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Defective Products Archives

Asbestos Found in Some Children's Crayons - Beware When Buying Back-to-School Products

Asbestos is a known carcinogen that reportedly kills up to 15,000 Americans every year. And it's still legal to put it in products. But is was a bit surprising to find asbestos in children's crayons, according to tests commissioned by EWG Action Fund, a 501(c0(4) organization. The EWG (Environmental Working Group) Action Fund's mission is to protect the health of people and the environment by educating the public and lobbying on a wide range of environmental issues. Four brands of crayons and two kids' crime scene fingerprint kits were reported to contain asbestos fibers. It released the information to raise awareness about the asbestos threat in well-known products - from vehicle brakes to building materials and even children's items. The EWG Action Fund reports that a child exposed to asbestos is 3.5 times more likely than a 25-year-old to develop mesothelioma, a lung disease that is only caused by asbestos. With children returning to school, parents need to be careful in buying back-to-school supplies. Some of the brands of crayons that were identified to have asbestos are marketed under the names of Mickey Mouse, Power Rangers and Teenage Mutant Ninja Turtles in boxes of 28 crayons that can be bought online or at national retail chains. All of the products were made in China and were imported to the U.S. The U.S. Consumer Product Safety Commission (CPSC) has conducted its own tests on crayons and concluded that the risk of exposure to asbestos was "extremely low" and that it would continue to "monitor children's crayons to ensure they do not present a hazard because asbestos fibers are embedded in the crayon wax and that a children's body temperature is not warm enough to melt ingested wax and free the fibers. CPSC has not banned or regulated asbestos in crayons, toys or other children's products. It is reported that by the age of 10, the typical American child wears down 730 crayons, according to Crayola, the largest crayon manufacturer. One of the crime fingerprint kits that was named as containing possible airborne asbestos fibers was the Edu Science Deluxe Forensics Lab Kit. The EWG Action Fund tests were conducted under the direction of Sean Fitzgerald of the Scientific Analytical Institute in Greensboro, North Carolina. To read more about the tests conducted this year, go to:

Top Chicago law firm talks product liability

Product Liability: liability of a designer, manufacturer or seller of a product for injuries or damages suffered as a result of defects in the product or its user information. Our top Chicago law firm recognizes that product liability cases require complex litigation. The nature of a product liability claim depends on the jurisdiction, product type, and cause of the defect. Product defects can surface in different facets of the user experience, including defects in the design or manufacture of the product, as well as due to a lack of proper warnings about dangers associated with the product's use.

