This is the full text of a letter written by Rep. Mike Fitzpatrick (R-PA) to Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health for the FDA in which a congressman questions FDA over Essure Data.
Health & Medicine
In an unsurprising case of “duh!” federal investigators from the Government Accountability Office (GAO) came to the conclusion that the FDA is not doing well at one of its main responsibilities. The FDA is failing to properly track drugs after they hit the market. The GAO, Congress’ nonpartisan investigative department, discovered problems.
According to a statement from the FDA, “Cybersecurity threats to medical devices are a growing concern. The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices.” The agency has issued draft guideline to medical device makers as to how they can protect consumers from these cybersecurity issues.
U.S. District Judge F. Dennis Saylor IV said, “No!” to GlaxoSmithKline PLC’s latest move in the MDL the Big Pharma giant is in over its anti-nausea drug, Zofran. The plaintiffs claim that the “off-label” use of the drug for morning sickness caused birth defects. The GSK motion to dismiss in Zofran MDL denied.
Stryker, the Michigan-based medical device company, recently announced its acquisition of Sage, an intensive care product manufacturer. Stryker paid $2.76B to acquire Sage. The acquisition allows Stryker access to Sage’s main customer base, hospitals. Stryker will be better able to market its own products through these connections.
It reads like something out of an espionage thriller: major medical device company smuggles counterfeit materials into the U.S. and causes massive injuries to an unsuspecting public. Unfortunately, it’s far from fiction. A West Virginia plaintiff is suing claiming medical device maker Boston Scientific used counterfeit resin in vaginal mesh product.
Pfizer may have got a lucky break in the Lipitor multidistrict litigation (MDL). The popular statin drug used to treat high cholesterol has been linked to the development of type-2 diabetes. Based on a recent judicial order, the Lipitor MDL plaintiffs may be facing summary judgment in Pfizer’s favor. Is this Lipitor litigation’s last gasp?
Over 25,000 women (and many men, too!) around the U.S. are holding their collective breath waiting for a federal judge in Philadelphia to decide whether five suits against Big Pharma giant Bayer will proceed. The focus of the cases: did Bayer violate FDA rules regarding Essure? If the cases move forward and the plaintiffs win,
It’s that time of year, the dreaded cold and flu season. Many of us are used to heading for the doctor’s office at the first change of color in our mucus or for persistent coughs. Sometimes, these trips are proper. I had an upper respiratory infection the week before Christmas and my doctor gave me symptom-managing prescriptions that made life bearable. She did not, however, give me antibiotics; this was also the proper course of action. Antibiotic overuse creates health problems and isn’t always beneficial in treating the original illness.
One of the U.S.’ Big Pharma giants is opening the checkbook over an old drug, but this time the investors are getting the payout. Merck feels pain of securities settlement over now-recalled Vioxx pain reliever. The $830M settlement brings to a close a federal class action suit in which Merck’s investors claim the company didn’t adequately inform them of the risk of heart disease caused by Vioxx.