Lisa M. Robinson

All articles by Lisa M. Robinson

 

Texas Court Holds that Compounding Pharmacies are Subject to Requirements of the Texas Medical Liability Act

On April 24, 2015, in a significant win for pharmacies in the State of Texas, the Texas Supreme Court dismissed a plaintiff’s product liability action that alleged that the lipoic acid treatment she received caused her to go blind. The court held that the defendant compounding pharmacy that provided the supplement was entitled to protection under the Texas Medical Liability Act (TMLA) and dismissed the case. The decision is available here. In 2011, Ms. Miller was undergoing weekly injections of lipoic acid with her…  

Judge Precludes Plaintiffs’ Experts that “Cherry Picked” Evidence

A recent win for the defense in New Jersey highlights how challenging an expert’s use of unreliable data and methods can be an effective way to prevail. The carefully drafted February 20, 2015 opinion by Judge Nelson Johnson of the Superior Court of New Jersey was a major win for the pharmaceutical manufacturer of Accutane, an acne medication, which the plaintiffs’ said caused them to develop Crohn’s disease. The decision is available here through Law360. Judge Johnson issued his decision after a hearing that…  

Judicial Call for More Guidance on Punitive Damages Awards

Earlier this year, in a bellwether trial in the Actos multidistrict litigation, a Louisiana federal court jury awarded $9 billion  in punitive damages to plaintiffs who claimed that the use of the diabetes drug Actos caused bladder cancer. Not surprisingly, post-trial challenges followed. In particular, while the defendants did not challenge the amount of compensatory damages ($1,475,000), they argued that the award of punitive damages had to be reduced in order to comply with previous United States Supreme Court rulings that established limits on punitive…  

Defendants in Mass Tort Pelvic Mesh Lawsuits May Now Succeed With Removal to Federal Court – Non-Diverse Defendant Wins Dismissal

In a significant win for Secant Medical LLC, (Secant), Judge Arnold L. New of the Court of Common Pleas of Philadelphia County granted its motion to dismiss mass tort pelvic mesh personal injury claims in a decision dated August 22, 2014.  The court held that under the Biomedical Access Assurance Act (BAAA), Secant is not a manufacturer or seller of the pelvic mesh. Secant, a Pennsylvania company, was undoubtedly named to defeat diversity jurisdiction in an effort by plaintiffs to stay in state court in…  

First Drugs Approved for Combination Treatment of Melanoma by the FDA

Melanoma is the most aggressive type of skin cancer and is the leading cause of death from skin disease.  Last week the FDA approved GSK’s Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that cannot be removed by surgery or that is metastatic. The drugs were approved under the agency’s accelerated approval program.  More information is available click here. Previously both drugs were approved by the FDA as single agents to treat late-stage or unresectable melanoma. Both drugs are…  

PA Court Vacates $28 Million Verdict in Knee Replacement Case

A Pennsylvania Superior Court recently vacated a $27.6 million jury verdict against medical device manufacturer Zimmer Inc. (Zimmer), and marketing firm Public Communications, Inc. (PCI) in a case that involved Zimmer’s Gender Solutions Knee. The decision, which vacated the verdict on causation grounds, is available here. Zimmer’s Gender Solutions Knee is a knee replacement device specifically designed and manufactured for women. Zimmer hired PCI to produce a sales video featuring footage of patients who had received the Gender Solutions Knee. The plaintiff Margo Polett…  

New Liver Disease Medical Device May Help Cut Number of Transplants

Royal Free Hospital in London is conducting a trial of a new medical device to treat liver disease on a group of patients with severe alcohol-related liver failure.  Results have already shown that that patients’ liver damage can be reversed, which can dramatically improve a patient’s quality of life.  The new device, called an alfapump, is manufactured by the Swiss medical device company Sequana Medical and may radically change the treatment options for patients with severe liver disease in the future. Liver disease impacts the…  

Johnson & Johnson Settles Hip Implant Case Two Weeks Before Trial

Last week, Johnson and Johnson settled a bellweather case that was scheduled to commence on October 15, 2013 in California.  Plaintiff in that action claimed that his injuries were allegedly caused by the company’s ASR metal-on-metal hip implants.  The case is Ottman v. Johnson & Johnson, No. CGC-12-517391, in California Superior Court. The terms of the settlement are confidential. Another bellweather trial involving the company’s hip implants is scheduled to take place in early 2014 in Los Angeles. Johnson & Johnson and its subsidiary DePuy…  

Philips joins Allies in Effort to Test “Focused Ultrasound”

