Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Posted in Product Liability

According to the latest published medical research, women on combined hormonal birth control drugs, including the NuvaRing vaginal ring, and Yaz, Yasmin and Ocella birth control pills, may face a significantly higher risk of a heart attack or stroke compared to users of other forms of hormonal birth control.

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New England Journal of Medicine June 2012 Study

The New England Journal of Medicine published a study on June 14, which suggests that these forms of birth control that contain a combination of estrogen and progestin can double a woman’s risk of having a heart attack or stroke.

The Danish study, analyzed more than 1.6 million women aged 15 to 49. These women were taking low-dose estrogen birth control pills combined with progestins. They suffered heart attacks and strokes between 1.5 and 2 times more often than women not using hormonal contraception. The risks were as much 2.5 to 3 times higher among users of combined hormonal device, including vaginal rings, compared to non-users. The highest risks were seen in women over 45, or those who had high blood pressure.

Take Home Message: NuvaRing and Yaz, Yasmin Side Effects

NuvaRing, Yaz and Yasmin users may suffer a serious side effect associated with the use of these drugs, including Venous Thromboembolism (Blood Clots), Deep Vein Thrombosis (blood clots in the leg), Pulmonary embolism (blood clots in the lung), Heart Attacks and Strokes. Women need to understand the risks of serious side effects and possibly death, each time they pop a blood control pill or use a NuvaRing birth control device. They are not sugar pills.

What is NuvaRing?

NuvaRing was introduced in 2001 and is manufactured by the Merck/Organon pharmaceutical company. NuvaRing is a hormonal vaginal ring made of plastic that releases a combination of etonogestrel, a synthetic generation progestin, and the estrogen, ethinyl estradiol.

FDA October 2011 Study

In October 2011, a U.S. Food & Drug Administration (FDA) study the involving data on 800,000 American women using some form birth control between 2001 and 2008 revealed using NuvaRing increased the risk of blood clots, including deep vein thrombosis and pulmonary embolism, by 56% in comparison to older birth control pills.

British Medical Journal 2012 Study

The British Medical Journal, published a study on May 10, 2012, which found that NuvaRing users had a 6.5 times higher risk of experiencing a serious blood clot compared to women who did not use any form of hormonal birth control.

The likelihood of experiencing a dangerous blood clot was 90% higher among users of the vaginal ring than it was for women taking combined oral contraceptives containing levonorgestrel.

Over a Thousand NuvaRing Lawsuits

Hundreds of NuvaRing lawsuits alleging the device caused serious side effects, including blood clots, deep vein thrombosis, pulmonary embolism, heart attacks, strokes and wrongful death are currently pending in a multidistrict litigation in the U.S. District Court, Eastern District of Missouri (MDL No. 1964).

Additional NuvaRing lawsuits are pending in a Mass Tort proceeding in the Bergen County Superior Court of New Jersey (Docket No. BER-L-3081-09).

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The Problem with Yaz and Yasmin

Yaz and Yasmin both contain ethinyl estradiol, along with a synthetic progestin called drospirenone. Yaz and Yasmin are manufactured by the German pharmaceutical giant, Bayer.

The FDA’s study of hormonal contraceptives that was released last October suggested an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing pills compared to users of other hormonal contraceptives.

In a Drug Safety Communication issued on April 10, 2012, the FDA said it was requiring that the labels for drospirenone birth control be updated to warn that these contraceptives may be linked to a higher risk of blood clots.

Over Ten Thousand Yaz and Yasmin Lawsuits

More than 10,000 personal injury lawsuits that allege Yaz and Yasmin caused heart attacks, strokes, blood clots and other serious injuries are currently pending in the Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (MDL No. 2100) in the U.S. District Court for the Southern District of Illinois.

What to do if you have been injured?

Contact us here for further information or read our blog.

Victoza, one of newer diabetes drug has been associated with a number of serious side effects including Thyroid Cancer, Renal (Kidney) Failure and Pancreatitis.

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What is Victoza?

Victoza (liraglutide) is a once-daily, injectable diabetes drug used to help control blood sugar (glucose) in adults with type 2 diabetes.Victoza, made by Novo Nordisk, is an injectable diabetes medication that belongs to a class of drugs that mimic a hormone GLP-1.

