Category : Pharmaceutical Liability
FDA Says Avandia Linked to Cardiac Injuries, Recommends Pulling Drug off Market
If every person on anti-diabetes drug Avandia right now were to switch to a less risky alternative, there would at least 500 fewer cases of cardiac arrest and 300 fewer cases of heart failure every month. Those statistics come from a Food and Drug Administration report, which has been published by the New York Times.
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Pfizer Fined Record Civil Penalties over Off Label Marketing of Drugs
The world’s largest pharmaceutical company, Pfizer Inc., has agreed to pay record civil and criminal penalties amounting to $2.3 billion, over allegations that it promoted four of its medications for off label purposes.
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Zicam Cold Remedy Products Recalled after FDA Issues Warning
Matrix Initiatives Inc., the company that manufactures Zicam Intranasal Cold Remedy Products has recalled these products after it received a warning letter from the Food and Drug Administration. The FDA sent a warning letter stating that the products have been linked to anosmia, or loss of the sense of smell. The condition can be either temporary or permanent.
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Ceramic Artificial Hips May Harbor Defects
On the surface of it, it seems like it’s really not something to be overly concerned about. But add the possibility that it could be the harbinger of more serious dangers, and you begin to take the squeaking very seriously indeed. Many patients who have been fitted with ceramic hips are beginning to discover that their new hip squeaks as they walk, bend, or engage in otherwise routine behavior.
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Heart Devices could be Hacked, say Researchers
Hundreds of thousands of patients in the United States who have pacemakers implanted in their hearts might have a new danger to worry about, and it has nothing to do with the malfunctioning of their device. The new risk, as reported in the New York Times, comes from the potential for hacking of the pacemaker. It might seem like the plot of a sci-fi thriller, but although experts say there is no cause for concern, you have to wonder how much of a security risk this could pose.
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Irvine California company to pay $40 million to Heart Patient
A jury has awarded a Washington resident a sum of $40 million in compensation for the damage his heart received during a surgery at the Providence Everett Medical Center in September 2004. The man, Paramjit Singh, checked into the hospital in October 2004 for cardiac bypass surgery. While the surgery was in progress, a monitor malfunctioned and caused the catheter that was in his heart to overheat and caused his heart to get burned. The damage was so severe that Singh needed a heart transplant. Since then, Singh has reportedly been on anti-rejection drugs and has suffered other health problems as a result of the injury.
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Vioxx Set to Face Multiple Lawsuits
Even Merck’s proposed $4.85 billion settlement, which is to be endorsed by close to 44,000 plaintiffs, might not sound the end of all legal trouble for the company. It still finds itself facing a barrage of lawsuits from all directions, all of them related in some way to the Vioxx fiasco.
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Supreme Court Tie Allows Lawsuits Against Pfizer
The world’s largest drug maker, Pfizer, has suffered a setback as a deadlocked Supreme Court tied in its decision to reinstate a lower court ruling that would allow Michigan residents to sue the company.
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Wyeth to Pay Woman $2.57 Million Over Hormone-Replacement Drugs
Wyeth has had their first loss in a series of lawsuits over its hormonal replacement therapy drugs Premarin and Prempro. A jury has awarded a woman in Little Rock, Arkansas a sum of $2.75 million.
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Bayer Drug Trasylol Linked to Heart Attacks, Strokes
It’s a sad state of affairs that we’ve come to expect ineptitude from the FDA, a body that is entrusted with making sure that Americans have access to safe drugs. Once too often, we’ve see the agency fall flat on its face, like the scandal recently where the FDA approved drugs manufactured by a Chinese plant that it hadn’t seen the inside of in years.
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