Johnson & Johnson Legal Case Analysis, Essay Example

A legal settlement was made between the Federal Government and Johnson & Johnson based on allegations that the company illegally marketed Risperdal and other drugs. The case was based on the misbranding of drugs marketing them for purposes not previously tested and approved by the FDA. An unethical market behavior was also revealed during the case, namely that the company provided financial benefits for physicians at Omnicare, one of the largest pharmacy chains supplying medication for nursing homes. The company put patients at risks of side effects and claimed that the drugs were effective for diseases like dementia and children’s pediatric conditions.

The Prescription Drug Marketing Act (1987) protects the interest of patients, ensuring that all prescribed medication is safe and effective. Further, it does prevent ineffective, substandard and counterfeit drugs. (FDA Website)

§331 of FD&C (Food, Drug and Cosmetic Act, 2010) Chapter 3 states that “making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) is a prohibited act.

§ 355b makes it compulsory for manufacturers and distributors to report adverse effects of medication developed.
The company should have sought FDA approval before marketing the drug for the given purposes.

As a conclusion, the marketing behavior of Johnson & Johnson was not only unethical but unlawful as well, endangering patients and providing financial incentives for physicians to recommend a drug which was not approved by the FDA for the intended purposes, such as dementia and children’s psychotic conditions. Holder, the US Attorney General summarized the case as follows: companies “ “lined their pockets at the expense of American taxpayers (and) patients,” (CNN)

Works Cited

CNN Website. (2013) Johnson & Johnson In $2.2 Billion Settlement Over Drugs Marketing. Retrieved from http://edition.cnn.com/2013/11/04/health/johnson-and-johnson- settlement/

U.S. Food and Drug Administration. (n.d.) Regulatory Information. Retrieved from http://www.fda.gov/regulatoryinformation/