Personal Injury

May 19, 2011

Medical Malpractice Wrongful Death During Plastic Surgery

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 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.

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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.

May 2, 2011

Dallas Parkland Hospital Medical Malpractice

by Dr. Shezad Malik

U.S. Medicare and Medicaid officials have found problems at Dallas County’s general hospital after a newspaper investigation into a woman’s botched 2008 knee replacement surgery. This hospital became famous world wide after the Kennedy assassination in the 1960’s.

The U.S. Centers for Medicare & Medicaid Services found that failures by Dallas’s Parkland Memorial Hospital resulted, in some cases, in rape, amputation and death. Hospital officials have assured that they have resolved the problems cited in the report. The agency performed an inspection of the hospital after the Dallas Morning News reported on its investigation into the case of Jessie Mae Ned, whose knee replacement led to nearly follow-up surgeries, infections, amputation of her left leg and $1 million in Medicaid billings.

The inspection report by the federal agency noted that Parkland had no formal policy in 2008 for faculty supervision of doctors in the residency program of the University of Texas Southwestern Medical Center at Dallas. Those residents provide most of the medical care at Parkland, which is a teaching hospital.

In Ned’s case, the primary surgeon during her first operation, the knee replacement, had been out of medical school for almost a year. The young resident and a medical school student oversaw Ned’s care for the first 72 hours after her surgery but overlooked a rare surgical injury to a leg artery that led to her devastating postoperative complications. The records show a UT Southwestern faculty surgeon was present during the surgery, but show no sign of his involvement in the 72 hours of postoperative care.

The January federal inspector’s report showed that aside from failing to “ensure that the medical staff is accountable” for quality of care, “medical records were not complete.” Also, Parkland “failed to identify a medical error” until after the newspaper’s investigation.

Parkland is providing Ned with physical therapy and helping her learn to use the prosthetic leg she received in February. She has received no compensation from the hospital or the medical school for her lost limb.

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 30, 2011

Zimmer NexGen CR-Flex Porous Knee Litigation

by Dr. Shezad Malik

As a Dallas Zimmer NexGen CR-Flex Porous knee replacement system and lawsuit attorney, I am providing this Zimmer update.

Some Zimmer NexGen knee replacement systems have been linked to reports of pain, loosening of the implant and failure of the replacement knee leading to revision surgery. These cases are being reviewed by Zimmer NexGen knee lawyers, who are evaluating the damages for individuals who have experienced problems after a Zimmer knee replacement.

Several different components used as part of Zimmer NexGen knee replacement systems have been associated with a potential increased risk of problems, which may result in pain, limited range of motion, loosening of components or the need for additional revision surgery. In March 2010, data was presented by a group of knee surgeons that indicates nearly 9% of patients who received the Zimmer NexGen CR-Flex Porous Femoral component required revision knee surgery within two years and 36% showed signs of the replacement knee loosening.

At a conference of the American Academy of Orthopaedic Surgeons in March 2010, several prominent knee surgeons presented data on the outcomes of 108 knee replacement patients who received the Zimmer NexGen CR-Flex Porous Femoral component at Rush University Medical Center in Chicago.

After only two years, the researchers reported:

* 9 patients required knee revision surgery due to loosening and pain
* 39 patients showed evidence of radiographic loosening
It is suspected that the higher-than-expected failure rate is linked to design problems with Zimmer NexGen replacement knees, as the orthopedic surgeons concluded that they were not caused by surgical errors, problems with the techinque or the type of patient who received the knee implant.

More than 150,000 Zimmer NexGen CR and Zimmer NexGen CR-Flex Porous Femoral implants have been sold since 2003, and some doctors have reported experiencing a substantially higher-than-expected failure of the replacement knee within a few years of surgery.

The Zimmer replacement knee is a “high-flex” component, which attaches to the bottom of the thigh bone. In most knee replacement systems, a type of surgical cement is used to hold the implant in place. But, the Zimmer NextGen knee does not use a cement and this may be a design defect which increases the risk of a knee replacement loosening and needing additional surgery to revise the implant.

As a result of recalled Zimmer knee replacements and potential problems with the design for certain NexGen components, thousands of individuals may have been exposed to an increase risk of early failure. A number of individuals throughout the United States are pursuing compensation through a Zimmer NexGen knee replacement lawsuit as a result of the manufacturer’s failure to adequately research the artificial knee system or warn about the risk of Zimmer knee problems.