Johnson & Johnson’s Ethicon division tried, as it had before, to have its upcoming federal transvaginal mesh case thrown out of court. The healthcare giant was unsuccessful. On July 8, Judge Joseph Goodwin, who is overseeing about 75,000 federal transvaginal mesh cases in Charleston, West Virginia, ruled that federal preemption […]

A renewed debate about trucker safety is rolling down America’s highways following a vote by the Senate Appropriations Committee that weakens the rest regulations of those who operate 18-wheelers. The rules at risk call for truckers to stay out of the driver’s seat for 34 hours following any 60-hour, seven-day […]

In the state of Florida and other states that use no-fault auto insurance systems, specific issues involving insurance payouts are often part of traffic accident personal injury claims. Florida personal injury lawyers need to address these issues from a local and state perspective to help represent their clients’ interests in […]

MATTHEW K. SCHWENCKE earned his law degree from Stetson University College of Law, where he was a member of Stetson’s award-winning moot court board. While in law school, he served as intern to a federal magistrate judge and also prosecuted misdemeanor criminal offenses as a Certified Legal Intern for the […]

The U.S. Food and Drug Administration (FDA) is considered by many to be the premier safety and health regulator in the world. The agency oversees about one-quarter of all products Americans consume including food, drugs and medical devices. Most Americans assume they are safe with the FDA at the helm. […]

The drumbeat was pretty loud as the government headed toward a shutdown – repeal the 2.3 percent tax on medical devices that was going to partially fund the Affordable Care Act. The medical device lobby called the tax an unfair burden that would hurt the industry and its ability to […]

Last month, the U.S. Food and Drug Administration issued a Safety Communication to set some general guidelines for physicians and patients who have metal-on-metal (MoM) hip implants. Last month the agency also issued a proposed order that would require MoM hip manufacturers to submit premarket approval (PMA) applications before they […]

It is so interesting to delve into how a corporation thinks. Not in that they think like a person – even though the U.S. Supreme Court recently gave corporations First Amendment rights – but in that they groupthink. Take the case of transvaginal mesh. A trial is underway in Superior […]

When our clients discover that their metal-on-metal (MoM) hip has failed and never went through U.S. Food and Drug Administration (FDA) approval for safety and efficacy, they ask – how did that happen? Most Americans do not understand that medical devices are largely unregulated, even for those devices that are […]

By the end of the year, the U.S. Food and Drug Administration (FDA) had stated it would make sure that high-risk medical devices were approved through the most stringent premarket approval (PMA) review process to assure the safety of consumers. But it looks as though that will not happen. High-risk […]