Product Liability

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 23, 2011

DePuy Pinnacle Replacement Hip MDL

by Dr. Shezad Malik

As a DePuy Pinnacle hip lawsuit attorney, I am providing this update regarding the location of the MDL centralization.

All federal lawsuits over DePuy Pinnacle hip replacement problems have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the Northern District of Texas.

The U.S. Judicial Panel on Multidistrict Litigation issued an order establishing the MDL, which will result in the transfer of at least 57 DePuy Pinnacle hip lawsuits currently pending in federal district courts throughout the United States.

The litigation will be centralized before Judge Kinkeade for coordinated handling. In addition, as new complaints are filed by individuals who have experienced problems with a DePuy Pinnacle hip replacement, those cases will also be transferred to the Northern District of Texas for pretrial proceedings.

All of the lawsuits involve similar allegations that the DePuy Pinnacle Acetabular Cup System was defectively designed or manufactured, and that inadequate warnings were provided about the risk of complications or problems following hip replacement.

The MDL Panel determined that the actions all involve common questions of fact and that centralization of the cases will serve the convenience of the parties and witnesses, as well as promote the just and efficient conduct of the litigation. Establishing a DePuy Pinnacle Hip MDL will also help eliminate duplicative discovery, prevent inconsistent pretrial rulings on discovery and other issues, and conserve the resources of the parties, the lawyers and the court.

The Panel selected the Northern District of Texas for the DePuy Pinnacle MDL because it is a geographically central location and has favorable docket conditions. The cases will be assigned to Judge Kinkeade, who is currently presiding over at least one of the cases, as the Panel determined that Judge Kinkeade has a current caseload conducive to handling the litigation.

Although plaintiffs requested that the centralized proceedings only include the DePuy Pinnacle metal-on-metal hip replacements, excluding those that use a polyethylene liner, the Panel determined that at this early stage the scope of the docket will not be limited. Therefore, lawsuits over all configurations of the DePuy Pinnacle Acetabular Cup System will be included as part of the MDL, as the manufacturer requested.

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 16, 2011

Zimmer Durom Cup Hip Lawsuit Update

by Dr. Shezad Malik

As a Zimmer Durom Cup hip lawsuit attorney, I am provided this litigation update.

The pending federal Zimmer Durom Cup hip lawsuits that were consolidated and stayed in the multidistrict litigation, or MDL, are now starting to move forward, as Zimmer has been ordered to answer the complaints in cases where mediation has occurred and no settlement has been reached.

Some Zimmer Durom Cup settlement agreements have been reached, and mediations are continuing in other claims. At least seven lawsuits were designated this month as “Non-Settling Cases”, which will allow discovery to begin.

In June 2010, all product lawsuits regarding Zimmer Durom Cup hip replacements were consolidated and centralized as part of an MDL in the U.S. District Court for the District of New Jersey.

In a recent court order, Judge Arleo lifted the stay with respect to the non-settling Zimmer Durom Cup lawsuits, allowing the parties to begin the exchange of information needed to prepare the cases for trial. The parties have been permitted to proceed with depositions with respect to common issues and case-specific issues in the non-settling cases.

The Zimmer Durom Cup hip implant was first introduced in the United States in 2006, and almost immediately complaints emerged about a high number of hip replacement failures involving the Zimmer Durom Cup, where the component loosened and required revision surgery.

A temporary Zimmer Durom Cup recall was issued in July 2008, so that revisions could be made to the product’s warnings and instructions to ensure that doctors were properly trained on the surgical techniques needed to implant the artificial hip correctly. Read the FDA Zimmer Durom Cup recall packet.

Approximately 12,000 individuals had the Zimmer Durom Cup hip system implanted between 2006 and 2008. While Zimmer’s 2008 estimates suggested that failure rates as high as 5.7%, some claims have suggested that between 20% and 30% of people may experience problems with a Zimmer Durom Cup hip.

