Defective Products

Mirena IUD Devices

November 30, 2012 | John Suthers

Injuries continue to be reported by women implanted with Mirena IUD devices. Mirena is a small, t-shaped plastic device that is inserted into the uterus by a trained healthcare provider. It is intended to provide contraceptive protection for approximately five years. However, many side effects have been associated with the Mirena device, including abscesses, birth defects in newborns, embedment in the uterus, erosion of areas adjacent to the device, perforation of the uterus, intestinal perforations or obstruction, and pelvic inflammatory disease. The most serious cases involve extra-uterine migration of the device, which occurs after the device has been properly placed. In some cases, years after being properly inserted, the Mirena device can perforate the uterus and migrate into the abdominal cavity. This can cause injury to adjacent organs, formation of scar tissue or adhesions, an even a medically necessary hysterectomy. In cases where the Mirena device has migrated into the area of other organs, surgery is almost always required to remove the device. Some women have suffered serious and debilitating or potentially life-threatening complications as a result of migration of the Mirena device.

The Mirena IUD is manufactured by pharmaceutical giant Bayer Healthcare Pharmaceuticals, Inc., which is a U.S. subsidiary of Germany-based Bayer. It was FDA-approved in 2000 as a contraceptive for women who have had at least one child. In 2009, it was also FDA-approved to treat heavy menstrual bleeding in women who prefer intrauterine contraception as their means of birth control. On January 14, 2010, the FDA sent a letter to Bayer, warning Bayer of its marketing practices involving Mirena. Bayer had been engaged in a consumer-directed program in which Mirena representatives travelled to consumers’ homes. According to the warning letter, the manufacturer of Mirena “overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.”

If you or someone you know had to have a Mirena IUD device surgically removed because it had migrated from its original position and perforated the uterine lining or an adjacent organ, you may have potential lawsuit against the manufacturer of Mirena. Suthers & Harper is investigating potential Mirena lawsuits involving patients who were implanted with the Mirena IUD device, but had to have it surgically removed after it migrated.

Mesh Litigation Update

November 9, 2012 | John Suthers

A new multidistrict litigation (MDL) proceeding has been formed for transvaginal mesh products manufactured by Coloplast Corporation. This MDL proceeding will take place in the Southern District of West Virginia, with Judge Joseph R. Goodwin presiding. The new Coloplast MDL joins 4 others in that Court involving transvaginal mesh product manufacturers C.R. Bard, Ethicon, Inc. (a division of Johnson & Johnson), American Medical Systems, Inc., and Boston Scientific Corporation. In excess of 1,000 cases have been consolidated into these 5 multidistrict litigation proceedings. Other mesh-related cases are pending in State Courts around the United States.

Coloplast Corporation acquired the urology business division of Mentor Corporation. In doing so, Coloplast entered into the business of selling mesh products intended to treat conditions known as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These mesh products are surgically implanted through the vagina in women who are suffering from POP and SUI. The 3 Coloplast vaginal mesh products intended to treat POP are Novasilk Synthetic Flat Mesh, Exair Mesh, and Restorelle Smartmesh. Coloplast’s bladder sling products intended to correct SUI include the Omnisure Sling, Minitape Sling, Aris Transobturator Sling, Supris Suprapubic Sling, and the T-Sling with Centrasorb.

Recently, the United States Food and Drug Administration (FDA) issued an updated safety communication in which it warned doctors, healthcare professionals, and patients that the placement of surgical mesh through the vagina to treat POP and SUI may present greater risks for the patient than other procedures which do not involve the use of mesh. The FDA’s investigation of problems associated with the use of transvaginal mesh to treat POP and SUI is ongoing.

Fungal Meningitis Outbreak

October 17, 2012 | John Suthers

During the past few weeks, we have learned of a growing number of fungal meningitis cases linked to a batch of contaminated epidural steroid injections created by the New England Compounding Center. Meningitis refers to inflammation of the meninges, which are the membranes covering the brain and spinal cord. Common types of meningitis are viral and bacterial meningitis which can be highly contagious and begin with flu-like symptoms. Often these types of meningitis may go undiagnosed as patients will simply write it off as a seasonal flu. Unlike viral and bacterial meningitis, fungal meningitis is not contagious and cases currently under investigation by the CDC are limited to those who received the affected steroid shot.

