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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250px-Tacrolimus-1YAT-ball-and-stick-model 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 their new organ?

According to a recent Pro Publica Investigation, that is the unsettling reality facing Joe DeMayo, a transplant recipient who was prescribed generic tacrolimus manufactured by Intas Pharmaceuticals. Despite faithfully taking the drug as directed, his donated kidney began to fail much earlier than expected. What DeMayo didn’t know—and what thousands of patients across the country likely didn’t know—is that the FDA had found serious manufacturing violations at the Indian factory where his medication was produced, including the manipulation of drug-testing records.

As New York medical malpractice attorneys, we are deeply concerned by the implications of this case—not only for DeMayo, but for the many transplant patients who trust that the drugs they take are both safe and effective.

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Defective Baxter PumpInfants in neonatal intensive care units rely on precise intravenous infusions for survival—but a recent recall by Baxter International reveals that a widely used infusion pump may be putting vulnerable newborns at risk.

Baxter has issued a Class I recall—the FDA’s most serious designation—for its Novum IQ large volume pump after the device was linked to a serious injury caused by under-infusion. According to the FDA, variability of just 10% in infusion delivery can lead to dehydration, malnutrition, inadequate drug therapy, and even death in infants. Yet Baxter has allowed over 34,500 affected units to remain in hospitals across the U.S. and Canada.

The Risk to Infants: Under-Infusion Can Be Catastrophic

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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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Lithium ion battery can be dangerousThe recent announcement by the Fire Department of New York (FDNY) regarding the forthcoming federal ban on unregulated lithium-ion batteries for e-bikes and e-scooters marks a significant milestone in enhancing public safety. As legal professionals specializing in lithium battery-related accidents, we recognize the profound implications this legislation holds for consumer protection and the reduction of fire-related incidents.

Understanding the Legislation

The Setting Consumer Standards for Lithium-Ion Batteries Act, integrated into the federal budget, mandates the Consumer Product Safety Commission (CPSC) to establish national safety standards for rechargeable lithium-ion batteries utilized in micro-mobility devices. This initiative, championed by Senator Chuck Schumer and New York’s congressional delegation, aims to address the surge in fires attributed to substandard batteries.

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Our personal injury Law Firm has 12 personal injury attorneys recognized in the edition of Best Lawyers 2025Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf is proud to announce that a total of 9 of our distinguished attorneys have been recognized in the 2025 edition of The Best Lawyers in America, and an additional 3 attorneys have been recognized in Best Lawyers: Ones to Watch in America. This significant honor highlights the firm’s ongoing dedication to excellence and its unwavering commitment to delivering outstanding results for our clients.

Honorees in The Best Lawyers in America (2025 Edition)

Marijo C. Adimey

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The headquarter of Philips in AmsterdamIn the ever-evolving landscape of medical technology, the recent recalls by Philips underscore the critical importance of product safety and the potential consequences when things go wrong. As product liability lawyers, these incidents highlight the vital role of legal oversight in safeguarding patient welfare.

Philips Recall of MRI Coils: A Closer Look

On July 9, 2024, Philips announced the recall of several models of Sense XL Torso coils used in MRI scanners, following reports of overheating and subsequent burns to patients. This recall, affecting over 1,000 devices worldwide, has been classified as a Class I event by the FDA, indicating the most severe risk level. The core issue lies in the coils heating up excessively during MRI scans, leading to serious injuries, including twelve reported cases of burns. Although no deaths have been reported, the potential for severe harm necessitates immediate action.

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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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Orla Baxendale lost her life due to anaphylactic shock resulting from a severe allergic reaction to a cookie manufactured by Cookies UnitedAs the legal representatives of Órla Baxendale, it is with profound sorrow and heavy hearts that we, at Gair, Gair, Conason, Rubinowitz, Bloom, Hershenhorn, Steigman & Mackauf, confirm the tragic passing of Órla Baxendale on January 11, 2024. Órla, a talented dancer, was just 25 years old when her life was cut short due to anaphylactic shock resulting from a severe allergic reaction.

Órla’s passing stemmed from an unfortunate incident involving the consumption of a cookie manufactured by Cookies United and sold by Stew Leonard’s, which contained undisclosed peanuts. This tragic oversight has led to the recall of the Vanilla Florentine Cookies from Stew Leonard’s stores in Danbury and Newington, CT, for the period of November 6 – December 31, 2023.

Preliminary investigation has revealed that Órla’s death occurred due to the gross negligence and reckless conduct of the manufacturer and/or sellers who failed to properly identify the contents of the cookie on the packaging. This failure in proper disclosure has led to this devastating yet preventable outcome.

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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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