Testosterone

Legal Developments
AbbVie Inc. Rejects $140M AndroGel Verdict

Last month, the U.S. District Court in Northern Illinois awarded $140 million to plaintiff Jeffrey Konrad after he suffered a heart attack following prescribed use of AndroGel. Manufactured by AbbVie Inc., AndroGel is a topical replacement testosterone therapy for daily use by adult males with low or no testosterone.

Just last week, AbbVie publicly rejected the jury’s finding that they “misrepresented and concealed AndroGel’s harmful side effects,” calling for Judge Matthew Kennelly to either reject the verdict or significantly reduce the award amount.

This is the second trial marking AbbVie’s defeat. The first trial also resulted in a $150 million award, which they are appealing.

Mental Wellness

Veterans’ Health
Mental Health Services Expanded for Some Veterans

Just two days after a U.S. Air Force veteran shot and killed 26 people in a Texas church, the House has passed legislation broadening some veterans’ access to mental health care.

The Hill reports that until this legislation goes into effect, only veterans with an other-than-honorable discharge are eligible to receive mental health assessments and services. When it does go into effect, it will serve “former military service members discharged under conditions that were not honorable who participated in combat operations or experienced sexual abuse.”

No comment has yet been given as to why veterans with a disorderly or bad conduct discharge will not be covered by the bill.

Invokana

Drug Developments
New Invokana Study Results in Renal Improvement

Currently the top prescribed sodium-glucose cotransporter 2 (SGLT2) in the U.S., Invokana has once again been the focus of a renal-based CANagliflozin cardioVascular Assessment Study (CANVAS) spanning over six years. One of the study’s major findings was a 47% reduced rate in end-stage kidney disease.

First approved by the U.S. Food and Drug Administration (FDA) in 2013, Invokana’s main functions are to block the reabsorption of glucose in the kidney, increased glucose excretion, and lower blood glucose levels.

Just last year, the FDA strengthened its warning of Invokana use to reflect an increase in the risk of leg and foot amputations. To date, this warning is still in place.

IVC Filters

Device News
IVC Filter Placements Declines

The 2010 FDA warning about the risks of long-term Inferior vena cava (IVC) filter use seems to have resonated with the public. According to Med Page Today, the number of IVC filter placements has steadily declined across the U.S. since then.

Healio reports: “Among U.S. regions, the mid-Atlantic had the highest rate of IVC filter placements per 100,000 hospital discharges in 2014 (387), with the Pacific had the lowest (251).”

IVC filters were designed to protect against stroke and pulmonary embolism by stopping blood clot migration to major organs. Both retrievable and permanent filters have caused serious complications that involve hospitalization, including inadvertent arterial puncture, and vein or organ perforation.

Hernia Mesh

Studies
Synthetic Hernia Mesh Fails in Latest Study

Five types of synthetic and biological mesh were recently studied over 180 days on an inflamed incisional hernia, and synthetic mesh resulted in far more complications.

Synthetic hernia mesh has long been reported to cause serious injury and hospitalization. Lawsuits have become recalls after many plaintiffs claim synthetic mesh is not compatible with human tissues. Its plastic composition has led to infections and abscesses. In contrast, biological mesh consists of tissues from cadavers or animals, making incorporation much easier.

Due to an increase in hernias, the global hernia mesh market could reach nearly $200 million by the year 2025.

In February 2016, an EU-funded Green Nano Mesh was launched in Ireland to create “biodegradable nano- and micro-scale fibrous hernia meshes.” Development research is continuing.