Fast-Track Approval of Medical Devices Called into Question

The United States is the largest medical device market in the world with sales expected to reach $133 billion by 2016. In most cases, medical devices save and improve lives. Unfortunately, not all devices undergo the same rigorous review process before hitting the market. A number of new medical devices can and do bypass scrutiny by the U.S. Food and Drug Administration (FDA) through a fast-track approval process called the 510(k) program. If a manufacturer can prove that its product is "substantially equivalent" to an existing product, it can avoid stringent premarket testing. While the 510(k) clearing process provides patients with quick access to new products, there is an unsettling consequence: Medical devices can be implanted in patients without requiring manufacturers to prove safety and effectiveness. And in fact, a recent study published in JAMA Internal Medicine found that only eight of the 50 new devices cleared through the program from 2008 to 2012 included required scientific data. Defective Medical Devices Raise Concerns Here are just a few examples of more notable defective medical devices that have caused injury to patients: Knee and Hip Replacements - Clinical evidence continues to show that the design of some knee and hip replacement implants is seriously flawed. Adverse results include failing to properly bond to the thigh bone, improper placement or loosening after surgery. Bone fractures can occur as well as dislocation of the joint. Symptoms patients may feel range from general pain to swelling to an inability to walk. In 2013, The New York Times reported that Johnson & Johnson knew an all-metal hip implant would fail within five years in nearly 40 percent of patients who had the surgery. Transvaginal Mesh Complications - Surgical mesh, composed of synthetic materials, is permanently implanted in patients to repair weak or damaged tissue. But in certain procedures it can cause life-changing health complications, including mesh erosion when the device migrates from its point of placement and cuts through the soft tissues of the vagina or pelvic organs. In addition, patients have experienced pain, bleeding and urinary complications, which the product was designed to fix in the first place. Defibrillator Leads - Defibrillator leads are implantable wires that connect the defibrillator to the heart. In the event of a heart attack, defibrillators automatically administer corrective shocks. Over the past decade, there have been several high-profile examples of defibrillators malfunctioning, causing the device to fire unexpectedly or fail to fire at all when a patient's life is at risk.   Protect Yourself with These Tips These tips from Consumer Reports can help protect you or loved ones from the risk of defective medical devices: Consider the alternatives: If your doctor suggests an implant, simply ask what will happen if you don't get it. Sometimes patients aren't adequately informed about the alternatives. For example, women who received transvaginal mesh for prolapse repair may not have needed surgery. But people ill enough to require an implantable defibrillator for their heart may not have a choice. Research the device: The Food and Drug Administration's website,, contains information on device safety warnings, complaints and recalls, which are all accessible by searching the name of the device. Also look for patient forums and other information about the device by searching online. Write down the details: Ask for the brand name, model and serial number (if applicable) of your device so that if you learn of a warning or safety recall, you'll know whether yours is one of the problem models. Don't panic: If you learn there are problems with your device, don't assume that it has to be removed. Contact your doctor and learn to recognize possible negative side effects in your case. - See more at: Read here for seven medical device failures that caught the FDA's eye:

Illinois Legislature Considers Passing Law on Banning Bumper Pads on Cribs

The Illinois state legislature House lawmakers approved a bill that bans the sale of crib bumper pads. They also endorsed a bill that would set state standards for the crib padding. The bumpers are intended to keep baby's limbs from getting caught between crib bars and to protect them from bumping their heads against side rails. The American Academy of Pediatrics has warned that crib bumpers can cause suffocation. House Bill 3761 passed the chamber by a vote of 63-48 on April 21, 2015, following vigorous debate, reports The State-Journal Register, the state capital's main newspaper. The bill was introduced by Emily McCasey (D-Lockport). It makes the sale and manufacture of any solid padding for the inside of baby cribs illegal. Mesh padding is excepted. "In order to protect our infants, this is an important step forward to get this dangerous product that has been linked to dozens of deaths off the market in the state of Illinois," McCasey told the Register. The city of Chicago has already banned the sale of baby crib bumpers. Child-care providers also are not allowed to use them. Last year, House Bill 5348 passed the House and the Senate Public Health Committee, but in June the state Senate failed to call the bill for a vote on the floor. Safety groups supported legislation to ban the sale of crib bumper pads in Illinois due to the risk of suffocation. HB 5348 was supported by a wide range of Illinois organizations including SIDS [Sudden Infant Death Syndrome] of Illinois, Inc., Everthrive, Illinois Action for Children, and the Illinois Association for the Education of Young Children. Representatives from those organizations reportedly spent hours talking to legislators in the Capitol to lobby for passage of the bill. Last year, the American Academy of Pediatrics, Illinois Chapter, and the Injury Prevention & Research Center at the Ann & Robert H. Lurie Children's Hospital of Chicago reportedly asked pediatricians around the state to contact senators about the importance of safe sleep. Illinois PIRG, March of Dimes, Pathways, Shane's Foundation and Cribs for Kids, a national group, also reportedly lent their support. This year's HB 3761 is now headed to the Illinois Senate. A similar bill there is sponsored by Sen. Julie Morrison (D-Deerfield).

