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.

Sending a Text to a Driver: R U Liable?

You send a text message to your buddy who is on a cross-country road trip, or to your spouse who is in the middle of a daily freeway commute. While busy reading your message, your buddy hits a pedestrian, or your spouse rear-ends another vehicle. Next thing you know, you’re slapped with a personal injury lawsuit. Sound crazy? Maybe not, if a recent New Jersey court decision has anything to say about it.

Here’s what the New Jersey Superior Court, Appellate Division held in their opinion in Linda Kubert, et al. vs. Kyle Best, et al., (which was filed on August 27):

    “The sender of a text message has a duty under the common law of negligence to refrain from sending a text to a person who the sender knows, or has special reason to know, is then driving and is likely to read the text while driving.”

The court didn’t extend liability to the specific case before it, finding insufficient evidence that the sender of the text breached any such duty under the circumstances. But they made clear that the potential for this kind of liability exists in New Jersey.

Let’s break this down a little bit: When it comes to civil tort liability — which means being on the legal hook for any harm or damages caused by something you did or didn’t do — the first thing the injured person must show is that you owed them some kind of legal duty of care. If you have no such duty, you’re not liable for any resulting injuries. It’s that simple.

So, what the New Jersey appellate court is doing here is opening the door for tort liability to extend to the sender of a text message, saying that if they know or have “special reason” to know that they’re sending a text to someone who is driving, they owe a legal duty — an obligation to anyone who may be injured by the driver’s inattention in the seconds spent reading the message — not to hit “Send.”

Is this a bit of a legal stretch? Aren’t drivers solely responsible for what they do and don’t do behind the wheel? Is “Bloombergian” a word? These are all good questions. Every state has laws prohibiting “distracted driving” in general, and most states have passed laws that specifically forbid using a handheld device to send and read text messages while driving.  If a driver is found to have violated these traffic laws in connection with a car accident, that’s a pretty clear-cut case of liability for any harm caused to other drivers, passengers, pedestrians, and so on. And the driver’s legal duty extends to keeping their hands off a phone while driving, regardless of who may or may not be texting, and devoting their total attention to what’s happening on the road.

Some might say that’s as far as the law should go, and they might wonder where it all ends. What about texting a surgeon while they are on call? Or a professional pilot? How about your rodeo clown buddy who stops to read your knock-knock joke while the cowboy gets a longhorn in his backside? That all may seem farfetched, but before you text your driving pals in the Garden State, know that you may be heading down a costly road.

NFL and Players Reach $765M Concussion Lawsuit Settlement

The National Football League and more than 4,500 of its former players have reached a $765 million agreement to settle lawsuits alleging that the league hid the dangers of brain injuries and didn’t do enough to protect players from concussions.

The lawsuit, which includes former stars like Tony Dorsett and Jim McMahon, plus the family of the late Junior Seau, has been making its way through U.S. District Court in Philadelphia. Last month, the NFL filed a motion asking the court to dismiss the case, but instead of ruling on the motion one way or another, U.S. District Court Judge Anita B. Brody ordered both sides to mediation. Today’s announced settlement agreement is a product of those mediation sessions.

According to the New York Times, “the money would be used for medical exams, concussion-related compensation and a program of medical research for retired players and their families. The N.F.L. also agreed to pay [the plaintiffs'] legal fees.”

The settlement comes at a time when unprecedented attention is being paid to player safety at all levels of the game — from the NFL and college all the way down to Pop Warner leagues — with a particular emphasis on preventing, diagnosing, and treating head injuries like concussions. (Learn more about Legal Liability for Brain Injuries.)

In the not-so-distant past, after a violent helmet-to-helmet collision, an NFL player was said to have had his “bell rung,” and he might spend a play or two on the sidelines in many instances. These days, team medical staff is on strict notice, and players must pass a rigid protocol when a concussion is suspected. It isn’t rare for a concussion to lead to weeks of a player being designated as “Out” on a team’s injury report, and teams are operating with an abundance of medical caution when it comes to players who have histories of concussions and other head injuries.

The Washington Post recently published an article spotlighting the NFL’s complicated dance on the line between player safety and league culpability: Do No Harm: NFL Tries to Improve Player Safety Without Admitting to Any Liability for Past. And PBS’ Frontline has weighed in on the topic in a timely feature focused on Football Head Injuries.

Study Shows All-Time Low Medical Malpractice Payouts in 2012

Payouts to patients who have been harmed by medical malpractice fell to the lowest on record in 2012, according to consumer rights watchdog group Public Citizen.

