Category Archives: Recalls and Safety Announcements

FDA Lets Avandia Up Off the Mat

Harsh sales restrictions on the once-popular diabetes medication Avandia have been lifted by the FDA. Use of the drug will no longer be limited to certain patients, and new labeling will be pretty much in-line with other prescription diabetes meds. Maybe you’re reading this and asking yourself, “Hey, isn’t the FDA sort of doing a complete 180 on Avandia?” Not a bad question.

The restrictions have been in place since 2010, when, on the heels of a study that linked Avandia use to an increase in heart problems, the FDA ordered that Avandia only be prescribed to certain diabetes patients whose condition could not be adequately controlled with any other medication.

The FDA wasn’t done with Avandia in 2010. The following year, the agency announced that the drug would no longer be available through retail pharmacies, and that only a very limited number of patients would still be able to receive it. Those patients needed to be enrolled in a special program before receiving Avandia via mail order, from specially-certified pharmacies.

So, why the regulatory change of heart now? A recent clinical trial suggested that Avandia use actually comes with no elevated risk of heart attack or death when compared with other diabetes drugs. Not that the new study was without controversy — check out this Wall Street Journal article featuring a few barbs from critics of the trial and the way it was carried out.

It sounds like Avandia’s new labeling will be pretty standard, according to the FDA announcement: “The FDA anticipates that the new indication will state that the drug may be used along with diet and exercise to improve control of blood sugar in patients with type 2 diabetes mellitus, an indication similar to other diabetes drugs currently available.”

Learn about Product Liability Claims Involving Pharmaceutical Drugs.

Tesla Model S Gets Federal Safety Probe After Fires

On the heels of three incidents in which Tesla Model S cars have caught fire after striking road debris, the federal government has announced that it is investigating a potential vehicle safety defect involving the popular electric car — specifically, the effect of “undercarriage strikes” on the vehicle’s battery compartment.

Here’s what the NHTSA’s Office of Defects Investigation had to say in announcing the Tesla probe:

    The ODI is aware of two incidents occurring on US public highways in which the subject vehicles caught fire after an undercarriage strike with metallic roadway debris. The resulting impact damage to the propulsion battery tray (baseplate) initiated thermal runaway. In each incident, the vehicle’s battery monitoring system provided escalating visible and audible warnings, allowing the driver to execute a controlled stop and exit the vehicle before the battery emitted smoke and fire.
    Based on these incidents, NHTSA is opening this preliminary evaluation to examine the potential risks associated with undercarriage strikes on model year 2013 Tesla Model S vehicles.

According to the Washington Post, it’s not clear whether Tesla CEO Elon Musk asked the NHTSA to look into the issue — Musk claims he did, but the head of the agency said he was “not aware” of any such request.

In any case, Musk isn’t thrilled with the picture that the media is painting when it comes to the Model S and its propensity to catch fire, and he may have a fair point.

In a blog post on the Tesla website, Musk makes the argument that three incidents of fire involving the Model S does not add up to a safety problem, especially when you put that incident rate side-by-side with the one for gasoline-powered cars. Here is the numbers breakdown from Musk:

    There are now substantially more than the 19,000 Model S vehicles on the road, for an average of one fire per at least 6,333 cars, compared to the rate for gasoline vehicles of one fire per 1,350 cars. By this metric, you are more than four and a half times more likely to experience a fire in a gasoline car than a Model S! Considering the odds in the absolute, you are more likely to be struck by lightning in your lifetime than experience even a non-injurious fire in a Tesla.

Salmonella Illnesses Linked to Foster Farms Chicken

At least 278 cases of salmonella illness have been linked to Foster Farms chicken products from processing facilities in California, the U.S. Department of Agriculture’s Food Safety Inspection Service has announced.

The specific affected products haven’t been pinpointed, but so far federal safety officials have identified raw Foster Farms chicken products that consumers should be on the lookout for. According to the Public Safety Alert from the FSIS, raw products that came from the three facilities in question will have one of these unique identifying numbers inside of a USDA mark of inspection or somewhere on the packaging:

  • “P6137”
  • “P6137A”
  • “P7632”

FSIS also says that the products were mainly distributed to retail outlets in California, Oregon and Washington State. The majority of the 278 reported illnesses have been in California, but NBC News reports that people in 18 states have been sickened.