Victoza is manufactured by Novo Nordisk and was approved by the FDA in January 2010. Liraglutide, works as a glucagon-like peptide-1 (GLP-1), it triggers the production of insulin when blood sugar levels rise too high.

Victoza FDA Controversy

In clinical trials, pancreatitis, or inflammation of the pancreas, occurred more with Victoza than with other diabetes drug.

The Victoza studies had indicated that the drug increased the risk of pancreatitis 3.7-fold when compared to patients receiving other medications. A review of the FDA adverse event reporting database indicates that in just its first 17 months on the market, the agency received 200 reports of pancreatitis in Victoza patients, according to Public Citizen. Public Citizen is a consumer advocacy group.

The FDA has asked Novo Nordisk to conduct a five-year study to look at Victoza’s risk of pancreatitis, seriously low blood sugar levels, allergic reactions, and thyroid and other cancers.

FDA Victoza Thyroid Cancer Warning

In June 2011, the FDA issued a warning that Victoza had been linked to thyroid cancer. According to its safety alert, the FDA’s Adverse Event Reporting System had received 25 claims of Victoza thyroid cancer from February 2010 to September 2011.

FDA Victoza Kidney Injury Warning

In May 2011, a warning was added to the “Warning and Precautions” section of the Victoza label regarding the drug’s association with renal impairment. The warning states that renal impairment “has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis.” The label advises doctors to “use caution when initiating or escalating doses of Victoza in patients with renal impairment.”
FDA Victoza Pancreatitis Warning

According to the June 2011 FDA Safety Communication, there were also at least 200 cases of acute pancreatitis and 28 cases of pancreatic cancer reported during the same period.

Public Citizen Victoza Allegations

“The FDA’s frequent solution to serious safety issues identified with new drugs is reckless: The agency simply describes the risks in the drug label and hopes that physicians and patients will pay attention,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said in a statement. “But more and more people are taking this drug, and more people are experiencing serious health problems as a result. Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market.”

Recently plaintiff attorneys have filed a motion to consolidate Pradaxa lawsuits that are currently on file in the U.S. District Courts federal court system.

The motion requests the Judicial Panel on Multidistrict litigation (JPML) to create a MDL (multidistrict litigation), for all Pradaxa product liability lawsuits.

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There are more than 20 lawsuits filed against Pradaxa drug manufacturer, Boehringer Ingelheim. All of the lawsuits allege that the drug maker failed to adequately warn about the side effects of Pradaxa.

Furthermore the plaintiffs allege that they suffered serious injuries or death from unstoppable bleeding problems.

What is a MDL and Coordination?

The plaintiffs requested that all cases be centralized for coordinated pretrial proceedings before U.S. District Judge David R. Herndon in the Southern District of Illinois.

MDL consolidation is common in drug pharmaceutical litigation, to reduce duplicative discovery and avoid inconsistent pretrial rulings from different federal courts located throughout the United States.

Each lawsuit remains an individual case. If a Pradaxa settlement is not reached during pretrial proceedings, each individual claim would then be remanded back to the original federal district court where it was filed for a trial date.

What is Pradaxa?

Pradaxa (dabigitran) is a direct thrombin inhibitor anticoagulant that is marketed by Boehringer Ingelheim and released in October 2010 as a superior alternative to Coumadin (warfarin) for prevention of stroke among patients with non valvular atrial fibrillation.

Patients on Coumadin can suffer bleeding side effects and can be treated with Vitamin K, fresh frozen plasma and blood transfusions to reverse the drug’s anticoagulant effects.

Unfortunately there is no reversal agent for Pradaxa. This means that bleeding events can lead to serious injury or death.

Further compounding the problem, is that there is no standard method with which to measure the anticoagulant effects of Pradaxa, unlike Coumadin.

Institute for Safe Medication Practices Report

According to a recent report by the Institute for Safe Medication Practices (ISMP), Pradaxa had the most complaints of any drug on the market.

These included 542 patient deaths, 2,397 reports of hemorrhaging, 644 strokes and 291 cases of acute renal (kidney) failure.

According to Johnson & Johnson (JNJ)’s Ethicon unit, the company has announced in a letter this week that it intends to stop selling four vaginal mesh implants. The letter was sent to the court overseeing the Vaginal Mesh lawsuits.

