The Recall Lawyers

During a recent recall compliance audit, the FDA discovered that King International has closed its doors and abandoned any attempt to recall its ShoulderFlex Massager. King International, in cooperation with the FDA, initiated the recall of its ShoulderFlex Massager on August 31, 2011. At the time, the FDA was aware of reports of one strangulation death and one near strangulation death. Because of these adverse events, the FDA classified the recall as a Class I.

A Class I recall is the most serious type of recall. The FDA uses this high-risk distinction only when there is a reasonable probability that the product will cause serious adverse health consequences or death. A recall's classification determines not only the steps the company has to take, but also the FDA's level of oversight. For any class of recall, the FDA's main goal is to ensure that the actions taken by the company are adequate to protect the public health. In a Class I recall, the FDA conducts a number of audits to make sure the company's recall efforts are appropriate and effective.

Continue reading "FDA: King Int'l Failed To Comply With ShoulderFlex Recall" »

Winn-Dixie Stores, Inc., one of the nation's largest food retailers, has voluntarily recalled its Winn-Dixie Brand Italian Green Beans, because they may contain peanuts. The recalled products were sold in 14.5 oz. cans with a best by date of Sept. 2014 and a UPC code of 2114021236.

Persons with a peanut allergy or severe sensitivity to peanuts can experience a serious or life-threatening allergic reaction if they consume peanut products. A peanut allergy is one of the most common causes of severe allergy attacks, especially among children. Minor to severe reactions are characterized by gastrointestinal, skin and respiratory symptoms. Persons with severe sensitivity to peanuts may experience potentially life-threatening anaphylactic shock. Anaphylactic shock is an allergic reaction in which the release of histamine causes difficulty in breathing, swelling, heart failure, circulatory collapse, and sometimes death. There is no cure or therapies to eliminate or lessen the severity of peanut allergy. Strict avoidance of peanut and peanut-ingredient is the only way to prevent an allergic reaction.

Continue reading "Winn-Dixie Brand Italian Green Beans Recalled" »

The U.S. Food and Drug Administration recently notified healthcare professionals of a Class I recall of CareFusion AVEA Ventilators. Ventilators provide continuous breathing support for the care of patients who require mechanical ventilation. The AVEA ventilator has the ability to automatically shut off under certain circumstances. The FDA issued the Class I recall because a false alarm within the ventilator has been known to stop ventilation and thus cease to provide respiratory support.

Class I recalls are reserved for defective products that predictably pose life-threatening injuries. Thankfully, the FDA initiated the recall of the AVEA ventilators before this fatal glitch resulted in tragedy.

Multiple Retailers, including Supervalu Inc., Walgreen Co., Kroger Co. and Safeway, have pulled 12.5-ounce cans of Enfamil Newborn with the lot number ZP1K7G off the shelves of their stores after Ten-day-old Avery Cornett died Sunday after getting sick several days earlier after ingesting Enfamil Newborn Formula in Lebanon, Ohio.

Continue reading "Enfamil Newborn Formula Pulled Off The Shelves of National Retailers" »

In 2007, the U.S. Consumer Protection Safety Commission (CPSC) announced a recall of one million Bumbo Child Sitters. The device was designed to be used with infants who had not yet developed their own ability to sit up. The recall warned that the device was not to be used on countertops, chairs, tables or other elevated surfaces because there was a danger that infants can flip out of the device, receiving serious head injuries. The product was recalled and the company added a warning label warning users not to use the device on such surfaces.

However, serious injury may still occur from use on the floor. A Texas couple has brought a suit against the manufacturer for their child's head injuries which occurred under parental supervision and on while on the floor. Infants are able to escape the device and still receive serious head injuries, even if only situated on the floor.

Continue reading "Bumbo Child Sitter Still Dangerous, Still Sold After Recalll" »

Sales of the Infuse bone-growth protein made by Medtronic Inc. are in a nosedive after reports that the U.S. Senate is investigating safety problems with the product.
Medtronic sold $800 million worth of Infuse in its latest fiscal year, but Infuse sales are now declining sharply in the wake of news reports about safety issues.

A recent analysis, for example, showed that when the growth protein is used in spine surgery there is a possible higher rate of cancer. The types of cancer cited in the study include, breast cancer, pancreatic cancer, and prostate cancer. If you or a loved one has been injured by Infuse, contact the attorneys at Jones Ward PLC for a free consultation. Call Jasper Ward at 502-882-6000 or email jasper@jonesward.com.

Evidence is mounting that Bayer's birth control pills are unreasonably dangerous, particularly in light of safer alternatives. Yasmin, Yaz, Beyaz and Safyral are fourth generation contraceptive drugs that contain drospirenone, a new type of synthetic progestin. During the month of December, several FDA advisory groups met to review Bayer's warnings for these birth control pills.

Bayer's first drospirenone birth control pill, Yasmin, was developed and released in May 2001. With the approval of Yaz in 2006, Bayer's heavy marketing campaign took off. Bayer's advertisements targeted women's sense of freedom and individuality. It also directed Yaz and Yasmin for uses not FDA approved, including bloating, muscle fatigue, aches, and PMS. The campaign proved a huge success. In 2008 Bayer's Yaz and Yasmin profits were a staggering $998 million.

Then the problems surfaced. Women began having strokes and heart attacks due to venous thromboembolisms (blood clots) and pulmonary embolisms. Many healthy and young women with no other risk factors had their gallbladders removed. A significant number of studies and other evidence suggest a link between drospirenone and these gallbladder injuries. Additionally, these women share a common denominator: they all took a birth control pill in the Yaz-family. In response to the rising number of adverse events, the FDA ordered Bayer to spend $20 million on corrective advertising.

