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Archive for the category: US Food and Drug Administration
  • Tracking Medical Device Implants

    In an attempt to protect consumers from the dangers of defective medical devices, the U.S. Senate recently proposed draft legislation that would require manufacturers to conduct ongoing safety studies of medical devices even after the device has obtained the approval of the U.S. Food and Drug Administration (FDA).  The legislation was drafted, in part, as a response to the increasing number of lawsuits that have been filed against the manufacturers of defective medical devices, particularly vaginal mesh implants. Currently, the FDA permits certain medical devices to be approved under its 510(k) system, which requires only that manufacturers demonstrate that their product is substantially similar to one already on the market.  The Senate pointed to the 2010 recall of the DePuy ASR hip implant system, which was approved under 510(k) procedures, as evidence that the current guidelines are ineffective in protecting the public from dangerous and defective medical devices. With respect to the specific dangers associated with transvaginal mesh implants, the FDA has also requested that manufacturers of vaginal mesh implants, such as Bard and Johnson & Johnson, provide additional information regarding the companies’ safety inspections and recall procedures. Since 2008, the FDA has warned consumers and health practitioners since 2008 about serious complications associated with vaginal mesh implants that are used to treat pelvic organ prolapse and stress urinary incontinence.  According to the FDA, more than 1,000 reports from nine surgical mesh manufacturers, including American Medical Systems, Bard, Boston Scientific, Caldera, Ethicon, Gynecare, Johnson and Johnson, Mentor and Sofradim, have been filed with the FDA’s adverse events reporting database.  The American of Obstetricians and Gynecologists and the American Urogynecologic Society issued a joint statement last November recommending that the use of transvaginal mesh be limited.  Although the FDA is continuing its safety review of vaginal mesh implants, there are currently no plans to issue a recall of these products. Hundreds of lawsuits have been filed against the manufactures of transvaginal mesh implants, as well.  C.R. Bard and Johnson & Johnson face hundreds of lawsuits from women claiming that their transvaginal mesh implants caused scarring, pain, bleeding, blood vessel damage and other complications. If you have been injured by a medical device, such as transvaginal mesh or a hip replacement system, you may wish to consult with an experienced product liability attorney.  At Ankin Law Offices, LLC, our knowledgeable Chicago product liability attorneys focus on protecting the victims of dangerous and[READ MORE…]

  • BPA Litigation Hits Roadblock

    Litigation pending over BPA in plastic bottles has hit a major roadblock.  Last month a Missouri federal court denied class certification for the plaintiffs’ claims over the use of bisphenol A in baby bottles and sippy chips.  The plaintiffs’ claims were part of multidistrict litigation pending in a federal court in Missouri.  Multidistrict litigation, or MDL, is a federal court procedure whereby civil actions with common issues of fact are combined for purposes of discovery procedures and pre-trial motions. Although the court initially refused to certify three proposed multistate classes in 2011 based on issues regarding choice of law, commonality, and damages, the court granted the plaintiffs an opportunity to show that a class of Missouri-only consumers is appropriate for class certification.  The plaintiffs then filed a motion for class certification of claims brought by Missouri-only plaintiffs against three manufacturers of baby bottles and children’s sippy cups – Handi-Craft Company, Gerber Products Company, and Evenflo Company, Inc. In denying the plaintiffs’ motion for class certification of Missouri-only plaintiffs, the court focused on the plaintiffs’ lack of standing.  A court may not certify a class if the proposed class includes members who lack standing to bring a lawsuit against the respective defendants.  The plaintiffs’ class in this case included individuals who had not suffered an injury, such as those individuals who knew about BPA’s existence and the potential dangers associated with BPA but purchased the products despite possessing this information. The court also denied class certification based on issues of reliance.  For instance, plaintiffs argued that knowledge includes only consumers’ reliance on defendants’ alleged nondisclosure of the dangers associated with BPA.  The court disagreed with plaintiffs’ assessment, however, and explained that the issue of reliance presupposes that the consumer did not know the relevant information.  Since many plaintiffs in this case did possess knowledge regarding the potential dangers of BPA prior to purchasing the products, reliance could not be asserted. Moreover, the court determined that the proposed class included individuals who may not have suffered an injury even if they were unaware of BPA when they purchased the products.  The plaintiffs argued that the class members were injured through the lack of material information prior to making their purchases, but the court held that the consumers were purchasing baby products and not information. In addition, the court found that there were concerns regarding commonality of claims with respect to the proposed[READ MORE…]

