Drug Law Center gives you the information you need to explore your legal options.
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Attorney & Publisher Jonathan Rosenfeld
About the Drug Law Center The Drug Law Center is sponsored by lawyers who represent individuals and families who have suffered a serious injury or death from a dangerous drug or medical device. While these medical inventions have been marketed to improve the quality of life for people, unsafe drugs and poorly designed medical devices can drastically reduce the quality of life for the individual and his or her family.
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Epi Pen Go WrongIn August 2017, the U.S. Attorney’s Office of the Federal Justice Department announced that Mylan Inc., a large pharmaceutical company, and Mylan Specialty L.P. settled a federal liability case by paying $465 million. The federal government had alleged that both companies violated the U.S. False Claims Act when they misclassified their brand-name EpiPen ‘epinephrine delivering device’ as a generic product, which allowed them to underpay Medicaid on earned rebates.

This financial settlement agreement followed the March 2017 announcement by Pennsylvania-based Mylan N.V. that their manufacturing partner Pfizer-owned Meridian Medical Technologies would expand a voluntary recall of their defective EpiPen auto injectors. This involved selected lots of the brand-name delivery device that included the EpiPen and EpiPen Junior. The generic forms of the epinephrine delivery device were not included in the voluntary recall.

Deceiving Medicaid

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Scoliosis Magnetic SystemThe Nuvasive Magec System is an effective magnetic technology that treats scoliosis using adjustable growing rods. In the past, these growing rods needed to be replaced during follow-up surgeries. However, the latest minimally invasive technology allows the rods to be adjusted using an external remote controller to avoid repeated surgical procedures. The newly redesigned Nuvasive Magec System can treat idiopathic and early-onset scoliosis.

In early September 2016, the Food and Drug Administration cleared the Nuvasive spinal implant system to treat patients suffering from early-onset scoliosis involving comprehensive spinal deformities. Their “RELINE” device is the only available small stature system manufactured with ‘easy to use’ components and small adjustable rods to maximize successful surgical outcomes in the U.S. The FDA 501(K) clearance indicates that the adjustable rods are safe to use with Magnetic Resonance Imaging (1.5 T) devices.

Doctor Suken Shah of the Alfred L. Dupont Hospital for Children stated in prepared remarks that “having clear, defined guidance for conditional MRI compatibility with [the NuVasive Magec System] helps alleviate uncertainty that may have limited surgeons from using the innovative Magec system. This clearance opens up the door for more patients and their families to benefit from this life changing technology.”

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Heating and Cooling Patient Sorin 3TThe Sorin 3T Heater Cooler System is an advanced medical device used in operating rooms around the world. The machine regulates the patient’s body temperature during complex heart surgeries that require the heart and the flow of blood to be stopped during the procedure. Germany-based LivaNova Inc, the manufacturer of Sorin 3T Heater Cooler, created the device that uses three unique circuits to make sure the patient’s body is sufficiently heated or cooled throughout the surgery. However, in recent years, the machine has been linked to TM (non-tuberculosis mycobacteria) infections and other severe side effects.

Since the end of 2016, the manufacturer of the device, the Centers for Disease Control and Prevention (CDC), and hospitals throughout the U.S. have warned patients who have undergone cardiopulmonary operations involving the Sorin 3T Heater Cooler System. Their urgent warnings have informed patients of the potential risk of exposure to Mycobacterium chimaera contamination involving deadly bacteria that could potentially grow in the device’s water tank. If the bacteria are present, they can aerosolize from the machine and spread throughout the OR (operating room) and into the patient’s chest opened cavity through the air or through a transfer onto surgical tools.

How Does the Heater Cooler Device Work?

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Heart Rate MedicationAmiodarone (pacerone & nexterone) is a medication formulated to improve heartbeat rhythm. Doctors prescribe the drug to patients with life-threatening ventricle-related heart rhythm disorders to ensure the heart beats normally. The ventricles are the heart’s lower chambers that allow blood flow out from the heart.

The medication Amiodarone (pacerone) is affected for treating ventricular fibrillation and ventricular tachycardia. The medication was first discovered in 1961 and received final FDA approval in December 1985. The drug has not been approved by the Food and Drug Administration (FDA) for any other condition.

How Amiodrone Works

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Mandibular FixatorThe DePuy Synthes Craniomaxillofacial Distraction System (external mandibular fixator) consists of multiple internal distractors that stabilize or lengthen lower jaw bones and along the side of the lower jaw bone plate. Surgeons implant the device in adults, children, and infants to correct post-traumatic and congenital birth jaw bone defects. When installed properly, the distractors can gradually expand the length of the bone. DePuy Synthes is a subsidiary of the healthcare and pharmaceutical giant Johnson & Johnson.

