Articles Posted in Medical Devices

In 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

The 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.”

The 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?

The 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.

In 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?

Introduction

The power morcellator injury attorneys at the Drug Law Center are taking up new claims from women who have been diagnosed with various forms of cancer after undergoing any medical procedure that required the use of a power morcellator. It has been found that while these devices allow surgeons to perform operations with smaller incisions, they can also spread cancer tissue and make it far more likely for women who have undiagnosed cancer to suffer from advanced stage forms of cancer which may have otherwise been treated or prevented in an appropriate time frame.

The History of Power Morcellators

Introduction

The Essure injury attorneys at the Drug Law Center are committed to the pursuit of justice on behalf of the many women who have suffered catastrophic and debilitating injuries due to the Essure Permanent Birth Control System. While this product is marketed as a safe and easy alternative for tubal litigation, many women believe that these claims are erroneous and that it needs to be pulled from the market due to the severe risk of injury that women face when electing to have this system implanted. If you or a loved one has been injured, we would like to hear your story and have the opportunity to fight on your behalf.

How the Essure Permanent Birth Control System Works

Attorneys Explain Mechanics and Complications Related to Bair Huggar Warming Blankets

The Bair Hugger infection attorneys at the Drug Law Center routinely work with clients who developed infections linked to the use of the Bair Hugger therapy blankets often used during surgical procedures to regulate patients’ body temperatures. Research has linked the use of these devices with an increased risk of infection and disease because they may pull pathogens from the floor and distribute them onto the patient’s opened body. If you underwent surgery and one of these warming blankets was used during your procedure, you may be entitled to compensation for any of the injuries you suffered as a result.

The History of the Bair Hugger Warming Blanket

Attorneys Provide Introduction to IVC Filter Complications and Lawsuits

The IVC (Inferior Vena Cava) filter injury attorneys at the Drug Law Center are taking on claims on behalf of the many people who were injured due to complications stemming from removable IVC filters. These devices are intended to capture and break apart blood clots in the leg so that they do not migrate to major organs such as the heart or lungs, but they have been linked to serious internal injuries. In some cases, doctors were unable to remove the devices safely due to migration or fracturing of the device. If you have been injured, we would like to learn more about your story.

A History of IVC Filters

Transvaginal Mesh Lawyers Explain Dangers and Legal Issues Involved in Transvaginal Mesh Lawsuits

The transvaginal mesh attorneys at the Drug Law Center are taking on new cases involving anyone who has been seriously injured due to complications linked to transvaginal mesh products. It has been discovered that the manufacturers of these products knew of the potential risks and refused to remove their products from the market. Many women elected to have mesh devices implanted for the treatment of conditions such as pelvic organ prolapse and incontinence only for the devices to erode prematurely and cause debilitating injuries. We are committed to fighting for justice on behalf of the countless number of women who have been injured needlessly by these products.

The History of Transvaginal Mesh