Personal Injury

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.

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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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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