Personal Injury

July 12, 2011

Yaz Pulmonary Embolism PE

As a Yaz, Yasmin and Ocella Blood Clot side effect and wrongful death attorney, and Texas medical doctor I am providing this update.

In one of the latest court battles pitting consumers against a giant drugmaker, thousands of victims are alleging Bayer did not provide adequate warnings about the health risks associated with Yaz, and they are blaming the drug for causing blood clots, heart attacks, strokes and sudden deaths.

Yaz and its predecessor, Yasmin, are oral contraceptives, including widely used generics such as Ocella, that contain a combination of the estrogen ethinyl estradiol and a synthetic hormone drospirenone. Both drugs were made by Berlex Labs, which was acquired in 2006 by Bayer Healthcare, the U.S. division of Bayer AG. The Food and Drug Administration approved Yasmin in 2001, and five years later they allowed Berlex to begin selling Yaz, another version of the drug.

The two pills, backed by heavy marketing campaigns, quickly became best-sellers, generating billions in annual sales for Bayer. When they were approved by the FDA, the pills were considered safer than older forms of oral contraceptives because they were taken for 24 days rather than the usual 21. But there were concerns about the health risks associated with drospirenone. A year after Yasmin went on the market, the nonprofit consumer advocacy group Public Citizen placed the drug on its list of “Do not use pills.”
The group warned consumers that Yasmin did not work better than older oral contraceptives that were less likely to cause dangerous side effects like blood clots. Sidney Wolfe, director of Public Citizen’s Health Research Group, said “When you have enough evidence to suggest that there is no unique benefit and there are unique risks, that should be it.”
In the case of Yaz, the product liability lawsuits claim that Bayer provided inadequate warnings about the health risks for women taking the drospirenone-containing birth control pills.

Yaz Pulmonary Embolism PE Risks
It is important to understand that if you are taking Yaz birth control, you are at a higher risk of Yaz pulmonary embolism. Women in the following categories have an even higher risk for Yaz related pulmonary embolism:

If you are over the age of 35
If you smoke more than 15 cigarettes per day
If you have a family or personal history of pulmonary embolism or blood clots
Yaz Death
Pulmonary embolism usually results in death because the emergency units cannot reach the patient in time. A staggering statistic is that 33 percent of all untreated pulmonary embolism attacks result in death. It is hard to process that the death may have been prevented with adequate information and packaging. Women should have been informed of the increased risks involved with taking Yaz birth control including PE and death.

More than 1,000 lawsuits have been filed in Bergen County — one of four courts where the mass tort litigation will be heard. Thousands of other cases are filed in courts in Philadelphia, California and Illinois.

In June, FDA regulators acknowledged new evidence that raised more questions about the safety of Yaz and birth control pills like it, including the top-selling generic Ocella. The agency posted a notice on its website saying it was aware of studies recently published in the British Medical Journal that showed oral contraceptives containing drospirenone were two to three times more likely to cause blood clots than other birth control pills.

July 10, 2011

Miami VA Colonoscopy Hepatitis C Case Goes to Trial

by Dr. Shezad Malik

As a Dallas Medical Malpractice attorney, and Texas medical doctor, I am providing this update regarding the medical malpractice cases in Miami VA hospital with improperly cleaned equipment.

A Miami U.S. Air Force vet who says he contracted hepatitis C from a colonoscopy done at the Miami VA hospital with improperly cleaned equipment will go to trial in Miami federal court. A Coral Gables veteran who filed the medical malpractice lawsuit, claims that an improper colonoscopy at the Miami Veterans’ Administration hospital gave him hepatitis C.

11,000 U.S. veterans received colonoscopies with improperly cleaned equipment at VA hospitals in Miami, Murfreesboro, Tenn., and Augusta, Ga., between 2004 and 2009. Of the veterans who had the procedure at the three facilities, five have tested positive for HIV, 25 for hepatitis C and eight for hepatitis B.

Robert Metzler, now 69, a U.S. Air Force veteran, says he got a colonoscopy at the Miami VA hospital in 2007 and two years later was told he has hepatitis C.

