Joseph J. Welter

All articles by Joseph J. Welter


Congress to Codify FDA Recent Decision Not to Seek Enforcement of Low Risk Mobile Medical Apps

On September 25, the FDA released a guidance document related to Mobile Medical Applications (“MMAs”), which provided critical industry guidance as to which MMAs will be considered medical devices and subject to regulation by the FDA.  On September 30 we reported on these new rules (click here) and on October 23 we also presented a webinar entitled “Mobile Medical Apps: FDA Regulation and Product Liability Implications” which was recorded and is available here.  In particular, the FDA exercised its discretion not to enforce…  

Webinar: Mobile Medical Apps: FDA Regulation and Products Liability Implications

Sign up today for a free webinar on Mobile Medical Apps: FDA Regulation and Products Liability Implications The webinar will be held from 2-3 p.m. (EDT) Wednesday, October 23, 2013. Click here to register. This webinar will address:
  • An overview of the FDA’s final guidance on MMAs;
  • Predictions for the level of oversight the FDA will exert over MMAs;
  • How the traditional products liability theories of design defect, warning defect, and failure to warn, operate in the MMA context; and
  • Ways in which creators of

FDA Issues Final Rule on Unique Device Identifiers for Medical Devices

On September 20, 2013, the Food and Drug Administration issued a final rule implementing a unique device identifying (UDI) system to identify and track medical devices.  There are two main aspects to these new regulations: (1) rules related to what, when and how devices are to be labeled; and (2) a database designed to identify and track all UDI devices.  The overarching goal of these new rules is to improve the quality of information in adverse event reports, identify problems more quickly, expedite recalls…  

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…  

Bellwether Trials Set in Mirena IUD Birth Control MDL

Selecting bellwether cases for trial is one of the most important strategic decisions a company will face in mass tort and multi-district litigation.  Currently, Bayer is defending approximately 123 lawsuits consolidated into an MDL in federal court in New York.  Some have made projections that the number of cases may grow into thousands – not an uncommon tactic in seeking to leverage larger settlement dollars. In addition to the MDL, there are approximately 200 cases consolidated in New Jersey state court. Mirena is a small…  

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…  

Court Rejects Misrepresentation Claim Against Manufacturer For Ingestion of Others’ Generic Drugs

On July 29, the district court in the Eastern District of Kentucky dismissed several claims against Eli Lilly and Company (Lilly) in which the plaintiffs admitted that they could not prove that they ingested any product manufactured, sold, or distributed by Lilly. A copy of the opinion can be found here. This Multi-District Litigation relates to Darvocet, Darvon, and propoxyphene products, pain medications that the FDA stated in 2009 were linked to “fatal overdoses.” In these particular cases, the plaintiffs conceded that they had…