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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 Posted in Product Liability

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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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HyundaiA Hyundai employee who provided key information about a defective engine in vehicles manufactured by the Korean carmaker  was awarded $24 million by the U.S. auto safety regulator. In 2016, Kim Gwang-ho informed the National Highway Traffic Safety Administration (NHTSA) that his employer, Hyundai was not addressing a design flaw linked to its Theta II engines, which were prone to seizing up and even catching fire. Kim provided an internal report from the quality strategy team to management that their inaction in addressing the engine fault would cause an increase in crashes.

After NHTSA officials received the information, they began an investigation in 2017 and found out that Hyundai and its subsidiary Kia did recall vehicles for this defect but the recall was too late and the information provided about the issue was inaccurate according to them.  In 2020, Hyundai and Kia agreed to pay a record $210 million in civil penalty for delaying the recall of their vehicles after they learned about the defective engine.

Maximum percentage awarded to the whistleblower

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Best Law Firms - Standard BadgeOur New York Personal Injury Law Firm is proud to announce that Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf has been named a Tier 1 firm in New York City for 5 practices by U.S. News – Best Lawyers® “Best Law Firms” 2022. These practices are:

  • Medical Malpractice Law – Plaintiffs
  • Personal Injury Litigation – Plaintiffs
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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-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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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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dangerous sunscreen productsSome popular sunscreens and after-sun products contain a high level of benzene, a carcinogen linked to blood cancer, according to recent tests effectuated by Valisure, a consumer protection group. No level of benzene in cream, spray or lotions is safe for humans. Additionally previous studies have also found that  applying sunscreen increases the penetration of benzene through the human skin.

Valisure fount the highest level of benzene in the following  products:

  • The SPF 100+ Ultra Sheer Weightless Sunscreen Spray by Neutrogena with up to 6.26 ppm average level of benzene in a tested batch 
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Gair-Gair_Tony-Gair_02Our partner Anthony Gair has carved out a reputation as one of the best product liability lawyers in NYC.  Yesterday he talked to CNBC journalist Lauren Thomas about the refusal by Peloton to comply with the Consumer Product Safety Commission and recall its high-end treadmill Tread+. 

Multiple children  and a pet have been injured and recently a child died in a Peloton Tread+ treadmill accidents but Peloton has been very reluctant to cooperate with the federal safety agency. The company is fighting a request to recall the dangerous product and refuses to provide the name of the child who recently died after getting stuck under the high end Peloton treadmill.

“The CPSC must have reason to believe that the treadmill wasn’t designed appropriately” said Anthony Gair.  According to him, Peloton might not have done a hazard analysis before launching the product or if they did, he questions if they knew about the danger and ignored it.

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