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 product liability

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Beech-Nut Product recallAttention parents, some Beech-Nut products may potentially be dangerous for your children and should be returned to the manufacturer for a refund. After a consumer found a small piece of glass in a jar Beech-Nut Stage 2 Sweet potato & Chicken, the manufacturer issued a voluntary recall of the product. The recalled product is in a 4oz glass jar marked “DEC 2016” and includes product numbers “12395750815” through “12395750821” on the cap. It bears the establishment number “P-68A” inside the USDA mark of inspection.

 

 

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LACTATED_RINGERS_IRRIGATIONHopsira announced a voluntary product recall after reports from customers indicated that a lot of Lactated Ringer’s Irrigation, 3000mL may be contaminated with mold. Lactated Ringers Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection, intended only for sterile irrigation, washing and rinsing purposes. Contaminated solution can be  fatal if used on patients as it may cause bacteremia, sepsis, septic shock and endocarditis. This product is used on humans and animals. Read the press release from Hospira

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childrens-tylenolMcNeil Consumer Healthcare, a subsidiary of Johnson and Johnson agreed to pay $25 million for selling children medicine contaminated with metal.  The case started in 2009 after a consumer complained that he found black specks in a bottle of Infants’Tylenol. After analysis it appeared that faulty manufacturing was to blame for leaving particles of nickel and chromium in the liquid medicine. This discovery led to massive recalls  of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products and seriously tarnished J&J’s reputation. Read more on Reuters

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CREPatients and family of patients that have been infected by contaminated duodenoscopes at UCLA Hospital started  to file product liability lawsuits against Olympus, the manufacturer of the medical devices. 18 year old Aaron Young was the first one to file his lawsuit. The high school student is still hospitalized and receiving treatment for  carbapenem-resistant Enterobacteriaceae (CRE), a bacteria highly resistant to antibiotics that can kill up to 50% of patients infected. The family  of Antonia Cerda who died in the same hospital after contracting the “superbug” also filed a lawsuit against Olympus for wrongful death, alleged negligence and fraud. Antnonia Cerda was 48 year old and the mother of 4 children.  Both lawsuits have not yet named UCLA as the hospital said the cleaning protocol provided by Olympus was applied.

Today CNN announced that the duodenoscopes used in the procedures that spread the superbug were indeed not approved by the FDA. Olympus started to sell the TJF-Q180V duodenoscope in 2010 without  asking for clearance and the FDA did not become aware until the end of 2013 or beginning of 2014.  Olympus said it didn’t think it needed the FDA’s permission to sell the device, but now at the request of the agency, it has applied for that permission. That application is still pending. Read more on the CNN website

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oxy Elite dangerous productThe FDA is asking consumers to stop using the weight loss product  Oxy Elite Pro Super Thermogenic after the agency found  that the product was tainted with fluoxetine, a potential harmful class of drugs called serotonin reuptake inhibitors (SSRIs). When used without doctor supervision, SSRIs can have serious side effects such as sucidal thougts, abnormal bleeding and seizure. SSRIS use can be deadly and result in ventricular arrhythmia or sudden death when mixed with other medications such as aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar disorder, blood clots, chemotherapy, heart conditions, and psychosis. Read more in the FDA press release

It is not the first time that the FDA has discovered hidden ingredients in Oxy Elite Pro.  In october 2013, 1 person died and 11 suffered serious personal injury and had to be hospitalized for liver failure in Hawaii after they used Oxy Elite Pro. The product was subsequently pulled from shelves nationwide. (see previous blog)

 

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Trellis 6In December, Covidien announced a voluntary recall of  its Trellis-6™ and Trellis-8™ peripheral infusion systems  after customers reported a manufacturing error where the proximal and distal balloon inflation ports were labeled incorrectly resulting in the potential for incorrect sequence of balloon deflation. An incorrect sequence of balloon deflation  could potentially create blood clots that could travel downstream and go to the lungs and seriously injure the patient. Today Medtronic, that just acquired Covidien announced that the recall has now been classified as a class I recall by the FDA. Read more in the press release

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ignitionGM defective ignition switch and Takata defective airbags accounted for a large part of the recalls.According to the automakers, GM recalled about 27 million vehicles last year, Honda recalled about 8.9 million vehicles last year, Fiat Chrysler recalled about 8.8 million, Toyota recalled about six million and Ford recalled almost 4.9 million.Airbag defects led to one third of all the recalls in 2014. The previous record was of 30.81 million cars recalled in 2004. Manufacturers recalled 22 million vehicles in 2013 and 16 million each year in 2012 and 2011.

Also 7.7 million child safety seats were recalled in 2014, the second highest number since such statistics started to be collected in 1972. Read more in the New York Times

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AED.jpgWhen a person is injured or dies because of an automated external defibrillator failure, it is often the result of a defective design or a manufacturing flaw such as the inadequate quality control of outsourced components. Automated External Defibrillators (AEDs) are usually stored in public places and ready for use if someone suddenly suffers from a life threatening cardiac arrhythmia. Unfortunately these medical devices have a history of malfunctions. In the last 10 years the FDA received more than 72,000 medical reports associated with defective AEDs. During the same period of time, 111 recalls were conducted affecting more than two million defective products.

Therefore the FDA decided to take additional steps to improve the quality of these products. The agency issued a final order that will require AED manufacturers to submit premarket approval applications (PMAs), which undergo a more rigorous review than what was required to market these products in the past.

Read the FDA press release here

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Death, injury and warranty claims can serve as an early warning of defects or other problems in a car and manufacturers are required by law to submit this information to the government. For the last 11 years, Honda consistently under reported these claims and was fined $70 million for not doing so (see Honda Fined for Violations of Safety Law).Even though this penalty is the highest amount ever fined a car manufacturer by the federal regulators it still seems very modest in comparison to the revenue of the giant car manufacturers. The Obama administration wants to raise the maximum fine to $300 million but would that be enough?

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To administer non sterile products intended for training to patients is medical malpractice that can have very dangerous consequences. Recently Wallcur, a company that sells medical products intended for training purposes only, received reports that some of its training Sodium Chloride IV Bags had been used outside of their intended use and administered to patients. These bags are not sterile and are for simulation purposes only. To prevent these products from being injected in humans or animals, the company recently issued a product recall and is intending to improve the labels before to continue the distribution of these products..

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