Personal Injury

June 16, 2011

Fosamax Bisphosphonate Femoral Fracture Litigation

Dr Shezad Malik Law Firm is currently evaluating and accepting Fosamax long bone fracture cases and defective drug product liability claims. We are providing this Fosamax lawsuit update for the benefit of our readers and current Fosamax injury clients.

$fort_worth_fosamax_fracture_attorney.jpg$

All federal Fosamax Femur low-impact bone fractures lawsuits have been consolidated for pretrial proceedings as part of a new MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the District of New Jersey.

At least 37 Fosamax fracture lawsuits are currently pending in federal district courts throughout the United States, and those cases will be transferred to New Jersey for further litigation. In addition, as new complaints over femur fractures on Fosamax are filed in the federal court system, they will also be added to this new MDL.

Fosamax lawsuits over jaw problems, known as osteonecrosis of the jaw, which will remain centralized as part of a different MDL in the U.S. District Court for the Southern District of New York.

All of the complaints involve similar allegations that side effects of Fosamax, can increase the risk of atypical thigh bone fractures, which often occur with little or no trauma at all. Plaintiffs claim that Merck failed to adequately warn about the risk of femur fractures from Fosamax, or that users should seek immediate medical attention if they experience groin pain, which may occur several weeks before a complete fracture while on Fosamax.

In October 2010, the FDA required new warnings about the risk of bone fractures from Fosamax and other similar bisphosphonate medications. There are currently more than 900 Fosamax jaw lawsuits consolidated in New York, as part of an MDL that was established in August 2006. Fosamax fracture lawsuits were previously excluded from that MDL, because it was determined that the evidence of general causation leading to femur fractures would likely differ substantially from cases dealing with jaw bone damage.

June 5, 2011

FDA To Investigate YAZ, Yasmin and Ocella

by Dr. Shezad Malik

As a Texan YAZ, Yasmin, Ocella Dangerous Drug and Side Effect Attorney and medical doctor, we are in the process of evaluating, accepting and filing lawsuits against Bayer regarding the dangerous side effects of YAZ, Yasmin, Ocella oral contraceptives.

The Food and Drug Administration said it is conducting a safety review of certain types of drospirenone containing birth-control pills to see if they increase the risk of blood clots when compared to other older birth control pills.

The FDA said the review is focusing on products that contain drospirenone, which is used in pills including Yaz and Yasmin, which are marketed Bayer AG. Drospirenone is a type of female sex hormone called a progestin.

Most birth-control pills contain two types of hormones, estrogen and progestin. The FDA said two recently published studies reported a greater risk of blood clots for women taking birth-control pills containing drospirenone, compared to birth-control pills containing another progestin known as levonorgestrel.

The FDA said some previous studies have reported that the risk of blood clots for women who use birth-control pills containing drospirenone is higher than that for women who use birth-control pills containing levonorgestrel.

Blood clots form inside a vein, known as deep vein thrombosis, or DVT. The clots can break loose and travel to other areas of the body such as the lungs, known as pulmonary embolism, or PE.

The FDA said it is “currently evaluating the conflicting results from these studies and will look at all currently available information to fully assess the risks and benefits of drospirenone-containing birth-control pills.” An FDA-commissioned study involves more than 800,000 U.S. women and results are expected later this summer.

The European Medicines Agency said the risk of developing blood clots for oral contraceptives containing drospirenone was higher than that of pills containing levonorgestrel. EMA said the product labels of birth-control pills containing drospirenone will be updated.

The most recent studies were published earlier this year in the British Medical Journal. They compared women taking birth-control pills containing drospirenone with women taking birth-control pills containing levonorgestrel and found the risk of blood clots to be 2 to 3 times greater among women taking drospirenone products.

June 4, 2011

Cell Phones and Brain Cancer Attorney

by Dr. Shezad Malik

As a Dallas, Texas Personal Injury and Product Liability attorney I am providing this update regarding the risk of brain cancer and cell phone use.

In 2010, a major study in 13 countries found no clear evidence that exposure to the radiation from cellphones causes brain cancer. The International Agency for Research on Cancer, a unit of the World Health Organization (WHO), declared this week that the radiation is “possibly carcinogenic” to humans.

The agency, stated that heavy users of cellphones had an increased risk of developing a rare brain tumor known as a glioma. Cellphones were placed in a “possibly carcinogenic” category.

The report comes as a proposed class action lawsuit against 19 defendants, mostly cell phone manufacturers and telecommunications companies, has landed at the U.S. Supreme Court. The defendants which include Nokia, AT&T Inc and Samsung Electronics Co Ltd are accused of misrepresenting that their cell phones are safe, when they in fact knew of potential dangers.

Still, many experts remain skeptical, and despite a huge world wide increase in cellphone use over the past twenty years, brain cancer rates in the United States have been declining. Scientists are unclear as to how the radio frequency waves emitted by cellphones, which may break chemical bonds and disrupt DNA, cause cancer.

The Food and Drug Administration, which regulates the safety of cellphone emissions, said it would review the forthcoming research study carefully but that “the existing weight of scientific evidence does not show an association between non-thermal radio frequency energy and adverse health outcomes.”
Heavy users of cellphones might want to use headsets, speaker phones or text messaging to keep the device at a distance. Many folks would be surprised to learn that cellphone manufacturers, to prevent personal injury liability claims, already advise users in very small print to hold the phones a short distance from the body while making telephone calls.