  • Johnson & Johnson Recalls 12 Million Bottles of Motrin

    Healthcare and pharmaceutical giant Johnson & Johnson (J&J) recently issued a recall of approximately 12 million bottles of its popular pain reliever, Motrin, due to concerns that the Motrin IB pills may not dissolve and begin working as quickly as intended, resulting in delayed pain relief, as the pills approach their three-year expiration date.  The recall only affects Motrin IB from retailers, and not those in the hands of consumers, since there is no safety risk. The recalled bottles of Motrin were sold in 24 or 30 count packages that were distributed in the United States, Puerto Rico, the Bahamas, Fiji, Belize, St. Lucia and Jamaica.  There are 59 affected lot numbers, all of which are listed on the product’s Web site at http://www.motrin.com.  The affected bottles of Motrin were manufactured between February 2009 and July 2011. J&J’s Prior Recalls J&J has been plagued by safety problems and efficacy concerns with respect to its products for the past several years.  Since September 2009, J&J has recalled a number of prescription and over-the-counter medications, including children’s and adult Tylenol and Motrin, Benadryl, Zyrtec, Rolaids, Simply Sleep pills, Prezista (an HIV medication), Levaquin (an antibiotic) and Topamax (an epilepsy medication).  The manufacturer has also recalled a number of its medical devices, including hip replacement systems, contact lenses and diabetes test strips. As we reported, earlier last year, J&J was ordered to pay $1.8 million to an 82-year-old man from Minnesota who claimed that he was injured by Levaquin, an antibiotic used to treat infections such as pneumonia and chronic bronchitis, as well as sinus, urinary tract, kidney, prostate and skin infections.  Levaquin has been known to cause complications including tendon damage, Achilles tendon rupture, inflammation, Achilles tendonitis, and injury to the rotator cuff, biceps, hand and thumb that may require extensive surgery and could leave the patient incapacitated and facing large medical bills. J&J’s recalls cost the company $900 million in 2010 alone as a result of lost revenue from products pulled from store shelves, factory renovation costs, and legal expenses.  J&J’s Consumer Healthcare factory in Fort Washington, Pa., has been closed since spring 2010 when serious health problems forced the company to undergo a comprehensive renovation and rebuilding of the facility. J&J’s safety and efficacy concerns have sparked the interest of the federal government as well.  The U.S. Food and Drug Administration (FDA) and Congress are both investigating how the company’s[READ MORE…]

  • Cantaloupe Listeria Outbreak Takes the Lives of 29

    A nationwide listeria outbreak in contaminated cantaloupe has gripped the country.  Claiming 29 lives, the cantaloupe listeria outbreak is among the deadliest food poisoning outbreaks since 1924.  Thousands of pounds of Jensen Farms and Carol’s Cuts cantaloupes have been recalled due to concerns about listeria contamination. Specifically, the recalls include several hundred pounds of fresh-cut cantaloupe shipped from Carol’s Cuts LLC in Kansas City.  The cantaloupe was sold in 5-pound trays as chunks and as an ingredient in 8-ounce containers of mixed fruit medley between August 26, 2011 and September 12, 2011 to institutional food customers, including restaurants in Kansas, Missouri and Nebraska. In September 2011, Jensen Farms in Colorado recalled whole Rocky Ford cantaloupes.  Jensen Farms ceased production and distribution of its cantaloupes while an investigation was conducted by the company and the U.S. Food and Drug Administration (FDA) into the cause of the contamination.  The FDA determined that the listeria contamination was caused by poor sanitary practices at a packing facility. The recalled Jensen Farms cantaloupes were shipped between July 29, 2011 and September 10, 2011, and distributed to a variety of states, including Illinois.  The cantaloupes have a green and white sticker that reads: “Product of USA- Frontera Produce-Colorado Fresh-Rocky Ford-Cantaloupe” or a gray, yellow, and green sticker that reads: “Jensen Farms-Sweet Rocky Fords. Even though the contaminated cantaloupes have been recalled for nearly two months now, illnesses and deaths continue to rise due to the fact that listeria, a foodborne illness that can cause stillbirths, illness and death, can live in the body for several weeks before causing a person to become ill.  To date, the listeria outbreak has been blamed for at least 139 illnesses and 29 deaths, according to the Centers for Disease Control and Prevention. Symptoms of listeria include muscle aches, abdominal pain, nausea, diarrhea, severe headaches and fever. Listeria infections can be diagnosed by blood tests and are treated with antibiotics. Food Safety Recommendations The FDA recommends that consumers follow the following food safety tips: Wash hands with soap and warm water for at least 20 seconds before and after handling food. Wash the inside walls and shelves of the refrigerator, cutting boards and countertops and sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water.  Use a clean cloth or paper towel that has not been previously used to dry the surfaces. Immediately clean[READ MORE…]