May 14, 2011

Depakote Lawsuits Filed For Children with Spina Bifida and Other Neural Tube Birth Defects

by Dr. Shezad Malik

Abbott Laboratories is being sued by children who were born with birth defects, after their pregnant mothers took the epilepsy drug Depakote.

The Depakote lawsuit was filed on May 3 in St. Clair County Circuit Court in Illinois by plaintiffs from across the country. The complaint alleges that Abbott Laboratories failed to fully research the side effects of the antiepileptic drug and failed to adequately warn about the risk of spina bifida and other birth defects from Depakote.

Depakote was approved in the United States in 1978 for treatment of certain forms of epilepsy. Depakote pregnancy side effects have been linked to an increased risk of severe birth defects when taken during the first trimester.

According to allegations, Abbott knew about the potential risk of Depakote birth defects on or before the date it began marketing the drug in the United States, and failed to adequately warn women or the medical community about the true nature and extent of the risk.

In 1995, a study reported an incidence rate of neural tube defects from Depakote, that was ten times greater than with other anti-epileptic drugs. Other research has found that more than one out of every ten infants exposed to Depakote during the first few weeks of pregnancy may develop major congenital abnormalities.

The families allege that Abbott attempted to minimize the risk of Depakote birth defects and disregarded the danger on the product labeling. The drug maker has also allegedly worked to expand the drug’s use through “off-label” promotions for depression, bi-polar disorder and treatment of migraines.

In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect. Birth defects associated with Depakote include spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems.

In May 2010, medical researchers found that Depakote injuries to infants could occur after using the drug as early as the first trimester, which means that by the time many women discover they are pregnant, it could be too late to get off the drug and avoid birth defects for their unborn child.

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 9, 2011

Zimmer NexGen LPS Lawsuit

by Dr. Shezad Malik

As a Zimmer NexGen LPS Lawsuit Attorney, I am providing this update.

Product liability lawsuits have been filed by individuals who experienced problems with Zimmer NexGen LPS knee replacements, alleging that they required revision surgery after the artificial replacement knee systems began to loosen or fail.

The Zimmer NexGen LPS knee lawsuits were filed by Angela Coleman, of Michigan, David R. Langevin, of Minnesota, and Barry Davis, of Kentucky. All three complaints involved knee replacements with Zimmer NexGen Legacy Posterior Stabilized (LPS) parts, which use a “high-flex” femoral component.

The Zimmer NexGen LPS “high-flex” components are designed to allow a greater degree of flexion than the standard femoral component. The plaintiffs allege that higher flexation places the knee replacement at a higher risk of loosening.

Plaintiffs indicate that the device maker created the impression that using the Zimmer NexGen knee was safe, despite knowledge of serious injuries associated with the components. According to allegations raised in the complaints, Zimmer understated the risk of problems with Zimmer NexGen LPS-Flex Gender Solutions.

According to a study published by The Journal of Bone and Joint Surgery (British Edition) in 2007, researchers found that 38% of individuals implanted with a Zimmer NexGen LPS-Flex total knee replacement reported loosening shortly after 2 years post implant, with more than half of those individuals requiring knee revision surgery due to pain.

A Zimmer NexGen LPS recall was issued in September 2010, involving certain high-flex femoral components that were found to have nonconforming and inconsistent geometry. Over the past year, a number of patients throughout the United States have filed a Zimmer NexGen knee replacement lawsuit alleging that they experienced similar problems as a result of design defects associated with various components.

In March 2010, concerns were raised when Dr. Richard A. Berger, presented data that suggested problems with the Zimmer NexGen CR-Flex knee resulted in the need for revision surgery in nearly 9% of cases examined and caused knee replacement loosening in more than a third of cases. Most of the complaints filed in recent months over the Zimmer knee replacements have been Zimmer NexGen CR-Flex lawsuits.

May 5, 2011

Bisphosphonate Use and Atypical Femoral Fractures

by Dr. Shezad Malik

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.

$fort_worth_fosamax_fracture_attorney.jpg$

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.

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.