The strain linked to this outbreak is known as Salmonella Heidelberg. Salmonella-related illnesses are some of the most common foodborne illnesses, but infections can be serious and even life-threatening especially, for the very young and the elderly. According to the FSIS, “the most common symptoms of salmonellosis are diarrhea, abdominal cramps, and fever within eight to 72 hours. Additional symptoms may be chills, headache, nausea and vomiting that can last up to seven days.”

On the legal side, lawsuits over food poisoning aren’t the easiest to win. If you get sick after consuming a certain product or dining in a certain restaurant, it is one thing to suspect that you ate something that was “bad.” Proving it is another story. It usually requires the preservation of evidence (i.e. a portion of what you ate) and authentication of the source (i.e. that it came from a certain manufacturer or restaurant). But when foodborne illness is tied to a public safety announcement (like this one) or to the recall of a certain product, it may make for easier sledding from a potential plaintiff’s perspective.

FDA Unveils New Medical Device Tracking System

From knee replacements to defibrillators and stents, all kinds of medical devices will be coded with a unique identifier and tracked electronically under a new system announced last week by the U.S. Food and Drug Administration.

The new FDA rules are intended to make it much easier for doctors and patients to understand which devices have been identified as problematic — even recalled — by manufacturers and federal health officials.

According to the FDA press release on the new “unique device identification” system, there are two key components:

    The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product’s lot or batch number, expiration date, and manufacturing date when that information appears on the label. The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier.

Learn more about the FDA’s new Unique Device Identification System.

The past decade or so has seen an influx of new medical devices on the market, and an aging population is living longer and putting those devices to good use. A surge in medical device defects was almost inevitable.  Don’t take our word for it. Check out the FDA’s list of Recent Medical Device Recalls, and see how long it takes you to scroll all the way down.

Legal action over defective defibrillators, hip implants, and other medical devices has also made headlines in recent years, and cases like these raise some pretty unique legal issues. Learn more about Lawsuits Over Defective Medical Devices.

Total Recall Information Available to Vehicle Owners Under New Federal Rule

Wondering whether your car has been the subject of any manufacturer recalls? What about the defect history of that gently-used SUV you’re thinking about buying? It hasn’t been all that easy to track down critical information like this, but that could all change thanks to a new federal requirement announced by the National Highway Safety Administration (NHTSA).

By this time next year, you’ll be able to enter your vehicle identification number (VIN) into an online auto manufacturer database, and get detailed information on any recall affecting your car, light truck, or motorcycle. According to the NHTSA, manufacturers will be required to update the databases at least weekly, and a related search feature will also be available on the federal government’s official automotive safety website www.safercar.gov.

“Currently, consumers are limited to general searches by vehicle make and model year on the NHTSA website. With the new VIN search feature, consumers will be able to tell whether a specific vehicle is subject to a recall and whether the vehicle has received the remedy,” the NHTSA said in its press release announcing the new rule.

What are your legal options if your vehicle is recalled, or if you’re in a car accident where a vehicle defect may have played a part? Learn more in our Nolo articles Safety Recalls for Cars and Motorcycles and Product Liability Claims Involving Defective Cars.

How Safe is Your Small Car?

The Insurance Institute for Highway Safety is at it again, totaling brand new cars in the interest of keeping consumers informed, and keeping carmakers’ feet to the fire when it comes to vehicle safety.

The latest round of IIHS testing ran a dozen 2013 model year “small cars” through the “small overlap” crash scenario, where the front of a vehicle strikes a five-foot tall barrier that is offset on the driver’s side. The vehicles are traveling 40 miles-per-hour at the time of impact, and a “dummy” (the IIHS’s word, not ours) is belted into the driver’s seat.

Vehicles were rated based on a number of factors, including structural integrity, restraint system performance, and ability to prevent or minimize car accident injuries.

You can check out the full results of the IIHS small overlap crash test here. But it looks like Honda owners can rest a little easier at night, as two- and four-door model Civics were the only cars to earn the top rating of “good.” But there may be some tossing and turning for owners of the Nissan Sentra, Kia Soul, and Kia Forte, all of which earned an overall rating of “poor.”

So, why judge cars based on how they perform in a “small overlap” crash test? IIHS explains in a press release announcing the results: “In many vehicles the impact at a 25 percent overlap misses the primary structures designed to manage crash energy. That increases the risk of severe damage to or collapse of the occupant compartment structure. Also, vehicles tend to rotate and slide sideways during this type of collision, and that can move the driver’s head outboard, away from the protection of the front airbag. If the dummy misses the airbag or slides off of it, the head and chest are unprotected.”

