Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Posted in Medical News

As a Texas medical doctor and Fosamax femur fracture injury Attorney, I am fielding many calls from concerned plaintiffs regarding their side effects from using Fosamax and similar drugs. We are providing the following update and commentary.


A FDA advisory committee wants the agency to limit the duration of bisphosphonate therapy for treatment of osteoporosis. This year, the FDA required that all bisphosphonates used to prevent or treat osteoporosis warn on their labels that optimal duration of use hasn’t been determined. The issue has become concerning to the FDA as reports have emerged linking long-time bisphosphonate therapy with increased risk of atypical fractures.

The Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee met to discuss whether emerging reports of adverse events should cause the FDA to change the label to indicate that the drug not be used long term. The medical advisers did not press the issue as strongly as the F.D.A. staff itself did in a 45-page report issued on Wednesday. The staff report said studies “suggest no significant advantage of continuing drug therapy beyond five years.”

As a Texas medical doctor and Medical Malpractice attorney, I am providing this case law update and commentary.


As part of Texas’s tort reform laws, enacted by the Texas legislature in 2003, one of the requirements in order to file a medical malpractice claim, was the furnishing of a medical expert’s report within 120 days of filing the lawsuit.The 5th District Court of Appeals says that the legislation serves the state’s interest in preventing frivolous medical liability lawsuits and related health care system costs. This medical expert report requirement is also known as the Texas’ certificate-of-merit law, and is similar to many other states’ medical malpractice reform.

Recently Texas’ certificate-of-merit law passed another constitutional challenge after the 5th District Court of Appeals validated the requirement for plaintiffs to file an expert report demonstrating the merits of a medical liability case.

As a Texas medical doctor and Transvaginal Mesh Attorney I am providing this information and commentary.


11.6% of women who undergo surgery with transvaginal placement of Ethicon Gynecare Prolift Mesh for repair of pelvic organ prolapse (POP) have to undergo additional operations due to post operative complications.

This complication rate was found as a result of a new study, published by the American Journal of Obstetrics and Gynecology. Most of the re-operations were due to urinary incontinence that occurred after the mesh was implanted, with other problems including transvaginal mesh complications and prolapse recurrence.

Researchers reviewed the outcomes for 524 patients who received the Ethicon Gynecare Prolift vaginal mesh over a 4 year period. At a follow up of 38 months, 11.6% had to undergo reoperation after receiving the Prolift Mesh for pelvic organ prolapse. Over 50% of those reoperations were due to urinary incontinence, More than 25% due to mesh-related complications and more than 25% due to recurring prolapse. The researchers found that the number of mesh-related complications and POP decreased when experienced medical teams implanted the mesh.

The Gyncare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems was first introduced in September 2005, and Gynecare Prolift+M variations were introduced in May 2008. The vaginal mesh or bladder sling is designed reinforce weakened or damaged tissue on the pelvic floor that hold organs in place, such as the bladder, the uterus and the rectum.

Recently, the FDA issued a warning about the risk of problems with Ethicon Gynecare vaginal mesh and other similar products used for pelvic organ prolapse. The agency declared that transvaginal surgical mesh for pelvic organ prolapse does not provide any benefit over other means of treatment, and has been associated with hundreds of reports of serious problems.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh problems after pelvic organ prolapse repair surgery, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infection, pelvic pain, urinary problems, vaginal scarring among other complications.

A number of Gynecare Prolift mesh lawsuits have been filed against Ethicon, Inc., which is a subsidiary of Johnson & Johnson. At least 400 complaints have been filed in New Jersey state court over the Prolift mesh and other similar vaginal bladder sling products made by Ethicon, such as Gynemesh, Prolene Mesh and TVT slings.

In addition to Ethicon vaginal mesh products, problems have also been associated with slings sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies. Transvaginal mesh lawyers are also reviewing potential claims against manufacturers of these products for women who experienced problems with surgical mesh for pelvic organ prolapse repair.

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As a Texas medical doctor and Dallas Hydraulic Fracking Attorney I am providing this information and commentary.


The EPA is prohibited from regulating hydraulic fracturing under the Safe Drinking Water Act. On July 28, 2011, the EPA proposed federal regulations to reduce smog-forming pollutants released by the hydraulic fracturing approach to gas drilling.

According to the EPA, If approved, the rules would amount to the first national standards for fracking of any kind. The agency sets guidelines when companies inject fluids underground, but in 2005 Congress prohibited the EPA from doing so for fracking. Regulation has been left to the states, some of which compel companies to report what chemicals they use and have imposed tougher well-design standards.

