Author Archives: Michael D. Shalhoub

Eleventh Circuit Rejects Plaintiff’s Expert Evidence on Daubert Grounds

An important and interesting Daubert opinion was issued yesterday by the 11th Circuit which affirmed the trial court’s Daubert preclusion order against the plaintiff’s experts in litigation seeking to prove that the use of a denture adhesive causes neurological disease.  The decision sets forth the infirmities in the plaintiffs’ expert evidence under Daubert standards. This blog post will be short and reportorial, rather than analytic, because the authors have worked extensively for the defense in the denture cream litigation, and on the Chapman case itself,…

Continue Reading....

Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. To read the rest of this blog entry, authored by Jesse D. Rutter of Goldberg Segalla, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation.

Continue Reading....

First New York Court Rejects Controversial Drug Developer Liability Rule

In a controversial 2008 decision in Conte v. Wyeth, Inc., 168 Cal. App. 4th 89 (Cal. Ct. App. 2008), a California Court of Appeals held defendant drug developer, Wyeth, Inc., liable for inadequate warnings in connection with the plaintiff’s use of a competitor’s generic version of the gastrointestinal reflux drug Reglan. The court in Conte held “the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product,…

Continue Reading....

The Manufacturer Made Me Do It – One Claim By Negligent Surgeon Survives

California certainly breeds interesting cases. In the Chao case, available here, recently decided by a federal judge in the Southern District of California, the plaintiff was not an injured person. He was an orthopedic surgeon found to be negligent in his treatment of a patient by an arbitration panel, which awarded in excess of $2 million to the patient. The surgery was a hip replacement surgery during which the surgeon lacerated the patient’s femoral artery. Following the award, the orthopedic surgeon brought an indemnity action…

Continue Reading....

D.C. Circuit to Determine if FDA can Regulate Stem Cell Treatments

The intersection of what is the practice of medicine and what is a regulated drug or biologic is an interesting place with constitutional and regulatory implications. These issues have come to the forefront in a significant case involving an autologous stem cell procedure used by an orthopedic group in Colorado.  In United States of America v. Regenerative Sciences, LLC, 878 F. Supp. 2d. 248 (D.D.C. 2012), available here,  a D.C. district court judge issued an opinion addressing many of these constitutional and regulatory issues, which…

Continue Reading....

FDA e-Learning Course on Evaluating Drug Promotion

Off label promotion of drugs and devices is an issue that the FDA looks at very closely. Such off label promotion risks the product being viewed as misbranded which has significant regulatory and litigation risk. Companies and the lawyers that represent them in these kinds of cases are well aware of the importance of vigilance in preventing off label promotion. The FDA is now taking an educational role for consumers and health care providers. Together with Medscape, it is offering a continuing education course, intended…

Continue Reading....

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…

Continue Reading....

Generic Drug Manufacturer Loses Battle on Preemption, But Wins War on Causation

Are state law claims against a generic drug manufacturer preempted where labeling of the generic drug differs from the brand name drug labeling?  In a recent drug liability case decided in the federal district court in Arizona, the court said no and held that the plaintiff’s claims were not preempted.  Nevertheless, the court concluded that the plaintiff’s physicians did not read or rely on the labeling and, therefore, Arizona law required dismissal of the plaintiff’s claim.  The case is Carter v. APP Pharmaceuticals and can…

Continue Reading....

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

Continue Reading....

New FDA Guidelines on Medical Device Mobile Apps

Scores of apps are available in the iTunes Store and the Android equivalent that are related to health and well being. This past week FDA issued a guidance (FDA Guidance for Mobile Apps) for Mobile Medical Applications which provides critical and much needed guidelines for industry as to which mobile medical apps are and are not going to be regulated by FDA as a medical device.  Last Thursday the FDA also engaged in a Twitter chat meeting for a question and answer session…

Continue Reading....