Wrongful Death

May 25, 2011

SimplyThick Necrotizing Enterocolitis NEC

Dr Shezad Malik Law Firm is investigating the connection between SimplyThick and cases of <a href="http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002133/“>necrotizing enterocolitis (NEC) in premature infants. What is the Connection Between SimplyThick and Necrotizing Enterocolitis?

NEC has no definitive known cause. An infectious agent has been suspected, as cluster outbreaks in neonatal intensive care units (NICUs) have been seen, but no common organism has been identified. Pseudomonas aeruginosa is suspected for causing necrotizing enterocolitis in premature infants and neutropaenic cancer patients, often secondary to gut colonization. A combination of intestinal flora, inherent weakness in the neonatal immune system, empirical antibiotic use for 5 days or more, alterations in mesenteric blood flow and milk feeding may be factors. The most common area of the bowel affected by NEC is near the ileocecal valve (the site of transition between the small and large bowel). NEC is almost never seen in infants before oral feedings are initiated. Formula feeding increases the risk of NEC by tenfold compared to infants who are fed breastmilk alone. Expressed breast milk protects the premature infant not only by its antiinfective effect and its immunoglobulin agents but also from its rapid digestion.

There are 15 reported cases of necrotizing enterocolitis in premature infants who were fed mother’s breast milk or infant formula thickened with SimplyThick, and 2 of the babies have died. The babies were fed SimplyThick for varying amounts of time before symptoms of NEC appeared. Major NEC symptoms include the following:

green vomit
diarrhea or bloody stools
swollen belly (abdomen)
red or blue color in the belly
breathing problems
slow heart rate.

The cases of necrotizing enterocolitis all involve premature infants who became sick over the past six months. Necrotizing enterocolitis most often occurs in babies within the hospital early in their premature course. But among the SimplyThick babies, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.

Severe cases of NEC can result in the following:

A segment of intestine may need to be removed.

Scarring and narrowing of the bowel.

The intestine may not be able to absorb nutrients normally, malabsorption.

If SimplyThick caused the NEC, and the baby dies, then the family has a wrongful death claim against the manufacturer.

May 21, 2011

SimplyThick Necrotizing Entercolitis Recall

by Dr. Shezad Malik

As a Dallas SimplyThick Necrotizing Enterocolitis attorney, I am providing this FDA update and press release.

FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue. SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.

On May 20, the FDA issued a SimplyThick public health warning following 15 cases of necrotizing enterocolitis (NEC) in premature infants who were fed it, including at least two deaths. The FDA said the thickening agent should not be given to any infants who were born before 37 weeks of gestation.

FDA officials said they were first made aware of the potential risk of bowel problems from SimplyThick after reports were submitted by doctors to the FDA’s Adverse Event Reporting System (AERS) on May 13. At least four different medical centers have had infants contract necrotizing enterocolitis from SimplyThick.

FDA officials indicate that they are unable to determine, why SimplyThick side effects would cause necrotizing enterocolitis in premature infants. The condition usually affects infants very early, but those that appear to be related to SimplyThick had a late onset, with some not being affected until they had been released from the hospital.

Necrotizing enterocolitis is an intestinal disorder that results in inflammation and necrosis of intestinal tissues. It is usually diagnosed in premature babies and can be life-threatening. Symptoms can include a bloated abdominal area, green-tinged vomiting and blood stools.

The FDA is currently investigating the link between SimplyThick and the bowel problems for infants. Parents, doctors and care givers are urged not to give SimplyThick to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:

Completing and submitting the adverse report online: www.fda.gov/MedWatch/report.htm

Downloading the pre-addressed, postage-paid FDA Form 3500 (calling 1-800-332-1088 request the form), and faxing it to 1-800-FDA-0178; or
Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

May 19, 2011

Medical Malpractice Wrongful Death During Plastic Surgery

by Dr. Shezad Malik

As a Dallas Fort Worth Personal Injury and Medical Malpractice attorney, I providing this tragic case of wrongful death following a fairly common plastic surgery procedure.

Lisa Martinez, 32, went in for a procedure with Dr. Robert Young, a San Antonio plastic surgeon. Lisa was getting a plastic surgery procedure known as a “Brazilian Butt Lift.”

According to court documents, Dr. Young was collecting fatty tissue from the hips and lower and mid back, and then injecting it back into her buttocks. During the surgery, according to the medical examiner, Lisa suffered intra-abdominal hemorrhaging due to a perforated aorta. The artery supplying blood to the rest of the body was punctured. The family ordered an autopsy and the family is filing a medical malpractice lawsuit.

