The rumors of Avandia's total removal from the retail market became a reality this week, when the U.S. Food and Drug Administration (FDA) announced that starting in November, the once-popular type 2 diabetes drug will no longer be available to almost all patients.
Avandia (or rosiglitazone maleate), manufactured by GlaxoSmithKline, earned FDA approval in 1999. Since then, it's been a popular prescription option for controlling blood sugar in adults with type 2 diabetes.
But Avandia has also been linked to an increased risk of heart attack since 2007, and the FDA hasn't been shy about limiting sales of the drug since that time. Avandia's complete removal from the market became a distinct possibility in September 2010, when the FDA ordered severe restrictions on the drug.
This week's action doesn't amount to a complete FDA recall of Avandia, but it's about as close as it gets. According to the FDA's announcement, after November 18, 2011 Avandia (and its companion rosiglitazone medicines Avandamet and Avandaryl) will no longer be available through retail pharmacies. Only a very limited number of patients will still be able to receive these drugs, and they must be enrolled in a special program before they'll receive the medicine via mail order, from specially-certified pharmacies.
Late last week, a jury in Mississippi handed down the largest-ever verdict in an asbestos case, awarding $322 million in damages to a former oil field worker who developed health related problems linked to asbestos exposure.
Attorneys for Thomas C. Brown, a 48-year-old former oil field "roughneck," argued that Brown had inhaled asbestos dust on the job, and that the manufacturers and sellers of the asbestos (defendants Chevron Phillips Chemical Co. and Union Carbide Corp.) failed to take proper steps to warn of the dangers of the materials. Brown developed asbestosis and other health problems after years on the job, and now needs to be on oxygen around the clock. A civil court jury in Jackson, Mississippi sided with Brown and ordered the companies to pay up, to the tune of $322 million. That's the largest single verdict ever in an asbestos case, at least according to one of Brown's lawyers. The defendants have (surprise, surprise) called the verdict outrageous and are vowing to fight the award via an appeal to the Mississippi Supreme Court.
Brown's asbestos-related health problems stemmed from on-the-job exposure that began over 30 years ago, but asbestos is still a problem (and sometimes an unavoidable one) for a lot of workers in the U.S. As many as 1.3 million people in the U.S. are exposed to significant amounts of asbestos in the workplace, according to the Occupational Safety and Health Administration (OSHA).
Get more information on asbestos -- including related health and legal issues -- in Nolo's Asbestos, Chemicals, and Toxic Torts topic.
Chevrolet is recalling over 2,000 of its popular Cruze model compact cars because of a potential problem with the steering wheel column that could result in the steering wheel literally coming off in the driver's hands. It happened to one Cruze driver recently. Thankfully, no car accident or injuries resulted. But the single incident did initiate the recall of 2,100 model year 2011 Cruze vehicles, since once is enough when it comes to a steering wheel falling into a driver's lap (it's right up there with a gas pedal getting stuck).
According to the NHTSA recall database, the problem is that some steering wheels may have been improperly fastened during manufacturing, and could separate from the steering column. General Motors (which owns Chevrolet) says that GM and Chevrolet dealers will inspect (free of charge) the steering wheel and steering column of affected Cruze models to ensure proper assembly. If you own a Cruze vehicle that's being recalled, you'll likely be hearing from GM or your dealer soon, if you haven't been contacted already. You can also get in touch with Chevrolet directly at 1-800-630-2438 or visit GM's website for car owners.
Learn more about vehicle recalls and defects in Nolo's article Product Liability Claims Involving Defective Cars.
A new product safety information database has been launched by the federal government, giving consumers a one-stop online portal to report and research hazards in almost every kind of product under the retail sun. The new www.SaferProducts.gov was launched by the U.S. Consumer Product Safety Commission (CPSC) on March 13.
You can use the new SaferProducts.gov database to:
- report any actual injury caused by a consumer product,
- report on safety risks you've noticed in certain dangerous products, and
- research the safety record of products you own or are thinking about buying.
So, how does the product safety risk reporting system work? After a consumer submits an online report to SaferProucts.gov -- detailing an injury or safety hazard linked to a product -- CPSC reviews the report to make sure it contains all required information. Qualifying reports are then sent to the product's manufacturer, and that company has 10 days to respond to and/or comment on the consumer's claims about the product's safety. After those 10 days, the consumer's report and the manufacturer's response are posted on the SaferProducts.gov database. (Manufacturers can also register their companies on SaferProducts.gov using the Business Portal.)
You can learn more about the new SaferProducts.gov in this Q&A from CPSC.
New federal guidelines on child passenger safety advise parents to keep their kids in rear-facing car seats for as long as possible, to keep them as safe as possible in a vehicle accident.