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Johnson & Johnson said it has requested approval from the Food and Drug Administration to stop “commercializing” the devices
FDA Warnings

According to the FDA, J&J had sold one of the implants, the Gynecare Prolift, for three years without proper regulatory approval.

The regulatory agency issued an order in January that J&J and 30 other makers of vaginal mesh implants study organ damage and other health complications blamed on the products, which are used to treat female stress urinary incontinence and pelvic organ prolapse.

The affected products includes the Prolift, Prolift+ M, TVT Secur and Prosima surgical meshes. Ethicon said it’s asked the agency to let it continue selling a fifth product, the Gynecare Gynemesh, with a change to the labeling that restricts its use.

Thousands of Lawsuits expected

According to the hundreds of lawsuits filed, the meshes are pushed into place through incisions in the vagina, and have eroded and shrank over time, causing pain and injuries. Experts believe that since trans vaginal mesh surgery is commonly used procedure for stress incontinence and pelvic prolapse , the number of lawsuits is only expected to increase with time.

Patients have filed suits against J&J, C.R. Bard Inc. and Endo Health Solutions Inc., along with other manufacturers.

FDA Reports

The FDA report last year found a fivefold increase in deaths, injuries or malfunctions related to vaginal mesh for pelvic organ prolapse. Later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.

Ethicon introduced its Gynecare Prolift mesh in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened muscles. The FDA said it learned of the Prolift only in 2007, when J&J sought approval for a related product.

The company said it could market the Prolift without approval because it was so similar to the already approved Gynecare Gynemesh. The FDA cleared the Prolift in May 2008.

The case is In Re Ethicon Inc. Pelvic Repair System Product Liability Litigation, MDL No. 2327, U.S. District Court for the Southern District of West Virginia (Charleston).

DePuy ASR metal on metal hip implant recipients in states with a 2 year Statute of Limitations, may lose their rights to file a lawsuit if they do not file their lawsuit before August 23, 2012. J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S., saying more than 12 percent of the devices failed within five years. Over 6,000 lawsuits in federal and state courts describe patients in pain and immobilized by joint dislocations, infections and bone fractures.

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What is Statute of Limitations?

Every state has a law called the statute of limitations (SOL) that sets a limited time period in which a lawsuit can be filed. The reason for this law is that the courts want to have a finite time for folks to bring claims and not have an unending litigation time period. If a person with a legal claim fails to have a lawsuit filed within this time period, then their claim can be forever lost.

Why is the SOL for Most DePuy ASR Hips August 2012?

In the United States, the majority of states use a two year time period for the SOL. The remainder of states have a 1 to 6 year time period for the SOL.

Individual states use different rules to calculate when these time periods start running and when it is determined too late to bring a lawsuit.

The official DePuy Recall Notice was issued on August 24, 2010. The two year period from that Recall Notice will expire on August 23, 2012. Therefore lawsuits for folks who claim that they were injured by DePuy ASR hips must be filed in those states with a 2 year statute of limitations or it may be too late for those patients to make a claim.

States With a 2 Year Statute of Limitations

Arizona, Alabama, Alaska, California, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, North Dakota, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, and West Virginia.

Exceptions to the Statute of Limitations

Many states have what is called a “Discovery Rule” which means that the Statute of Limitations does not start until a person would reasonably know that they might have a liability claim. But because of the widespread publicity and the FDA warnings, most experts believe that the statute of limitations began to run in August 2010.

Take Home Message

If you or a loved one has had a DePuy ASR metal on metal hip implanted, please seek legal advice and file your DePuy claim as soon as possible, to preserve your legal rights.

Folks with a DePuy ASR Hip Implant should have a detailed review of their case done immediately because once the statute of limitations has run there is no way to reopen or restart it.

What is Infuse?

The Medtronic Infuse bone graft is a genetically engineered liquid protein that helps the body to grow its own bone. It includes a bioengineered protein manufactured by Wyeth, called bone morphogenetic protein (BMP).

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Scope of the Infuse Problem

Medtronic’s Infuse Bone Graft is used in about a quarter of the estimated 432,000 spinal fusions performed in the U.S. annually, according to the New York Times.