The lawsuits were filed after a 2009 investigation by the VA’s own Administrative Investigation Board revealed more than 11,000 colonoscopies were done at three VA hospitals using equipment that had been rinsed after each patient rather than being sterilized by steam and chemicals as called for by the manufacturer. Investigators who took apart water tubes on some of the equipment that was supposed to be clean and ready for use instead found “discolored liquid and debris.”
The AIB report said the colonoscopies in Miami were done in an environment of inadequate training, lack of supervision and inadequate communication.

U.S. Army veteran Juan Rivera of Miami sued for medical malpractice when he became HIV positive after a colonoscopy at the Miami VA hospital, that case settled out of court in March 2011.

In the Metzler case, court papers filed by the USA in April 2011 argue that the chances that the veteran contracted hepatitis C from the VA equipment are no more than “two in one trillion.” Hepatitis C can’t survive outside a human host for more than four days, the documents say, and “substantially more than four days had passed” between any previous patient with Hepatitis C who had a colonoscopy and the one performed on Metzler.

Metzler’s case is based on the claim that he had a blood test in August 2006 at the VA, with no sign of hepatitis C. His colonoscopy was in June 2007 and he was notified in March 2009 that he needed to come in to the VA for testing because the endoscope used in the procedure may have been contaminated, accodring to his lawyer. A month later, he was told he was positive for hepatitis C.

July 7, 2011

Multaq Study Stopped: Linked to Other Heart Problems

by Dr. Shezad Malik

As a Multaq Dangerous Drug attorney and Texas medical doctor, I am providing this information on a drug company sponsored trial of its drug Multaq, which was halted because of increased cardiovascular side effects and injuries.

Sanofi, maker of dronedarone (Multaq), has stopped its phase 3b trial of its antiarrhythmic drug due to an increase in cardiovascular events seen in patients with permanent atrial fibrillation – an unapproved indication for the antiarrhythmic drug. The PALLAS trial was testing the drug in patients with permanent atrial fibrillation (AF) and at least one other cardiovascular disease risk factor; at present, dronedarone is approved in patients with nonpermanent AF.

According to the primary medical investigator, “. . . there was a significant increase in major cardiovascular events, and in our study that was defined as a composite of stroke, MI, systemic embolism, or cardiovascular death. . . . These were pretty important events.”

Multaq, is approved for patients with the non-permanent kind of atrial fibrillation. The trial, known as the PALLAS study, was testing Multaq’s usefulness in patients with permanent atrial fibrillation (more than 6 months of the abnormal rhythms).

Dronedarone has faced a range of criticisms since its approval in the US in July 2009, including questions about its safety/efficacy tradeoff and the design and execution of the ATHENA study. Just last week, newspapers in France reported that French health authorities had concluded that the efficacy of dronedarone was “insufficient”—an opinion that could lead to the drug being dropped from the country’s drug reimbursement formulary.

Dronedarone, sold by sanofi-aventis, is currently approved to treat atrial flutter and paroxysmal or persistent – but not permanent atrial fibrillation.

The phase 3b trial, called PALLAS, had enrolled 3,148 patients with permanent atrial fibrillation, with 70% showing symptoms for more than two years, according to a company statement. Sanofi did not specify the cardiovascular events seen in the dronedarone-treated patients, or the magnitude of the increase.

In January, sanofi-aventis and the FDA warned that reports of acute liver injury associated with the drug had been received. The statement noted that patients with permanent atrial fibrillation and “vascular risk factors” are at high risk for cardiovascular events.

An earlier trial of dronedarone in patients with relatively severe heart failure, called ANDROMEDA, was halted early when mortality in patients receiving the drug was found to be twice that seen in the control group.

Sanofi-aventis has alerted healthcare professionals to several reports of liver function test abnormalities and hepatocellular injury in patients treated with its atrial fibrillation drug dronedarone (Multaq). The Dear Healthcare Provider letter included two post-marketing case reports of acute liver failure that required transplantation, occurring at four-and-a-half and six months after the start of dronedarone therapy. The patients – both female and about 70 years old – had had normal hepatic serum enzymes before starting the drug.

