by patients.

Crestor History

The FDA withheld approval for Crestor following concerns to the recall of Baycol and the kidney and muscle side effects reported in Crestor drug trials that were similar to those associated with Baycol. The FDA approved Crestor in August 2003 for the 5, 10, 20, and 40 mg doses following a clinical trial involving approximately 12,000 patients. The 80 mg dosage was not approved.

In March 2004, the non-profit organization Public Citizen asked the FDA to remove Crestor from the market, stating that Crestor side effects were severe and that the drug should never have been placed on the market. Read the FDA response to the Public Citizen petition on Crestor. The FDA issued a Public Health Advisory for Crestor on June 9, 2004, warning of the “increased risk for serious muscle toxicity (myopathy) associated with Crestor use, especially at the highest approved dose of 40 mg.”
In March 2005, the FDA issued an alert warning that “Rhabdomyolysis (serious muscle damage) has been reported in patients taking Crestor as well as other statin drugs. The labeling for Crestor has been revised to include information on the safe use of Crestor to reduce the risk for serious muscle toxicity, especially at the highest approved dose of 40 mg.”
Zocor Side Effects and Warnings

FDA in June 2011 warned about the risk of muscle injury in patients taking the highest dose of anti-cholesterol Zocor. Now patients and plaintiffs considering a Crestor lawsuit may be considering if the FDA’s Zocor warning applies to Crestor side effects. The FDA has recommended to patients and doctors that, “Zocor, Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.”

SEARCH Study Results Leads to FDA Zocor Warning

The recent FDA study was based on data from the trial SEARCH (Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine) which assessed the frequency of serious cardiovascular injuries, including heart attack and death, in patients who took the maximum Zocor dosage of 80 mg as compared to those who took only 20 mg of the drug.

Crestor Side Effects Similar to Zocor Warning

Zocor muscle injuries are similar to the Crestor side effects. The higher the dosage of a “super-statin,” the greater the risk a patient runs of developing Crestor side effects such as muscle pain and weakness, and the potentially fatal rhabdomyolysis, in which muscle fiber breakdown products is released into the bloodstream and causes kidney damage or failure.

June 16, 2011

Fosamax Bisphosphonate Femoral Fracture Litigation

by Dr. Shezad Malik

Dr Shezad Malik Law Firm is currently evaluating and accepting Fosamax long bone fracture cases and defective drug product liability claims. We are providing this Fosamax lawsuit update for the benefit of our readers and current Fosamax injury clients.

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All federal Fosamax Femur low-impact bone fractures lawsuits have been consolidated for pretrial proceedings as part of a new MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the District of New Jersey.

At least 37 Fosamax fracture lawsuits are currently pending in federal district courts throughout the United States, and those cases will be transferred to New Jersey for further litigation. In addition, as new complaints over femur fractures on Fosamax are filed in the federal court system, they will also be added to this new MDL.

Fosamax lawsuits over jaw problems, known as osteonecrosis of the jaw, which will remain centralized as part of a different MDL in the U.S. District Court for the Southern District of New York.

All of the complaints involve similar allegations that side effects of Fosamax, can increase the risk of atypical thigh bone fractures, which often occur with little or no trauma at all. Plaintiffs claim that Merck failed to adequately warn about the risk of femur fractures from Fosamax, or that users should seek immediate medical attention if they experience groin pain, which may occur several weeks before a complete fracture while on Fosamax.

In October 2010, the FDA required new warnings about the risk of bone fractures from Fosamax and other similar bisphosphonate medications. There are currently more than 900 Fosamax jaw lawsuits consolidated in New York, as part of an MDL that was established in August 2006. Fosamax fracture lawsuits were previously excluded from that MDL, because it was determined that the evidence of general causation leading to femur fractures would likely differ substantially from cases dealing with jaw bone damage.

June 5, 2011

FDA To Investigate YAZ, Yasmin and Ocella

by Dr. Shezad Malik

As a Texan YAZ, Yasmin, Ocella Dangerous Drug and Side Effect Attorney and medical doctor, we are in the process of evaluating, accepting and filing lawsuits against Bayer regarding the dangerous side effects of YAZ, Yasmin, Ocella oral contraceptives.

