The first St. Jude Riata bellwether trial is scheduled for February 3, 2015, according to court documents. The patients chosen for the case allege that the Riata defibrillator leads are defective.
In one case, a patient died and the others allege injuries following a heart procedure that was allegedly caused by the Riata’s defects. A Scheduling Order filed on January 24, 2014 in the U.S. District Court for the Central District of California, Southern Division indicates the plaintiffs chosen for the bellwether cases; a pre-trial conference date is set for January 12, 2015 and discovery will remain open until October 21, 2014. Continue reading
Testimony has wrapped up in the trial of a lawsuit brought by about three dozen passengers from the Carnival Triumph cruise ship that drifted at sea for days in February 2013. The passengers sued over medical and mental health problems they say were caused by conditions on the disabled ship.
The cruise ship left Galveston, Texas on February 7, 2013, for a four-day cruise. On February 10, around 5 a.m., a fire broke out in the ship’s engine room, and the ship was left drifting without engine power and largely without most electricity. Ventilation systems and toilets did not function and water supplies were limited. Passengers reported human waste running in the hallways, noxious odors, and extreme heat, according to the Associated Press (AP). The ship was towed to Mobile, Alabama, where passengers disembarked on February 14. Carnival Corp. offered every passenger a $500 check, a voucher for a future cruise, refunds of most on-board expenses, and reimbursement for transportation back to Galveston. Continue reading
A bill introduced last month in Maryland’s General Assembly would ban the marketing and sale of energy drinks to minors, which, in Maryland, is anyone under the age of 18.
If the bill becomes law, Maryland would be the first state with such a ban, CNBC reports. Delegate Kathleen Dumais, who submitted the bill, said, “The bill is modeled on existing legislation aimed at preventing tobacco marketing which targets minors.” For a first offense the penalty would be a fine of up to $5,000, with a $10,000 fine for a second offense and a $20,000 fine for a third offense. Continue reading
The U.S. Food and Drug Administration (FDA) has designated GE’s recall for Giraffe and Panda neonatal infant warmers and resuscitation systems as Class I, which is the agency’s highest-risk label. The Class I label means that exposure to the recalled device could lead to serious injury or death. The recall, which was initially issued last October, affected the following products:
- Giraffe Warmer with Resuscitation System
- Panda Warmer with Resuscitation System
- Giraffe Stand-Alone Infant Resuscitation System
- Resuscitation System Upgrade Kits
- Panda Freestanding with Resuscitation System
The machines are used to resuscitate infants and regulate body temperature. According to the FDA memo, the devices were recalled because some parts were assembled backwards. This could cause the systems to deliver too much or too little oxygen to newborns, leading to serious injury and possibly death. The agency said that infants at higher risk include those who are critically ill, premature and low-birth weight. The machines were manufactured between April 1, 2007 and October 31, 2013 and distributed from October 1, 2007 and October 31, 2013.
GE has had some safety issues with its neonatal systems in the past year. In February 2013, the company recalled its upgrade kits for some mislabeled infant warmers, which could lead to the delivery of inappropriate amounts of oxygen. The FDA also designated that recall as Class I due to risk of injury or death. Last April, a warning was also issued for certain Giraffe incubators and OmniBed systems. The company said that the systems had a faulty part that could cause the machines to forget its previous settings when turned off and then on, or in the case of power outage. This could lead to the patient getting inappropriate oxygen and temperature settings.
Despite Mounting Lawsuits and Injuries Associated with Approved Testosterone Drugs, FDA Approves Another Testosterone Medication
The U.S. Food and Drug Administration (FDA) just announced its approval of Endo International Plc’s Aveed, a drug it previously rejected not once, but three times. Aveed is a testosterone replacement therapy that is approved to treat male hypogonadism.
Male hypogonadism is a condition in which the male body produces low levels of testosterone. Testosterone is the male hormone responsible for maintaining muscle bulk, sexual function, and bone growth. Low levels of testosterone may lead to reduced libido, fatigue, and depression, according to Reuters. Continue reading
General Motors Co. said it is questioning employees involved in the handling of the recall of cars whose faulty ignition switches have been linked to 13 deaths in crashes where air bags did not deploy.
A team of attorneys investigating the recall of more than 1.6 million vehicles is interviewing employees to learn how the company handled the issue since it was first discovered in 2004, according to people familiar with the situation who asked not to be identified, Reuters reports. Greg Martin, a GM spokesman, did not give details of the probe but said that chief executive Mary Barra promised an “unvarnished” look at how the process was handled. Continue reading
The family of a hospital patient found dead in a stairwell 17 days after she disappeared from her room has filed a wrongful death claim against the city of San Francisco, which owns and operates the medical facility.
A wrongful death claim is the precursor to a lawsuit when a governmental body is named as a defendant. Lynne Spalding’s son and daughter filed the claim; their mother entered San Francisco General Hospital on September 19 and was found dead in a hospital stairwell on October 8. The claim describes a series of errors by the hospital and the San Francisco Sheriff’s Department, which provides security for the facility, the Los Angeles Times reports. Continue reading
A new study published in the Lancet evaluates patient to nurse ratios and nurses’ educational background in relation to inpatient hospital deaths. The authors of the study, entitled RN4CAST, found that mortality rates increased with increased nurse workload and decreased when more nurses has bachelor’s degrees in nine European countries.
The study, which was published online on February 26th, aimed “to inform decision making about nursing, one of the largest components of hospital operating expenses”. According to the authors, policies frequently try to constrain hospital expenditure and growth, even though there are concerns that this might compromise patient safety. “Hospitals are a target for spending reductions.” they wrote, and nursing is a “so-called soft target because staff cuts quickly save money. The actual cost of improved efficiency is much more difficult, they wrote. The researchers cited two other studies showing that highlight the effects of nursing staff cuts; England’s Francis Report discusses how nurses were criticized for not being able to make up for poor care after staffing was cut and the Keogh review, which looked at 14 hospital trusts in England, found that inadequate nurse staffing was an important factor for consistently high death rates. Continue reading
Thoratec Corporation, just issued a global “Urgent Medical Device Correction Letter” as an update to its labeling concerning the use of its HeartMate II® LVAS Pocket System Controller, a medical device, according to a recent U.S. Food and Drug Administration (FDA) announcement.
Thoratec also issued the letter to update training materials on the HeartMate II® LVAS Pocket System Controller. The letter followed some serious, even fatal, difficulties experienced by patients and caregivers. Continue reading
After nearly a decade of investigating and more than a dozen fatal crashes, General Motors recently almost 1.4 million cars for a defective ignition switch that can accidentally shut off the car’s engine and electrical system, and disable the air bags.
The first fatal crash believed to be related to ignition switch killed 16-year-old Amber Marie Rose on July 29, 2005. The air bag in her 2005 Chevrolet Cobalt did not deploy when the car crashed. But The New York Times reports that General Motors knew of “at least one incident” in 2004 in which the engine shut off after the driver “inadvertently contacted the key or steering column,” according to the chronology GM provided to the National Highway Transportation Safety Administration (NHTSA) this week. Continue reading