FDA Again Strengthens Requirements For Mesh

Mesh warnings from the U.S. Food and Drug Administration (FDA) are nothing new, but last week the FDA announced that surgical mesh to treat pelvic organ prolapse (POP) will be reclassified as a Class III (or high risk) medical device. Part of the FDA press release also indicated that manufacturers will need to receive premarket approval (PMA) for their safety and effectiveness in order to keep selling their product.

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Jury Awards Over $12 Million in Johnson & Johnson Mesh Trial

Yesterday, a Philadelphia jury ruled Johnson & Johnson (J&J) must pay an injured woman $5.5 million in compensatory damages for its negligence over the defectively designed Prolift pelvic mesh. Today, the jury also awarded her $7 million in punitive damages – a sum intended to punish Johnson & Johnson for having marketed an unsafe product.

This was the second product liability trial involving Prolift mesh, one of the most widely used pelvic meshes produced. The first Prolift trial of Linda Gross in 2013 resulted in a $11.1 million ruling for Ms. Gross but did not find the mesh was defective in its design. That verdict is still under appeal.

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Angel Reyes Blog - Why We Don't Care About Automobile Fatalities

Statistically speaking, flying in a commercial airliner is one of the safest forms of travel. But if an airliner crashes and people are killed the incident makes front page and sometimes national headlines and people are scared to death. The same goes for the infrequent railroad accident where a few people are killed. Railroad transportation officials quickly become outraged and publicly call for more safety measures to be put in place to protect passengers.

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Angel Reyes Blog - Powerful Trucking Lobby Impedes Truck Safety Reforms

A recent article in the New York Times, made a very interesting observation. The author stated that “more people will be killed in traffic accidents involving large trucks this year than have died in all of the domestic commercial airline crashes over the past 45 years.” Statistics that are this skewered are sure to spark ones interest as to exactly how are people being killed by 18-wheelers on our nation’s highways and how Congress is being manipulated by the trucking lobby to quell any chance we have at true highway safety reform.

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Angel Reyes Blog - New Analysis Says Antidepressant Paxil Is Unsafe for Teenagers

The benefits of taking the anti-depressant drug Paxil have always been marginal at best and the serious consequences of it’s side effects have been either misrepresented or downplayed. When an initial study of the now-popular antidepressant was conducted on 100 patients with depression-related psychological issues, patients were given 3 different pills and the results of their mood recorded. The first group was given Paxil. The second group was given the existing leading prescription antidepressant, and a third group given a placebo. Results of the study concluded that there was no discernible difference in a standard depression questionnaire given all of the patients. Paxil did rate better on another test of mood measures but this was only on a secondary level.

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Angel Reyes Blog - Arbitration a Legitimate Threat to Our Justice System

Arbitration clauses are becoming an effective tool for employers and certain litigation-prone professions like medical doctors, hospitals, nursing homes and automobile manufacturers to bypass the legal system. The vast majority of people who sign an employment contract, service agreement, or purchase contract have no idea that they are signing away their right to take the company or person to court should a dispute arise.

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Angel Reyes Blog - Smarter People Have Fewer Motor Vehicle Accidents

Even though the roads that we drive on nationwide are getting statistically safer, the improvements to motor vehicle safety have not been shared equally by everyone. A recent study has shown that people with a higher education have a lower probability of being involved in a fatal motor vehicle accident than people with less than a high school diploma. The study in the American Journal of Epidemiology finds that since 1995, most driving safety improvements have gone to people with higher education. And in the lower-educated group, the mortality rate is even increasing.

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Angel Reyes Blog - Johnson and Johnson Targeting Small Children with Risperdal

While Johnson and Johnson enjoys an excellent reputation as one of America’s leading medical companies, it might surprise some people to discover that over 90% of Johnson and Johnson’s net income is derived from sales of pharmaceutical drugs and medical products and not “shampoo and baby powder” that has branded the company “squeaky clean”. And while you’ll rarely hear this coverage in the local media, Johnson and Johnson is coming under fire and losing lawsuits for the way they have marketed their billion-dollar antipsychotic drug Risperdal.

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Angel Reyes Blog - Falling Profits Affect Industry's Safety Policies

According to the Wall Street Journal, the number of workplace fatalities, those who died as a result of a job-related accident, is rising and at it’s highest level since 2008. The data shows that approximately 4700 people died from work-related accidents in 2014, the most recent year statistics were gathered, up from the 4500 or so deaths a year earlier. The largest increase in the fatality rate in terms of demographic was the death rate for female workers which almost doubled from 8% to 13% of all workplace accidents. This trend toward increasing workplace fatalities is troubling for OSHA officials who fear that increases in their safety enforcement efforts money are not having the desired effect of reducing work-related fatalities.

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Angel Reyes Blog - Texting and Driving Now Worse Than Drinking and Driving

Distracted driving has been around as long as driving itself. Whether it is children crying or fighting in the back seat, a puppy jumping around on a driver’s lap, or simply taking one’s eyes of of the road to tune the radio, distracted driving has been the cause of countless motor vehicle accidents and fatalities. It’s just in the last five to ten years that distracted driving has become the number one cause of motor vehicle accidents surpassing driving under the influence of drugs or alcohol. In addition, distracted driving is the number one cause of death in young people under the age of 33. The primary reason for the surge in distracted driving accidents is the explosion of smart phone usage and using your device to send and receive text messages and receive and review notifications.

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