December 15, 2010

Drop-Side Cribs Banned by U.S. Government

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.

December 8, 2010

Unnecessary Stents, Medical Fraud, and a Slow-Smoked Pig

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.

November 22, 2010

Four Loko and Other Caffeine-Alcohol Drinks: Last Call?

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):

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.

November 9, 2010

Drowsy Driving: AAA Sends a Wake-Up Call

"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.

October 27, 2010

Bitter Pill: GlaxoSmithKline Pays $750M Over Defective Drugs

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.

October 25, 2010

Halloween Safety Tips for Kids and Parents

If there's one thing that's less exciting to get on Halloween than pennies and raisins, it's tips on keeping things safe. But October 31 is right around the corner, and for kids there's the good kind of scared (ghoulish costumes and haunted houses) while parents and homeowners get the bad kind -- the dangers posed by certain costumes, questionable candy, dark streets, and unsafe property.

So at the risk of donning a Debbie Downer costume this year, here's an old pillowcase full of safety tips for trick-or-treaters, parents and caregivers, and homeowners who are getting ready for Halloween.

Costumes: Make sure costumes and accessories are flame-resistant. Avoid really baggy costumes that can pose a tripping hazard. For greater visibility -- especially since it gets darker earlier this time of year -- use flashlights and apply reflective tape to darker costumes.

Candy and Treats: Parents and caregivers should always inspect their young trick-or-treaters' haul of candy for evidence of tampering or anything that looks suspicious. One good rule of thumb is to avoid any treats that don't appear to be factory-wrapped.

For Homeowners: Keep all walkways, stairs, lawns, and driveways well-lit and free of obstacles. Also, make sure any candle-lit jack-o-lanterns and all other open flames are attended at all times and out of reach of young kids. Otherwise you could be starring in your own personal horror film: The Attack of the Premises Liability Lawsuit.

For Pedestrians and Drivers: Trick-or-treaters and other pedestrians should stay on sidewalks and other designated walkways at all times, and only go up to homes that are well-lit or show other signs that trick-or-treaters are welcome. Drivers should use extra caution and drive slowly in any neighborhood where kids might be out trick-or-treating, and be especially vigilant for pedestrians crossing the street outside of the usual crossing areas.

Get more Halloween safety tips from the Centers for Disease Control and Prevention and the U.S. Consumer Product Safety Commission.

Related information from Nolo:

October 21, 2010

Meridia Recalled Over Heart Risks

Meridia manufacturer Abbott Laboratories has agreed to stop marketing the popular weight loss drug in the U.S., after a study raised serious concerns over a link between Meridia use and heart problems.

The announcement of the Meridia recall came on October 8, 2010. The main impetus for Abbott's action (with a strong nudge from the FDA) was a recently concluded study that showed an increased risk of heart attack and stroke in patients that were taking Meridia, and minimal weight loss benefits in light of those health risks. The 60-month study (called the Sibutramine Cardiovascular Outcomes, or "SCOUT" trial) followed 10,000 men and women who were given Meridia or a placebo. Development of cardiovascular problems was closely monitored in these patients, while progress in their weight loss was also tracked.

According to the FDA, results of the study showed a 16 percent increase in the risk of serious (sometimes even fatal) heart events like heart attacks and strokes in patients who were given Meridia, compared with patients who took the placebo. At the same time, there was only a slight difference in weight loss progress when the Meridia group and the placebo group were compared.

A day after the Meridia recall announcement, this Washington Post article labeled the weight loss pill's withdrawal "the latest setback in the long, frustrating quest for a pharmaceutical solution to the nation's obesity epidemic."

Meridia (sibutramine) was approved by the FDA in 1997, as a prescription weight loss medication intended for use by patients who were considered obese under the body mass index (BMI) measurement standard.

Related information from Nolo: