Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
In the Spotlight
On May 9, 2003, the U.S. Attorney's Office for the District of Massachusetts announced that Bayer Corporation, the pharmaceutical manufacturer, had been sentenced and ordered to pay a criminal fine of $5,590,800 stemming from its earlier plea of guilty to violating the Federal Prescription Drug Marketing Act by failing to list with the FDA its drug product, Cipro, that was privately labeled for an HMO. Such listing is required under the federal Food, Drug & Cosmetic Act. The Federal Prescription Drug Marketing Act, Pub. L. 100-293, enacted on April 22, 1988, as modified on August 26, 1992 by the Prescription Drug Amendments (PDA) Pub. L. 102-353, 106 Stat. 941, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. ” 331, 333, 353, 381, to establish requirements for distributing prescription drug samples.
The guilty plea by the company was entered into as part of a global settlement reached with the government that also requires Bayer to pay over $255 million to resolve its civil and criminal liabilities in connection with the scheme by which it allegedly sold re-labeled products to an HMO at deeply discounted prices, and then concealed its obligation to pay millions in rebates to Medicaid. As part of the announced settlement, Bayer agreed to settle its civil liabilities with 49 states and the District of Columbia for losses suffered from the company's failure to report the price of the private label Cipro, and later Adalat CC, as its best price for those drugs.
According to the release, the government's investigation stems from a qui tam suit filed by a former manager at Bayer, who also reported the conduct to law enforcement authorities. The press release is posted at www.usdoj.gov/usao/ma/presspage/May2003/
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.