Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf is a New York Plaintiff's personal injury law firm specializing in automobile accidents, construction accidents, medical malpractice, products liability, police misconduct and all types of New York personal injury litigation.

Articles Tagged with product liability

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MeFDA-logodtronic HeartWare Ventricular Assist Device (HVAD) device caused the wrongful death of more than 3,000 people since it was introduced on the market more than 10 years ago. The sale and distribution of the heart pump was stopped in June last year but many patients still have the pump implanted in them. Now some of the batteries powering the device might be deadly too.

Medtronic announced last May that a model of battery that was powering the Medtronic HeartWare Ventricular Assist Device (HVAD) was defective and that it could cause serious personal injury or death if it was not changed for a new battery. An urgent Medical Device Correction letter was sent out by Medtronic to all affected customers on May 5th  recalling 429 devices manufactured in April 2021. Then a month later, after the company received 1,159 complaints including 6  injuries and one death, the recall of the same model of batteries was extended to those that were distributed since January 2009.

The recall affects 23,372 Medtronic HVDA Batteries with model number 1650DE that were distributed between January 1st 2009 and now

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hospital patientMore than 150 models of medical devices manufactured by more than 100 manufacturers and equipped with PTC Axeda agent and Axeda Desktop Server  have dangerous cybersecurity vulnerabilities that could potentially harm patients. The Axeda agent and Axeda Desktop server  sold by PTC are  components allowing one or more people to view and operate the same remote desktop, through the Internet. However,  it was recently found that hard-coded credentials were used in these components making them particularly vulnerable to cyber attacks. Hard code credential  is a practice used by software developers in which authentication data such as password are embedded directly in the source code. This practice was identified 9 years ago as a significant cybersecurity threat and is considered outdated and dangerous. It is particularly concerning that medtech vendor PT  is still selling products using this technology, especially products providing remote support functionality which are among the most targeted by hackers.  Hard code credential vulnerabilities, if exploited, allow hackers to fully access the system, execute remote code, change the configuration, read or save changes directly to files and folders on the user’s device, access user’s login information and flood the targeted device or network with traffic until the target cannot respond or simply crashes, preventing access for legitimate users. Designing medical devices containing such outdated and dangerous components is negligence that can cause injury or death to patients.

Defective medical devices with cybersecurity flaws are considered the number one health technology hazards in 2022 by the ECRI Institute. The FDA issued a cybersecurity alert and the Cybersecurity and Infrastructure Security Agency issued an advisory with a detailed description of the vulnerabilities,  recommendations to mitigate them and a list of the main manufacturers  using Axeda agent and Axeda Desktop servers in some of their products. Among them are Accuracy, Agilent, Bayer, BD, Elektra, GE, Roche Diagnostic, Smith Medical and Varian. These manufacturers have all released their own information in regards to affected products.

Read more in Medtech Dive

 

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IPhone_12_-_3A recent study found that strong magnets in some electronic devices can interfere with the good functioning of  pacemakers and result in potential injury or death for the wearer.   “If you carry a portable electronic device close to your chest and have a history of tachycardia (rapid heartbeat) with an ICD, strong magnets in these devices could disable your cardioverter defibrillator,” said lead author Corentin Féry, a research engineer at the University of Applied Sciences and Arts Northwestern Switzerland, Institute for Medical Engineering and Informatics.

Devices that have been identified as potentially dangerous for people who have a cardioverter defibrillator are the new Apple 12, Apple Airpods charging cases, the second generation of Apple pencils and the Surface Pen from Microsoft. In the study, researchers were able to deactivate five different types of defibrillators by simply putting the electronic devices next to the defibrillators. Deactivation would occur when Apple products were at a 0.78 inch distance from the pacemaker and 1.14 inches for the Microsoft pen.

The study is a confirmation of a previous warning by the FDA that some electronic devices such as mobile phones and smart watches might cause some medical devices implanted in patients to switch to “magnet mode”. Many implanted medical devices are designed with a “magnet mode”,  which is a safety features that for example allows patient with such devices to undergo some medical procedures such as MRI. However this safety feature can actually become dangerous for patients, especially those wearing a pacemaker, if an electronic device such as a cellphone can switch the pacemaker to “magnet mode”.

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annabis edible are attractive to childrenMore and more children are getting injured after ingesting cannabis products that are being packaged in multicolor packaging and look like children treats. Hospitals are seeing an increase in young children getting poisoned after inadvertently ingesting THC edible products.

Most cannabis edible products look like regular children treats such as gummy bear, chocolate bars, candies, lollipop with packaging that are colorful and attractive to children. Some of them even mimic famous brands of candies such as the THC infused Zombie Skittles whose manufacturer was recently sued by Wrigleys, the manufactured of the “real Skittles”.

In a recent article, the Children Hospital of Philadelphia, Center for Injury Research and Prevention, describes the case of an elementary school child who went to a local grocery store with her parents and picked a “Krispy Treat” snack.  The parents did not notice that the colorful packaging of the treat indicated that the treat contained delta-8-THC which is now sold in the Philadelphia region as a “legal high”.  The child ingested the entire snack and only at dinner time parents noticed that their daughter started to get distressed, holding her head, becoming drowsy and loosing her balance. They rushed the child to the emergency room where she was hooked to a respirator and transferred to the intensive care unit until doctors figured out that testing showed that she was poisoned by THC and that she would recover soon.