The Food and Drug Administration said it is conducting a safety review of certain types of drospirenone containing birth-control pills to see if they increase the risk of blood clots when compared to other older birth control pills.

The FDA said the review is focusing on products that contain drospirenone, which is used in pills including Yaz and Yasmin, which are marketed Bayer AG. Drospirenone is a type of female sex hormone called a progestin.

Most birth-control pills contain two types of hormones, estrogen and progestin. The FDA said two recently published studies reported a greater risk of blood clots for women taking birth-control pills containing drospirenone, compared to birth-control pills containing another progestin known as levonorgestrel.

The FDA said some previous studies have reported that the risk of blood clots for women who use birth-control pills containing drospirenone is higher than that for women who use birth-control pills containing levonorgestrel.

Blood clots form inside a vein, known as deep vein thrombosis, or DVT. The clots can break loose and travel to other areas of the body such as the lungs, known as pulmonary embolism, or PE.

The FDA said it is “currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth-control pills.” An FDA-commissioned study involves more than 800,000 U.S. women and results are expected later this summer.

The European Medicines Agency said the risk of developing blood clots for oral contraceptives containing drospirenone was higher than that of pills containing levonorgestrel. EMA said the product labels of birth-control pills containing drospirenone will be updated.

The most recent studies were published earlier this year in the British Medical Journal. They compared women taking birth-control pills containing drospirenone with women taking birth-control pills containing levonorgestrel and found the risk of blood clots to be 2 to 3 times greater among women taking drospirenone products.

June 4, 2011

Cell Phones and Brain Cancer Attorney

by Dr. Shezad Malik

As a Dallas, Texas Personal Injury and Product Liability attorney I am providing this update regarding the risk of brain cancer and cell phone use.

In 2010, a major study in 13 countries found no clear evidence that exposure to the radiation from cellphones causes brain cancer. The International Agency for Research on Cancer, a unit of the World Health Organization (WHO), declared this week that the radiation is “possibly carcinogenic” to humans.

The agency, stated that heavy users of cellphones had an increased risk of developing a rare brain tumor known as a glioma. Cellphones were placed in a “possibly carcinogenic” category.

The report comes as a proposed class action lawsuit against 19 defendants, mostly cell phone manufacturers and telecommunications companies, has landed at the U.S. Supreme Court. The defendants which include Nokia, AT&T Inc and Samsung Electronics Co Ltd are accused of misrepresenting that their cell phones are safe, when they in fact knew of potential dangers.

Still, many experts remain skeptical, and despite a huge world wide increase in cellphone use over the past twenty years, brain cancer rates in the United States have been declining. Scientists are unclear as to how the radio frequency waves emitted by cellphones, which may break chemical bonds and disrupt DNA, cause cancer.

The Food and Drug Administration, which regulates the safety of cellphone emissions, said it would review the forthcoming research study carefully but that “the existing weight of scientific evidence does not show an association between non-thermal radio frequency energy and adverse health outcomes.”
Heavy users of cellphones might want to use headsets, speaker phones or text messaging to keep the device at a distance. Many folks would be surprised to learn that cellphone manufacturers, to prevent personal injury liability claims, already advise users in very small print to hold the phones a short distance from the body while making telephone calls.

June 2, 2011

Propecia Side Effect Attorney

by Dr. Shezad Malik

We are currently evaluating and accepting PROPECIA induced sexual dysfunction cases.

Eddie Sebastia from Florida has filed a product liability lawsuit against Merck, he alleges that side effects of the hair loss drugs Propecia and Proscar ruined his sex life.

The Propecia erectile dysfunction lawsuit was filed by Sebastia, claims that Merck failed to warn doctors and patients that side effects of Propecia, or Proscar, could result in permanent sexual problems.

Sebastia took Propecia and Proscar from 1998 to 2008, and claims that the medications caused him to develop erectile dysfunction, testicular pain, descreased sex drive, depression and anxiety.