Continue reading "Yaz/Yasmin: FDA Reviews Bayer's Warnings" »

The controversy over the Infuse bone-growth protein made by Medtronic continues, with California's attorney general issuing another subpoena to Medtronic forcing the company to cough up documents.
Medtronic, based in Minnesota, already is under fire for allegedly downplaying the safety risks associated with Infuse. According to news reports and scientific studies, the potential dangers of the drug include uncontrolled bone growth, a heightened risk of cancer, and male sterility. If you or a loved one has been injured by Infuse, contact the attorneys at Jones Ward PLC for a free consultation. Call Jasper Ward at 502-882-6000 or email jasper@jonesward.com.

Drug maker Merck & Co. has agreed to pay $950 million and to plead guilty to a criminal charge. It was accused of marketing its painkiller Vioxx for off-label uses, uses for which the FDA had not approved the drug. While doctors may prescribe drugs for off-label uses, drug makers cannot market their drugs for such use. The allegations against Merck were that it illegally promoted the sale of Vioxx to ease the pain of rheumatoid arthritis prior to its approval to do so in 2004.

This is not the only legal trouble the drug company has faced over Vioxx. In 2004, Merck withdrew Vioxx from the market because of its link to increase in stroke and heart attacks. Merck previously agreed to pay a $4.85 billion settlement to individuals who were taking the drug and their families. It settled potential claims of unions and insurers for $80 million. It also agreed to pay $12.5 million to shareholders for their derivative claims against the company's officers stemming from the sale of the drug.

Continue reading "Drug Company Agrees to Pay Additional $950 Million" »

A U.S. Food and Drug Administration advisory committee recommended stronger warning labels for Bayer's birth control pills Yaz and Yasmin. By a 21 to 5 vote, the panel recommended changing the contraceptives' labels to reflect the possibility that the pills could lead to a higher risk for blood clots or deep vein thrombosis (DVT). Currently, the labels suggest the risk of blood clot is similar to those of other contraceptives that combine estrogens and progestins.

FDA spokeswoman Morgan Liscinsky said the panel acknowledged the conflicting data but "definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data." While some physicians do not believe this risk is enough to change their prescribing habits, others, including members of the FDA advisory committee, disagree. In an interview with the Wall Street Journal, committee member Sean Hennessy of the University of Pennsylvania stated physicians should use an abundance of caution because "these drugs ought to be rarely used."

Continue reading "FDA Panel Recommends Stronger Warning for Yaz and Yasmin" »

Club Car LLC, in cooperation with the U.S. Consumer Product Safety Commission, recently issued a voluntary recall on several models of its Precedent golf cars. According to Club Car, the fuel tank seam can separate causing a fuel leak. The obvious risk of fire posed by the leaking fuel prompted the recall. The recalled cars were sold nationwide from April 2011 through May 2011 and can be identified by model number located above the passenger's side floor board. The recall involves Precedent models: CF, PR, and PY. Club Car and the Commission urge consumers to stop using the recalled cars immediately.

Ford announced today that it is recalling its Ford Fusion and Mercury Milan 2010 and 2011 models. The recall is limited to those vehicles with 17 inch wheels. Ford has said that the wheels"can fall off cars." Federal regulators discovered that the bolts holding the wheels are subject to fracture. In the event of such a fracture, vibration occurs which, if ignored, could cause the wheels to fall off.

Ford has said however, that it is not aware of this causing any crashes to date. Owners of these vehicles are asked to bring their vehicles to Ford dealers where lug nuts will be replaced.

Today, Fair Oaks Dairy Products, LLC and the U.S. Food and Drug Administration issued a voluntary recall of certain one half pound packaged cheeses and cheese gift boxes sold between September 30, 2011 and December 3, 2011. Laboratory analysis found that Fair Oaks four year aged cheddar cheese contained listeria monocytogens, a potentially deadly organism. As a precautionary measure, Fair Oaks has recalled not only its cheddar cheese but also all of its cheeses and cheese gift boxes produced in its plant from September 30, 2011 through November 17, 2011.

Listeria can cause serious and sometimes fatal infections in young children, the elderly, or others with weakened immune systems. Among pregnant women, listeria infections can cause miscarriages and stillbirths. Healthy individuals typically suffer from short-term symptoms such as stiffness, nausea, abdominal pain, diarrhea, high fever, and headaches. If you or someone you know is experiencing any symptoms of listeriosis you should contact your physician.

See's Candies, Inc. and the U.S. Food and Drug Administration (FDA) recently announced a recall of certain 8-ounce Almond Clusters because they may contain peanuts. Approximately 3,600 boxes of See's Candies Almond Clusters are affected by this recall. The recalled boxes were sold in various See's Holiday Gift Centers in Arizona, California, Colorado, Hawaii, Indiana, Kansas, Maryland, Michigan, North Carolina, Nevada, New York, Nebraska, Oklahoma, Oregon, Virginia, Washington, Florida, Georgia, Tennessee, Texas, Mississippi and Louisiana.

Persons with a peanut allergy or severe sensitivity to peanuts can experience a serious or life-threatening allergic reaction if they consume peanut products. A peanut allergy is one of the most common causes of severe allergy attacks, especially among children. Minor to severe reactions are characterized by gastrointestinal, skin and respiratory symptoms. Persons with severe sensitivity to peanuts may experience potentially life-threatening anaphylactic shock. Anaphylactic shock is an allergic reaction in which the release of histamine causes difficulty in breathing, swelling, heart failure, circulatory collapse, and sometimes death. There is no cure or therapies to eliminate or lessen the severity of peanut allergy. Strict avoidance of peanut and peanut-ingredient is the only way to prevent an allergic reaction.