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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 Tagged with medical malpractice

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grand-round-1Our Managing Partner Ben Rubinowitz conducted Grand Rounds for the Department of Radiology at Mount Sinai Hospital in NYC. The talk was titled ”Preventing Medical Malpractice.” 

In this presentation Mr Rubinowitz showed real life examples of medical negligence and then cross examined various residents, fellows and attending physicians to educate them on medical errors that had taken place in the past that resulted in injury and death to his clients.

The point of the lecture and demonstration was to teach medical residents and attending physicians about medical failures which were preventable — but when not properly and timely addressed, those failures and omissions often lead to catastrophic injury.

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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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Surgery at HospitalWhile too many hospitals in the US are sacrificing patient safety for profit, a small number of them are dedicated to focus on healthcare safety and quality.

NYU Langone Hospitals in New York, NY, Gouverneur Hospital in Gouverneur, NY, White Plains Hospital in White Plains, NY and NYU Langone Hospital Long Island in Mineola, NY are the only 4 hospitals in New York state that have been included in the Best Hospitals in America compiled by Money and the Leapfrog Group.

The Leapfrog Group is a nonprofit organization helping consumers to make informed decision. To be part of the list, hospitals that previously received a A grade from a previous assessment went through an additional assessment of  39 performance measures in the 7 following categories:

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cyber attack can arm patientsHospitals are one of the favorite targets of ransomware hackers because hospitals simply can’t afford to have their IT down as it can cause severe harm or even death to patients. As a result when a hospital  has its systems blocked by hackers it might be more willing to pay a ransom than any other type of organization in order to get their systems working again.

Recently, a debt collection company working with 657 healthcare providers announced that it had been the victim of a cyber attack. Hackers were able to obtain patients information including their name, address, social security number and medical information. It is unclear so far how many patients have been affected but this might have been of of the largest healthcare data breach of 2022.

CISA warns hospitals and healthcare providers of Maui ransomware

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Medical Malpractice Lawyer Ben RubinowitzOur Managing Partner, Ben Rubinowitz,  has been invited to speak at the American Urologic Association’s annual meeting in New Orleans this Friday. 

This is one of the largest medical conferences in the world and is attended by more than 25,000 Urologists.

Due to the successful results our firm has had in medical malpractice cases, Ben has been asked to share his knowledge with treating urologists.

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hospital patientEvery year the ECRI institute releases a list of top main concerns that may lead to patient harm and medical malpractice. While cybersecurity was one of the main concerns in the previous years, the ongoing Covid 19 crisis put a lot of pressure on hospital staffing and “staffing shortages” is now at the top of the concerns  followed by worker’s mental health and racial disparity in treatments.

The pandemic emphasized concerns that were already latent in the American healthcare system but that have worsened during the pandemic:

  1. Staffing shortages: the registered nurses median age is 52 year old with 20% of them being older than 65 year old. Young nurses are needed but nursing schools are missing proper resources such as faculty, clinical sites, classroom spaces and budget. As a result 80,407 nursing school applicants were turned down in 2019.  In the coming years, staff shortages will be experienced at all levels of the healthcare system from nursing assistants to technicians such as laboratory technicians as well as critical care doctors, hospitalists, pharmacists and respiratory therapists.
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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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OxyContinThe lawyers for Dr Xiulu Ruan and Dr Shakeel Kahn will argue tomorrow before the Supreme Court of the United States that the criminal standard that physicians faced is not applied consistently among the federal circuits. Dr Xiulu Ruan was one of the largest prescribers of quick-release fentanyl drugs in the US and he is serving a 21-year sentence in federal prison. Dr Shakeel Kahn is serving a 25-year sentence after running pill mills in Arizona and Wyoming.  Their lawyers want their convictions to be overturned but the probability that it occurs is extremely low. However what the lawyers want is that the Supreme Court define a uniform standard that would allows doctors to raise a “good faith” defense and as a result a jury would be able to consider if a doctor was using his or her best medical judgement.

For doctors and patients all over the country the case is not about judging if Ruan and Kahn were bad actors among doctors and committed medical malpractice  but about good doctors who are risking criminal investigation because of  a difficult decision they made.  When the opioids started to flood the market 20 years ago, excessive prescribing was common. In order to curb the actual opioid crisis, authorities have been investigating prescription habits intensively to the point that doctors are now scared to prescribe them to their patients even though they need them.  People coming out of surgeries are being left to unnecessarily suffer because hospitals have implemented drastic guidelines and long term chronic pain patients can’t find a doctor anymore and have to turn to the illegal market.  As prescriptions for opioids fell down, the opioid deaths hit a record high last year in the US with most deaths being related to illegally obtained opioids.  Recent studies indicate this is not a coincidence as long term patients that have been cut from their doctors find themselves in the emergency room because they were poisoned by illegal drugs or committed suicide (See New England Journal of Medicine).

A recent article in the New York Time discuss this difficult issue extensively.

 

 

 

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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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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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