Propecia (finasteride) was approved in 1992 for the treatment of benign prostatic hyperplasia, and also is approved to treat male pattern baldness. It was originally marketed by Merck as Proscar.

In March, 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. They also agreed that in some cases these side effects appeared to be permanent.

While the drugs carried some warnings, the lawsuit alleges that those warnings were insufficient and understated the potential risks.

June 1, 2011

YAZ, Yasmin, Ocella Dangerous Drug Side Effect

by Dr. Shezad Malik

I am a Texas YAZ, Yasmin, Ocella Dangerous Drug Attorney and medical doctor and we are in the process of evaluating, accepting and filing lawsuits against Bayer regarding the dangerous side effects of YAZ, Yasmin, Ocella oral contraceptives.

Bayer’s birth control pills will be reviewed by FDA regulators after some studies suggested they may cause more blood clots than other oral contraceptive medicines.

According to the FDA, two recent reports in the British Medical Journal found a twofold to threefold greater risk of blood clots in women taking pills like Bayer’s Yaz.

European regulators said last week that they were revising the products’ prescribing information to include the new safety findings.

While all birth control pills pose a risk of blood clots, the F.D.A. review focuses on the hormone drospirenone, found in Bayer’s Yaz, Yasmin, Beyaz and Safyral. The agency expects to have results later this summer of an 800,000-person study it commissioned to examine the risks.

In the meantime, regulators said doctors and patients should watch for symptoms of blood clots, including leg or chest pain.

RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

May 26, 2011

DePuy Pinnacle Replacement Recall Lawsuit

by Dr. Shezad Malik

As a DePuy Pinnacle Hip Failure and Replacement Attorney, I am providing this new information for my product liability clients.

On August 2010, there was a recall of the DePuy ASR XL artificial hip, and now DePuy may be facing the recall of the Pinnacle Acetabular Component. All federal lawsuits over DePuy Pinnacle hip replacement problems have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the Northern District of Texas, Dallas.

The U.S. Judicial Panel on Multidistrict Litigation issued an order establishing the MDL, which will result in the transfer of 60 DePuy Pinnacle hip lawsuits currently pending in federal district courts throughout the United States.

Like the DePuy ASR XL, the Depuy Pinnacle is a metal on metal system that was designed to last at least 10-15 years but now, orthopedic surgeons are reporting that these devices have been failing within one to two years of being implanted into their patients.

DePuy, a division of Johnson & Johnson, has implanted over 150,000 Pinnacle hip replacements since 2001. Its recent recall of the defective ASR metal-on-metal hip implant systems has thousands of hip implant patients to have additional hip revision surgeries.

The ASR and Pinnacle are both metal on metal systems, and the ASR is a monoblock design, the Pinnacle uses a modular system. The ASR cup is made of one solid piece of metal, the Pinnacle has an outer shell and the Pinnacle is designed allow the surgeon the option to place a metal, ceramic or polyethylene liner inside the metal outer cup.

The Pinnacle 36 mm Ultamet Metal-on-Metal component is failing at an unacceptably high rate. Research suggests that there is a design problem, and the device has been created with one of the lowest clearance levels in the industry. Experts investigating the product design believe that DePuy created a very narrow window for proper placement of the prosthesis and inadequately trained surgeons in the proper implantation technique.

The recalled DePuy ASR system and the Pinnacle was permitted under the U.S. Food and Drug Administration’s (FDA) 510(k) approval process, which allows a medical device to be placed on the market without being subjected to clinical trials as long as the manufacturer can show that the device is “substantially equivalent” to a device already approved on the market. DePuy’s ASR system avoided clinical trials by showing that it was similar to the DePuy Pinnacle hip replacement system.

The FDA has received complaints and adverse incident reports against the Pinnacle system, and the Pinnacle’s propensity to prematurely separate from the bone. Constant friction in the metal on metal Pinnacle causes an increased risk of metallosis, the release of metal particles into the surrounding soft tissue or bloodstream, particularly chromium and cobalt.

The Dr Shezad Malik Law Firm hip replacement team continues to investigate claims of Pinnacle failures and counsel our clients on what to do in the event that they need revision surgery.