Category Archives: Uncategorized

Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…

Continue Reading....

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…

Continue Reading....