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Health Canada Warns that Some Insulin Pumps have Risk of Tubing Detachment

Unomedical a/s in consultation with Health Canada waned that insulin pump infusion sets manufactured by Medtronic of Canada Inc., Roche Diagnostics, LifeScan Canada Inc, and Auto Control Medical Inc. have a risk of tubing detachment. In an urgent safety notification issued November 21st, Health Canada stated that manufacturers have been receiving growing reports of tubing become detached from the connect/disconnect location.

Insulin pumps are used to deliver insulin through a catheter in the skin in patients with diabetes. The infusion sets can be programmed to administer small doses of insulin continuously or a larger dose close to mealtime to control blood sugar. More Health Canada Warns that Some Insulin Pumps have Risk of Tubing Detachment

Medications Most Frequent Trigger of Fatal Allergic Reactions, Study Suggests

Death from serious allergic reactions, or anaphylaxis, is most often triggered by medications, a study suggests. Researchers from Albert Einstein College of Medicine and Weill-Cornell Medical College published a study in the Journal of Allergy and Clinical Immunology analyzing the triggers for anaphylaxis-related deaths.

The study looked at 2,458 anaphylaxis-related deaths that occurred between 1999 and 2010 using diagnostic codes on death certificates identified in the US National Mortality Database. More Medications Most Frequent Trigger of Fatal Allergic Reactions, Study Suggests

Boston Scientific Sees First Federal Trials over Transvaginal Mesh

For the first time, federal trials are taking place over allegations that Boston Scientific’s transvaginal mesh implants caused injuries in women. According to Reuters, one trial taking place in Charleston, West Virginia involves four women implanted with the Obytryx transvaginal mesh to treat stress urinary incontinence. The second trial is taking place in Miami, and involves women implanted with the Pinnacle used to treat pelvic organ prolapse.

Pelvic organ prolapse is when the organs begin to droop from their normal location and push against the walls of the vaginal. Stress urinary incontinence is the involuntary release of urine during everyday activities such as laughing or sneezing. Transvaginal mesh is supposed to treat these conditions by providing additional support to the pelvic walls and muscles, but numerous women allege that the devices only caused more problems. The devices have allegedly caused complications such as pain, bleeding, nerve damage and mesh erosion. Transvaginal mesh devices is now one of the most sued-over medical devices, Reuters reports. More Boston Scientific Sees First Federal Trials over Transvaginal Mesh

Potential Settlement may Resolve another 1,000 ASR Lawsuits for $250 million

Johnson & Johnson may settle another 1,000 ASR hip implant lawsuits for $250 million. According to Bloomberg, two people familiar with the litigation said that the company is considering whether or not to offer the same settlement terms it used to resolve 8,000 ASR cases, where the company agreed to pay $250,000 per surgery and over any related medical expenses. The recalled metal-on-metal hip implant is defectively designed and causes complications through the release of metal debris, patients allege.

“This is a sign that J&J is trying to get a solid handle on its whole ASR problem,” a professor of product-liability law at the University of Richmond in Virginia told Bloomberg. “They are not done paying yet, but they are moving in the right direction.” More Potential Settlement may Resolve another 1,000 ASR Lawsuits for $250 million

GM Ignition Switch Defect Linked to 30 Fatalities

General Motors Co.’s ignition switch defect is attributed to one more death, bringing the death toll up to 30, according to a report from the office of the attorney managing the compensation fund. Since the beginning of October, seven deaths have been linked to the problem, Law360 reports. The report shows that 1,580 total claims have been received since the fund began accepting claims in August; this is up 1,517 from last week.

Millions of cars have been recalled due to the ignition switch defect, which causes cars to stall and disables air bags when the switch unexpectedly takes the car out of “run” mode. Law360 reports that most recalls required replacing or modifying the key. A replacement ignition switch was required in 2.6 million vehicles. More GM Ignition Switch Defect Linked to 30 Fatalities

Study Examines Rate of Medication Errors Young Children

Between 2002 and 2012, a child experienced a medication mistake roughly every eight minutes, a new study shows. The study, which was published in the journal Pediatrics, found that the most errors occurred with painkillers such as aspirin, followed by cough and cold medicines and allergy medicines.

