Important News & Recalls
GM Has Ordered new Switches Long Before the Recall
According to a report from The Wall Street Journal, General Motors (GM) Co. ordered half a million ignition switches to replace the defective products in Chevrolet Cobalts and other small vehicles. This took place nearly two months prior to informing the federal safety regulators of the issue that resulted in numerous accidents. According to a series of emails, an order of 500,000 replacement ignition switches was ordered from Delphi Automotive.
To read the full story, click here.
Fireball Whiskey is Recalled in Europe, but not in the U.S.
According to Fox News, Fireball Whiskey is being recalled in Europe because of its propylene glycol additive. It is not being recalled from the U.S. market because it does, however, meet North American food regulations and standards. Newsday reported that Fireball Whiskey is being recalled in the countries of Finland, Sweden, and Norway.
To read the full story, click here.
Testosterone Supplementation Safety Questioned by FDA
According to a report from the Wall Street Journal, the Food and Drug Administration has raised questions about whether taking testosterone supplementation to battle the effects of aging in older men. Research from the Journal of the American Medical Association shows that men who use testosterone supplements have a 29% higher chance of suffering from stroke or heart attack. The actions that the FDA will take are still unclear at this point.
To read the full story, click here.
FDA requires companies to pull so-called Ebola treatments:
As reported by CBS, the Federal Trade Commission (FTC) has warned several websites that claim that their products are cures to Ebola. The government sent a warning letter to these companies on the basis that they are violating Federal drug marketing laws. FTC's Dr. Serena Viswanathan is quoted stating that no FDA-approved products are currently on the market that are a cure or prevention of Ebola.
To read the full story, click here.
Canada private drug company recalls organ rejection drug:
As reported by Reuters UK, a private drug manufacturer has recalled a collection of its organ-rejection drug called Apo-Mycophenolic Acid on account of a labeling error. According to a statement from Health Canada, Apotex Inc. recalled the drug due to an error in the labeling of the drug, which provided inaccurate dosage for proper use. The drug is given to patients recovering from organ transplants for the purpose of thwarting symptoms of rejection, which can be threatening to the patient's life. The importance of the proper dosage of the drug could affect the effectiveness of its purpose and the patient's chance of recovery and survival.
To read the full story, click here.
Alabama High Court reaffirms decision on generic drugs:
In an ongoing battle over the question of who holds liability for injuries caused by generic drugs, the Alabama Supreme Court made a loud statement in a decision where it stated that brand name drug makers can be held liable for warnings on generic counterparts of their products. The decision was by no means a landslide, with the court being split as closely as possible on the decision and Cheif Justice Roy Moore dissenting with two other justices. The case, which was an appeal from a 2013 decision, was closely watched for by prominent figures in the legal community, the business world and especially the pharmaceutical industry. The nine-panel court stated in its decision that the plaintiffs did have grounds to sue the brand-name manufacturer if the generic company had simply copied the warnings for its drug from that of the brand-name--a policy that is permitted and, in fact, required by the U.S. FDA.
To read the full story, click here.
High doses of antidepressants linked to self-harm in youths:
According to a report from USA Today, it has become evident that there is a link between high doses of antidepressants and suicidal behavior in young people. While the Food and Drug Administration (FDA) has required drugmakers to list all such warnings on antidepressants for a number of years, a new study has found that the risk for deliberate self-harming doubles when depressed youths start medicating with higher-than-usual doses—particularly in those under the age of 25. For this reason, the study adds support for guidelines that would call for prescribing antidepressants at lower doses. According to the study's author, "There's no evidence that higher initial doses are going to help more than lower doses." Instead, they just add risk.
To read the full story, click here.
FDA defends generic drug label proposal before U.S. House of Representatives:
According to a report from Reuters, an official of the U.S. Food and Drug Administration appeared before the U.S. House of Representatives and defended a proposal that would require generic drug manufacturers to update the prescribing information on their products—should they come across new safety information. Those who oppose this proposal have explained that this would leave drug makers open to product liability lawsuits and even increase drug costs, but the FDA countered that the move is needed to "create parity" between branded and generic drug makers. Instead of waiting for the branded company to make these changes, the FDA is now asking generic drug makers to make this call.
