This highly-qualified expert in chemistry and pharmaceuticals has 20 years of experience in his field. He has experience with analytical chemistry analysis, formulation chemistry, and FDA regulation, and his work has involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug formulation, stability studies and the management of CROs. He earned his BA ...
This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he ...
This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), ...
This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence.
Her experience includes serving as a member of the ...
This certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. ...
This extremely qualified clinical expert is an internationally recognized clinical pharmacist, author, patient advocate, and expert in patient adherence with medications and the development of multi-component patient education programs that increase patient adherence from worldwide clinical trials through product launch through post-marketing stages and increase patient safety. She has expertise in the translation of complicated medical terminology into language the ...
This expert has been practicing anesthesiology at a 600 bed hospital in Southern California for nearly a quarter century. A graduate of UC Riverside, he attended medical school at Loyola Stritch School of Medicine in Illinois and thereafter completed residencies in General Surgery and Anesthesiology at Loma Linda University Medical Center. A diplomate of the American Board of Anesthesiology and an active member of the American Society of Regional Anesthesia and Pain ...
This expert has decades of experience in pre-clinical through Phase IV research. Apart from standard statistical methods, he has special expertise in adaptive methods, recurrent event methods, experimental design, assays, mathematical modeling and simulation, data-mining and super-computer applications. As an independent statistician he serves on numerous data and safety monitoring boards and regularly interacts with FDA and EMA personnel on behalf of his clients. With ...
In early January 2021, U.S. District Court Judge Robin Rosenberg moved to dismiss economic damages and design defect claims against major drugmakers in the ongoing Zantac multidistrict litigation. Judge Rosenburg ruled that these claims against Sanofi, GlaxoSmithKline, Pfizer, and Boehringer…
The announcement comes just months after Bayer agreed to a $12.1 billion plan in June to settle various lawsuits it had inherited from its $63 billion acquisition of Monsanto. This most recent deal was reached to settle a portion of…
The FDA receives thousands of reports each year detailing the deaths, serious injuries, and malfunctions associated with medical devices. This is in order to monitor the safety and performance of medical devices. As a service to device manufacturers, physicians, patients,…
Co-authored by Kelly Lhungay. Stryker Orthaepedics is a medical equipment firm which develops and produces hip implants, among other medical equipment. Stryker’s Rejuvenate Modular Hip System, a hip replacement device, was first introduced in 2009. It was marketed to younger…
On February 19, 2013, the first of over 3,000 Actos lawsuits went to trial in the Superior Court of California. The plaintiff in the case alleged that Takeda Pharmaceuticals, Asia’s largest drugmaker and Actos manufacturer, was negligent in presenting the…
The da Vinci Surgical System is an advanced medical device used to perform surgery, which is produced by Intuitive Surgical Inc. In recent months, a number of complaints have been levied against users of the surgical system, and, perhaps more…
Court: United States District Court for the Eastern District of Pennsylvania Jurisdiction: Federal Case Name: Blue Cross Blue Shield Ass’n v. GlaxoSmithKline LLC Citation: 2019 U.S. Dist. LEXIS 168107 A group of health insurance firms alleges they purchased improperly manufactured…
In this product liability case, the court must determine whether the oncology expert witness’s testimony is admissible under the Daubert standard. Specifically, the drugmaker defendant asserts the expert’s opinions on alternate dosing schedules and product labeling oversteps his area of…
Court: United States District Court for the Southern District of West Virginia, Charleston Division Jurisdiction: Federal Case Name: Winebarger v. Boston Sci. Corp. Citation: 2015 U.S. Dist. LEXIS 53892 Facts This Multi-District Litigation involved the use of transvaginal surgical mesh…
Court: United States District Court for the Middle District of Alabama, Northern Division Jurisdiction: Federal Case Name: West v. Janssen Pharms., Inc. Citation: 2017 U.S. Dist. LEXIS 124276 Facts This case involves two plaintiffs, West and Harper, who alleged that…
Court: United States District Court for the Eastern District of Pennsylvania Jurisdiction: Federal Case Name: Ctr. City Periodontists, P.C. v. Dentsply Int’l, Inc. Citation: 321 F.R.D. 193 Facts The plaintiffs brought this action against the defendants for breach of express…
This case involves a hip replacement device MDL. It was alleged that the device manufacturer did not provide proper adverse event reports to the FDA as the data was coming in. An expert in FDA regulations was sought to discuss how…
This case involves a distribution rights dispute between a skincare products company and another member of their LLC. The defendant company had exclusive worldwide distribution rights for certain products supplied by the plaintiff entity. However, under their contract, the plaintiff…
This case involves the alleged improper marketing of a particular opioid pain medication by a defendant pharmaceutical company. The allegations claimed that the defendant fraudulently marketed the drug in question for off-label uses and that the defendant was negligent in their…
This case involves numerous plaintiffs who suffered complications related to a birth control medical device. The plaintiffs suffered perforation of the uterus and other organs, migration of the device throughout the body, as well as immune reactions to the device…