The Infuse system involves three steps:

Small collagen sponges are used to absorb in bone morphogenetic protein (known as rhBMP-2), a substance that encourages bone growth. Sponges are then placed in small, hollow metallic cages. The cages are then implanted in the spine between vertebrae to support the spine while new bone grows between the vertebrae.

FDA Approved Infuse only for Anterior Lumbar Surgery

Medtronic’s Infuse Bone Graft system was FDA-approved in 2002 for anterior approach lumbar fusion surgery. Infuse was not, approved for other types of spine surgeries, including lateral or posterior approach lumbar fusion surgeries or for those on the cervical spine.

Medical research has demonstrated that both approved and off-label uses of Infuse Bone Graft system may cause serious and potentially fatal injuries, such as:

Cancer
Infertility/Sterility
Uncontrolled/Ectopic Bone Growth
Airway Swelling and Compression
Questionable Behavior by Medtronic Infuse Manufacturer

Medtronic, maker of Infuse Bone Graft System, should have conducted thorough and competent research into all possible risks of Infuse. But according to the Spine Journal, Medtronic caused the endangerment of patients who received the Infuse system.

The Spine Journal review found that the 13 original Medtronic-funded studies overestimated the usefulness and downplayed the risks of Infuse component rhBMP-2.

The authors of these studies received an estimated $12 million to $16 million each from Medtronic, and their studies frequently revealed absolutely no Infuse complications.

Other studies that weren’t funded by Medtronic have revealed serious and potentially fatal injuries associated with Infuse Bone Graft system.

Medtronic to Pay $85 Million Lawsuit

Medtronic has agreed to settle a shareholder lawsuit for $85 million, regarding accusations that the company made misleading statements about Infuse.

Shareholders claim that Medtronic failed to disclose that 85.2% of Infuse sales depended on off-label uses that are not approved by the FDA.

They allege that Infuse sales began to drop after the U.S. Department of Justice and the U.S. Senate launched investigations into whether Medtronic was illegally promoting off-label uses of Infuse to doctors.

According to attorneys, DePuy ASR hip implants which were recalled by the company in 2010, will start going to trial later this year to help determine liability and damages in more than 6,000 lawsuits.

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J&J’s DePuy unit recalled its 93,000 ASR hips worldwide in 2010, including 37,000 in the U.S. According to medical experts, more than 12 percent of the devices failed within five years.

According to the allegations raised in lawsuits, filed in federal and state courts, patients are in pain and immobilized by joint dislocations, infections, bone fractures, and a medical condition known as metallosis.

What is Metallosis?

Metallosis occurs when there is metal on metal grinding, which releases metal ions into the hip joint and into the bloodstream. This is a form of heavy metal poisoning.

Patients suing J&J, claim metal debris from the hips, made from a cobalt and chromium alloy, causes tissue death around the joint and may increase metal ions in the bloodstream to harmful levels.

Size of the Litigation group

There are approximately 4,200 federal lawsuits filed and consolidated in the multi-district litigation. According to attorneys, another 2,000 are in state courts, and both sides are negotiating bellwether trials or mini trials, to help resolve whether J&J bears blame and how much each case could be worth.

Cost of DePuy Litigation

The company said in January that it spent about $800 million on the recall in the past two years, while it wouldn’t estimate its product liability costs.

The first trial is scheduled to begin in state court in Las Vegas in mid-December. Another trial is slated for January in state court in Maryland. The first federal trial could be next March or April.

The federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

The Biomet M2a-Magnum hip implant is the latest metal-on-metal hip device to come under scrutiny following reports of a wide range of adverse side effects associated with it.

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What is Biomet M2A-Magnum Hip?

The Biomet M2A-Magnum Hip is a metal-on-metal hip replacement system that has been implanted in patients throughout the United States.

According to experts, the Biomet M2A Magnum metal on metal hip implant may be subject to early failure within a few years of surgery.

Many patients who were implanted with the Biomet Magnum hip implant have also reported loosening, dislocation, wear or failure of the implant due to the design of the device.

According to Biomet M2A Magnum hip lawsuits, these problems were known to the device manufacturer, yet they continued to market the implant as safe and effective.

Metal on Metal Hip Metallosis

Patients with a defective Biomet Magnum metal on metal hip implant may face metallosis, a medical condition where metal particles build up in the tissue around the implanted joint.

