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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FDA logoAs product liability attorneys, we recognize the critical importance of timely adverse event reporting by medical device manufacturers. Such reporting is not only a regulatory obligation but also a fundamental aspect of patient safety and corporate accountability. Delayed reporting can have significant legal ramifications, including:

  1. Regulatory Non-Compliance: Manufacturers are mandated by federal law to report adverse events to the FDA within 30 days of becoming aware of them. Failure to comply can result in enforcement actions, fines, and potential injunctions against the company.
  2. Increased Liability Exposure: Delayed reporting may be construed as negligence, exposing manufacturers to lawsuits from patients harmed by undisclosed device risks. Courts may view the failure to report promptly as a breach of duty to consumers.
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US_Supreme_CourtIn a pivotal decision, the U.S. Supreme Court has overturned the Chevron deference doctrine, fundamentally altering the landscape of federal agency authority. This 6-3 ruling in the case of Loper Bright Enterprises v. Raimondo is set to have far-reaching consequences across various sectors, including personal injury law.

Understanding Chevron Deference

Chevron deference, established in the 1984 case Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., mandated that courts defer to a federal agency’s interpretation of ambiguous statutes it administers, provided the interpretation is reasonable. This principle has played a critical role in how agencies like the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) enforce regulations.

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The headquarter of Philips in AmsterdamThe situation involving Philips and its decision to halt the sale of new sleep therapy and respiratory care devices in the U.S., as part of a consent decree with the FDA, raises serious concerns from a product liability perspective. This move, necessitated by significant quality issues that led to a massive recall of over 15 million devices, underscores a critical lapse in Philips’ quality control and regulatory compliance mechanisms. The revelation of such extensive quality problems not only erodes consumer trust but also exposes Philips to substantial legal and financial risks.

The consent decree, while a step toward remediation, highlights a reactive rather than proactive approach to product safety. The necessity for such an agreement reflects a failure in Philips’ internal processes to ensure the safety and efficacy of their products before they reach consumers. The impact of these failures is not trivial, considering the potential health risks to users of sleep therapy and respiratory care devices. Such situations demand rigorous scrutiny, as they can lead to severe health consequences for individuals relying on these medical devices for critical care.

The financial implications of the recall and the consent decree, including a significant provision of 363 million euros, indicate the scale of the impact on Philips’ operations. However, beyond the financial toll, there’s a broader consideration regarding the damage to the company’s reputation and the potential erosion of trust among healthcare providers and patients. This trust is paramount in the healthcare sector, where the stakes involve patient health and safety.

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Some Tesla vehicles are being recalledTesla, the electric vehicle pioneer, is recalling more than 2 million vehicles in the United States. This recall comes after a thorough investigation by the National Highway Traffic Safety Administration (NHTSA) found that Tesla’s Autopilot safety system was “not sufficient to prevent driver misuse.”

The recall affects a wide range of Tesla models, including the 2012-2023 Model S, 2016-2023 Model X, 2017-2023 Model 3, and 2020-2023 Model Y, all equipped with Autosteer, a feature that Tesla describes as “traffic-aware cruise control.” According to the recall notice, in certain circumstances when Autosteer is engaged, the controls may not be sufficient to prevent driver misuse.

Autosteer is designed to maintain speed, detect lane markings, and monitor the presence of other vehicles. However, Tesla emphasizes that drivers must keep their hands on the steering wheel and be prepared to take immediate action while using the feature.

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plastic syringes can be defective
The Food and Drug Administration’s recent focus on the potential quality issues of plastic syringes manufactured in China has sent ripples through the healthcare and legal communities. As product liability and medical malpractice attorneys, we are closely monitoring this situation, which raises significant concerns about patient safety and the legal implications for manufacturers, healthcare providers, and consumers.

The FDA’s investigation was sparked by reports of quality issues with several Chinese manufacturers. The primary concerns include leaks, breakages, and the inability of these syringes to deliver the correct dose of medication. These issues are not just minor inconveniences but potential hazards that could lead to serious medical complications.

The FDA’s advice to healthcare providers and consumers to consider using non-Chinese manufactured syringes where possible highlights the gravity of the situation. For healthcare providers, this advisory necessitates a review of their supply chains and a potential shift in procurement strategies. Consumers, particularly those who rely on syringes for chronic conditions, are now faced with the additional burden of verifying the origin of their medical supplies.

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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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