Product Liability

Published on: February 23, 2015

Superbug outbreaks related to duodenoscopes : hospital negligence or product liability ? And what is the FDA doing about it?

Since 2009, the FDA has been aware that duodenoscopes manufactured by Japanese companies Olympus, Pentax and Fujifilm have been at the origin of the spread of sometimes fatal spread of pathogens but did nothing to change the situation. Hospitals that faced such outbreaks began sterilizing the devices more rigorously and the transmission of dangerous disease stopped. Therefore, the suspicion was that the superbug outbreak happened because of medical malpractice during which the hospital staff didn’t respect the sterilization procedure. However for the first time on Thursday the FDA said that even hospitals that fully respected the sterilization process could have their devices infected by the superbug. However the FDA didn’t propose to improve the sterilization procedures. They only issued a “safety communication” warning healthcare providers that duodenoscopes’ “complex design” may impede effective sterilization. The problematic part is a movable “elevator” mechanism at the tip of the duodenoscope: Its moving parts have microscopic crevices where bodily fluids can remain after standard cleaning. The FDA and the manufacturers are aware of this deadly manufacturing flaw but the FDA didn’t require the manufacturers to improve their device either. Read more on Reuters

Published on: February 17, 2015

A previous voluntary recalls of defective peripheral infusion systems manfactured by Covidien, a company recently aquired by Medtronic, has now been classified as a class I recall by the FDA

By GGCRBHS&M

Trellis 6 In 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

Published on: February 17, 2015

In 2014 car companies recalled a record number of 63.95 million vehicles to repair potential manufacturing defects and prevent car accidents

By GGCRBHS&M

GM 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

Published on: January 28, 2015

To prevent personal injury or death related to defective automated external defibrillators, the FDA just announced that manufacturers will now be required to submit premarket approval applications for their new products

By GGCRBHS&M

When 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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Published on: January 14, 2015

Honda just got fined a record amount of $70 million for not reporting 1729 death and injury claims as well as warranty claims but the fine seems modest compared to the $1.5 billion operating profit the car company recorded between July and September

By GGCRBHS&M

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?

Published on: January 12, 2015

A company selling products intended for medical training purposes is recalling some of its practice IV Bags as reports came out that they were being used on patients

By GGCRBHS&M

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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Published on: November 18, 2014

A motorsports manufacturer which allegedly failed to report defective minibikes and go-carts recently agreed to pay a $4.3 million civil penalty

By GGCRBHS&M

Baja%20Motorsports%20mini-bike1.jpg Baja Motorsports knowingly failed to report immediately defects and an unreasonable risk of serious injury involving 11 models of minibikes and go-carts said the Consumer Product Safety Commission in charges that were resolved by a settlement reached recently between the two parties.

The defective minibikes and go-carts were sold by Baja Inc., and its corporate affiliate, One World Technologies Inc., of Anderson, S.C. in the United States from 2004 to 2010. During that period of time Baja received several reports that people had been injured, including a child who was severely burned, after the gas cap leaked or detached from the fuel tank. Baja also received reports of stuck throttles. The CPSC charged that the the throttle could stick, due to an improperly positioned fuel line and throttle cable, posing a sudden acceleration hazard. The company didn’t file a full report with the CPSC until June 2010.

1.2 million Defective Smoke/CO Alarms Recalled by Kidde Because of Alarm Failure

By GGCRBHS&M

defective%20alarm.jpg Some Kidde alarms may be defective and fail to alert consumers of a fire or a CO incident. Kidde residential smoke alarm model i12010S with manufacture dates between December 18, 2013 and May 13, 2014, combination smoke/CO alarm il2010SCO with manufacture dates between December 30, 2013 and May 13, 2014, and combination smoke/CO alarm model KN-COSM-IBA with manufacture dates between October 22, 2013 and May 13, 2014 are being recalled by Kidde. The defective alarms are white and round (see picture) with the name Kidded engraved in front of the alarm. These alarms were sold at major retail stores such as Home Depot and also online through Amazon and other online retailers. Consumers who own this product should immediately contact Kidde to have it replaced.
Read more here

Published on: October 2, 2014

10 of our Personal Injury Lawyers selected for the 2014 New York Super Lawyers list

By GGCRBHS&M

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We are proud to announce that for the ninth consecutive year our attorneys have been named to the New York Super Lawyers list. In 2014 ten of our lawyers were selected. These are: Ben B. Rubinowitz, Anthony H. Gair, Howard Hershenhorn, Jeffrey B. Bloom, Richard M. Steigman, Jerome I. Katz, Ernest R. Steigman, Stephen H. Mackauf, Seymour Boyers and Christopher L. Sallay. Peter J. Saghir was again selected to the Rising Stars list.

Our firm is located in Manhattan and handles all types of catastrophic personal injury and wrongful death cases from traffic accidents, construction accidents, medical malpractice to product liability in New York and New Jersey.

Since 1919, the firm has built is reputation as one of the top injury law firms in the United States by limiting its practice to a select group of serious and substantial tort cases so that extensive personal attention and meticulous trial preparation are afforded to each of our clients on all matters. The results speak for themselves as for the last 10 years our firm has obtained verdicts or settlements exceeding $1 million for more than 425 cases.

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Published on: September 18, 2014

Lawmakers on Capitol Hills strongly criticize the National Highway Traffic Safety Administration for overlooking evidence and failing to identify the deadly defect in General Motors cars

By GGCRBHS&M

David Friedman, the head of the NHTSA who testified Tuesday at a Senate hearing about the NHTSA’s handling of the ignition switch defect in General Motor’s cars faced heavy criticism from both parties. The agency was accused of being irresponsible, of failing to use its full authority over automakers and of failing to discover defects that consumers had alerted the agency to.

Just before his testimony the House Committee on Energy and Commerce also released a Staff Report on the GM Ignition Switch Recall that concluded that the “NHTSA had ample information to identify a potential safety defect as early as 2007.”

Read more in the New York Times and in Automotive-Fleet.com

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