In this case, the contaminated product, created by a compounding center, tested positive for strains of fungus – including one that is present in wood rot. You may not be familiar with how a compounding pharmacy differs from your local pharmacy, or how each is individually regulated by the FDA. Compounding centers create custom formulations of medications in order to fit patients’ needs that may not be able to be met with a manufactured drug product. Currently, more than half of the nation’s 56,000 community-based pharmacies provide some level of basic compounding services and one to three percent of all prescriptions dispensed in the U.S. are compounded.

Compounding pharmacies are licensed and regulated by individual states, but the final products created by a compounding pharmacy are not subject to FDA regulations that manufacturers of drugs must follow. The New England Compounding Center has voluntarily recalled products related to the outbreak, but the CDC, recommends all products from the center be avoided while the investigation continues.

The CDC estimates that as many as 14,000 patients may have been given the tainted product tied to the outbreak. Since last week, the outbreak has been connected to 205 infections spread throughout 15 states and 15 reported deaths. So far no cases have been identified in Georgia but it is important to note that the CDC has marked Georgia as a state that received the affected product.
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UPDATE: Steroid For Back Pain That Was Recalled Due To Risk Of Fungal Meningitis Continues To Claim Lives

October 10, 2012 | Dustin E. Davies

The toll from the outbreak of fungal meningitis tied to contaminated steroid shots has now killed 12 people in the United States with that number expected to rise.

On Tuesday, the outbreak claimed four more lives and Florida became the latest state to report at least one death linked to the illness in a widening health scare.

Since the September 25 recall of three lots of a steroid produced by New England Compounding Company, the outbreak has spread to 10 states and infected 121 people, according to state health departments and the Centers for Disease Control and Prevention.

Steroid for Back Pain Recalled Due to Risk of Fungal Meningitis

October 9, 2012 | Dustin E. Davies

The New England Compounding Center, a pharmacy that distributed a steroid for back pain, has issued a voluntary recall of all of its products, due to an outbreak of fungal meningitis.

The Food and Drug Administration had previously told health professionals not to use any products distributed by the center. The Centers for Disease Control and Prevention has confirmed 105 cases of the rare form of fungal meningitis. The outbreak spans nine states and has killed at least eight people. The states with reported cases are: Florida, Indiana, Maryland, Michigan, Minnesota, North Carolina, Ohio, Tennessee and Virginia.

The steroid linked to the outbreak had already been recalled, and health officials have been scrambling to notify anyone who may have received an injection of it.

On September 25, 2012, the New England Compounding Center, located in Framingham, Massachusetts, voluntarily recalled the following lots of methylprednisolone acetate (PF) 80mg/ml:

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #05212012@68, BUD 11/17/2012

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #06292012@26, BUD 12/26/2012

Methylprednisolone Acetate (PF) 80 mg/ml Injection, Lot #08102012@51, BUD 2/6/2013

On October 3, 2012, the compounding center ceased all production and initiated recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration. A list of all recalled products related to the fungal meningitis outbreak can be found here.

It is not yet known exactly how many people may have been affected, though it could affect hundreds or even thousands of people who received the steroid injections for back pain from July to September.

The recalled products were distributed to clinics in the following states:

California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia.

Meningitis is caused by the inflammation of protective membranes covering the brain and spinal cord. Fungal meningitis is not contagious as are its more common viral and bacterial counterparts.
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Bard® PerFix® Hernia Plug — Increased Risk of Nerve Entanglement

September 20, 2012 | Dustin E. Davies

The Bard® PerFix® Hernia Plug, introduced by Davol, Inc. and C.R. Bard, Inc., in 1993, is a medical device used to repair “primary and recurrent inguinal hernias.”

