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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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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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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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Local Fake Doctor Charges Clients Thousands of Dollars

In Boerne, Texas, a woman going by the name(s) Catherina Hunter or Katrinca Hunter stole the identity of a Chicago based doctor and pretended to be a highly qualified medical professional with multiple advanced degrees. For months she preyed on one of the most vulnerable segments of the sick, Stage IV cancer patients. Working out of her office at Hope of Life Alternative Treatment Center, she charged her clients thousands of dollars for daily visits, almost six times the rate similar treatments cost in places where they are common like California. She promised a 97% success rate by treating them...

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Volkswagen Clean Diesel Litigation

The defeat device allows the cars to “know” when the vehicle is undergoing testing by the EPA. During testing, the vehicles produce the promised emissions and achieve the guaranteed fuel efficiency. However, when owners drive the vehicles in normal, non testing conditions, they have emissions over the standards set by the Environmental Protection Agency, or EPA. The EPA has cited Volkswagen for multiple violations. The emissions scandal affects millions of vehicles in both the United States and in Europe. Originally, the EPA only cited the 2.0 litre diesel models, but upon more investigation, the EPA added 3.0 litre diesel vehicles...

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Birth Injury and Trauma

We Can Help with Your Birth Injury/Trauma Claim! The incompetence or negligence of medical professionals often turns what should be a blissful occasion into a nightmare. Sometimes injuries to an infant during birth are unavoidable but, frequently all of the resulting struggles were avoidable. Birth trauma can lead to lifelong conditions that add up to millions of dollars in medical fees over time. These potential decades of problems are not easy to face alone and an experienced attorney like we have here at the Janicek Law Firm. Some Examples of Birth Injuries are, but not limited to: • Cerebral palsy • Erb’s palsy • Subconjunctival hemorrhage •...

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Spreading Superbugs: The CRE Outbreak

Recently the news has reported that a superbug in hospitals has caused deaths on both coasts.  First, the UCLA Ronald Regan Medical Center announced that 7 people were infected by the superbug since and that two individuals had died.  A hospital in Charlotte, North Carolina, recently announced that they had a patient die from the same superbug found in the UCLA hospital. The name of the superbug is carbapenem-resistant Enterobacteriaceae, or CRE.  CRE is normally found in hospital settings, and, over time, CRE has developed a resistance to most antibiotics.  Generally spread through touch, healthcare workers may spread CRE by failing...

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Artificial Hip Lawsuits

The Janicek Law Firm, PC is currently litigating mass tort claims involving Metal on Metal Artificial Hip injuries. Thousands of men and women have received a Metal on Metal Artificial Hip system since 2003. Many of these artificial hip systems have been recalled because of the dangerous side effects caused by manufacturing defects. We are currently taking cases involving the following products: Stryker Rejuvenate and ABG DePuy ASR and Pinnacle Biomet M2a Magnum and Taper Smith & Nephew Zimmer Durom Wright Conserve and ProFemur Problems associated with Metal on Metal Artificial Hip implants include: Corrosion and Fretting of the artificial hip Severe pain in hip area Elevated cobalt and/or chromium levels in...

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