To read the full story, click here.
Lawsuit sheds light on the relationship between doctors & device makers:
According to a report from the Wall Street Journal, a lawsuit that has been filed against Johnson & Johnson has shed light on the close relationship between medical device makers and the medical community (i.e. doctors). It has become apparent that there may be a conflict of interest, as the paper noted that there have been numerous allegations of the company's involvement in attempts to influence the language in treatment guidelines for prolapse. They even went as far as to attempt to alter the language of a research paper related to the transvaginal mesh for which they are now being sued.
To read the full story, click here.
Merck agrees to settle NuvaRing cases nationwide for $100 million:
According to a report from Detroit Free Press, Merck has agreed to settle all NuvaRing cases nationwide for $100 million. The company has been targeted in more than 1,850 lawsuits for manufacturing the dangerous birth control product, NuvaRing. Now, they have agreed to settle these claims as long as 95% of all eligible claimants opt into their settlement program—the deadline for which ends today (March 10, 2014). Those who qualify include women who have suffered life-threatening injuries and chronic conditions as a result of NuvaRing use, as well as the families of those who were fatally injured. If you believe that you are entitled to compensation, it is imperative that you discuss your case with an attorney immediately.
To read the full story, click here.
Coloplast A/S agreed to pay $16 million to settle vaginal mesh lawsuits:
According to a report from Bloomberg News, Coloplast A/S, a Danish medical device manufacturer, has agreed to pay $16 million to settle about 400 lawsuits related to defective transvaginal mesh products. This means that each claimant will receive approximately $40,000 for the injuries they have suffered; however, Coloplast isn't the only company who is facing lawsuits over vaginal mesh inserts. Others like Johnson & Johnson, C.R. Bard and Endo Health Solutions have also been sued for manufacturing similar products. "It appears that momentum is building for some type of global resolution as more of these vaginal-mesh cases settle," states Cal Tobias, a product-liability law professor at the University of Richmond.
To read the full story, click here.
FDA is being urged to revoke their approval of a new opioid painkiller:
According to a report from Newsday, a coalition of healthcare professionals and addiction experts are urging the U.S. Food and Drug Administration (FDA) to revoke their approval of the opioid painkiller, Zohydro (hydrocodone bitartrate). The coalition members are concerned that the painkiller will carry a high risk of abuse, since the FDA approved the capsules without requiring tamper-resistant formulations that would make it impossible to crush them into powder—which is typically the preferred form for abuse. More than 125,000 Americans have died from painkiller abuse over the last decade, so it is no wonder that people are up in arms about the release of this potentially dangerous drug.
To read the full story, click here.
NHTSA investigates GM's delayed recall of small cars:
According to a report from Bloomberg News, the National Highway Traffic Safety Administration (NHTSA) is investigating why it took General Motors Co. (GM) so long to recall 1.6 million cars with an ignition-switch defect—which was linked to 13 deaths. If the agency finds that the automaker failed to pursue a recall when it knew that the cars were defective, GM could be fined as much as $35 million. In response to these allegations, GM said that it was "deeply sorry," and has since doubled the number of cars that they are will fix and expanded the number of affected models from two to seven; however, it is unlikely that this will deter the NHTSA from issuing a penalty against the automaker.
To read the full story, click here.
FDA plans to strengthen security of medicines imported to the United States:
According to a report from The Wilmington News Journal, the U.S. Food and Drug Administration (FDA) has announced that they will be implementing the Secure Supply Chain Pilot Program—which aims to enhance the security of medicines being imported to the United States. This program will allow the FDA to allocate more funds to imports surveillance, which, in turn, will help them to prevent the entry of high-risk drugs that are "the most likely to compromise the quality and safety of the U.S. drug supply." According to Carol Bennett, the acting director for the FDA's Office of Compliance, they will be creating incentive for manufacturers to adopt best practices for supply chain integrity.
To read the full story, click here.