The organization recently looked at data from the National Practitioner Data Bank, a database used by the federal government to track payouts in medical malpractice cases nationwide.

Here is a look at some trends over the last 10 years, as captured in the report ”No Correlation: Continued Decrease in Medical Malpractice Payments Debunks Theory That Litigation Is to Blame for Soaring Medical Costs”:

  • Malpractice payments made on behalf of doctors fell for the ninth consecutive year in 2012, and the overall number of payouts (9,379) is the lowest on record.
  • Medical malpractice payments have dropped by almost 29 percent, while national health care costs have climbed 58 percent.

As the name of the study suggests, Public Citizen asserts that the numbers challenge the popular notion that high-priced payouts to medical malpractice plaintiffs is a key contributor to rising health care costs.

(Medical Malpractice Q&A)

But what about other aspects of the health care cost spectrum; not just the end game of verdicts and settlements?   Are doctors and other health care providers spending unprecedented amounts on liability and malpractice insurance, thanks in part to the fear of having to defend against the next big medical malpractice verdict? Public Citizen says no, pointing to the fact that medical liability insurance premiums  fell to 0.36 of 1 percent of health care costs, the lowest level in the past decade.

And speaking of medical malpractice, a recent investigation and report by USA Today finds that state medical boards aren’t doing nearly enough to strip the licenses of doctors whose checkered professional histories feature numerous instances of misconduct and treatment errors that have brought harm to patients: Thousands of Doctors Practicing Despite Errors, Misconduct.

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.

Get a Jump on Trampoline Safety

If you’ve got a trampoline in your backyard, your first priority is to keep things safe for kids and anyone else who might end up using it. (That includes neighborhood foxes.)

Homeowners need to be particularly mindful of any potential dangers when it comes to the condition of a trampoline and the way it is being used. Otherwise, you could open yourself up to legal liability for any injury that ends up occurring. And even when the liability provision of your homeowners insurance coverage kicks in, it can still end up costing you by way of increased premiums or even a cancelled policy.

The safety-related steps you need to take depend on the law in your state, and especially whether or not a trampoline is considered an “attractive nuisance,” which would trigger a heightened set of precautions for kids visiting your property, even when they are technically trespassing. (Learn more about homeowner liability for trampoline injuries and attractive nuisance laws.)

With that in mind — alongside the reminder that there were over 83,000 trampoline-related emergency room visits in 2011 alone — the U.S. Consumer Production Safety Commission recently offered some Trampoline Safety Tips for parents and homeowners:

  • only one person on the trampoline at a time
  • no somersaults
  • shock-absorbing pads should completely cover the trampoline’s springs, hooks and frame
  • trampoline should be placed well away from structures, trees and other play areas
  • no child under 6 years of age should use a full-size trampoline.
  • do not use a ladder with the trampoline, because it provides unsupervised access by small children
  • always supervise children who use a trampoline, and
  • use a trampoline enclosure to help prevent injuries from falls.

‘Texas Giant’ Roller Coaster Accident: What Does the Law Say?

Over the weekend, a Dallas woman was killed when she fell from a roller coaster car on the 14-story tall Texas Giant ride in Arlington’s “Six Flags Over Texas” amusement park.  (You can get more details on the accident from the Fort Worth Star Telegram article.)

Let’s take a look at a few legal “hotspots” related to this story:

There is Limited Government Regulation of Roller Coasters.  You might be surprised to learn that for fixed-site rides like those at any Six Flags amusement park, there are no federal safety regulations in place. Only about half of U.S. states regulate fixed-site rides and conduct park inspections, and Texas is not one of them (there is no state regulatory agency set up to monitor the safety of amusement parks). Learn more about Amusement Park Accidents and the Law.

Six Flags Could Be Liable for a Park Employee’s Negligence. There has been at least one witness report suggesting that, before the ride departed, the accident victim expressed concern over whether or not the car’s safety bar was working properly. (The Dallas Morning News has detailed some safety and staffing concerns at the park.)

If it is shown that a park employee’s negligence caused or contributed to the accident, then that worker’s carelessness will be imputed to the owners and operators of the park, under a legal theory known as “vicarious liability.” So, let’s say that it is park policy for employees to check that each Texas Giant coaster car’s safety bar is properly engaged prior to the start of the ride, and it’s also shown that a worker failed to do that in this case. Six Flags could be on the financial hook for the victim’s death in that situation, most likely in the form of a wrongful death lawsuit.

