Group Recommends Genetic Testing for Susceptibility Serious Skin Recations Associated with Carbamazepine
A Canadian drug safety group has recommended genetic testing for gene variants associated with the risk of developing Stevens-Johnson syndrome, a serious, possibly fatal, skin reaction in patients taking the drug carbamazepine.
The Canadian Pharmacogenomics Network for Drug Safety (CPNDS) has recommended testing for the alleles HLA-B*15-02 and HLA-A*31:01 that affect histocompatibility before patients begin taking the anti-seizure medication carbamazepine. The study was published online March 5 in Epilepsia. Continue reading
Transvaginal mesh lawsuits are on the rise and a continuing legal issue for Boston Scientific, Mass Device reports. In their most recent 10-k report, the company said that there is an ever-increasing interest in lawsuits over their pelvic mesh devices. As of late last month, there were at least 18,000 lawsuits, including 8 reported class actions, in the United States. There were 1,700 cases pending in one Minnesota state court alone. Pelvic mesh cases have also been filed in Canada, where there are over 10 lawsuits, including 3 class actions. Boston Scientific is accused of fraud, failure to warn and other offenses. Plaintiffs claim that the company was aware of the risks but made no effort to inform the public. Continue reading
A verdict of $3 million has been returned against Janssen Pharmaceuticals, Inc., a Johnson & Johnson unit, in a case alleging the company failed to warn about side effects associated with its epilepsy drug Topamax during pregnancy. The lawsuit was filed by the Wisconsin family of 5-year-old Payton Anderson, who was born with a cleft lip after her mother, Kelly, took Topamax to treat chronic migraines while she was pregnant. Philadelphia County Court of Common Pleas heard on Tuesday that Janssen allegedly didn’t update the label on Topamax to warn about recent research showing that it can increase the risk of cleft lips and cleft palates in newborns.
According to Law360, the lawsuit was first filed in December 2011. It is the third case of its kind filed in Philadelphia to go to trial, and court records show that more are on the way; over 130 additional lawsuits are pending as part of the a mass tort litigation. The previous two cases to go to trial returned verdicts in favor of the plaintiffs. A $4 million was returned in October and a family won $10 million after a verdict returned in their favor in December. A fourth Topamax lawsuit in Philadelphia went to trial late last month. Continue reading
Federal safety regulators have received hundreds of complaints over the past 11 years about General Motors (GM) vehicles that allegedly shut down when being driven, leading to potential dangerous and deadly outcomes.
A recent The New York Times investigation revealed that GM allegedly did not then conduct an investigation and has announced its vehicles are associated with 13 deaths and that it must recall 1.6 million cars worldwide. An analysis of the 260 consumer complaints made to the National Highway Traffic Safety Administration (NHTSA) indicated that, since February 2003, the NHTSA has received approximately two complaints monthly over possibly dangerous vehicle shutdowns, but responded that there was not enough evidence to conduct a safety investigation, the Times wrote. The last recorded complaint was filed last week. Continue reading
After a a capsule of a heart medication was discovered in a bottle of the antidepressant drug Effexor XR (venlafaxine), Pfizer Inc. has recalled two lots of Effexor and one lot of generic venlafaxine.
A 25-mg Tikosyn capsule was discovered in a bottle of Effexor XR, according to the drug maker’s press release, posted by the U.S. Food and Drug Administration (FDA). Tikosyn (dofetilide) is used to treat irregular heartbeat and if it is taken by a patient “where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, [it] could cause serious adverse health consequences that could be fatal.” Although Pfizer, to date, has not received any other such reports, the company has undertaken the recall as a precaution because the two drugs were packaged on the same line. Continue reading
Overuse of antibiotics has been a concern in recent years. The Centers for Disease Control and Prevention (CDC) says that in some hospitals, doctors are prescribing three as more antibiotics than in other institutions. The large discrepancy indicated that in many situations, the use of antibiotics can be reduced. The agency published a study online in Morbidity and Mortality Weekly Report showing that antibiotic prescribing can be improved by more than 30 percent. Continue reading
A state investigation has cited St. Benedict’s Senior Community for a patient death that occurred after three nurses failed to provide any type of emergency care. The nursing home, located in St. Cloud, Minnesota, is responsible for the death, the investigation found. A report from the Minnesota Department of Health found that this neglect happened even though the resident stated that resuscitation efforts should be made if he is in a life-threatening situation.
St. Benedict’s is run by CentraCare Health. Their central Minnesota network includes six hospitals, six nursing homes, senior housing in six communities and 17 clinics.
The resident died on June 29th, after feeling dizzy and becoming unresponsive. At first, staff detected a pulse and relocated him to his bed. When they checked his pulse again and found none, they did not perform CPR because a supervisory nurse said that “there was no witness to the resident’s last breath [and] too much time had gone by,” Both nurses who checked the pulse felt that CPR should have been performed, but instead they followed the order from the supervisory nurse. A physician for the case confirmed that CPR should have been performed. The resident died ten minutes after first feeling dizzy.
The two nurses who checked for a pulse were fired two days after the resident’s death. The supervisory nurse was retrained in policy and procedure.
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