Investors can Continue to Bring Claims Against KV Pharmaceutical
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The U.S. Eighth Circuit Court of Appeals ruled that investors can continue to bring claims against KV Pharmaceutical Co. (KV) for making false or misleading statements to the U.S. Food and Drug Administration (FDA). The ruling was reached […]
FDA Issues New Warning for Popular Type 2 Diabetes Drug
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new […]
FDA Approves New Cholesterol-Reducing Drug
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law The first of a new class of cholesterol-lowering drug was approved by U.S. regulators on Friday. The new medicine is a highly anticipated medical advance that, unfortunately, will have the effect of escalating already growing drug costs. This […]
Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases
Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application). Federal preemption […]
DEA Offers New Prescription Drug Return Policy
By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering […]