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 defective product

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Stapler recalled by J&JFrom the Medical Malpractice and Product Liability Attorneys at Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf

Johnson & Johnson’s Ethicon division has issued a correction and Class 1 recall of its Echelon surgical stapler reload cartridges, following reports of a serious defect linked to at least one death and multiple injuries. The U.S. Food and Drug Administration (FDA) has confirmed that 678,526 units are affected by the recall, which involves staplers used to cut and staple tissue during surgery.

The FDA warned that the stapler may lock during use, failing to properly cut or seal tissue. This malfunction can result in the device becoming trapped in the patient, causing surgical delays, excessive bleeding, hemorrhagic shock, emergency conversion to open surgery, and even death.

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The lithium battery of this bike might be defectiveAncheer is recalling the potentially defective lithium battery of 22,000 e-bikes. The recall decision was made after the company received 6 reports of accidents that include batteries igniting and causing sparks, fires and/or explosions. Among the 6 accidents reported, 4 resulted in burn injuries.

The battery recalled is a cylindrical battery that looks like a water bottle and is mounted on the Ancheer e-bikes model AM001907. The model number can not be found on the bike but on the packaging and on the user manual.

The recalled Ancheer e-bikes models were sold between January 2016 and June 2022 by major retailers including Walmart, Sears, Amazon, eBay, Overstock, Aliexpress, Ancheer, Newegg, Rakuten and Wish.

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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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Infusion pumps are at risk of cyber attacks75% of infusion pumps used by hospitals and other healthcare providers are at risk of being compromised by hackers and as a result can cause harm to patients or expose sensitive data.

Infusion pumps are some of the most commonly used medical devices and some big hospitals are managing thousands of these devices. A recent study by Palo Alto Networks’ Unit 42, looked at 200,000 infusion pumps manufactured by 7 different companies and being used by multiple hospitals and healthcare organizations that are all using IOT Security to monitor their medical devices.

Researchers found that an alarming number of these devices were highly vulnerable to cyber attacks with 40 known security gaps identified among the devices. Additionnally, 70 types of alert messages received from  these devices through the IOT security network where identified as messages related to security issues.  Most vulnerabilities identified were leakage of sensitive information and unauthorized access causing the device to become unresponsive.

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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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FDA-logoAfter a recent study pointed fingers at the mismanagement of medical device recall by the FDA (see previous blog),  further investigations are confirming an outdated and broken system that leaves patients at risk of serious injury and death as unaware doctors continue to use defective devices on their patients.

A recent example of this outdated process is the recall of a sleep apnea ventilator device manufactured by Philips. It is not clear so far as to when exactly, Philips executives found out that the foam used to dampen the noise of the machine was breaking down and could potentially be inhaled or ingested by patients, exposing them to carcinogenic or toxic effects. However, the company announced publicly, on April 26th, while reporting Q1 earnings that it was creating a provision of 250 million Euros to cover costs related to possible risks to users in some sleep and respiratory care machines. While the company had probably already identified that the defective devices were the ones manufactured between April 2007 and April 2021, it waited almost two other months to initiate a recall and warn consumers of potential carcinogenic and toxic effects.  After the issuance of the recall, the FDA issued a safety communication on June 30. It took until July 22nd for the FDA to classify the recall as class I event and publish a public notification.

Does this mean that all patients have been contacted and had their ventilator changed? Not at all. In the actual process, the customers of the manufacturer, such as the hospitals, the providers, the retailers or the distributors are in charged of contacting the patients and they usually don’t do it.  Instead, doctors wait for the patients to come in with symptoms.

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A defective moped lithium battery is at the origin of a fire that killed 9 year old Remi Fernandez in his new apartment in Queens. Remi had just moved with his parents into a new apartment located on 102nd Road near 84th Street in  Ozone Park, Queens, when a fire that was sparked by the battery of a moped charging in the apartment erupted around 2:00 am while the family was sleeping. Remi’s father suffered burn injuries as he was trying to rescue his little boy from their basement apartment. The apartment where the family had just moved in had no smoke alarm. The basement had been illegally converted into an apartment.  The rest of the building was deemed unsafe by the Department of Buildings and all residents had to be evacuated. 10 other people including a firefighter were injured and transported to the hospital to be treated.

55 fires caused by defective lithium ion batteries over the last 12 months in New York City

Fire caused by defective lithium-ion batteries are on the rise in New York City. According to the NY Daily News, there were 55 fires caused by these types of batteries in New York City between August 1st 2020 and August 1st 2021 compared to 22 for the same period a year earlier.  Sadly Remi is not the first victim to die in one of these fires. Last May in the Bronx, a 91 year old woman died and 11 people were injured in a fire sparked by a defective lithium battery in the third floor apartment of a six-story building in the Bronx. Earlier in January, a   scooter charging in the living room of a Bronx apartment was at the origin of another fire that killed one and injured 12 others.

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Ventricular_assist_device (1)Medtronic stopped the sale of the defective HeartWare Ventricular Assist Device, or HVAD last June after more than 3,000 patients died and 20,000 were injured.

Since 2011, multiple problems with the device have been reported to the Food and Drug Administration but the agency never took any decisive action to make sure the manufacturer  fixed the problems. The FDA and its Center for Devices and Radiological Health are in charge of making sure that medical devices are safe and effective for patients however as we highlighted in a previous blog, the agency policy is too accommodating with manufacturers. It has the power to seize products or to issue fines but rarely uses it.

In the case of the HeartWare Ventricular Assist Device, the FDA knew about issues with the product as early as 2011 when the product was developed by the parent company HeartWare and was seeking FDA approval. An inspector mentioned in its report that engineers were not reviewing documents fully before approving them and that the employee assigned to quality control did not have sufficient training. The company told the FDA they would take corrective actions.

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16 people were injured after a defective pedal on their peloton bike broke. Five of them required medical care such as stiches in their lower leg.  Peloton Interactive, Inc. a New York based company, received so far 120 complaints of defective pedal and announced on October 15 that it was recalling the PR70P Clip-In Pedals fitted on Peloton bikes  which were sold between July 2013 and May 2016. The potentially defective pedal has a orange logo and the name Peloton is printed in white letters next to it.  It was manufactured in Taiwan. While Peloton recommend consumers change their pedals every year, consumers who bought the PR70P Clip-In Pedals are being notified directly by the company that will let them know how they can receive free pedals with accompanying instructions on how to install them.

5,700 defective Extension Cord Splitters sold by Homerygardens at Walmart and Amazon.com recalled the same day

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