The new EPA proposal would limit emissions released during the stages of natural gas production and development, and targets the volatile organic compounds released in large quantities when wells are fracked. According to the EPA, drillers would have to use equipment that captures these gases. According to environmental experts, the proposed rules represent a step by federal regulators amid a growing controversy over fracking’s safety.

The American Petroleum Institute, the country’s main oil and gas lobbying group, has requested that the EPA delay finalizing the rules for at least six months beyond the current Feb. 2012 deadline.

The Marcellus Shale Coalition, a group representing gas drillers in the Northeast, issued a statement criticizing the proposed regulations, saying they would “undercut” gas production.

The EPA proposal is the result of a successful 2009 lawsuit brought against the agency by WildEarth Guardians and another advocacy group alleging that the agency had not updated air-quality rules as required. The EPA is supposed to review such rules at least every eight years, but in some cases had not done so for 10 years or more.

According to Jeremy Nichols, the climate and energy program director for WildEarth Guardians, hydraulic fracturing is a major source of emissions because when fluids used to frack a well return to the surface, they carry gases that can be vented into the air. In fracking’s case the soupy return contains methane, volatile organic compounds and toxic chemicals such as benzene, which generally spray into the environment. In some gas drilling areas, where emissions from drilling are particularly high, they no longer meet federal air quality standards.

The EPA proposal also calls for reducing emissions of toxic chemicals, such as cancer-causing benzene, produced by processing, transmitting and storing natural gas. Some environmentalist experts were disappointed that the proposed rules do not target methane, a potent greenhouse gas that is also the primary ingredient of natural gas. The oil and gas sector accounts for nearly 40 percent of all methane emissions nationwide, according to the EPA.

Click here. Drilling Regulatory Staffing in Your State. Search for how many wells have been drilled and how many gas regulators are in your state.

Click here. Graphics: What is Hydraulic Fracturing? Anatomy of a Gas Well

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As a Texas medical doctor and Ethicon Gynecare Transvaginal Mesh Lawsuit attorney, I am providing this important update regarding the New Jersey litigation involving these products.


Several hundred patients have filed a transvaginal mesh defective product lawsuit in New Jersey state court against Ethicon, Inc. and Johnson & Johnson over side effects from their Gynecare mesh products. Gynecare mesh products are used for treatment of pelvic organ prolapse and stress urinary incontinence.

Women filed these lawsuits, received Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or another pelvic mesh product manufactured by Ethicon, a subsidiary of Johnson & Johnson.

These transvaginal mesh products are used strengthen damaged tissue, to repair pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). These products were marketed as a safe and effective alternative to traditional surgical procedures, and women allege that Ethicon Gyncare mesh problems caused them to experience pelvic pain, infections, urinary problems, erosion of the mesh and other complications.

All of the Ethicon Gynecare mesh lawsuits filed in New Jersey state court are centralized for pretrial proceedings before Judge Higbee in Atlantic County. According to court information, there are now about 500 cases that have been filed.

The lawsuits claim that Johnson & Johnson knew the products were unreasonably dangerous, but continued to manufacture and sell them. Other a;;egations iclude manufacturing a defective product, negligence, failure to warn, strict liability and fraud.

According to a study in the Journal of the American College of Obstetricians and Gynecologists, researchers concluded that there was a high rate of vaginal mesh failure with Gynecare Prolift mesh, while providing no difference in cure rates.

Earlier, the FDA issued a warning about the risk of problems from transvaginal mesh when used for pelvic organ prolapse, indicating that the agency was unable to find any significant benefit for the products over other available means of treatment.

In addition to Johnson & Johnson’s Ethicon mesh products, problems have also been associated with transvaginal mesh sold by American Medical Systems (AMS), Boston Scientific, C.R. Bard and other companies.

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As a Dallas Dangerous Drug attorney, I am writing about this interesting medical study in the recent American Journal of Medicine.


According to the findings of a new medical study, patients with hypertension and heart problems who regularly take common over-the-counter painkillers could be at a greater risk of heart attack, stroke and death.

Non-steroidal anti-inflammatory drugs (NSAIDs) have been used in pain management in patients with osteoarthritis and other painful conditions. In the United States an estimated 5% of all visits to a doctor are related to prescriptions of non-steroidal anti-inflammatory drugs and they are among the most commonly used drugs. In 2004, rofecoxib, VIOXX, marketed as a cyclo-oxygenase-2 (COX 2) selective inhibitor, was withdrawn from the market after the results of a randomized placebo controlled trial showed an increased risk of cardiovascular events associated with the drug.

In this recent study, patients with heart disease and high blood pressure were at 47% increased risk of the cardiovascular events if they were chronic users of non-steroidal anti-inflammatory drugs (NSAIDs), examples include Advil, Aleve, Celebrex, Motrin and the recalled drug Vioxx.