2,000 Pradaxa lawsuits have been filed against Boehringer Ingelheim:
According to a report from Reuters, more than 2,000 lawsuits have been filed against the German drugmaker, Boehringer Ingelheim, in the United States. The company has come under fire for its blood-thinning drug, Pradaxa, which is used for stroke prevention. While the drug has proven to be effective at cutting the rate of fatal or debilitating strokes in the elderly, numerous lawsuits have reported that the drug can cause severe and fatal bleeding—which is a factor that must be weighed against the drug's life-saving potential. Boehringer Ingelheim has since released the following statement: "We are certain that we can show in the legal cases that we have worked very carefully and responsibly."
To read the full story, click here.
Kroger is accused of deceiving consumers by misbranding their poultry:
According to a report from the New York Times, Kroger has been sued for deceiving consumers. The supermarket operator has been accused of marketing a store brand as products from humanely raised chickens when the animals were actually raised under standard commercial farming. The products were packaged with labels that claimed that the chickens were raised in a "humane environment," but the lawsuit contests that the animals were handled by Perdue Farms—which follows industry practices like electrically stunning the birds before they are slaughtered. According to a Kroger spokesman, Keith Dailey, the company has not seen a copy of the complaint and has no comment.
To read the full story, click here.
FDA updates safety requirements for infant formula manufacturers:
According to a report from the New York Times, the Food and Drug Administration (FDA) has updated safety requirements for infant formula manufacturers. These changes will require companies to tighten their quality control and reporting procedures—which will include testing their products for contamination from pathogens like salmonella. Although most companies already meet these safety standards, the new rule will give the FDA more control over enforcing them. It will also ensure that all infant formula contains federally required nutrients (i.e. proteins, carbohydrates, fats, vitamins and minerals). The changes will be open to public comment for 45 days.
To read the full story, click here.
Missouri house panel advances limits on medical malpractice claims:
According to a report from the St. Louis Post-Dispatch, a committee in the Missouri House of Representatives has endorsed legislation that would place a cap on some medical malpractice awards. The measures would limit non-economic damages to $350,000—which does not include economic damages like lost wages or medical expenses. Supporters of this legislation claim that it is necessary to keep medical malpractice insurance premiums from soaring and potentially driving doctors out of the state; opponents argue that it could let bad doctors off the hook and make it more difficult for victims to bring a lawsuit. Similar medical malpractice caps were declared unconstitutional by the state Supreme Court just two years ago.
To read the full story, click here.
ConAgra issues a recall for 5,200 cases of mislabeled soup:
According to a report from The Wall Street Journal, ConAgra Foods Inc. has decided to recall about 5,200 cases of Healthy Choice Chicken with Rice Microwavable Bowl Soup due to mislabeling. People that are allergic to products containing egg, gluten or wheat could be at risk, which is why the recall was initially ordered; however, this recall only affects certain soups. No illnesses have been reported, but anyone who has Celiac disease or who is allergic to wheat or egg products should avoid consuming the product in question—which includes the 14 oz. microwavable bowls of "Healthy Choice Chicken with Rice" soup with a "best by" date of June 9, 2015. The product was distributed in 23 states.
To read the full story, click here.
NHTSA investigates 2008 Honda Accord side airbag misfires:
According to a report from USA Today, the National Highway Traffic Safety Administration (NHTSA) will be investigating claims that the side airbags on 2008 Honda Accords can inflate when the front doors are closed. The probe covers about 363,000 cars from the 2008 model year. So far, the NHTSA has received 28 complaints and reports of two injuries. According to one report, a driver's 9-year-old son was in the back seat of his car when the airbag went off with a loud boom. The boy suffered a concussion and blood behind his ear, but Honda is denying that it is their fault. "Now I have an injured child and the car with about $7,000 damage," explains the complainant.
To read the full story, click here.
is being sued for using unsafe quantities of 4-methylimidazole:
According to a report from Courthouse News Service, PepsiCo has been sued for selling products that contain unsafe levels of the carcinogen, 4-methylimidazole—which is a byproduct of caramel coloring. One complaint states that the carcinogen is "sufficient to expose California consumers to substantial health risks," and that PepsiCo has deceptively omitted the fact that their products contain these amounts of 4-Mel. According to findings from the National Toxicology Program, 4-Mel has been known to cause lung tumors in laboratory animals. The executive director of the Consumer Reports Food Safety & Sustainability Center also claims that "there is no 'safe' level of 4-Mel."
