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the mismanagement of medical device recall by the FDA (see previous blog),  further investigations are confirming an outdated and broken system that leaves patients at risk of serious injury and death as unaware doctors continue to use defective devices on their patients.

A recent example of this outdated process is the recall of a sleep apnea ventilator device manufactured by Philips.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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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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Dan-and-ElisaA faulty medical determination of child abuse or neglect can destroy the life of a child and its family. “Measure twice, cut once,” is a great rule for carpenters; it’s also an important lesson for Child Protective Services. 

In a recent article, Daniel Pollack, an attorney and professor at Yeshiva University’s School of Social Work in New York City, and Elisa Reiter, a Board Certified Attorney in Family Law by the Texas Board of Legal Specialization, look at the recent House Bill 2536  that was recently passed in Texas.   The bill allows parents who are accused of child abuse or neglect to ask for a second medical opinion before CPS terminates their parental rights. The bill especially seeks to protect parents of special needs children.

The bill was created after the family of Drake Pardo, a special needs child,  went through an unjustified ordeal with CPS.  The drama started when the Pardo family filed a complaint against a hospital that did not take care of them proprely. In a retaliation move, a doctor at the hospital filed a complaint with Child Protective Services based on a faulty medical report. As a result, Child Services showed up at the Pardo’s door in April 2019 and immediately removed 4 year old Drake from his parents. The parents had to fight an intense legal battle and were not allowed to take their child back until October 2019.

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The off-label use of Acellular Dermal Matrix (ADM) products in implant-based breast reconstruction can result in post surgical complications and problems for patients up to two years after the surgery according to a recent analysis by the FDA.

Off-label use not approved by FDA

Accellular Dermal Matrix is a type of surgical mesh that is developed from human or animal skin.  It has been approved by the FDA for specific use such as hernia surgery and more recently many surgeons specializing in breast reconstruction after a mastectomy have been using the product off-label.  The off-label use of ADM for breast reconstruction has never been approved by the FDA and a recent analysis found that some patients suffered complications up to two years after the surgery.

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top 10 patient safety concern ECRIEvery year, ECRI publishes a list of the top 10 patients safety concerns. This year the number one safety concern is the disparity of treatments based on races and ethnicities. The maternal mortality for example is 3.3 times higher for black mothers than white ones.  The Covid19 crisis also highlighted this concern with a much higher number of black and Latino Americans dying from the disease.  While looking at Covid19 deaths in the US, 32.5% of the victims are from Hispanic descent while Hispanics represent 18.5 % of the US population. Race disparities are also significant while looking at deaths from strokes. While black adults are 50% more likely to have a stroke than white adults,  black men are 60 % more likely to die from it than white men and black women 30% more than white women. Health organizations must incorporate health equality in their strategic planning.

The top 2 patient safety concern identified by ECRI is the emergency preparedness and response in aging services. The covid19 pandemic and previous hurricane situations have shown that aging services such as nursing homes and other elderly facilities are not well prepared for emergency situations.  Plans must be developed and communicated to all parties from resident, to staff, families, public and emergency responders.

The top 3 patient safety concerns that were uncovered during the actual pandemic is that, globally, the US Health system was absolutely not ready for a pandemic. From the inability to triage and plan patients flow, under capacities, inadequate supplies of medical equipment, mortuary mismanagement and the mishandling of infection prevention and control, the crisis showed that pandemic preparedness across the health system is a major patient safety concern.

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endoscopic surgeryInappropriate cleaning of medical devices especially the cleaning of flexible endoscopes continue to be a significant cause of deaths and serious injuries to patients.

Not adequately processed reusable devices are a main conduit for healthcare associated infections which according to previous reports have caused at least 2 million infections and the death of 90,000 patients.

A  previous study at 3 large American hospitals and published in the American Journal of Infection Control found that more that 70% of reusable medical scopes ready for use on patients tested positive for bacteria.

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280px-Patient_receiving_dialysis_03The corporate dialysis industry is resorting to unethical tactics and medical malpractice to prevent patients getting the kidney transplant they need to survive and to keep them on dialysis for years. As a result, many patients who had to go to dialysis centers several times a week during the pandemic, caught Covid19 and died. In a recent investigation, ProPublica describes the multiple obstacles that JaMarcus had to go through to be able to get on the list for a kidney transplant before the covid19 pandemic hit and he ultimately died from contracting the virus at a dialysis center.

In the US, two companies, DaVita and and Fresenius, control 70% of the dialysis market

Patients who require dialysis are mostly patients who suffer form diabetes and who develop end stage kidney failure. While many of these patients could be saved by receiving a kidney transplant, two corporate dialysis companies are spending millions in heavy lobbying so they can continue to get multi billion dollar revenues from mostly Medicare patients who are getting dialysis multiple times a week instead of receiving the transplant they need. According to a recent article in Kaiser Health News, over the last 4 years DaVita and Frenesius spent $212 million just in California to influence voters and politicians and fight a ballot initiative that would have capped their profits.

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metal in mask MRIThe FDA recently received a complaint from a patient whose face was burned after wearing a facemask with metal during a MRI. The patient was undergoing a 3 TESLA MRI scan of the neck. The burns were consistent with the shape of the mask.

It is clearly negligent to allow a patient to enter an MRI without checking for metal in a face mask. Anyone who is being scheduled for a MRI procedure must be checked for metal placed in or on their body including in their face mask.

Typically, patients undergoing an MRI are submitted to a metal checklist during which they are asked if they are wearing electronic devices, had metal in their eyes, have implants, had previous surgery on their head or ears or are wearing items such as jewelry, hearing aids, medication patches and obviously these days, a mask that doesn’t contain metal.

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photo__2573607_christopher_conadio_pp-1Our partner, Christopher Donadio will be one of three Distinguished Panel Members at the “How to Effectively use a Neurosurgeon in the Courtroom” CLE program organized by The New York City Chapter of the American Board of Trial Advocates (ABOTA) & The Defense Association of New York tomorrow from 5:00pm to 7:00 pm EST via ZOOM.

Christopher will speak about the Plaintiff’s Perspective while the second panel member, Jenine Gerrard, a defense attorney with Lewis Brisbois Bisgaard & Smith LLP will speak about the Defense Perspective. The other member of the panel is Dr. Christopher Allyn Lycette, a Board Certified Neurosurgeon. The program will be moderated by Sean Dugan, an attorney with Martin Clearwater & Bell LLP.

Suitable for both  experienced and newly admitted attorneys, the panel fulfills 2 CLE skills credits. It is not too late to subscribe for this 2-hour Zoom Program that will start tomorrow, Tuesday November 12 at 5:00pm. Click here to subscribe or download the PDF

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Drive_Thru_DrugsDispensing errors occur when a pharmacy commits a medication error and patients receive a different drug, a different dosage or a different drug quantity than their doctor prescribed. Sometimes when the doctor prescribed several medications, the pharmacy might also miss one. While most patients realize when the pharmacy did not give them the proper medication, some don’t. Medication errors by pharmacies can result in more harm to a patients and even death in some cases.

As doctors, pharmacies and patients are adapting to new safety guidelines related to Covid-19, pharmacies should also create new protocols to prevent the risk of medication errors.

The increase in phone prescriptions as well as not delivering the medication at the counter but offering curbside pick-up, drive-through window, home delivery, or mailing the medication can lead to an increase in medication errors if the pharmacy doesn’t take extra safety steps to prevent them.