Philips joins Allies in Effort to Test “Focused Ultrasound”

Philips and the Focused Ultrasound Foundation have collaborated with The Institute of Cancer Research (ICR), London, and The Royal Marsden NHS Foundation Trust to create a focal point for ultrasound therapy research at the ICR and The Royal Marsden in London.  The new initiative will be a state-of-the-art resource for clinicians and scientists in oncology working with high intensity focused ultrasound therapy.  Its goal is to develop clinical evidence and establish best practices, standards and procedures and train those who will deliver that care. Focused…
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Alabama Supreme Court, Latest to Consider Liability for Generic Drugs

The relationship between brand name and generic drugs on the market continues to fuel litigation battles across the country.  On June 24, we reported that the United States Supreme Court held that state-law tort claims against generic drug manufacturers are preempted under the Hatch-Waxman Amendments to the federal Food, Drug and Cosmetic Act. Our June report is available click here.  In July, we reported that the Eastern District of Kentucky dismissed claims against a brand name manufacturer for warnings contained on generic versions of…
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FDA Encourages Pediatric Drug Studies

The U.S. Food and Drug Administration is using its authority under laws passed by Congress in order to encourage and promote pediatric drug studies. The Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA) are laws passed by Congress to increase pediatric drug testing. Prior to BPCA and PREA, 80 percent of drugs given to children were only tested as safe and effective on adults. That number has been reduced to 50% and the goal is to reduce that further. As an…
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New York Federal Court Upholds “Failure to Update” Theory

For those who follow pharmaceutical litigation, the issue of preemption – as discussed primarily by the U.S. Supreme Court in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical Co. v. Bartlett, as well as in a host of other state and federal court opinions – continues to be an important battleground.  Although most courts have rejected the plaintiffs’ efforts to pursue failure-to-warn claims against generic drug manufacturers, based on the generic drug makers’ federal law “duty of sameness,” under which a warning label for a…
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FDA To Require New Warnings on Drugs Containing Acetaminophen of Serious Skin Reactions

The Food and Drug Administration is going to require warning labels be added to prescription drugs containing acetaminophen based on the drug’s association with rare skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP).  The FDA will also be asking manufacturers of over the counter drug products containing acetaminophen to warn about serious skin reactions. The FDA’s action was based on a review of the FDA Adverse Event Reporting System database and the existing medical literature.  The…
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Foreign Manufacturer of Surgical Masks Hit With FDA Warning Letter

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to a manufacturer of surgical masks.  The manufacturer, located in Taiwan, was subject to inspection by the FDA that revealed numerous violations of the Federal Food, Drug, and Cosmetic Act (the act).  The FDA determined that the masks (medical devices) were adulterated and misbranded under the act. Violations included failure to conform with current good manufacturing practice requirements of the Quality System found at Title 21, Code of Federal Regulations (CFR), Part 820;…
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Google Glass v. HIPAA

It is too soon to tell how fast and how far the Google Glass trend will spread.  We have all signed the HIPAA disclosure forms and seen the cover page over the sign-in sheet that “keeps us from seeking the other patients’ name” at the doctor’s office. Will we soon be asked to check our Google Glass at the door?  Reportedly, the Google Glass only needs a line of sight to record images.  If that is true, then wearing the newest, coolest tech gadget could…
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Google Glass – Through a Different Lens

EP Global Communications, Inc. claims that it is in the process of filing over 50 patents to protect a new wave of smart technology. EPGL claims that their technology will allow doctors to use a device such as a Google Glass to view feedback data in real time while performing surgery.  It remains to be seen what specific technology the full arsenal of patents will seek to guard, but we know that their focus appears to be on hands-free technology with a variety of applications.…
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A Potential Godsend to Mothers-to-Be

After a 30-year hiatus, the Food and Drug Administration (FDA) has once again approved a drug to specifically treat morning sickness.  Diclegis, made by Canadian Duchesnay Inc., is scheduled to be available in June 2013.  Diclegis combines Vitamin B6 and antihistamine doxylamine in a time released formula to prevent nausea before it sets in. The same drug combination was marketed as Benedectin from the 1950’s to 1980’s.  Despite no conclusive medical evidence that it caused birth defects and court rulings in its favor, Merrell Dow…
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Medical Device Tax – What is It?

The medical device tax is a 2.3 percent excise tax on the sales price of taxable medical devices.  The tax applies to almost all FDA registered devices.  Those devices range from hip implants to tongue depressors.  The medical device tax has been compared to excise taxes on tobacco and alcohol products. Who is paying this tax? The manufacturer or importer, with limited exceptions.  Thus, companies are losing 2.3 percent off the top of their margins.  Commentators argue that the tax will thwart invention. Others argue…
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