Drugs & Medical Devices

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.

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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Ethicon Recalls Pelvic Mesh Products

June 6, 2012 | John Suthers

Ethicon, Inc., a subsidiary of Johnson & Johnson and manufacturer of pelvic mesh products, advised the United States Food and Drug Administration (FDA) this week that it is recalling four of its mesh, pelvic floor repair products. Additionally, Ethicon is asking the FDA for 120 days to “cease commercialization” of its products, notify customers, and allow physicians and hospitals time to choose different treatments for patients. Ethicon also plans to stop or change its marketing materials and revise its product labeling, limiting the use of certain products to abdominal procedures. These devices, many of which were made of synthetic polypropylene, have been used previously to treat women with conditions known as pelvic organ prolapse and stress urinary incontinence. Our law firm has filed lawsuits on behalf of women who suffered injuries after being surgically implanted with such devices, alleging that these devices were ill-suited for use in a woman’s pelvic floor area. Ethicon’s decision to recall four of its devices and stop marketing them for use in treating pelvic organ prolapse and stress urinary incontinence is an important step for thousands of women who have suffered injuries and continue to suffer because of these products.

Lawsuits on behalf of women who were injured by transvaginal mesh products have been consolidated in the United States District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin for pretrial proceedings. You can read the letter notifying the Court of Ethicon’s decision to recall its products. This litigation is what is known as multidistrict litigation (MDL), in which similar cases pending throughout the U.S. against a manufacturer or manufacturers are consolidated in one Federal Court for purposes of coordinating pretrial discovery and achieving consistency of rulings on evidentiary issues. The Court appoints a Steering Committee on behalf of the Plaintiffs and Defendants, who work together on resolving issues that come up during the course of the litigation. If an individual’s case is not settled or tried by a jury while it’s pending in the MDL Court, that individual lawsuit can be referred back to the United States District Court in the state where the Plaintiff resides or where the injury occurred, and be tried before a jury there.

Suthers & Thompson represents clients in pelvic mesh lawsuits against various manufacturers, including American Medical Systems, Inc. (AMS), C.R. Bard, Inc. (Bard), Boston Scientific, and Johnson & Johnson and its subsidiary, Ethicon. For more information regarding the pelvic mesh lawsuits, please see the Transvaginal Mesh and Bladder Slings page at our website.

Metal-on-Metal Hip Implants: Adverse Consequences

March 23, 2012 | John Suthers

Many of our readers may recall that DePuy Orthopaedics, a subsidiary of Johnson & Johnson, voluntarily recalled two models of its hip replacement products in August of 2010 because of high failure rates. Since the recall of the DePuy ASR devices, approximately 5,000 lawsuits have been filed against DePuy Orthopaedics on behalf of individuals who were surgically implanted with the recalled DePuy ASR hips. Many of these individuals have had to undergo further surgery to have the recalled products removed and replaced.

These metal-on-metal hip prostheses began to grow in popularity in the early 2000s. Manufacturers claimed they have greater advantages and fewer limitations than the typical polyethylene-on-metal hip implants. One of DePuy’s biggest selling points was that the metal-on-metal devices had superior wear properties, meaning that they would last longer than the conventional devices and thus, have to be replaced less often. This led to greater use of the metal-on-metal devices, especially in younger individuals who were undergoing hip replacements. It has been estimated that as many as 500,000 individuals worldwide have all-metal hip prostheses. The DePuy ASR metal-on-metal devices were surgically implanted in 93,000 people worldwide between 2003 and 2010.

Studies have shown a significant number of metal-on-metal hip prostheses have failed due to accelerated wear of the articular surface (the metal ball and metal socket). Imagine rubbing two pieces of metal together for anywhere from 16 to 24 hours a day. Eventually, the metal surface begins to wear and debris is released. Likewise, accelerated wear of the metal ball and socket in an all-metal hip prosthesis causes metal debris to be released into the body’s soft tissue surrounding the hip joint. Eventually, the metal debris works its way into the bloodstream. Many of the individuals who were surgically implanted with the DePuy ASR hip replacement devices were found to have elevated levels of cobalt, chromium and other metals in their bloodstream, a condition known as metallosis.