While typical hip implants consist of components made of metal and plastic, the Biomet Magnum has three all-metal components, a metal femoral head, metal taper insert and metal acetabulum cup.

As the metal parts grind against each other, microscopic metal debris may be released into the hip joint, which causes localized inflammation, loosening and other systemic problems associated with metal hip poisoning.

Metal-on-Metal Hip Replacements Biomet Magnum
In recent years, similar problems have affected many patients with DePuy ASR, DePuy Pinnacle, Wright Profemur and other “metal-on-metal” hip replacement systems.

The Biomet Magnum device includes chromium and cobalt in its composition, and both the femoral head and the acetabular cup contain these metals.

The American Academy of Orthopaedic Surgeons expressed alarm in October 2010 regarding potential problems with metal-on-metal hip replacements.

Its warning, directed to consumers and medical providers, stated that pain continuing for months following implantation might be a symptom of metallosis (metal poisoning).

Biomet Magnum Hip Device Recall?

In May 2011, the Food and Drug Administration (FDA) ordered twenty-one manufacturers of hip implant devices to collect and report data on metals levels in the blood of implant patients as well as the adverse health effects that may be caused by them.

About one-third of all hip replacement surgeries in the United States are performed using metal-on-metal devices, and all are now implicated in the examination of them.

A Tennessee man has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage.

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According to the complaint, Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects may be irreversible.

The plaintiff alleges that he was prescribed Pradaxa, and after 2 months of use, he suffered a cerebral hemorrhage, as well as other severe personal injuries which are permanent in nature.

Pradaxa FDA Approval

Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in October 2010 and is one of a number of new blood thinners that have been touted as a superior alternative to warfarin.

Both warfarin and Pradaxa pose a risk of serious bleeding. But warfarin bleeding can be stopped with the administration of vitamin K or a drug called recombinant factor VIIa. There is currently no practical antidote for Pradaxa bleeding.Pradaxa bleeds cannot be stopped since there is no known reversal antidote for this drug.

Pradaxa 260 Deaths

Last year, Boehringer Ingelheim, acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa.

The Institute for Safe Medicine Practices (ISMP) reported that Pradaxa was associated with a total 856 reports of serious, disabling or fatal injury, including 117 bleeding deaths, in the second quarter of 2011.

FDA Investigates Pradaxa

The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects, while regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

Pradaxa the Hits keep coming

According to Bayer AG, the German pharmaceutical giant has shelled out $142 million so far, in settlements of U.S. lawsuits claiming that its Yaz, Yasmin and Ocella line of birth-control pills caused blood clots.

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Bayer, said today in its Stockholders’ Newsletter for the first quarter, that it has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused blood clots that can lead to heart attacks, deep vein thrombosis, pulmonary embolism and strokes.

The company said it paid $142 million in the settlements, for an average of about $218,000 a case.

According to experts, Bayer’s strategy is to avoid the possibility of a large jury award in these clot cases; settlements provide a fixed and determinable amount when it comes to the cost of resolving these cases.

Bayer’s Hit could be as high as $2.65 Billion

Bayer’s update comes after financial analysts estimate that the drugmaker may have to pay more than 2 billion euros ($2.65 billion) to resolve all the cases over the contraceptives.

FDA New Warning Label

The U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen blood-clot warnings on their products.

FDA Drospirenone Blood Clot Triple Risk

Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.

The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line.

Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them one of the drugmaker’s biggest-selling drugs.

Federal 11,900 Suits

As of April 18, Bayer faced 11,900 lawsuits over Yaz and Yasmin in the U.S. involving about 14,000 plaintiffs, the company said.

YAZ Gallbladder Cases

Bayer is rejecting women’s claims that the contraceptives damaged their gallbladders or caused them to suffer from gallstones.

Yasmin Bellwether Trials on Hold

The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.

The Judge David R. Herndon, of the U.S. District Court for the Southern District of Illinois, extended a stay for the bellwether process on April 19, delaying all deadlines for the third time this year.

The bellwether process was established in the Yaz MDL to allow the parties to prepare a small group of cases for early trial dates and help gauge how juries are likely to respond to certain evidence that is presented throughout the litigation. Bellwether trials are often scheduled in complex pharmaceutical litigation to help facilitate settlement negotiations.

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).

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