For everything you ever wanted to know about making a claim for vehicle damage or injury after a car accident, check out Nolo’s new website all-about-car-accidents.com.

Chrysler Recalls 2.7 Million Jeep Vehicles Over Fire Risk

Chrysler is recalling more than 2.7 million Jeep vehicles over the risk that rear-end collisions could cause the vehicles to catch fire, due to a potentially defective gas tank design.

Over the past few weeks Chrysler has been involved in a lot of back-and-forth with the National Highway Traffic Safety Administration (NHTSA), which requested that the automaker issue a voluntary recall over the problem.

Car companies tend to go along with these kinds of NHTSA requests without putting up much of a fight, but Chrysler had refused to issue any recall until it was up against an NHTSA-imposed deadline for compliance with the request. (See NHTSA resources on the Chrysler recall.)

The recall involves the following Jeep sport utility vehicle models:

  • Jeep Grand Cherokee for model year 1993 to 2004, and
  • Jeep Liberty for model year 2002 to 2007.

According to the Los Angeles Times, Chrysler’s strategy may end up paying off when it comes to the alleged vehicle defect: “By choosing to blink in a high-stakes game of chicken, Chrysler may in fact come out the big winner. That’s because the proposed repair — installing low-cost trailer hitches — could prove far less expensive than other potential remedies.”

For Jeep owners with questions about how the recall affects them, hopefully this MSNBC article has the answers: What Worried Owners Can Do About Jeep Recall. And if you’re interested, learn about your legal options for vehicle defects.

Airbag Recall Affects 3.3M Vehicles

Some overly-enthusiastic passenger-side airbags are to blame for a worldwide recall that is affecting more than 3.3 million Honda, Mazda, Nissan, and Toyota vehicles worldwide.

The problem is that the airbags may deploy with too much force, resulting in metal shards showering the passenger cabin of the vehicle, which could make a bad situation worse for people who are involved in a car accident.

For Honda, this week’s airbag recall joins a list of others dating back to 2008, although prior problems involved driver’s side airbags deploying with too much force.

The airbags were manufactured by Japan’s Takata Corporation, according to the New York Times, and some of the affected airbags were also sold to BMW and General Motors, so we likely haven’t heard the last word on vehicles that have been affected by this problem.

For details on affected vehicles (all of which were model year 2000 to 2004 as of now) and instructions for vehicle owners, check out this L.A. Times article and the press releases linked up here: Honda | Toyota.

Learn more about vehicle recalls and defects.

Defective Artificial Hip Verdict: Jury Awards $8M

Johnson & Johnson has been ordered to pay $8 million in damages to a retired prison guard who received a defective artificial hip that was manufactured (and later recalled) by the health care giant.

A Los Angeles jury sided with plaintiff Loren Kransky and placed Johnson & Johnson on the legal hook for marketing a defective product and failing to warn consumers about the health risks associated with the all-metal artificial hip device, 93,000 of which were recalled in 2010.

According to the Los Angeles Times, the financial hit that Johnson &  Johnson took today could have been a lot worse: the plaintiff’s attorney asked the jury to order the company to pay another $179 million in punitive damages. When the jury declined that request, you could probably hear the sigh of relief coming all the way from J&J headquarters in New Brunswick, New Jersey.

Learn more about Product Liability Claims Involving Medical Devices.

Ground Turkey Recalled Over Salmonella Link

Over 36 million pounds of ground turkey is being pulled from stores — and hopefully, from consumers’ fridges and freezers too — in one of the country’s largest-ever meat recalls.

The fresh and frozen ground turkey is produced by Cargill Meat Solutions Corporation, and affected products include well-known brand names like Honeysuckle and Shady Hill Farms.

The recalled turkey has been linked to dozens of salmonella cases. At least 76 people have been sickened, and one person has died. Federal safety officials are still trying to pinpoint the exact source of the problem, although right now attention is being focused on a Cargill production plant in Arkansas, a facility that has been shut down as part of the investigation.

To learn whether any of the recalled Cargill turkey products may be hanging around in your fridge or freezer, check out this full list of products affected by the turkey recall, from the USDA. And if it turns out you’ve got them, toss them.

Although the problem seems to be limited to Cargill’s Arkansas facility, the affected products have been distributed nationwide, and the list of people who have been sickened so far includes residents of at least 25 states.

To learn more about the health and legal issues related to food poisoning outbreaks and recalls like this one, check out Nolo’s articles Food Poisoning and Foodborne Illness and Lawsuits Involving Food Poisoning.