All surgical procedures are associated with complications, and the surgeon has to take care to avoid the complications and to be vigilant in order to diagnose, recognize and treat the potential complications.

The failure to diagnose, recognize and treat the potential complications, is considered negligence and forms the basis of a medical malpractice lawsuit.

The surgeon should have anticipated some bleeding from this type of surgery and if the patient continues to deteriorate, then he needs to take extra steps to diagnose and treat the problem. Here it appears that the perforation in the aorta, which is extremely rare complication from this type of surgery, considering the anatomy, was unrecognized and untreated leading to the tragic outcome of death.

Will there be any justice for Lisa and her family, who have been impacted by this tremendous loss? Only time will tell. In Texas medical malpractice cases, pain and suffering is capped at $250,000 and if Lisa was not employed, that would be the maximum compensation the family could possibly receive. And only if they are successful in a jury trial. In Texas in medical malpractice cases, the plaintiffs are only successful in 15% of lawsuits. In other words 85% of Texans are poured out, so much for Tort Reform. Good luck to you if you get injured or killed by medical malpractice.

May 1, 2011

Antidepressant SSRI Birth Defects & Cranial Malformations

by Dr. Shezad Malik

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 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 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 22, 2011

Car Accident Guru Reveals The Most Dangerous Time for Accidents

by Dr. Shezad Malik

As a Dallas Car Accident Attorney I am providing this update regarding the most dangerous time for car accidents in Dallas.

Minimizing risk is not about when you are on the road, but how careful you are while on the road. The most dangerous month, is August, and Saturday the most dangerous day, according to the National Highway Traffic Safety Administration.

Auto accidents kill more than 40,000 people in the U.S. each year; they are the No. 1 cause of death for people between the ages of 1 and 34.

Time of Day Does Matter According to the the Insurance Institute for Highway Safety, IIHS, an average 6.6 people are killed between the hours of 5 p.m. and 6 p.m., and another 6.6 between the hours of 6 p.m. and 7 p.m. Those rates are the overall highest of any time during the day. In 2007, 14,055 people were killed in the 5 p.m. hour. But the hours between midnight and 4 a.m. have the highest number of fatalities when calculated as a percentage of the amount of people on the road, according to AAA. During that time, statistically speaking, 5.87 per 100 million people on the road will be killed.

Time of day plays an important role in evaluating fatal crashes, because other dangerous factors are increased at night. Drunk driving, speeding and driving without a safety belt all increase during the night hours and each factor contributes directly to increased fatality rates.

Speeding is a factor in 30% of all fatal crashes, according to the NHTSA. 18% of fatal crashes during the day are alcohol-related, while 54% of crashes at night are alcohol-related. Two out of three the people killed at night are not wearing a seat belt.

Nationwide, 49% of fatal crashes happen at night, with a fatality rate per mile of travel about three times as high as daytime hours. During the day, the percentage of unrestrained fatalities tends to be under half.

The fewest deaths by crash in 2007, the latest year with complete data, happened early in the morning, between 4 a.m. and 5 a.m. Those hours see significantly less traffic–only 9% of the average amount during peak hours.

Mid-week days like Tuesday and Wednesday also pose the lowest number of fatalities, both averaging fewer drivers and 96 and 100 deaths per day, respectively. So the answer is if you want to drive without getting killed, limit your driving to Tuesday and Wednesday morning, between 4 and 5 am. Hardly a practical solution to this epidemic.

Weekends–when the greatest number of people are on the road–predictably see the highest numbers of crash victims, with a combined average of 143 deaths for Saturday and Sunday, according to the IIHS.

Dog Bites And Dog Attacks

by Dr. Shezad Malik

I have handled a few dog bite cases in my time. Nothing galls me more, especially when a child gets mauled by a so called pet dog. As a Dallas Dog Bite and Dallas Dog Attack Attorney, I have heard many instances where a dangerous dog such as a pit bull attacked a child aged around two years old or other infants. The child did not stand a chance.

Currently I am handling a case where a 2 year child was attacked and mauled by a small stray chihuahua dog who had been taken in 2 weeks earlier. My 2 year old client was bitten on the face and sustained injuries to her lip…the injuries could have been a lot worse.

I will keep you readers appraised of the development in my case.

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.