Toxic Injury

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 20, 2011

Steven Johnson’s Syndrome Verdict Against J&J Motrin

by Dr. Shezad Malik

As a Dallas, Texas Steven Johnson Syndrome attorney, I am providing this jury verdict against J&J Motrin.

A Pennsylvania jury ruled that a Johnson & Johnson (JNJ) unit must pay $10 million in damages to the family of a 13-year-old girl who suffered skin burns and eye damage after she took Children’s Motrin.

Jurors found J&J’s McNeil Consumer Products unit liable for Brianna Maya’s injuries. Maya, was left blind in one eye and suffered burns over 84 percent of her body after taking Motrin in 2000 when she was 3 1/2.

J&J, and McNeil have faced at least two other jury trials over claims the companies hid the pain relievers’ links to Stevens-Johnson Syndrome, an allergic drug reaction that can leave patients with damaged eyes, blistered mouth and burned skin.

A California jury cleared J&J and McNeil of liability in 2008 for injuries suffered by an 11-year-old girl who took the pain relievers and developed the syndrome. Two years later, a federal jury in Illinois awarded a woman who took Children’s Motrin and suffered similar injuries $3.5 million in damages. A judge threw that award out on procedural grounds.

In the Philadelphia case, Maya’s attorney argued that Maya developed a rash, skin lesions, eye infections and lung damage after taking Children’s Motrin in 2000, according to court filings. He contended J&J officials didn’t include a warning on that year’s label alerting consumers the fever medicine can trigger Stevens- Johnson Syndrome.

The companies later warned that ibuprofen, the pain reliever’s active ingredient, could trigger “a severe allergic reaction,” the symptoms of which could include rashes and blisters, according to court filings. The Philadelphia Court of Common Pleas jury found that McNeil was negligent for not providing a proper warning about Children’s Motrin’s risks and that failure was “a factual cause” of the girl’s injuries. The panel rejected claims that the pain reliever was defectively designed or that McNeil officials’ conduct warranted an award of punitive damages.

The case is Maya v. Johnson & Johnson, 002879, February Term 2009, Court of Common Pleas, Philadelphia County (Philadelphia).

May 10, 2011

FDA Investigates Metal on Metal Hip Manufacturers

by Dr. Shezad Malik

The Food and Drug Administration has ordered all producers of “metal-on-metal” artificial hips to undertake studies, which have been linked to high early failure rates and severe health effects.

The producers of “metal-on-metal” hips will have to conduct studies of patients to determine whether the implants are shedding high levels of metallic debris.

The FDA on May 6 sent the request to J&J and 20 other device makers, including Biomet Inc., Stryker Corp. and Zimmer Holdings Inc., asking them to conduct postmarket surveillance of the hip replacements.

Metal-on-metal hips, in which the ball-and-socket components are made from metals like cobalt and chromium, accounted for about one-third of the 250,000 hip replacement procedures preformed annually in the United States.

In March, the British Orthopaedic Association, reported that one model of all-metal hip made by a unit of Johnson & Johnson was projected to fail in one-half of the patients who received it within six years after implant. The company no longer sells the ASR device.

The British medical group also estimated, based on hospital data, that the early failure rate for all-metal hips made by other manufacturers was higher than expected, ranging from 12 to 15 percent within five years after implant. Artificial hips are designed to last for 15 years or more.

According to Dr. Maisel, the F.D.A. official, it was up to each manufacturer to determine how to conduct its studies. Under the agency rule, producers have 30 days to file a proposed plan with the F.D.A. He also said companies would be expected to collect information from patients who received the devices, including taking blood samples to determine the levels of metallic ion in their systems.

The companies are also being asked to determined how frequently the devices are failing.

“This is the largest group of studies that we have asked for,” for an approved class of devices, said Dr. Maisel.

Along with the DePuy division of Johnson & Johnson, other major producers of hip implants include Zimmer, Stryker, Biomet and Wright Medical.

May 3, 2011

DePuy ASR Hip Recall Metallosis Explanation

by Dr. Shezad Malik

Over the last few months our office has been inundated with phone calls from patients suffering from bone pains, hip dislocations, injuries and concerns over the DePuy ASR Hip Implant Recall that officially began in August of 2010. Texas hip replacement patients with the ASR implant devices in them have raised serious concerns about their blood cobalt levels and chromium levels and are rightly concerned about what the future holds for them.

Nobody looks forward to having a hip replacement, it is usually an option of last resort, especially with the long, slow recovery time and the pain and suffering that it is involved. Toxic cobalt levels have been linked to an inflammatory condition that is linked with necrosis of surrounding tissue and eventual bone loss in the hip joint.

The Food and Drug Administration (FDA) recently launched Web information pages to address the risks and side effects associated with metal-on-metal hip implants. A serious concern with metal hip implants is metallosis. Metallosis is the result of the body reacting to a metal implant. It occurs when the rubbing of metal-on-metal components releases cobalt and chromium ions into the bloodstream. The resulting local effect is inflammation and scarring around the implant. Other side effects associated with metal-on-metal hip implants include pain in the groin, hip or leg, swelling near the hip joint and a limp or change in walking ability.

The ASR Hip Resurfacing System and ASR XL Acetablular Systems were recalled after the devices were associated with higher failure rates than other models. A second, corrective surgery was needed in 12 to 13 percent of patients five years after the initial operation.

We currently have a client who was the recipient of bilateral DePuy ASR hips. Over the past few months she began to experience increasing pain in the hips joints. Simultaneously, it was noted she had elevated cobalt and chromium blood levels. Just last week, she had both DePuy hips removed and replaced in a lengthy operation.

I admire her courage to having both surgeries at the same time. She explained, that she had no choice, she was a care giver to an elderly mom and her husband and did not have the time to go through 2 separate hip surgeries, to deal with recovery and rehabilitation period, which could last several months. We spoke to her today, one week out of her surgery. She was recovering from the ordeal and was in good spirits.

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 29, 2011

Allergan $212M Verdict in Botox Brain-Injury Lawsuit

by Dr. Shezad Malik

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

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

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

April 25, 2011

DePuy ASR Hip Recall Guide and Metallosis Risk

by Dr. Shezad Malik

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

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

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

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

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

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

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

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

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

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

April 20, 2011

Can I Get Compensation For a DePuy Hip Replacement Lawsuit?

by Dr. Shezad Malik

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

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

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

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

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

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

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

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

April 19, 2011

Veterans’ Case Toxic Tort Claim Over Agent Orange Dimissed

by Dr. Shezad Malik

The U.S. Court of Appeals for the Federal Circuit has dismissed an Agent Orange petition in a case originally brought by Vietnam veterans more than 30 years ago. This is a sad and tragic verdict for our men who gallantly fought for this country and who have been severely impacted by the diseases brought on by toxic exposure.

After their disability claims were denied, five veterans in 1979 filed a challenge to a 1978 Veterans’ Administration publication suggesting that only limited claims could be brought based on chemical exposure to Agent Orange and other defoliants during the Vietnam War.

The Federal Circuit, after recounting the labyrinthine history of the case, ruled that it lacked jurisdiction because there was no court avenue for procedural challenges to Department of Veterans Affairs regulations until the 1988 Veterans’ Judicial Review Act.