Philips and the Focused Ultrasound Foundation have collaborated with The Institute of Cancer Research (ICR), London, and The Royal Marsden NHS Foundation Trust to create a focal point for ultrasound therapy research at the ICR and The Royal Marsden in London.  The new initiative will be a state-of-the-art resource for clinicians and scientists in oncology working with high intensity focused ultrasound therapy.  Its goal is to develop clinical evidence and establish best practices, standards and procedures and train those who will deliver that care. Focused…  

FDA Releases New Guidelines for Oversight of Clinical Trials

This past week, the Food and Drug Administration released Guidance for Industry on “Oversight of Clinical Investigations – A Risk-Based Approach.”  The purpose of the Guidance is to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for clinical studies of medical devices, human drug and/or biological products. While these guidelines are not mandatory, they do reflect the FDA’s thinking on the topic and are certainly industry-based recommendations. In this new Guidance, the FDA describes strategies that reflect a modern, risk-based approach…  

FDA Says Intuitive May Have Failed to Test Some Da Vinci Robots

The United Stated Food and Drug Administration said Thursday that the robotic surgical device manufacturer Intuitive Surgical Inc. may have failed to test some of its da Vinci robotic surgical system equipment in accordance with acceptable factory testing standards. According to the FDA, Intuitive has informed customers that 30 devices may not  reached compliance standards; the agency has called the action a “class 2 recall”  (“a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health…  

Supreme Court Holds that State Law Tort Claims Regarding Labeling of Generic Drugs are Preempted

In Mutual Pharmaceutical Co. v. Barlett, plaintiff Karen Bartlett alleged that she took Mutual’s generical non-steroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.  She suffered a rare hypersensitivity reaction three weeks after she started taking and she was left severely disfigured with burn-like lesions over two-thirds of her body.  The plaintiff’s action was based upon a design defect theory after her failure-to-warn claims were dismissed prior to trial and the district court rejected the defendant’s preemption defense. A…  

Endo Settles Some Vaginal Mesh Lawsuits for $55 Million

An Endo Health Solutions (ENDP) Inc. agreed to pay $54.5 million to settle some lawsuits that allege that its vaginal-mesh implants eroded in some women and left them incontinent and in pain. Officials of American Medical Systems, Inc.,  (AMS) which manufactures vaginal-mesh devices, including Perigee, Apogee, and Elevate, said it was paying to resolve an undisclosed number of suits. Endo representatives earlier this years said that suits filed over the implants had risen to about 5,100.  Endo acquired AMS for $2.9 billion in 2011. Endo…  

Intuitive Not Negligent in Training Doctor To Use da Vinci Robot

A jury in Washington State found Intuitive Surgical Inc. not negligent in the training of a doctor who performed surgery on a patient using its da Vinci robot surgical system.  The patient, Fred Taylor, later died. The jury in Port Orchard, Washington, reached their 10-2 verdict after a five-week trial.  It was the first of at least 26 lawsuits against Intuitive involving its da Vinci robotic system.  Taylor suffered multiple medical complications after surgery to remove his prostate gland in 2008 and died last…  

Food and Drug Administration Sends Letter to Biosense Technologies Regarding Urinalysis Phone App

After months of complaints from experts that the uCheck app is a medical device that failed to seek FDA approval, the U.S. Food and Drug Administration send a letter this week to Biosense Technologies, the maker of uChek smartphone-enabled unrinanalysis system instructing it to seek 510(k) clearance of its mobile medical application or to convince the FDA that such clearance is not necessary. James Woods a deputy director with the FDA, stated in the letter, “Please note that though the types of urinalysis dipsticks…  

DePuy Wins Second Hip Implant Trial

After a five-week trial, an Illinois jury made up of seven women and five men reached its verdict, just one day after it started deliberations, and it was in favor of the Johnson & Johnson subsidiary DePuy Inc. In Carol Strum v. DePuy Orthopaedics, plaintiff claimed that the ASR XL implant she received in 2008 had a defective designed that caused it to shed large amounts of debris from metal-on-meal ware and made it prone to premature failure. DePuy had argued over the course of…  

Food & Drug Administration Admits It Could

Food & Drug Administration (FDA) Commissioner Margaret Hamburg testified before the U.S. House Energy and Commerce Committee’s Oversight panel about the agency’s actions leading up to the outbreak of meningitis that was linked to a compounding pharmacy last year and admitted that she regretted that the FDA did not do more and was not more directly engaged. She also acknowledged that the FDA had stopped conducting routine inspections of compounders as it developed a guidance documents for their regulation.  The FDA had stopped inspections because…