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FDA responds to Big Pharma’s Citizen Petition

Big Pharma asked the U.S. Food and Drug Administration to overhaul a newly finalized regulation that gives the agency wide latitude to police off-label promotion. Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization and a drug maker coalition known as the Medical Information Working Group, filed the petition on February 8, 2018.  The petition claims the rule contains unconstitutional policy changes. These organizations represent many drug makers, and their petition challenges the FDA's new rule for evaluating “intended use” of prescription drugs and medical devices.  An important concept, intended use helps the FDA assess whether companies are intentionally marketing products for unapproved uses. The...

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Are your nursery products safe for your children?

A new study found that every eight minutes a child is injured in an accident involving baby products like carriers, crib bedding, and strollers. That means approximately 66,000 injuries occur a A study by Nationwide Children’s Hospital, indicates this number continues to grow. Since January 1991, researchers have looked closely at nursery product related injuries. Baby carriers caused the most injuries (20%) followed by cribs and mattresses (19%) and strollers and carriages (17%). Most of the injuries happened at home and about 80% of the time they involved falls.  In the last 8 years of the study,  nursery product-related injuries steadily increased, rising by nearly...

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Multidistrict Litigation: What and Why?

Previously, The Janicek Law Firm provided a further understanding of MDL cases and how they work. Multidistrict litigation works well for large, complex cases that involve one or more common issues of fact. In the federal system, the Judicial Panel on Multidistrict Litigation decides when to transfer cases to an MDL. It usually occurs when there are large numbers of cases against common defendants and the courts expect more plaintiffs to file lawsuits. At the state level, a similar body or a state supreme court can decide to consolidate similar cases. Type of Cases Subject to Litigation Multidistrict litigation cases include damages due to dangerous...

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Multidistrict Litigation: Know How It Works

  Multidistrict litigation includes lawsuits involving dangerous narcotics, medical devices, aircraft crashes, and intricate issues affecting a large group of people.  Federal judges transfer these cases and consolidate them into multidistrict litigation (MDL). How Multidistrict Litigation Works In 1968 Congress created the Multidistrict Litigation system in order to manage multiple federal civil cases that share a common issue, and are transferred to a single district court. The goals of MDL are to save money and time by joining similar cases into one action. The United States Judicial Panel on Multidistrict Litigation decides when multiple lawsuits should be consolidated into an MDL. The panel consists of seven members...

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Understanding Multidistrict Litigation: Part 1

Multidistrict litigation Multidistrict litigation (MDL) is a procedure in which federal civil cases from around the country are transferred to one court. The court consists of a panel of seven judges appointed by the Chief Justice of the United States Supreme Court. The judicial panel has the ability to transfer related cases to one federal judge for organized and united pre-trial discovery.   Due to difficulty courts had in coordinating over a thousand related cases that were pending in 36 districts around the country, the panel was created in 1968. This procedure avoids duplication of discovery, prevents pretrial rulings, and conserves...

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Know Your Surgeon: How Unprofessional Behavior Impacts Your Health

The Correlation Between Poor Doctor Behavior and Complications in the OR Recent studies by Vanderbilt University suggest a correlation between surgeons who are rude to patients and colleagues and those which may pose a threat in the operating room. Studies link  unprofessional surgeon behavior with infection and complications during surgery. Complications are common in patients whose doctors reportedly receive many complaints in regards to poor behavior. Complaints involved exasperated phone calls to hospital staff from patients, or relatives. A surgeon’s unprofessional behavior may affect patient’s in several ways. Surgeons who treat patients poorly may behave the same colleagues, leading to distractions, low morale, and...

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‘Dr. Death’ receives life sentence for botched surgeries

Police arrested Dr. Christopher Duntsch or ‘Dr. Death’ as he has been named by the media, in July 2015 on five aggravated assault charges. He left four of his patients crippled and two others died between July 2012 and June 2013 according to Dallas News.  A Dallas jury sentenced neurosurgeon Christopher Duntsch to life in prison for a botched back surgery he performed that left his elderly patient, Mary Efurd then 74, crippled and in constant pain. She lost a third of her blood and the full use of her legs. She believed that Dr. Duntsch was doing the “right”...

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Xarelto Lawsuits: How Janicek Law Can Help

The Janicek Law Firm  previously reviewed the negative implications of Xarelto. Since 2011, the number of lawsuits filed against Bayer Healthcare, the manufacturer and Janssen Pharmaceutical, the marketer of the drug, on behalf of victims suffering as a result of taking Xarelto continues to grow. What is Xarelto? Doctors prescribe Xarelto (rivaroxaban),an anticoagulant or blood thinner, to prevent the formation of blood clots. It also treats strokes, pulmonary embolisms, blood clots, and to helps prevent deep vein thrombosis.  Doctors and the drug  manufacturer know of life threatening side effects and complications from the use of blood thinners. These side effects include excessive bleeding to the point of causing death,...

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Brief Considerations of America’s Opioid Use

In the 1990’s, pharmaceutical companies began the wide scale advancement of their agenda to push long term use of opioid prescriptions for a wide range of ailments. They based their beliefs on limited scientific data which led them to believe patients would not develop long term addictions to the medications. The effects swept the country as patients were prescribed medicine that wasn’t even effective against some chronic pains. The medical field was under the false premise that there “was virtually no dose-ceiling” and the patients should be prescribed to the point when they reached pain relief. Under this mantra, patients...

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Canadian Nurse Charged with Killing 8 Patients

            Last month in Canada, a woman was arrested for the murder of eight elderly nursing home patients over the past seven years. She is a college educated nurse who was responsible for creating care plans and administering medications. An unknown source tipped off the local authorities of her alleged unimaginable actions. It is claimed she used medications to kill the patients before it was their time to go. Some of the earlier victims claim they had no idea and just assumed their family member had died naturally but not all of them. The most recent alleged victim’s son says...

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