FDA Alert Concerning Defective Design of DePuy Synthes Craniomaxillofacial Distraction System

In August 2014, the Food and Drug Administration (FDA) issued a Safety Communication warning doctors and patients of the defect design of the DePuy Synthes Craniomaxillofacial Distraction System. The highest designation Class I product recall announcement stated that infants undergoing the procedure may experience a sudden unexpected obstruction of the trachea that could result in respiratory failure and/or wrongful death. However, adults and children who can maintain an open airway have a decrease potential risk of suffering a severe injury with the device, compared to children who are 12 months old and younger.

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Tecfidera-infections from medicationTecfidera (dimethyl fumarate) is a highly effective oral drug brought to the medical marketplace by Biogenic, Inc. to treat MS (multiple sclerosis). The Food and Drug Administration (FDA) approved the drug in March 2013 to prevent the relapse of MS. However, one reported case has been noted on the updated FDA drug label (December 2014) linking Tecfidera (dimethyl fumarate) taken for multiple sclerosis with progressive multifocal leukoencephalopathy (PML), life-threatening brain infection.

This is the fourth case reported to the FDA, which resulted in an increased warning of the dangerous life-threatening side effects when taking medications to treat MS. The initial three cases of PML are apparently associated with the oral medication fingolimod among patients who had suffered severe low lymphocyte count (lymphopenia). However, the fourth case happened with “a patient with only moderate lymphopenia” that has raised concerning questions about Tecfidera’s effectiveness versus its safety.

A Confirmed Case of PML

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Recall of Zimmer ShouldersIn 2008, Biomet, Inc. launched their medical Comprehensive Reverse Shoulder System Humeral Tray device as a shoulder replacement implant to restore a patient’s arm movement. The clearance of the device by the Food and Drug Administration (FDA) bypassed the need for human clinical trials. Instead, the device was made available in the medical marketplace under the 510(K) fast-track program after Biomet showed that their new device was “substantially equivalent” to other shoulder replacement devices that had been previously approved by the FDA previously.

The comprehensive reverse shoulder system by Zimmer Biomet (in 2015, Zimmer Holdings acquired Biomet) provided significant benefits to patients who are suffering from rotator cuff tears who have developed severe shoulder arthritis arthroplasty conditions. In addition, surgeons use the new reverse shoulder system for patients who require a joint replacement from a previously failed implant device. When properly surgically implanted, the shoulder replacement device assists patients by restoring their arm movement.

What Is a Shoulder Replacement Device?

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The vaccination injury attorneys at the Drug Law Center remain committed to representing our clients who have been harmed by vaccines to ensure they receive financial compensation.

What are Vaccines?

Vaccines RecallsVaccinations are biologically prepared materials that provide acquired immunity to prevent the spread of life-threatening diseases that serve the public good at providing an effective and safe way to combat contagions. However, they are not without their controversy. While vaccines provide a safety net to the health and well-being of the population, some individuals develop severe adverse reactions when the vaccine is given orally, through an injection, or by aerosol. In an effort to ensure public safety, the U.S. government developed the National Vaccine Injury Compensation Program to provide financial recompense to those who suffered serious harm after receiving a vaccine.

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The infection injury attorneys at the Drug Law Center are reviewing and accepting cases from clients who suffered injuries caused by preventable superbugs.

What are Superbugs?

SuperbugSuperbug is a term that describes hearty strains of bacteria that are highly resistant to most antibiotics available today. Doctors typically referred to the resilient strains as “multi-drug-resistant bacteria.” That is because the bacterium is not resistant to every strain of antibiotic but one that usually requires two or more less-commonly used antibiotics to kill. The development of superbugs is thought to have occurred because of the overuse of antibiotics, especially in the United States.

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The gastrointestinal injury attorneys at the Drug Law Center are currently evaluating potential Reglan compensation claims for metoclopramide medication users suffering from Tardive Dystonia, Tardive Dyskinesia, or another associated condition.

What is Reglan?

Reglan (metoclopramide) RecallsReglan (metoclopramide) is a gut motility stimulating medication prescribed by doctors to treat GERD (gastroesophageal reflux disease) and gastroparesis in individuals suffering from diabetes mellitus. The medication is designed to increase upper digestive tract muscle contractions to empty the stomach into the intestines at the proper rate. Some doctors prescribe Reglan is a short-term solution for treating GERD-associated heartburn in individuals who have found no relief of their symptoms after using other drugs.

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