Hundreds of thousands of patients may have been exposed to toxic chromium and cobalt particles as their metal-on-metal hip implants wear, according to a joint investigation by the British Medical Journal and BBC Newsnight. The all-metal implants, including the DePuy ASR and one model of the DePuy Pinnacle product, Smith & Nephew’s Birmingham hip and Zimmer’s Durom hip, release particles of their chromium-cobalt alloy as the metal ball and socket wear against each other, causing tissue and bone death and possibly exposing patients to an increased risk of developing some forms of cancer. There is still uncertainty about just how much metal in the bloodstream constitutes a health threat. It is increasingly apparent, however, that many patients with metal-on-metal hip implants showed blood levels of ions higher than normal. As a result of the heightened awareness of the potential adverse effects of increased levels of cobalt and chromium in the bloodstream, physicians and scientists around the world are conducting ongoing investigations to learn more about the long-term consequences of defective metal-on-metal hip replacement devices.

The FDA has decided to gather and review all available information about currently marketed metal-on-metal hip replacement systems, including information related to adverse events that may be associated with increased levels of cobalt and chromium in the bloodstream. In May of 2011, the FDA issued a statement and wrote to 21 manufacturers, informing them that it was invoking a rule requiring post-marketing studies in cases where a hip implant’s failure could have serious consequences. Among other things, companies would be expected to take blood samples from patients to measure metal ion levels.

Symptoms of hip implant failure can include pain, inflammation or swelling in the area of the hip implant, a clicking or grinding sound coming from the hip area, and difficulty walking. Any person who has had a hip replacement should contact his or her surgeon to determine whether they received a metal-on-metal hip replacement device. If your orthopedic surgeon does not have this information, you should be able to obtain the information from the hospital where the surgery was performed. You can contact the medical records department at the hospital where the surgery was performed, give them the approximate date of surgery, and request a copy of your “implant log” or “sticker log.” This is the record in your hospital medical chart that shows the manufacturer and model of the device that was surgically implanted in you.
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Actos and Bladder Cancer

January 23, 2012 | John Suthers

Actos Packaging.jpg Manufactured by Takeda Pharmaceutical Company Limited and co-marketed in the United States by Eli Lilly and Company, Actos is a medication that is prescribed with diet changes and exercise to help regulate blood sugars for patients suffering from Type II diabetes. Prescribed in a daily 15 mg, 30 mg or 45 mg dose, Actos helps the body to be more efficient in its production, breakdown and absorption of blood sugars. When a person has too much blood sugar, the blood may become toxic to the organs, which are unable to use the sugar as fuel. Actos helps the muscles use insulin to absorb the needed sugar and keeps the liver from overproducing sugar. The Food and Drug Administration (FDA) has issued a warning, however, that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” The FDA also stated that the Actos label and patient Medication Guide must be changed to reflect the potential risk of bladder cancer. This announcement in the U.S. followed a more aggressive approach taken in France and Germany, which have both suspended sales and prescriptions of Actos.

The bladder is located in the center of the lower area of your belly, and is the part of your body that holds and releases urine. Symptoms of bladder cancer can include abdominal pain, painful urination, blood in the urine, urinary frequency, incontinence, fatigue and weight loss. Because there are many other conditions and diseases that can cause similar symptoms, it is important to see a doctor in order to rule out other possible causes. After performing a physical examination, your doctor may order diagnostic tests, such as an abdominal CT scan and a cystoscopy, which is a way to examine the inside of the bladder with a camera. Depending upon what is observed, a bladder biopsy may also be performed during the cystoscopy procedure. Additional diagnostic tests may include a urinalysis and a pelvic CT scan. If these tests confirm that you have bladder cancer, additional tests will then be done to determine whether the cancer has metastasized or spread. These tests are done to stage the cancer, as staging determines future treatment.

Bladder cancer is often treated with what is known as immunotherapy. A vaccine, known as Bacille Calmette-Guerin (commonly known as BCG) is generally used during immunotherapy for bladder cancer. It is administered through a Foley catheter directly into the bladder in an effort to trigger your immune system to attack and kill the cancerous cells. Treatment may also include surgery to remove the cancerous tumor, surgery to remove part of the bladder, or surgery to remove the entire bladder. Chemotherapy is also part of the treatment, sometimes in conjunction with radiation. Painful and unpleasant side effects can accompany all of these treatments. Like many forms of cancer, how well a patient does depends on the initial stage of the cancer and the patient’s response to treatment.