The new National Highway Traffic Safety Administration guidelines come on the heels of a recent American Academy of Pediatrics study, which looked at safety data on car accidents involving young children, and concluded that parents should keep kids in rear-facing seats until they're at least two years old or have clearly outgrown the seat. In short, parents shouldn't treat their kids' graduation to a forward-facing seat as an age-based milestone. As the NHTSA puts it, "there is no need to hurry to transition a child to the next restraint type."
- Birth to 12 Months: Always keep your child in a rear-facing car seat.
- 1 Year to 3 Years: Keep your child in a rear-facing seat for as long as possible. New studies show that a rear-facing seat is the best option for keeping your child safe in a car accident.
- 4 Years to 7 Years: Your child should be kept in a forward-facing car seat equipped with a harness, until they've outgrown the seat.
- 8 Years to 12 Years: Use a booster seat until your child is big enough to use a seat belt properly.
The new child safety seat recommendations are largely based on a combination of two factors that are unique to a young child's physical development: disproportionately large heads, and bones and musculature that may not be up to the task of providing adequate support for the head in an accident.
For more help understanding and complying with child restraint laws, check out and this Child Safety Portal from the NHTSA and this Chart of State-by-State Child Passenger Safety Laws.
Vaccine makers are shielded from certain kinds of personal injury lawsuits because of a 1986 law that set up a no-fault compensation system for injuries linked to childhood vaccines, the U.S. Supreme Court ruled today.
Today's 6-2 decision (Bruesewitz v. Wyeth LLC) came about after a Pennsylvania family tried to step outside the confines of the National Vaccine Injury Compensation Program after their claim was rejected under that process. The Bruesewitz family sued drug maker Wyeth in state court, alleging that their daughter had become disabled after receiving a diphtheria, tetanus, and pertussis (DTP) vaccine manufactured by a company now owned by Wyeth.
The Supreme Court upheld two lower federal court decisions in ruling that the National Childhood Vaccine Injury Act of 1986 insulates vaccine manufacturers from any kind of personal injury lawsuit alleging a design defect -- meaning all lawsuits that seek compensation for harm from a vaccine's side effects based on a theory that the vaccine could have been make safer.
The 1986 law, which set up the no-fault National Vaccine Injury Compensation Program, was enacted for two key reasons. First, expensive lawsuits over injuries from childhood vaccines were acting as a deterrent that kept many companies from working to develop new vaccines, even when those vaccines could provide a clear benefit to kids and to society in general. Second, families and kids who had been injured by childhood vaccines spent large amounts of money and time trying to get compensation through increasingly complex court cases. The National Vaccine Injury Compensation Program eliminates manufacturer liability for a vaccine's unavoidable, adverse side effects. Awards are paid out of a fund created by an excise tax on each vaccine dose.
Read the full text of today's decision in Nolo's Supreme Court Center: Bruesewitz v. Wyeth LLC. And to learn more about the National Vaccine Injury Compensation Program and how the claim process works, check out Nolo's article Vaccine Injuries: The Federal Compensation Program.
Two recent federal investigations have turned up no evidence that drywall found in homes is to blame for a number of deaths in Florida, Louisiana, North Carolina, and Virginia.
Today, federal product safety officials announced that an investigation looking into a potential link between drywall in homes at Fort Bragg and the deaths of at least three infants has turned up no such connection. The infants were said to have either lived in or visited two homes containing suspected problem drywall over a period beginning in 2007, on the base at Fort Bragg, which is a U.S. Army post in Fayetteville, North Carolina. But rounds of testing revealed that drywall in the homes was not "problem drywall" of the kind that has made headlines in recent years, and no drywall-related environmental factors could be linked to the babies' deaths, according to the U.S. Consumer Product Safety Commission (CPSC). Read the CPSC news release here and see the full report on the Fort Bragg investigation here (PDF file).
ABC11-WTVD in Raleigh-Durham reports on the case here (including an assertion that the investigation looked into as many as 11 infant deaths), and the station has also posted a PDF file collecting 263 pages of documents related to the investigation.
In January, CPSC released a report summarizing a separate investigation into the deaths of 11 adults (five in Florida, five in Louisiana, and one in Virginia) ranging in age from 59 to 86. That review -- which involved work by CPSC, CDC and a number of state health agencies -- concluded that "exposure to imported drywall was not believed to be a contributing factor" in the death of the 11 adults, all of whom "had one or more severe health conditions that were unrelated to imported drywall," including cancer and cardiac problems. You can read a PDF version of that report here.
