Product Liability

Published on: April 16, 2015

Beech-Nut recalls Classics Stage 2 Sweet Potato & Chicken after a piece of glass was found in a jar of the product

Attention 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.

Published on: March 17, 2015

After two patients suffered serious personal injury because they were administered non sterile simulation intravenous fluids at a New York urgent car facility, the NYSDOH and the CDC discovered that simulation medical products had inadvertently entered the clinical supply chain

By GGCRBHS&M

Two patients were seriously injured in a New York urgent care facility after they were inadvertently administered non sterile simulation intravenous fluids. They both experienced a febrile illness during administration and had to be hospitalized. One of them developed sepsis. Both of them survived.

The cases were reported to the New York State Department of Health (NYSDOH)last year. The NYSDOH began a collaborative investigation with the CDC in December. The investigation found that four other New York outpatient facilities had received Wallcur simulation saline. All facilities said they had ordered the real product and weren’t aware that they had received a simulation product until they were were notified by the NYSDOH. Fortunately none of the facilities had used the product yet.

Wallcur recalled all its saline simulation products from the market at the beginning of the year (see previous blog). Investigation was pursued by the CDC at a national level. So far nationally 9 adverse events have been reported for 25 people including 11 hospitalizations. Two deaths occurred even though it wasn’t clear that they were related to the administration of the product. All clinical facilities that received the products confirmed that they were not aware at time of purchase that the product was intended for simulation only. Read more on the CDC website

Published on: March 13, 2015

Hospira recalls Lactated Ringer’s Irrigation, 3000mL, a sterile solution for injection, because of potential mold contamination

By GGCRBHS&M

Hopsira 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

Published on: March 13, 2015

Tylenol manufacturer admitted selling metal contaminated drug and agreed to pay $25 million to resolve the case

By GGCRBHS&M

McNeil 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

Published on: March 5, 2015

With the first product liability lawsuits being filed against duodenoscope manufacturers, it was diclosed today that the devices that led to the CRE outbreak at UCLA where not FDA approved

By GGCRBHS&M

Patients 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

Published on: March 2, 2015

The weight loss supplement Oxy Elite Pro is a dangerous product that can potentially harm or kill consumers because it may contain selective serotonin reuptake inhibitors (SSRIs) used for treating depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphonic disorder (PMDD)

By GGCRBHS&M

The 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)

Published on: February 23, 2015

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

By GGCRBHS&M

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

Continue reading →