When a patient receives a life-saving kidney transplant, they rely on immunosuppressive medications like tacrolimus to prevent their body from rejecting the organ. These drugs are not optional—they are critical. But what happens when the very drug meant to protect a transplant patient may have contributed to the failure of…
Articles Posted in product liability
Legal Considerations Regarding Delayed Adverse Event Reporting by Medical Device Manufacturers
As 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: Regulatory Non-Compliance: Manufacturers are mandated…
Supreme Court’s Landmark Ruling Ends Chevron Deference: Implications for Personal Injury Law
In 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…
Philips’ Quality Control Failure: A Reminder of the Imperative for Regulatory Compliance and Patient Safety in the Medical Device Industry
The 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…
Tesla’s Recall: Autopilot Safety Concerns and Legal Implications
Tesla, 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…
Quality issues of Chinese-made plastic syringes can lead to serious harm to patients
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…
Battery problems with the Medtronic HeartWare Ventricular Assist Device (HVAD) causes 6 more patients to suffer personal injury and another one to die
Medtronic 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…
Recent cybersecurity alerts from FDA affect more than 150 different types of medical devices that if hacked can potentially result in harm to patients
More 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…
Apple 12 iPhone and other electronic devices with magnets may put pacemaker wearers at risk of injury or death
A 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…
Children injuries from Cannabis are on the rise
More 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…