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Medical Legal
Bio-Rad Labs Resolves FCPA Investigation with SEC and DOJ For $55 Million;…
Bio-Rad Labs recently agreed to pay a $14.35 million dollar penalty to resolve DOJ allegations that its subsidiaries…
Takeda, Lilly Have $9 Billion Punitive Damage Reduced to $37 Million in…
In April, we wrote that Asia's biggest pharmaceutical company, Takeda, and their marketing partner, Eli Lilly, faced $9…
Novartis Kickback Case Will Continue, Rules Federal Judge; What We Can…
Novartis must continue to litigate over its speaker programs, District Court Judge Paul G. Gardephe ruled earlier this…
RICO: Offering Co-Pay Coupons Does Not Constitute A Racketeering…
Pharmaceutical manufacturer co-payment coupons have come under a lot of scrutiny recently. HHS-OIG recently warned these coupons…
Ivy Sports Medicine v. Burwell, et al.: FDA May Not…
FDA does not have “inherent reconsideration authority” to reclassify medical devices without notice and a comment…
American Hospital Association Supports Stark and Anti-Kickback Safe Harbors…
In August, House Ways and Means Subcommittee on Health Chairman, Kevin Brady (R-TX), released the Protecting Integrity in…
False Claims Act: Device Maker Settles For $8 Million For Allegedly Selling…
An interesting False Claims Act issue cropped up in a recent $8 million settlement involving U.K.-based medical device…
Anti-Kickback Alert: Pharmaceutical Manufacturer Copayment Coupons and…
Pharmaceutical manufacturers routinely offer copayment coupons to reduce or eliminate the cost of patients'…
FCA Allegations Dismissed Against Pharmacies For Allegedly Overbilling…
A New York federal judge recently dismissed two separate cases brought by Fox Rx Inc.--one against Omnicare, the other…
PhRMA and DOJ Go Back and Forth Over Off-Label Speech and the First…
A whistleblower’s False Claims Act (FCA) suit in the Eastern District of California has caught the attention of the…