To read the full story, click here.
George's frozen chicken products are recalled for undeclared allergens:
According to a report from the Food Poisoning Bulletin, George's Inc. has decided to recall 1.25 million pounds of frozen pan-fried chicken tender products due to misbranding and undeclared allergens. The company's chicken products are made with wheat, which is a major food allergen that was not included on their labels. While no adverse reactions have been reported, George's Inc. is still planning to recall a variety of chicken products—including "George's Uncooked Breaded Chicken Breast Tenderloins" and "George's Uncooked Chicken Tenderloin Fritters." The mislabeling is said to be a product of an isolated printer issue.
To read the full story, click here.
Johnson & Johnson avoids $482 million verdict over heart device dispute:
According to a report from Bloomberg News, the U.S. Supreme Court has refused to revive a $482 million jury verdict against Johnson & Johnson. The company had been ordered to pay the ninth-largest patent verdict in U.S. history over disputed heart devices, but the verdict was later overturned; the appeals court claimed that the judge who was overseeing the trial had misrepresented Bruce Saffran's patent and that Johnson & Johnson's Cordis unit wasn't actually using his invention. When the case made its way to the U.S. Supreme Court, the justices decided to leave the federal appeals court decision intact.
To read the full story, click here.
Chrysler struggles to repair unsafe vehicles 14 months after recall:
New York Times explains that, fourteen months ago, Chrysler announced that it would be recalling about 745,000 Jeep Grand Cherokee and Jeep Liberty sport utility vehicles due to the fact that the front or side airbags could deploy without the vehicle actually being involved in a crash. So far, about 94% of these vehicles have yet to be repaired, leaving many owners angry and scared. According to the National Highway Traffic Safety Administration (NHTSA), the recall was prompted by more than 131 reports of airbags being deployed without the vehicle being involved in a crash; 62 people suffered burns, cuts and bruises as a result, so the public is now calling on Chrysler to make good on their promise.
To read the full story, click here.
Ford recalls 2011-2012 Explorer SUVs to replace steering gears:
According to a report from Autoevolution, Ford Motor Company has decided to recall 300 model year 2011-2012 Explorer SUVs to replace faulty steering gears that have been installed as service parts. The National Highway Traffic Safety Administration (NHTSA) stated that the "affected gears may lock, preventing the driver from being able to steer the vehicle"—which may ultimately increase the driver's risk of being involved in an accident. The recall is expected to commence on January 24, 2014, when Ford will start notifying Explorer SUV owners and dealers will start replacing the faulty steering gears.
To read the full story, click here.
CDC announces that 430 people have been affected by salmonella outbreak:
According to a report from Food Safety News, the U.S. Centers for Disease Control and Prevention (CDC) has announced that, as of January 15, a total of 430 people have been affected by a recent salmonella outbreak—six of which live in Missouri. The U.S. Department of Agriculture has speculated that the illness is associated with chicken products that were produced at three Foster Farms processing facilities in California. At least seven strains of Salmonella Heidelberg have made their way into 23 states and Puerto Rico, and 38% of all ill persons have been hospitalized. No deaths have been reported.
To read the full story, click here.
CSPI threatens to sue Kraft Food Groups, Inc. over claim of "natural" products:
According to a report from Food Product Design, the Center for Science in the Public Interest (CPSI) has threatened to sue Kraft Food Group, Inc. over their deceptive use of the word "natural" in the labeling of their products—which include Crystal Light's "natural" lemonade and ice tea mixes. According to the CPSI, Kraft's beverages contain artificial ingredients like citric acid, sodium citrate and potassium citrate. For this reason, they believe that the company has intentionally deceived consumers by claiming that these products are made entirely with natural ingredients. A spokesperson for Kraft Food Group, Inc. contends that their "labels comply with the law and are not misleading."
To read the full story, click here.