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 nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma in nursing from Evanston Hospital School of Nursing before earning her BS in ...
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 highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former ...
This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. ...
This expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the ...
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 has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods verification of New Drug Applications and Abbreviated New Drug ...
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 FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a ...
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 House Committee on Oversight and Reform recently released a report showing that seven popular brands of baby foods are contaminated with toxic heavy metals, such as inorganic arsenic, lead, cadmium, and mercury. Both the Food and Drug Administration (FDA)…
The regulation of electronic cigarettes—often called e-cigarettes—has yet again come before the federal appeals court. Last week, a unanimous panel of the D.C. Circuit U.S. Court of Appeals ruled that the U.S. Food and Drug Administration had the authority to…
There appears to be no slowing down for litigation surrounding JUUL, the electronic cigarette company named in a flurry of lawsuits in the past few years. Most recently, a derivate shareholder lawsuit was filed against Altria Group, a major investor…
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 Class I recall, the most serious type of FDA recall, announced the regulatory agency’s discovery that the insulin pumps were incorrectly dosing insulin and that use of the devices could cause serious injury or death. At least two lawsuits…
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,…
The oral anticoagulant Rivaroxaban, otherwise known as Xarelto, is yet another blood thinner at the center of a mass-tort action for its harmful effects on patients. Close to 3,000 lawsuits filed across the country have been consolidated into a multidistrict…
If you suspect a problem with a medical device, either that the device malfunctioned or that the device’s design makes it suspect to cause related problems in a patient, there is quite a bit of public data available to research…
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 Eastern District of Pennsylvania Jurisdiction: Federal Case Name: Ctr. City Periodontists, P.C. v. Dentsply Int’l, Inc. Citation: 2017 U.S. Dist. LEXIS 115373 Facts The plaintiffs, a group of dental professionals, brought a class…
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 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…