According to C.R. Bard, the PerFix® Hernia Plug, “requires less overall dissection” and a “tension-free” surgical technique which “results in increased patient comfort, faster rehabilitation and fewer recurrences.”

Despite this, there have been numerous concerns raised by both patients and physicians that the PerFix® Hernia Plug increases the risk of various health related complications, including but not limited to, Post-Herniorrhaphy Pain Syndrome and possible nerve entanglement, resulting in chronic pain and often the need for extensive treatment and surgical replacement of such medical device.

Gas Can or Flame Thrower?

August 14, 2012 | John Suthers

Many of us keep plastic gas cans in our garage or storage sheds. Unfortunately, most plastic gas cans are made without a safety feature known as a flame arrestor. The lack of a flame arrestor on a plastic gas can creates a dangerous condition, which could result in the gas exploding.

In a widely reported case, 3 year old Landon Beadore was helping his mother pick up toys in a storage cellar when he accidently knocked over a plastic gas can like the one pictured here. Vapors from the gas can went along the floor, and the pilot light on a nearby water heater ignited the fumes. The gas fumes flashed back to the nozzle of the gas can, causing it to explode and burning Landon over 47% of his body. Landon’s shoes literally melted onto his feet.

Tragedies similar to Landon’s have occurred more than 75 times across the United States, burning and killing children, teenagers and adults. Nearly 40% of the victims were children. Manufacturing experts and victims’ lawyers in these cases believe that a small part known as a flame arrestor, which costs less than $1, could have prevented these horrible injuries. Regrettably, despite evidence that these plastic gas containers are more prone to explosions, the manufacturers of the containers and the Consumer Product Safety Commission have not required the installation of flame arrestors on plastic containers or warned consumers of this potentially dangerous defect. Ironically, as far back as 1973, Consumer Reports magazine wrote: “Should fumes outside the gas can ignite as you pour or fill, a flash back fire is possible that could ignite the contents of the can itself. Such accidents can be prevented by a flame arrestor, which we think should be legally required in all openings like these.”

These tragic situations have come to light recently, but for a different reason than you would expect. A series of attacks have been launched by big business and tort reformers against victims’ lawyers and their clients as part of a propaganda campaign. Blitz USA, America’s largest plastic gas can manufacturer, recently announced that it is closing its factory after nearly 50 years in operation. The reason, the company claimed, is unwarranted products liability litigation. Blitz USA and other companies in the gas can manufacturing industry are blaming victims for their “ignorance” in causing or contributing to the cause of plastic gas can explosions. They cite “consumer misuse” as the main cause of these types of accidents. Rob Jakobe, another victim, disagrees. Mr. Jakobe was walking with a Blitz gas can on a crisp day in Oregon when a static electric discharge from his body caused the can to explode. Chad Funchess, another victim, was filling up his chainsaw when his Blitz gas can erupted and engulfed him in flames. William Melvin, yet another victim, was refueling his lawnmower when his Blitz gas can exploded and hurled him through his barn.

It’s regrettable that big business, including the U.S. Chamber of Commerce, is standing behind Blitz USA and other manufacturers of similar plastic gas cans despite the horrific burning injuries and deaths of more than 75 citizens. How many more people will be burned or killed before these gas cans are pulled off the market? In the meantime, consumers should consider buying a gas can with a flame arrestor. These cans are sometimes called “safety cans,” and are normally made of metal rather than plastic. Additionally, never forget how dangerous it is to use or store gasoline. Consider the following safety tips:

– Keep gasoline out of sight and secured away from children.

– Do not let children handle gasoline.

– Store gasoline in a safety can outside the home, such as in a detached garage or storage shed.

– Do not use or store gasoline near potential ignition sources, such as electrical devices or any device that contains a pilot light or spark.

– Never use gasoline inside the home or as a cleaning agent.

– Do not use gasoline to accelerate a flame on a charcoal grill, wood stove, brush fire or campfire.

– Do not smoke when handling gasoline.
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