Nintendo's newest hand-held device lets users play games in 3-D mode, but the company's vague warning on the use of the device by young children has left some people wondering if the lawsuit fix is in.
Nintendo posted a warning on its company website a few weeks ago, cautioning parents that children age six and under shouldn't use the new 3DS in 3-D mode because it could adversely affect eyesight development, as CNET reported. But the warning came without much in the way of details, like medical evidence of the health risks involved. So, is Nintendo just playing the older-than-Pong game of CYA, hoping that a preemptive warning will come in handy down the road if (or when) lawsuits get filed over the safety of the 3DS? The announcement was just a precautionary measure for customers, Nintendo president Satoru Iwata told the WSJ in a recent interview, although Iwata also didn't deny that worry over litigation may have factored into the warning.
Nintendo's warning on the potential dangerousness of the 3DS could play a part in the company's liability if product defect lawsuits are ever filed over the game. That's because a manufacturer's liability for a product's safety hinges partly on whether warnings were issued by the manufacturer, and whether those warnings were sufficient in light of the potential harm. Learn more in Nolo's articles Proving a Defective Product Liability Claim and Defective Product Claims: Theories of Liability.
Toyota will pay $32.4 million in fines over the company's bungled handling of recent recalls that affected millions of Toyota and Lexus vehicles, under a deal announced last week.
The 2009 and 2010 Toyota-Lexus recalls were prompted by a number of incidents in which drivers reported gas pedals "sticking" and causing unintended vehicle acceleration. The problem was that the gas pedals were getting caught in the vehicle's floor mats. These "unintended acceleration" incidents grabbed headlines and the instant attention of worried Toyota and Lexus owners. But, according to the U.S. Department of Transportation, early recall efforts by Toyota -- related to the pedal/floor mat issue and a separate steering column defect -- were too narrow in scope and didn't go far enough toward fixing the problems.
So, Toyota has agreed to pay the fines in response to the DOT's assertion that the company failed to comply with the National Traffic and Motor Vehicle Safety Act's rules for reporting safety defects to the National Highway Traffic Safety Administration. The $32.4 in fines adds up to the maximum possible penalty allowed under the law, and it's also the largest recall-related penalty ever paid by a car company, dwarfing the $1 million paid by GM in 2004, according to the Los Angeles Times.
For more information about the Toyota recalls -- and to understand the legal issues behind vehicle defects -- check out these articles from Nolo:
Drop-side cribs have been banned under new federal safety regulations announced Wednesday (December 15, 2010) by the U.S. Consumer Product Safety Commission (CPSC). Some are calling it the end of an era, given the drop-side crib's huge and decades-long popularity, but others are calling the ban long overdue. In the last nine years, defective cribs have been blamed for the deaths of at least 32 children, and millions of cribs have been recalled during that time -- with many of those recalls involving defects in the drop-side mechanism of different cribs.
The ban applies to the sale, manufacture, and re-selling of any drop-side crib. Service businesses that use or offer cribs (such as day care centers and hotels) will have one year to comply with the ban, by replacing any drop-side cribs with safe and CPSC-approved fixed-side models.
The CPSC recently described the dangers of drop-side cribs this way: "When drop-side hardware breaks or deforms, the drop side can detach in one or more corners from the crib. If an infant or toddler rolls or moves into the space created by a partially detached drop side, the child can become entrapped or wedged between the crib mattress and the drop side and suffocate. Infants can also strangle in the "V" shape formed by a drop side that detaches in an upper corner."
To learn more about crib safety standards, recent recalls, and how to make sure that your child's crib is safe, check out Nolo's recent article Crib Recalls, Safety, and Litigation.
For parents and caregivers who want to ensure that cribs and other baby furniture are up to safety standards -- and not subject to any recent recalls -- the CPSC has set up a special online Crib Information Center at www.cpsc.gov/info/cribs.
A Baltimore cardiologist's alleged pattern of unnecessarily inserting stents into patients is the subject of a recent U.S. Senate committee investigation and report. The story shines a spotlight on an emerging and disturbing trend in health care: doctors and hospitals churning out procedures that may or may not be necessary, and drug and medical device manufacturers rewarding those high-volume practices. Articles in The New York Times and The Baltimore Sun can give you more details about the Senate report and all the garish attention paid to Dr. Mark Midei for inserting Abbott Laboratories stents into patients like he was going for some kind of record. Those details include 585 stent procedures that weren't medically necessary, and a celebratory $2,000-plus dinner featuring a slow-smoked pig, with the bill paid by Abbott Labs in order to honor Dr. Midei's "achievements," according to allegations. Meanwhile, every single procedure (necessary or not) brought lucrative profits, including Medicare reimbursements.
