Category Archives: FDA

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Regulatory Recalls

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This Week’s Life Science Headlines

        Litigation

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New Liver Disease Medical Device May Help Cut Number of Transplants

Royal Free Hospital in London is conducting a trial of a new medical device to treat liver disease on a group of patients with severe alcohol-related liver failure.  Results have already shown that that patients’ liver damage can be reversed, which can dramatically improve a patient’s quality of life.  The new device, called an alfapump, is manufactured by the Swiss medical device company Sequana Medical and may radically change the treatment options for patients with severe liver disease in the future. Liver disease impacts the…

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This Week’s Life Science Headlines

        Litigation

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The US Food & Drug Administration is Looking into Whether Morning-After Emergency Contraceptive Pills Fail to Work in Women Over a Certain Weight

The FDA quickly addressed a recent report that European health regulators have ordered a label change on an emergency contraceptive product sold by French drugmaker HRA Pharma under the brand name Norlevo(levonorgestrel). The European authorities now require the drug’s labeling to address the potential that there is diminishing effectiveness of the pill depending upon the weight of the user. According to HRA, the emergency contraceptive begins to lose its effectivness for wormn who weigh more than 165 pounds and is completely ineffective for women…

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Pennsylvania Superior Court Upholds Dismissal of Suit Claiming Paxil Caused Birth Defects

The Pennsylvania Superior Court recently upheld the trial court’s ruling in Thomas v. SmithKline Beecham Corp., 27 Pa.D.&C. 5th 279 (Pa.Commw. Ct. 2012).  Thomas dismissed plaintiff’s wrongful death and survival claims based on her use of the antidepressant drug Paxil during pregnancy as time barred.  She ingested Paxil during her pregnancy and she was subsequently informed in 2001 that a fetal echocardiogram revealed that her fetus had congenital heart defects.  Three days later she chose to undergo a therapeutic abortion at less than…

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FDA Issues Warning on Philips Healthcare Defibrillators

On Tuesday, the Food and Drug Administration issued a warning that thousands of defibrillators manufactured by Philips Healthcare may malfunction during medical emergencies due to an electrical component failure.  The devices, called automated external defibrillators (“AED”), are used by consumers and first responders to restore patients’ heartbeats after cardiac arrest.  According to the FDA, Philips first issued a recall of 700,000 devices in September 2012 because of an internal electrical failure that could mistakenly indicate that the device was ready to be used.  The recall…

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This Week’s Life Science Headlines

        Litigation

Continue Reading....

This Week’s Life Science Headlines

        Litigation

Continue Reading....