Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Looks Can Be Deceiving (and Costly): The Legal Implications of Counterfeit Products to a Pharmaceutical Manufacturer
The World Health Organization has estimated that drug counterfeiting affects 5-8% of all drugs, representing approximately $10-$15 billion to the U.S. pharmaceutical market alone. The Food and Drug Administration has estimated that approximately 10% of the drugs in worldwide distribution are counterfeit, with most being sold in developing countries. Not surprisingly, the most commonly counterfeited drugs are those with the largest sales, as well as drugs with high profit margins and drugs that are easier to counterfeit.
The FDA has stated that, in recent years, counterfeiting has moved into the area of finished pharmaceuticals, more so than to the counterfeiting of bulk drug ingredients. Moreover, with the increase in sales of drugs over the Internet, the agency is becoming even more concerned about the prevalence of drug counterfeiting, and the increasing ease by which counterfeited drugs may be distributed into the marketplace.
The costs of counterfeit products to pharmaceutical companies can be enormous and the legal implications daunting. Negligence, product liability and breach of warranty are only some legal theories that a plaintiff's lawyer may use to challenge companies when counterfeited versions of their products surface. In addition, manufacturers doing business outside of the United States (particularly in developing countries) must be aware that sales of counterfeit drugs in those countries could lead to legal action being taken against them, where the legal system may be significantly different from that of the United States. Of course, sales of counterfeit drugs outside the United States can also expose a drug company to liability at home.
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?