In the letter, sanofi-aventis instructed healthcare professionals to tell patients to immediately report any symptoms suggestive of hepatic injury. According to the FDA, these include anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

Periodic liver enzyme tests, especially in the first six months of treatment, should also be considered, according to the FDA, although it is unknown whether such a strategy will prevent the development of liver injury.

Dronedarone’s prescribing information will be updated to include the guidance from the Dear Physician letter, and will be distributed after the FDA approves it. The agency confirmed that a warning about potential liver injury will be added to the drug’s label.

According to the FDA, from the drug’s approval in July 2009 through October 2010, about 492,000 prescriptions for dronedarone were dispensed and about 117,000 patients filled prescriptions at U.S. pharmacies.

The drug was approved with a Risk Evaluation and Mitigation Strategy to prevent use in patients with severe heart failure or in those with less severe heart failure who were recently hospitalized for the condition. Such patients had a doubling in the risk of death in a placebo-controlled study.

July 6, 2011

AMS Vaginal Sling Lawsuits

by Dr. Shezad Malik

As a Texas Bard Avaulta litigation and Product Liability Attorney and Texas medical doctor, I am providing this update.

Laura Jones, of El Paso, Texas, has filed a lawsuit against American Medical Systems (AMS) over problems with vaginal mesh manufactured by the company. Jones had an AMS vaginal sling implanted in June 2009 to restore normal vaginal structure. Following the pelvic organ prolapse surgery, Jones experienced severe pain, urinary problems and had to undergo surgeries to have the AMS surgical mesh removed. The complaint was filed last month in Los Angeles Superior Court by against AMS and a number of other unnamed manufacturers.

According to Jones’ lawsuit, the transvaginal sling eroded, shrunk and part of it extruded into her vagina. The complaint alleges that AMS failed to warn patients about the risk of vaginal mesh side effects, claiming that the manufacturer should be held responsible under theories of strict liability, negligence, breach of implied and express warranty, fraud, misrepresentation and violating California consumer protection laws.

Recently, several AMS vaginal mesh lawsuits have been filed for women who experienced problems after receiving pelvic organ prolapse products. The FDA issued a warning about vaginal mesh complications in October 2008, indicating that more than 1,000 people had reported experiencing problems with products made by at least nine different manufacturers. Recently a medical study revealed that there were more complications with the vaginal mesh slings. In the study published in the New England Journal of Medicine, researchers found that vaginal mesh surgery brought better results for treating pelvic organ prolapse, but carried risks of surgical complications and other problems after surgery, including pain during sex and new urinary incontinence.

Last year, settlements were reached in a number of Mentor ObTape vaginal mesh lawsuits filed by women who experienced problems after receiving that product. The product made by a subsidiary of Johnson & Johnson. The complaints alleged that the complication rate associated with Mentor ObTape mesh could be as high as 18%. The Mentor ObTape was removed from the market in 2006, three years after it was introduced.

Over the past year, a growing number of Bard Avaulta vaginal mesh lawsuits have also been filed by women who have experienced problems. All of the complaints involve similar claims that C.R. Bard’s Avaulta Anterior and Posterior BioSynthetic Support System, which was introduced in 2007, was negligently designed and that the company failed to warn patients of possible complications that can result in severe pain and disfigurement.

In October 2010, the federal Bard Avaulta litigation was consolidated as part of an MDL for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.

July 5, 2011

Chantix Increases Heart Attacks

by Dr. Shezad Malik

As a Texas Chantix side effect and Product Liability Attorney and Texas medical attorney, I am providing this update.

New medical research suggests that Chantix side effects increases the risk of heart attacks, strokes and other cardiovascular events.

Pfizer’s smoking cessation drug Chantix raises the risk of suffering a cardiac event by 72%, according to a study published in the Canadian Medical Association Journal.

Researchers found that those who took Chantix were substantially more likely to suffer heart problems than those who took a placebo, and two of the co-authors suggested that the findings were strong enough that the FDA should consider a Chantix recall due to the risk of heart attack and stroke.

The study comes just three weeks after the FDA issued a drug safety communication about the risk of heart problems from Chantix, warning that the smoking cessation drug might increase the risk of certain cardiovascular events, including the risk of heart attack, among individuals who had cardiovascular disease. The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk.

