This expert has over 30 years of experience in family and addiction medicine. After gaining his BS in pharmacy at Temple University School of Pharmacy, his degree in osteopathic medicine at the Philadelphia College of Osteopathic Medicine, and completing his residency in family practice at Underwood Memorial Hospital, he served as a staff physician in family practice at numerous northeastern hospitals and clinical practices. He is board certified in both family ...
This highly qualified pharmaceutical safety expert earned his BS in biochemistry and molecular biology at the University of Maryland before beginning his impressive career as a pharmaceutical scientist. He formerly worked as a research scientist at Alpharma Inc, as an associate research scientist at Purdue Pharma, and as a staff scientist at Covance Laboratories. He went on to become a research scientist and a scientist III at Actavis. Finally, he worked as a senior ...
This expert earned his BA in business law from Arizona State University. After graduation, he started and ran his own successful vape company for several years. In 2018, his local company was bought by a large national vape company, where he currently works as the Director of Arizona Operations....
This expert has over 20 years of experience in pharmaceutical regulation and compliance. He earned his BA from Harvard College and his JD from Harvard Law School. His areas of expertise involve the regulation, compliance, governance, and enforcement of the pharmaceutical industry, including discovery, development, manufacturing, marketing, and sales. He previously served as a trial attorney for the US Department of Justice and as the senior vice president of ...
This qualified expert has over 20 of experience years in the field of medical devices with an expertise in injectable drug technologies. Throughout his career, this expert has been employed by and consulted with multiple medical device and pharmaceutical companies and has gained significant experience in technological analysis, medical device engineering and manufacturing, product compliance, and testing and investigation. Currently, this expert is the president and ...
This highly-qualified expert has decades of experience working in medical device regulation and compliance. He earned a BS in chemistry as well as metallurgical engineering from the University of Notre Dame, an MS in regulatory affairs at Northeastern University, and an MBA in international business at Indiana University. He is a certified quality biomedical auditor and a certified medical device investigator. He has served as a consultant of medical device regulation ...
Dr. Stephen Amato has over 24 years of experience in Healthcare: Pharmaceuticals and Law & Legal: FDA & Drug Safety. He earned his BA in Biochemical Sciences from Harvard University, his Ph.D. in Molecular and Cellular Biology from Boston College, and his MBA in Marketing from Boston College. Today, this expert has Regulatory Affairs Certification by the Regulatory Affairs Professional Society and Private Pilot License by the Federal Aviation Administration. He is also ...
Dr. Amy Egan has over 15 years of experience in FDA Drug Safety and Regulatory Oversight. She earned her BS in Biology from Santa Clara University, her MD from Loyola University Stritch School of Medicine, and her MPH from Johns Hopkins Bloomberg School of Public Health. She completed her internship and residency in Internal Medicine at Evanston Northwestern Healthcare. Today, this expert is board-certified in Internal Medicine by the American Board of Internal Medicine. ...
Prof. Robin Feldman has 32 years of experience in the fields of Intellectual Property, Health, and Medicine. She earned her BA in International Relations from Stanford University and her JD from Stanford Law School. Formerly, this expert served as a Law Clerk at the United States Court of Appeals for the Ninth Circuit. Currently, she serves as the Director of the Center for Innovation, as an Albert Abramson ’54 Distinguished Professor of Law Chair, and as an Arthur J. ...
This expert has over 20 years of experience in the consumer brand industry. He earned his BS in marketing from Michigan State University and his MBA in marketing and strategy at the University of Pittsburgh. This expert has held multiple leadership roles at various food and beverage companies leading them to strategic scale. Formerly, he has served as a manager at Tetra Park, brand director at PepsiCo/SoBe, and chief marketing officer for Fuze Beverages. This expert then ...
This highly-qualified expert has over 30 years of experience as a market analyst and consultant specializing in the coffee industry. She earned her BS in marketing and management at SUNY Albany and is an active member and past president of the Internation Women's Coffee Alliance. In addition, she is a member of the Specialty Coffee Association of America and the ICE Research Program. This expert regularly contributes articles to industry publications such as Coffee and ...
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…