During the 11 year period of the study, researchers found that the rate of reported medication errors increased, except for cough and cold medicines. The authors attributed these findings to the efforts of a multipronged education campaign.“We think that multipronged effort had an effect,” said Henry Spiller, an author of the study and director of the Central Ohio Poison Center at Nationwide Children’s Hospital in Columbus to Reuters Health. “We can see a drop associated with these efforts.” More Study Examines Rate of Medication Errors Young Children

Limited Data on Medication Dosage for Children Leads to Uncertain Prescriptions

When it comes to clinical trials for a new medications, children are hardly ever included. As a result, most prescriptions for children are often more uncertain than for adults. According to Scientific American, only 46 percent of drugs used in kids have been approved by the U.S. Food and Drug Administration (FDA) for pediatric populations.

In the past, that statistic was much worse. Two pieces of litigation have been crucial to improving the rate of FDA approved drugs for kids. One law is The Best Pharmaceuticals for Children Act, which provides motivation by offering exclusive sale rights for a short period of time. The other law is the Pediatric Research Equity Act, which requires clinical testing in children if a drug can be used for the same purpose in children. The issue with this however, is that children often get diseases that adults do not. More Limited Data on Medication Dosage for Children Leads to Uncertain Prescriptions

In Whistleblower Trial over Guardrails, Trinity Allegedly Hid Failed Crash Tests

According to The New York Times, Trinity Industries was asked about their failure to disclose five failed crash tests to authorities in a whistleblower trial over their guardrails. Guardrails are put in place as a safety measure when an accident occurs. They are intended to absorb most of the impact when struck head-on in an accident. Additionally, the rail head is supposed to move metal safety out of the way; the flat piece of steel in front of the rail should slide along the rail to do this. Trinity’ changed the design in 2005, making the channel behind the rail head more narrow. This change can cause the head to jam and result in the rail being pushed into a vehicle instead, critics say. More In Whistleblower Trial over Guardrails, Trinity Allegedly Hid Failed Crash Tests

Nearly 7,000 DePuy Pinnacle Lawsuits Filed in Texas

As the first trial over the DePuy Pinnacle hip implant proceeds, cases continue to mount in the Dallas Division of the Northern District of Texas. As of September 30th, 6,849 lawsuits alleging injuries from the metal-on-metal version of the Pinnacle hip implant have been filed into the multidistrict litigation overseen by U.S. District Judge James E. Kinkeade.

The trial is over the lawsuit of a 58-year old Montana woman who received a Pinnacle hip implant on her right side and left side, in September 2006 and April 2007, respectively. After suffering from complications, she underwent her first surgery in 2010. She has undergone additional procedures since, the suit states. When surgeons removed the hip implant, they found that it had turned black due to metallosis, the suit alleges. The device also allegedly caused her to suffer elevated levels of cobalt in the blood, allegedly as a result of the Pinnacle’s defective nature. More Nearly 7,000 DePuy Pinnacle Lawsuits Filed in Texas

Jury Orders Takeda to Pay $2 Million in Actos Bladder Cancer Lawsuit

The seventh Actos lawsuit to go to trial resulted in a $2 million verdict for a woman who developed bladder cancer, allegedly due to taking the diabetes medication. According to Bloomberg, a Philadelphia jury found that Takeda Pharmaceutical failed to warn that Actos could increase the risk of bladder cancer. Actos litigation has been on the rise in recent years, in light of research linking the drug to bladder cancer.

The woman who sued Actos is a 79-year old retired accountant. She alleges that Actos is to blame for her bladder cancer, and that the company was aware of these risks but failed to notify her physician. During the trial, jurors heard that Takeda destroyed numerous documents related to the drug. More Jury Orders Takeda to Pay $2 Million in Actos Bladder Cancer Lawsuit