June 2, 2011

Propecia Side Effect Attorney

by Dr. Shezad Malik

We are currently evaluating and accepting PROPECIA induced sexual dysfunction cases.

Eddie Sebastia from Florida has filed a product liability lawsuit against Merck, he alleges that side effects of the hair loss drugs Propecia and Proscar ruined his sex life.

The Propecia erectile dysfunction lawsuit was filed by Sebastia, claims that Merck failed to warn doctors and patients that side effects of Propecia, or Proscar, could result in permanent sexual problems.

Sebastia took Propecia and Proscar from 1998 to 2008, and claims that the medications caused him to develop erectile dysfunction, testicular pain, descreased sex drive, depression and anxiety.

Propecia (finasteride) was approved in 1992 for the treatment of benign prostatic hyperplasia, and also is approved to treat male pattern baldness. It was originally marketed by Merck as Proscar.

In March, researchers from the U.S. published a study in the Journal of Sexual Medicine that found side effects of Propecia were linked to sexual problems in men. Researchers indicated that the class of drugs known as 5-alpha-reductase inhibitors can cause loss of libido, depression erectile dysfunction, reduced semen production and growth of male breast tissue. They also agreed that in some cases these side effects appeared to be permanent.

While the drugs carried some warnings, the lawsuit alleges that those warnings were insufficient and understated the potential risks.

June 1, 2011

YAZ, Yasmin, Ocella Dangerous Drug Side Effect

by Dr. Shezad Malik

I am a Texas YAZ, Yasmin, Ocella Dangerous Drug Attorney and medical doctor and we are in the process of evaluating, accepting and filing lawsuits against Bayer regarding the dangerous side effects of YAZ, Yasmin, Ocella oral contraceptives.

Bayer’s birth control pills will be reviewed by FDA regulators after some studies suggested they may cause more blood clots than other oral contraceptive medicines.

According to the FDA, two recent reports in the British Medical Journal found a twofold to threefold greater risk of blood clots in women taking pills like Bayer’s Yaz.

European regulators said last week that they were revising the products’ prescribing information to include the new safety findings.

While all birth control pills pose a risk of blood clots, the F.D.A. review focuses on the hormone drospirenone, found in Bayer’s Yaz, Yasmin, Beyaz and Safyral. The agency expects to have results later this summer of an 800,000-person study it commissioned to examine the risks.

In the meantime, regulators said doctors and patients should watch for symptoms of blood clots, including leg or chest pain.

RECOMMENDATION: If your birth control pill contains drospirenone, do not stop taking it without first talking to your healthcare professional. Contact your healthcare professional immediately if you develop any symptoms of blood clots, including persistent leg pain, severe chest pain, or sudden shortness of breath. If you smoke and are over 35 years of age, you should not take combination oral contraceptives because they increase the risk that you could experience serious cardiovascular events, including blood clots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

May 26, 2011

DePuy Pinnacle Replacement Recall Lawsuit

by Dr. Shezad Malik

As a DePuy Pinnacle Hip Failure and Replacement Attorney, I am providing this new information for my product liability clients.

On August 2010, there was a recall of the DePuy ASR XL artificial hip, and now DePuy may be facing the recall of the Pinnacle Acetabular Component. 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, Dallas.

The U.S. Judicial Panel on Multidistrict Litigation issued an order establishing the MDL, which will result in the transfer of 60 DePuy Pinnacle hip lawsuits currently pending in federal district courts throughout the United States.

Like the DePuy ASR XL, the Depuy Pinnacle is a metal on metal system that was designed to last at least 10-15 years but now, orthopedic surgeons are reporting that these devices have been failing within one to two years of being implanted into their patients.

DePuy, a division of Johnson & Johnson, has implanted over 150,000 Pinnacle hip replacements since 2001. Its recent recall of the defective ASR metal-on-metal hip implant systems has thousands of hip implant patients to have additional hip revision surgeries.

The ASR and Pinnacle are both metal on metal systems, and the ASR is a monoblock design, the Pinnacle uses a modular system. The ASR cup is made of one solid piece of metal, the Pinnacle has an outer shell and the Pinnacle is designed allow the surgeon the option to place a metal, ceramic or polyethylene liner inside the metal outer cup.

The Pinnacle 36 mm Ultamet Metal-on-Metal component is failing at an unacceptably high rate. Research suggests that there is a design problem, and the device has been created with one of the lowest clearance levels in the industry. Experts investigating the product design believe that DePuy created a very narrow window for proper placement of the prosthesis and inadequately trained surgeons in the proper implantation technique.

The recalled DePuy ASR system and the Pinnacle was permitted under the U.S. Food and Drug Administration’s (FDA) 510(k) approval process, which allows a medical device to be placed on the market without being subjected to clinical trials as long as the manufacturer can show that the device is “substantially equivalent” to a device already approved on the market. DePuy’s ASR system avoided clinical trials by showing that it was similar to the DePuy Pinnacle hip replacement system.

The FDA has received complaints and adverse incident reports against the Pinnacle system, and the Pinnacle’s propensity to prematurely separate from the bone. Constant friction in the metal on metal Pinnacle causes an increased risk of metallosis, the release of metal particles into the surrounding soft tissue or bloodstream, particularly chromium and cobalt.

The Dr Shezad Malik Law Firm hip replacement team continues to investigate claims of Pinnacle failures and counsel our clients on what to do in the event that they need revision surgery.

May 25, 2011

SimplyThick Necrotizing Enterocolitis NEC

by Dr. Shezad Malik

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).