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Category Archives: Products Liability
Some Newer Diabetes Drugs Linked To Lower Limb Amputations: "Significantly Increased Risk"
New Study Suggests Possible Drug Class Side Effects Of SGLT-2 Inhibitors Such As Invokana, Jardiance, And Farxiga (Posted by Tom Lamb at DrugInjuryWatch.com) Sodium-glucose cotransporter 2 inhibitors (SGLT-2 inhibitors) are relatively new medicines used to treat Type-2 diabetes. Included in this drug class are Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, Synjardy, Qtern, Steglatro, Steglujan, and Segluromet. A new medical study found that SGLT-2 inhibitors have a higher risk of leg, feet, and toe amputations when compared to older diabetes drugs such as sulfonylureas, metformin, and thiazolidinediones. In more detail, this article "Association Between Sodium-Glucose Cotransporter 2 Inhibitors and Lower Extremity Amputation Among Patients With Type 2 Diabetes", by Hsien-Yen Chang, PhD, et al., was published online August 13, 2018 by the medical journal JAMA Internal Medicine. Among the results found by medical researchers….. To continue reading this legal news please click Read full information...
Posted in Products Liability
Tagged "Significantly, Amputations, DIABETES, Drugs, Increased, Limb, Linked, Lower, Newer, Risk", some
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FDA’s IVD TA: It’s Not Just Technical Assistance
By Jeffrey N. Gibbs — Since 1992, the Food and Drug Administration’s (FDA’s) efforts to regulate laboratory developed tests (LDTs) have been one of the most controversial device regulatory topics. We have written about this topic multiple times (see our list at the end of this post). The focus of many of these posts has been FDA’s efforts to use guidance documents to regulate LDTs under the Federal Food, Drug, and Cosmetic Act. In short, we have questioned the legality of those efforts, and given the constraints imposed by the existing legal framework, its desirability. However, there is another way to approach LDT regulation: by enacting legislation. That would address the legality issue, and, if properly crafted, its desirability. A new law could provide an unassailable legal framework, while also addressing multiple concerns that have been raised: LDTs and kit manufacturers should be on a level playing field; the regulatory….. To continue reading this legal news please click Read full information...
Court Discusses “Distraction Doctrine” in Recent Restaurant Slip-and-Fall Case
Recently, a state appellate court issued a written opinion in a Georgia premises liability lawsuit that was filed against a Chick-Fil-A fast-food restaurant after the plaintiff tripped and fell in the restaurant’s parking lot. Relevant to this appeal was the plaintiff’s claim that she did not notice the cement parking barrier that caused her to trip because she was distracted by a car in the restaurant’s drive-thru lane. Ultimately, the court concluded that the plaintiff could not benefit from the “distraction doctrine” because she failed to prove that a hazard existed in the first place. The Facts of the Case The plaintiff parked in the defendant restaurant’s parking lot, entered the restaurant without issue, and ordered her food. When she was leaving the restaurant, she left the same way she had come in. However, in order to get back to her car the plaintiff had to cross the drive-thru lane. As the plaintiff was walking across the….. To continue reading this legal news please click Read full information...
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Tagged case, Court, discusses, Distraction, Doctrine, Recent, Restaurant, SlipandFall
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Red Tide Hits Florida – What You Need to Know
A lot of people get an incredible amount of enjoyment out of travel, and during the summer months when the ocean water is warm and the sun is pleasantly hot, Florida tends to be a popular place for tourist and vacationers to migrate to. However, the recent outbreak of red tide in this southern state has left many travelers wary of visiting, wondering if it might be better for them to reserve their beach vacation at an alternative location. Here is what you need to know about the red tide outbreak in Florida! What is Red Tide? A “red tide” is a commonly used term used to describe a harmful algal bloom. While many people tend to prefer the name “red tide,” scientists stick to “harmful algal bloom” when discussing these toxic events. While not all algal blooms are harmful, many that are caused by simple plants in the sea and freshwater are entirely destructive. These categories of algal blooms occur when colonies of algae grow until they are out….. To continue reading this legal news please click Read full information...