The warning risk of a heart attack or stroke from Chantix is just the latest of serious side effects associated with the drug. Warnings about the risk of life-threatening psychological side effects of Chantix, which increases the risk of suicide, was added to a black box on the medications label two years ago.

Chantix (varenicline) was approved in the United States by the FDA in 2006 as a prescription medication to help people quit smoking. The prescription medication designed to help people stop smoking already holds the title of being the drug associated with the most FDA adverse event reports of any prescription medication in the United States.

A number of Chantix lawsuits have been filed in courts throughout the United States on behalf of individuals who have died or suffered serious injuries as a result of a suicide or unusual behavior allegedly caused by Chantix.

June 26, 2011

DePuy ASR and Pinnacle Metal on Metal Hips

by Dr. Shezad Malik

As a DePuy ASR and Pinnacle Metal on Metal Hips attorney, I am providing this update. It is in our nature to want the latest and greatest — whether it is a faster car, a smarter computer or a smaller cell phone, and this applies equally to medicine, where we want the newest and presumably safer drugs and medical devices.

But medical innovation can become a trap for the unwary; we are now seeing this playing out with deadly consequences for thousands of patients who are using the 4th generation birth control pills Yaz and Yasmin over the safer 3rd generation older contraceptive pills and those folks who now are the recipients of metal on metal artificial hips.

The metal-on-metal hips, were regarded by hip manufacturers and surgeons as a technological break through over previous designs that used both metal and plastic. Now the FDA (who had been asleep at the wheel) and medical researchers are panicking to determine how many implant recipients have been injured by the devices.

The Food and Drug Administration recently ordered manufacturers of all metal hips to undertake emergency studies of patients. The rush to implant the latest and greatest, and patients’ demand shows how innovation’s siren call led a product promoted as a breakthrough without convincing evidence that it was better or even as good as existing options.

In 2010, DePuy, the orthopedics division of Johnson & Johnson, recalled one of its all-metal hips, the ASR, which was failing at a high rate. Furthermore, another DePuy product, the Pinnacle (which has not yet been recalled) is now under scrutiny for excessive failures. Another manufacturer, Zimmer Holdings, also briefly halted sales of one of its metal models, the Durom. DePuy, Zimmer and other companies continue to deny that there are any problems with their products.

THE modern artificial hip, which was developed in the 1960s, uses a simple design. A metal “ball” made of cobalt and chromium replaces the top of the thigh bone, while a “cup,” typically made of plastic, serves as an artificial hip socket. By the 1990s, the devices were considered highly effective, with studies then finding that implants still worked a decade after surgery in 95 percent of patients.

By 2008, metal on metal hips were used in one out of every three hip replacements, of approximately 250,000 hips implanted annually in the United States. By using a metal cup, which is thinner than a plastic one, a surgeon could implant a bigger ball component, which was assumed to be less likely to dislocate than a smaller one. But recent research, demonstrates that such oversized components may be the reason the devices shed metallic debris.

As the number of affected patients nationwide increased, it became apparent that the devices had not been properly tested. Under F.D.A. regulatory rules, most all-metal hips do not have to undergo clinical trials before sale. They are tested in labs on machines that simulate millions of steps to study the forces exerted by years of motion. According to testing experts, all-metal devices proved worse than metal-and-plastic ones to small variations in how they were implanted, with components sometimes striking together and generating debris.

The devices, as a group, are twice as likely as metal-and-plastic ones to require early replacement, according to data from Australia’s orthopedic registry, one of the most comprehensive databases on implants. Most importantly, damage from debris generated by metal implants in some patients, has caused crippling tissue and muscle damage, and has produced neurological problems, a condition known as metallosis.

It is estimated, about 500,000 patients in the United States may have gotten an all-metal hip, and thousands will have painful early-replacement procedures. The lawsuits against DePuy and other makers of all-metal hips may emerge as the largest product liability cases of this decade.

June 25, 2011

Supreme Court Immunizes Generic Drug Manufacturers

by Dr. Shezad Malik

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.