The Roller Coaster Car Manufacturer Could Be Liable If the Car’s Safety Features Malfunctioned. If the Texas Giant roller coaster car’s safety mechanisms did not function properly during the ride, and that failure played a role in the accident, then the car’s manufacturer could be held liable under a product liability legal theory. The Los Angeles Times reports that the German company that manufactured cars for the Texas Giant has already sent investigators to the accident scene in Arlington.

Six Flags Could Claim a Number of Legal Defenses. If faced with a personal injury lawsuit over the victim’s death, it’s a safe bet that Six Flags will try to argue a variety of legal defenses that are common in amusement park accident cases, including rider assumption of the risk, and rider non-compliance with park/ride safety rules. Learn more about Legal Defenses in Personal Injury Cases.

The Wrongful Death Case Against George Zimmerman

As you’ve no doubt heard by now, over the weekend a Florida jury acquitted George Zimmerman in the criminal trial over the death of 17 year-old Trayvon Martin. (Learn more about the criminal case here.) But that doesn’t necessarily mean Zimmerman has seen his last courtroom in connection with the incident. The NAACP is calling for a civil rights probe into the case, and Martin’s family could very well file a wrongful death lawsuit against Zimmerman in civil court.

As for the wrongful death angle, probably the most famous parallel here is the O.J. Simpson case. In 1995, Simpson was acquitted of the murders of his ex-wife and her friend, but was later placed on the financial hook for over $33 million in civil liability after the victims’ families brought a successful wrongful death lawsuit against him.

So, what might a wrongful death lawsuit against George Zimmerman look like? Under Florida’s Wrongful Death Act, a “personal representative” could go to court and file the civil suit on behalf of one or both of Trayvon Martin’s parents, as “survivors” of the deceased. Assuming Martin had no will and did not appoint a personal representative, Martin’s parents would likely qualify as “personal representatives” of his estate. So, the parents here could end up both 1) bringing the lawsuit, and 2) also being named as “survivors” who are entitled to compensation.

In wrongful death cases, “survivors” in effect “stand in the shoes” of the deceased when a wrongful act would have entitled the deceased person (Martin) to file a lawsuit and recover damages if death had not resulted from the defendant’s (Zimmerman’s) actions. Keep in mind here that Martin’s parents would not need to prove that Zimmerman committed a crime; it would be enough to show that Zimmerman’s carelessness or negligence resulted in Martin’s death.

There are restrictions on the kinds of personal injury damages that Martin’s parents could recover. They could get compensation for Martin’s pain and suffering in connection with his injuries and death. They could also recover the present value of “future loss of support and services” from the date of Martin’s death through a period of time that considers the life expectancies of Martin and his parents. Finally, reimbursement of funeral expenses is also an option under Florida law. (You can view the complete text of Florida’s Wrongful Death Act starting at Florida Statutes Title XLV section 768.16.)

Besides liability for money damages as a remedy (versus a penalty of incarceration for prosecution), the key difference between the criminal trial and any wrongful death civil proceeding is the “standard of proof.” The prosecutors needed to establish that Zimmerman was guilty of homicide (either second-degree murder or the lesser-included charge of manslaughter) “beyond a reasonable doubt.” Obviously, the jury found that the state’s prosecutors fell short of meeting this burden.

But in civil court, lawyers for Martin’s family would only need to prove that it is more likely than not that a wrongful act by Zimmerman caused Martin’s death. The legalese version of this standard is “by a preponderance of the evidence.” So, it’s a much lower bar that needs to be met in a civil case when it comes to proving liability.

Some Asiana Crash Injuries Linked to Seat Belts

Investigators continue to piece together the cause of the accident involving Asiana Airlines Flight 214, which crashed just short of a bay-adjacent runway at San Francisco International Airport on July 6th. In addition to two fatalities, there were over 150 passenger and crewmember injuries linked to the crash, and a pattern seems to be emerging when it comes to the cause of some of those injuries.

According to the Wall Street Journal, “[w]hen passengers began streaming into emergency rooms, hospital staffers said they saw many injuries associated with using seat belts that fasten around the lap,” the kinds of in-seat restraints that are used by the vast majority of airlines in all seating areas of their passenger aircraft.

WSJ notes that the design of these restraints — notably the absence of any chest or shoulder harness — is a practical one: “Seats where lap belts are used are now designed so that in a crash, passengers are cushioned by the seats in front of them. The seat back is designed to fall forward, absorbing the blow. [Installation of chest harnesses] would add to seats’ weight and require a heavier mounting system and floor frame, experts said.”

Over at CNBC, they’re opining that the absence of a safer seat belt system on planes comes down to questions of cost and comfort.

Learn more about injuries caused by seat belts and legal issues in airplane accident cases.