The findings were published in the latest issue of The American Journal of Medicine. The study looked at data on 882 long-term NSAID users and 21,694 nonchronic NSAID users. All had hypertension and heart disease and had an average age of 65. Researchers found that 4.4 out of every 100 chronic NSAID users suffered a nonfatal heart attack, nonfatal stroke, or died. The rate was only 3.7 out of 100 for nonchronic NSAID users.

After five years of chronic NSAID use, high blood pressure patients with heart disease were at 126% increased risk of death and 66% increased risk of heart attack.

In June, Danish researchers published a study that found that NSAIDs could cause abnormal heart rhythms. That study, published in the British Medical Journal, found a 40% to 70% increase in the risk of atrial fibrillation among NDAID users. Use of non-aspirin NSAIDs was associated with an increased risk of atrial fibrillation or flutter. Compared with non-users, the association was strongest for new users, with a 40-70% increase in relative risk (lowest for non-selective NSAIDs and highest for COX 2 inhibitors). Atrial fibrillation or flutter needs to be added to the cardiovascular risks to be considered when prescribing NSAIDs.

In January, researchers found that all NSAIDs appeared to increase the risk of heart problems, and all except Aleve carried an increased risk of cardiovascular death. The study was published in the British Medical Journal, focusing on nonsteroidal anti-inflammatory drugs (NSAIDs). The researchers looked at the cardiovascular risk of seven different generic NSAIDs, including generic Aleve (naproxen), Advil and Motrin (ibuprofen), Voltaren and Cataflam (diclofenac), Celebrex (celecoxib), Arcoxia (etoricoxib), Vioxx (rofecoxib) and Prexige (lumiracoxib).

In June 2010, Danish researchers published a study that found evidence of NSAID heart problems, with the recalled drug Vioxx, as well as Voltaren and Cataflam being linked to the highest risk of death due to cardiovascular problems. Voltaren and Cataflam were also associated with double the risk of heart attack, while Vioxx was linked to triple the increased risk. The study was published in Circulation: Cardiovascular Quality and Outcomes, that indicated the class of drugs, which include Motrin and Advil, increase the risk of cardiovascular problems in healthy users. The study indicates that the risk appears to vary widely from brand to brand, with Vioxx, Voltaren and Cataflam as the worst offenders, and the pain reliever Aleve actually appearing to lessen the risk of death.

Lawsuits over Vioxx were filed by thousands of people following a September 2004 recall of the drug amid reports that it increases the risk of heart attacks and strokes. The prescription medication, which was approved for treatment of chronic pain from arthritis and other conditions that cause acute pain, was used by more than 80 million people worldwide.

Keywords: Coronary artery disease, Hypertension, Myocardial infarction, Nonsteroidal anti-inflammatory drugs, NSAIDs, Advil, Aleve, Cataflam, Celevrex, Heart Attack, Heart Disease, Motrin, Stroke, Vioxx

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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.

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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.

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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.

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According to a large European study published this week, Bisphosphonates, a class of drugs used to prevent and treat osteoporosis is associated with an unusual type of thigh fracture.


According to orthopedic surgeons, they were seeing an increase in cases where are severe fractures in which the thighbone snaps in two. Last October, the federal Food and Drug Administration announced a change in labeling on the drugs to reflect the risk of atypical fractures in patients taking bisphosphonates.

In the current study, published in the New England Journal of Medicine, researchers analyzed data from all 1.5 million women in Sweden who were age 55 or older in 2008. They obtained X-rays of 1,234 of the 1,271 women with fractures and found 59 who suffered the more unusual kind of fracture.

The women with atypical fractures were also compared with 263 controls with fractures in a similar location. The researchers found that 78% of the women with atypical fractures took bisphosphonates, compared with 10% of controls.

Bisphosphonates, which include brands such as Actonel, Zometa and Boniva, are used mainly by post-menopausal women as a way to prevent fractures that are associated with osteoporosis. Some 36.5 million prescriptions were dispensed for the drugs in 2010, and total U.S. sales were more than $4.2 billion.

Bisphosphonates examples include: Alendronate (Fosamax), Etidronate (Didronel), Ibandronate (Boniva), Risedronate (Actonel), Zoledronic acid (Reclast).

Per Aspenberg, a professor of orthopedic surgery at Linköping University in Sweden and a co-author of the study, said the findings indicated a patient’s risk of fracture diminished by 70% after stopping the drugs for a year. Aspenberg noted that if a person has taken bisphosphonates for five years, they could stop taking the drug and its protective effect will last for at least another five years as the risk for atypical fractures decreases. Given this finding, Aspenberg thinks patients should take a drug holiday after five years.

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