  • Turkey Salmonella Outbreak

      The Centers for Disease Control and Prevention (CDC) is working with public health officials across the country and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) to determine the cause of a multistate outbreak of Salmonella Heidelberg infections that is likely caused by eating ground turkey.  To date, 77 persons from 26 states, including 7 persons from Illinois, have been infected with the outbreak strain of Salmonella Heidelberg between March 1 and August 1, 2011.  Because the outbreak strain of Salmonella Heidelberg is resistant to many commonly prescribed antibiotics, the risk of hospitalization or treatment failure may be increased. Who Has Been Infected? The illnesses reported to date began on or after March 9, 2011 and those infected with the Salmonella Heidelberg strain range in age from less than one year to 88 years old, with a median age of 23 years.  Nearly half (48%) are female and, of the 58 infected persons with available information, 22 (38%) have been hospitalized and one death has been reported. Those that became ill in the past 2-3 weeks may not be reported yet due to the lag time between a person becoming ill and the time that the illness is reported. How Is the Outbreak Being Investigated? The CDC believes that the Salmonella Heidelberg outbreak strain has been caused by ground turkey because nearly 50% of the ill persons for whom there is available information have reported eating ground turkey, a percentage that is significantly higher than the results from a survey of healthy persons. In addition, cultures of four ground turkey samples purchased from four retail locations between March 7 and June 27, 2001 indicated the presence of the outbreak strain of Salmonella Heidelberg.  Preliminary information has shown that three of these samples originated from the same production facility, with the fourth sample still under investigation. In order to determine the specific cause of the outbreak strain, the CDC and public health investigators are using DNA “fingerprints” of Salmonella bacteria to identify cases of illness that may be part of this outbreak. They are also examining data collected from a network of state and local public health laboratories and federal food regulatory laboratories that perform molecular surveillance of foodborne infections.  Product information, such as the date and location of purchase, is also being collected from ill persons to help with the public health agencies’ investigations. What Are[READ MORE…]

  • FDA’s Special Report on Product Safety and Quality

    The U.S. Food and Drug Administration (FDA) recently issued a special report on product safety and quality designed to meet the challenges imposed by the increasing number of FDA-regulated imports and a complex global supply chain.  The special report, entitled “Pathway to Product Safety and Quality,” reports that between 10 and 15% of all food consumed by households in the United States is imported from abroad, with nearly 2/3 of all fruits and vegetables and nearly 80% of all seafood consumed in the U.S. imported from abroad. Due to the expansion of food imports and globalization of the food supply chain, the FDA has expanded its regulatory capabilities and oversight functions through legislation such as the Food Safety Modernization Act. For example, the FDA has opened additional offices overseas in key international locations and increased the number of inspections of international drug manufacturers.  Because of the challenges brought about by a global food supply, the FDA seeks to take additional actions with respect to product safety and quality. Key Challenges of Today’s Global Supply Chain The FDA’s special report cites several challenges facing the global supply chain today, including the following: Demographic shifts among emerging markets Tension between resource consumption and environmental sustainability Increased pressure on companies to reduce prices and increase productivity Increased risks of fraud and economic adulteration of food and medical products due to pressures to maintain lower prices and changes to the global product flow Movement of companies to production facilities overseas in order to reduce production expenses Increased safety and quality risks due to flow of products through complex multi-step supply chain before reaching the U.S. market How the FDA Plans to Overcome These Challenges The FDA states in its special report that it is “committed to addressing its challenges and those of the future by implementing a strategy to enhance global product safety and quality, and in doing so more effectively fulfill its mission.”  In order to fulfill these goals, the FDA plans to “engage all stakeholders” in a transformation and reform process that will take several years and require “boldness, creativity, and patience.” The “Pathway” report cites four core building blocks upon which the FDA plans to implement changes in order to effectively meet the challenges of today’s global marketplace: Assemble global regulatory coalitions that are dedicated to expand and strengthen product safety around the world. Develop a global data information system and[READ MORE…]

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