Drug Manufacturers Underreporting Medication's Side Effects, Report Finds

According to a new study conducted by the Institute for Safe Medication Practices, the main mechanism for tracking and documenting serious side effects associated with medications is deeply flawed, according to The New York Times ("Drug Maker's Data on Side Effects Is Called Lacking in a Report," Feb. 2, 2015). The study found that this problem is attributable to drug manufacturers themselves, alleging that these companies are submitting incomplete information in the reports to the Food and Drug Administration (FDA), The New York Times reported. It is not that medication manufacturers are not submitting such reports to the FDA, but that reports do not meet the basic standards for completeness in that they omit the patient's age, sex and the date of the event complained of, according to The New York Times. This information is critical to the FDA for proper evaluation of how drugs affect specific groups of people, according to the Wall Street Journal. Drug manufacturers are required to disclose to the FDA each and every instance that comes to their attention of an adverse event attributable to a drug they manufacture under FDA rules. However, less than half of reports filed are considered "complete" under FDA standards, the Wall Street Journal reported. While a few companies were commended by the FDA for consistently submitting high quality reports, many others were condemned for a complete lack of due diligence, according to The New York Times story. Manufacturers responded to these allegations by claiming that the lack of information is attributable to the fact that consumers and/or doctors are not directly filing reports to the manufacturers, but instead the companies are left learning of the complications from medical literature that does not always contain the information the FDA claims is lacking, according to The New York Times.

Attorney Writes Article on Whether Drug Company Failed to Warn with Label

Pamela Sakowicz Menaker Writes Article for ABA Litigation News on New Case Dealing with Failure-to-Warn Regarding Drugs and Their Labels As a Contributing Editor of the American Bar Association (ABA) Section of Litigation News, Pamela Sakowicz Menaker, Communications Partner at Clifford Law Offices, authored an article discussing a recent case in federal district court in New Jersey that concluded "the plaintiff failed to allege a failure-to-warn claim against a drug manufacturer [who] complied with Food and Drug Administration (FDA) requirements to change its warning label..." Several ABA members commented on this case that received quite a bit of national attention regarding liability of drug companies and their compliancy with FDA requirements. The particular case at issue dealt with a post-menopausal woman who had taken the drug Fosamax for her osteoporosis. When she suffered an atypical femur fracture, she filed a complaint that Merck Sharp & Dohme Corp. drug company, maker of Fosamax, violated New York's failure-to-warn laws. It all came down to timing of the FDA label requirements, Merck's actions, and the adequacy and clarity of the label itself. To read more about this interesting issue and how the court came to its conclusion, go to:

FDA Approves Highest Number of New Medicines in 18 Years

Forty one novel medicines were approved in 2014 by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, fourteen more than in 2013, according to Reuters. While the FDA does not develop or test products, their experts review testing performed by manufacturers and grant approval when they determine that the overall benefit of the product outweighs the risks of the intended use, the Science Times Reported. This number is second only to the record high of medication approvals experienced in 1996, when 53 new medications were approved, according to the Science Times. European nations also saw a spike in recommendations for new drugs, driven mostly by expensive new treatments for rare and serious diseases, including many forms of cancer, the Science Times reported. With the medicine industry shifting their focus toward diseases requiring specialized products (where competition for the companies is limited), a reported forty percent of the new drugs approved in 2013 were geared towards rare diseases, according to Reuters. Increasing competition has caused the prices of many older medications to plummet, according to the Science Times. In 2014, two drugs were approved to treat cancer by helping the body's own immune system fight tumors, Reuters reported.

Keurig Recalls Millions of Coffee Brewing Systems

Keurig, a company best known for manufacturing easy-to-use, single cup coffee makers, has recalled approximately 6.6 million MIMI Plus Brewing Systems made between 2009 and 2014 in the United States, according to USA Today. The U.S. Consumer Product Safety Commission divulged that the recalls were a response to consumers reporting burn injuries, USA Today reported. In total, Keurig had received 200 reports of hot water spewing out of the brewer, including 90 reports of burn-like injuries, according to CBS News. Keurig has instructed customers to contact the company for a free repair kit for their coffee machines, but in the meantime Keurig pleads with owners of these defective devices to keep at least arm's length away from the brewers and to never brew more than two cups of coffee in a short period of time, CBS News reported.

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