Georgia Injury Lawyer Blog

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.

Nursing Homes Overbilling Medicare

November 15, 2012 | John Suthers

According to the Wall Street Journal, nursing homes are overbilling Medicare $1.5 billion dollars annually. A majority of nursing home residents are Medicare recipients, making Medicare a key payor for nursing homes throughout the United States. When residents are admitted to nursing homes, the nursing home is required to prepare a report known as a Minimum Data Set (MDS), detailing the type of care to be rendered to the resident and the degree or intensity of care, which is also referred to as the acuity. The amount of Medicare’s reimbursement to a nursing home is based on the acuity level. The greater the acuity, the larger the reimbursement. Increased care rendered to residents in nursing homes includes things such as speech therapy, physical therapy and occupational therapy.

The recent study by the Government, as reported in the Wall Street Journal, revealed that some nursing homes have been guilty of what is known as “upcoding,” a process in which they inflate their bill to Medicare by claiming that more intensive services were provided than were actually performed. For example, a facility may claim that physical therapy was rendered to a resident regularly when, in fact, little or no therapy was performed. In other cases, the study determined that nursing homes were providing inappropriate or unnecessary care for the sole purpose of inflating their bills to Medicare and receiving greater reimbursements.

Ironically, while nursing homes have been overbilling Medicare to the tune of $1.5 billion dollars annually, their lobbyists are asking Congress to enact a bill, HR 5, which would limit the recovery by a victim who has been abused or neglected in a nursing home. While nursing homes are defrauding the Government (and taxpayers), they are asking the Government to pass laws that would shield them from liability for negligently injuring residents. Keep in mind that many of these residents are part of the so-called “great generation,” comprised of men and women who fought for our country in World War II and other wars, built factories that provided jobs for thousands of citizens, and were tax-paying citizens themselves.

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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The Importance of an Investigation as Soon as Possible After A Truck Accident

October 5, 2012 | Dustin E. Davies

The importance of a thorough investigation after a serious truck accident cannot be Tractor Trailer.jpg overstated. Often, key evidence exists on an onboard computer on the truck and also in paperwork required to be maintained by truck drivers and trucking companies.

Investigations sometimes reveal that a trucking company or a specific truck driver did not follow federal regulations and even took steps to circumvent federal regulations with bogus entries on log books and inspection reports. Sometimes the paperwork can reveal warning signs to a company about the condition of the truck or trailer before an accident. In some cases, the condition of the truck or trailer, at the time of the wreck, is determined to be the cause of the crash.

Trucking companies are required to keep specific records on their drivers, trucks, and trailers, but are only required to keep that information for a limited period of time. It is important that the attorney for the accident victim contact the trucking company as soon as possible after an accident and demand that the evidence be preserved.

One tactic that has been used recently by trucking companies has been to quickly repair the truck and/or trailer, in an effort to deprive the objective inspection of the truck and/or trailer. Sometimes by the time an accident victim has hired an attorney, the truck and/or trailer has been placed back in service, resulting in critical evidence being lost.
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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.

ADDITIONAL HIP REPLACEMENT DEVICES RECALLED

September 11, 2012 | Dustin E. Davies

The FDA has ordered a review of all metal-on-metal hip implants due to mounting patient complaints. The DePuy Orthopaedics ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System were recalled in August 2010. Recently, the Smith & Nephew R3 Acetabular System was recalled in June 2012 and the Stryker Rejuvenate and ABG II modular-neck hip stems were recalled in July 2012.

The R3 Acetabular System hip device was designed to accommodate several different bearing surfaces such as plastic on metal, ceramic on ceramic, and metal on metal (“MoM”) and can be used with different combinations of femoral stem components to form a total hip replacement. The artificial hip implants that fall into this MoM group are all composed of a metal-containing hip socket and a metal-containing ball that fits into that socket and caps the end of the patient’s thigh bone. When an R3 metal liner is used in combination with a metal femoral head, then the resulting implant combination is a MoM hip replacement system. The recalled R3 Acetabular System consists of two components: the R3 acetabular cup and the R3 metal liners made of cobalt-chromium that fit within the acetabular cup. The R3 Acetabluar System used with a metal liner has been associated with causing injuries such as infections, fractures, and dislocations.

The recalled Stryker Rejuvenate and ABG II modular-neck hip stems can be used in conjunction with either metal or ceramic hip implants, but the component itself is a metal-on-metal modular junction. The metal-on-metal modular junction can fret or corrode, which may cause toxic metal debris to loosen and enter the bloodstream. This can result in pain, inflammation, swelling, tissue damage, necrosis, osteolytes, and even metallosis.
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Cantaloupe Food Poisoning Outbreak

September 11, 2012 | Dustin E. Davies

Listeria linked to cantaloupe killed at least 33 Americans and sickened another 147 last year, according to the Centers for Disease Control and Prevention, and a new cantaloupe food poisoning outbreak involving salmonella is under way in 21 states, with 204 confirmed infections and two deaths.

The tainted cantaloupe came from Jensen Farms in Colorado, where FDA investigators found listeria in pools of water on the packing facility floor, dirty equipment, and improper cooling methods. Retailers such as Wal-Mart Stores Inc. and The Kroger Co. allegedly sold the tainted fruit.

People stricken with listeriosis generally suffer a fever and sometimes gastrointestinal symptoms. The bacteria are invasive and can also cause meningitis, convulsions, septicemia and, in about 20 percent to 30 percent of cases, death. It also causes pregnant women to miscarry.

Two salmonella-related suits have already been filed, and dozens of cases stemming from the 2011 listeria outbreak are pending. The suits seek to hold the cantaloupe growers, as well as retailers, liable for this outbreak.

The complaint against Indiana cantaloupe grower Chamberlain Farm Produce Inc. and Wal-Mart filed in Calhoun County, Mich., Circuit Court on Aug. 23 is illustrative.

The plaintiff, Angela Compton, claimed that she bought three cantaloupes on July 12 from Wal-Mart and fed them to her children over the next few days. One child got sick on July 16, suffering from cramps, diarrhea and fever and was hospitalized for three days. The other child developed diarrhea, cramps, vomiting and a high fever a few days later and was twice taken to the emergency room.

Both children’s stool samples tested positive for Salmonella Typhimurium — the particular strain associated with the tainted cantaloupe, which authorities traced to Chamberlain Farm.

To food safety advocates, the back-to-back cantaloupe outbreaks underscore a regulatory failure. When Congress passed the Food Safety Modernization Act almost two years ago, the idea was to give the U.S. Food and Drug Administration more power to prevent food-borne illnesses. But key regulations implementing the law — including one dealing with produce safety — have stalled at the White House Office of Management and Budget, where they have been under review for nearly 10 months.

Last week, the Center for Food Safety sued the FDA and OMB in San Francisco federal court for failing to issue timely regulations. “FDA has missed not one, not two, but seven critical deadlines, and counting, in failing to implement [the law’s] major food safety regulations,” the complaint states. The FDA’s “failure to promulgate final regulations is not only a violation of the law but is putting human health and safety at imminent risk.”
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