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Tesla Motors is facing product liability lawsuitsA man who was seriously injured and whose wife died after their Tesla struck a fire truck while on Autopilot mode is suing Tesla for personal injury and wrongful death. Derek Monet was driving his car on autopilot on a highway in Indiana in December 2019 when the car crashed into the rear of a fire truck that was responding to an accident and was stopped on the road.  Derek suffered a broken spine and a broken femur and his wife died in the accident

In his claim Derek says Tesla knew that its software failed to react to emergency vehicles with flashing lights but did not recall its vehicles to update the software.  The claim was filed  after the National Highway Traffic Safety Administration launched an investigation last year and asked Tesla to release its non-disclosure agreements with drivers who were testing the “full-self” driving system. The NHTSA is aware of 11 similar accidents during which Tesla cars struck emergency vehicles with flashing lights and wants to know why the car manufacturer did not recall its vehicles after it transmitted a wireless software update designed to prevent crashes into stationary objects.

The 68 page lawsuit demonstrates how Elon Musk and other executives were well aware that the autopilot was not safe but that the company continued to “hype”  its cars as if they were

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HyundaiSome Kia vehicles may have defective airbags that may not deploy proprely in case of an accident according to a recall issued yesterday by the company.  The recall is affecting 410,000 vehicles including:

  • 253,281 Kia Soul manufactured between July 25, 2016 and December 24, 2018
  • 47,690 Kia Sedona manufactured between July 12, 2016 and January 10, 2019
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carbon monoxide danger signEvery year in the US, thousands of people are injured and an average 70 die from exposure to carbon monoxide after using a portable generator. With more and more power shortages caused by climate events, the number of deaths caused by dangerous carbon monoxide emissions from generators is on the rise in America. Last February in Texas, after a major power shortage, 1,400 people were treated in hospitals for carbon monoxide poisoning and 17 died.

One portable generator can emit the same amount of carbon monoxide as 450 cars together

According to a recent investigation by ProPublica,  the portable generator manufacturers are well aware of the danger of their products and over the years they have been resisting multiple attempts by the Consumer Product Safety Commission to require that their devices emit less carbon monoxide.

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Hospital PatientMost medical devices used by hospitals are legacy devices that are still operating on Windows 7 that Microsoft no longer supports.  Manufactured at a time when cybersecurity was not a preoccupation, these devices can now easily be hacked and potentially be dangerous to patients. As a result, on top of safeguarding traditional IT assets, hospitals now have to figure out a way to secure tens of thousands of legacy devices from hundreds of manufacturers connected to their network.  It is a real headache for most hospitals and healthcare organizations as many of them do not even keep an inventory of their medical devices. According to a recent study only 36% of healthcare organizations know where their medical devices are.

While some devices that can cause fatal injuries, such as insuline pumps or pacemakers, are being actively monitored and recalled by the FDA, it is estimated that all other medical devices have an average of more than 6 vulnerabilities per device and that 40% of devices used by hospitals are at the end-of-life stage and do not have security patches or upgrades available.

Not surprisingly, FDA regulations in this field are lagging with the agency only saying both hospitals and manufacturers are responsible for protecting devices from cyber attacks. Hospitals are pointing fingers at manufacturers for not providing the necessary support and want the FDA to mandate lifetime support of medical devices by manufacturers.  So far, the further the FDA went was to publish post-market guidance for medtechs on what they should do to secure their products. This is not enough as hospitals find themselves dealing with thousands of devices that they are supposed not only to track but also patch to prevent cyberattacks. With the ongoing Covid19 crisis, hospitals are unable to handle this task and as a result they become increasingly vulnerable to cyberattacks that could injure or kill patients.

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Volvo-Cars-LogoVolvo recalled another 195,000 potentially defective motor vehicles last week in the US after the company learned that a US driver was killed by the rupture of an air bag inflator. According to Volvo, the front driver’s airbags inflator of XC70 and V70 wagons models from 2001 to 2007 was manufactured by ZF/TRW  and could potentially explode and send shrapnel in the car.

The 195,000 vehicles recalled in the US last week are part of a worldwide recall covering around 768,000 vehicles.

The recall is reminiscent of the problem faced a few years earlier by bankrupt Japanese airbag inflator manufacturer Takata. Defective Takata air bag inflators caused the death of 18 people worldwide including 19 in the US. 400 people were also injured in defective Takata air bag inflator explosions.

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FDA-logoMany defective medical devices might still be used by medical professionals because deaths that occurred when using these devices are being mislabeled as injuries in the FDA Medical Database according to a study published last week in JAMA Network. The study looked at 290,141 reports of defective medical devices that resulted in serious injuries or deaths that were processed by an algorithm. They found that 52% were classified as deaths and 47.9% were classified by the algorithm as malfunction, injury, other or missing. Among these 47.9% that were not classified as death, 23% of these reports were indeed death reports that were not classified proprely by the algorithm. As a result many deadly devices might still be used on patients.  The FDA must review all reports classified as death but does not routinely review all reports that are classified as other or misfunction.

The most dangerous of all medical devices were the ventricular assist bypass devices. These devices represented 13% of all adverse event reports. Coming in second position was the dialysate concentrate for hemodialysis in liquid or in powder with 8.7% of all adverse event reports. The third most reported defective devices were the transcervical contraceptive tubal occlusion devices with 5% of all adverse reports.

The authors of the study also mention that 95% of the adverse event reports were made by manufacturers and not by healthcare facilities or physicians which might constitute a conflict of interest. The authors note that delays in reporting serious injuries or deaths were common. An example of this issue was the Essure permanent birth control device. 32,000 women reported issues with this device between 2002 and 2013 while the FDA only received 1,023 reports.

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