In non-emergency cases, stents are typically inserted only when an artery is completely or significantly blocked. That's because the use of stents brings serious health risks -- specifically, the increased chance that a patient will suffer blood clots, stroke, heart attack, and internal bleeding. And as the Times article points out, patients who have had stents inserted need to take blood-thinning drugs, and those medications come with their own unique risks. So it's not hard to see how inserting a stent when it's not medically necessary to do so can rise to the level of medical malpractice. Cue the hundreds of lawsuits that have been filed against Dr. Midei and St. Joseph Medical Center, according to the Times.
Looking for more information on the legal issues behind this developing story? You'll find dozens of articles and FAQs on medical malpractice cases and lawsuits involving medical devices in Nolo's Medical Malpractice and Dangerous Products and Drugs sections.
Like it or not, caffeine and alcohol are as American as Starbucks and Budweiser. But from now on, consumers looking to dabble in both are probably going to have to pick one vice or the other at a time. Last week, the FDA fired a loud warning shot over the marketing of drinks like Four Loko, Joose, and Core -- alcoholic beverages that contain caffeine as an "unsafe food additive," according to the health agency.
Here are the caffeinated alcoholic drinks affected by last week's FDA marketing warnings (click on a hyperlinked company name to see the FDA warning letter sent to that beverage's manufacturer):
- Core High Gravity HG Green, HG Orange, and Lemon Lime Core Spiked (Charge Beverages Corp.)
- Four Loko (Phusion Projects Inc.)
- Joose and Max (United Brands Company Inc.)
- Moonshot (New Century Brewing Co.)
The FDA is warning consumers that "individuals drinking these beverages may consume more alcohol -- and become more intoxicated -- than they realize," and that "drinking caffeine and alcohol together may lead to hazardous and life-threatening behaviors." It's not for nothing that in some circles these drinks are known as "blackout in a can."
On the heels of the FDA's warnings, a number of states have already banned the sale of drinks like Four Loko, including Massachusetts, Oregon, and Washington. And according to Time.com, at least one wrongful death lawsuit has already been filed over the safety of Four Loko.Learn more about unsafe products and FDA warnings in the Dangerous Products & Drugs section of Nolo's Accidents & Injuries Center.
"Asleep at the wheel" isn't just the overused metaphor flavor-of-the-month for politicians these days. According to a new study from AAA it's also a dangerous reality on the nation's streets and highways, one that's more common than you might think.
How bad is the problem of drowsy driving? 41 percent of drivers surveyed by AAA admitted to falling asleep at the wheel at some time in their driving history, and 10 percent of responders said that they had nodded off while driving at least once in the past year.
Being overly tired behind the wheel can pose many of the same risks that come from drinking and driving or talking on a cell phone or texting while driving. In terms of nationwide numbers, drowsy driving causes over 100,000 car accidents every year -- including 40,000 injuries and 1,550 deaths, according to research from the National Highway Traffic Safety Administration.
Learn more about causes of car accidents and how to prove fault with Nolo's Vehicle Accidents articles and FAQ.
Drug maker GlaxoSmithKline will pay a $750 fine to settle allegations that the company manufactured defective drugs -- including the antidepressant Paxil -- at a GSK facility in Puerto Rico.
Certain batches of drugs manufactured at the Puerto Rico plant were misidentified and were inconsistent in terms of their active ingredient levels and their purity -- in some cases falling "materially below, the strength, purity or quality specified in the drugs' FDA applications," the U.S. Department of Justice says. It's important to note that there were no reports of patients being harmed by the defective drugs; the penalty against GSK is for the company's ongoing violation of laws meant to ensure the drugs' quality and safety.
In addition to Paxil, other drugs that were allegedly manufactured with defects include Kytril (an anti-nausea drug), Bactroban (used to treat skin infections), and Avandamet (for treatment of Type II diabetes).
Under the deal, SB Pharmco Puerto Rico Inc. (a subsidiary of GSK) has agreed to plead guilty to charges related to the selling of the defective drugs. SB Pharmco will pay a criminal fine and forfeiture of $150 million, and another $600 million to settle allegations under the federal False Claims Act and related state claims.
Here's some related news, and it should serve as incentive for corporate mischief-spotters everywhere to grab their whistles and blow like Dizzy Gillespie. Cheryl Eckard is the ex-quality assurance manager at GSK who filed the whistleblower suit against the company in 2004, shining a spotlight on the questionable manufacturing practices at the Puerto Rico facility. Eckard will receive a lottery jackpot-like $96 million as compensation for coming forward and exposing GSK's wrongdoing.
Learn more about defective drugs and the legal issues they raise in Nolo's Dangerous Products & Drugs section.