Food and Drug Law Biotechnology

Food and Drug Law Biotechnology

Food and drug laws

What will be the likely outcome of this case and why?

According to the law, a corporation is a fictional 'person.' Shareholders and corporate officials are not responsible for the actions of such a fictional entity, under most circumstances, as they are officially employees of the company. An employer is legally responsible for the actions of its employees "if the employee was doing his or her job, carrying out company business, or otherwise acting on the employer's behalf when the incident took place" (Employer liability, 2010, Nolo). In this instance, the employees on the Board of Directors were not trying to intentionally commit fraud or deceive the public or the government, rather there were oversights committed at the factory that they did not correct before these oversights were noted.

If the CEO attempted to circumvent the law regarding appropriate food sanitation, and directed his subordinates to do so, he could be held liable. In this instance, it appears to be that the vice president had not yet corrected the problem, although he was in the process of doing so. Regardless, it is the company who is fined or held responsible as a whole for violations of the act, not the individuals in question. Unless he or she committed direct, personally-engineered violations of criminal law (such as tampering intentionally with the food) the CEO is not liable. Although it is within the FDA's power to instigate civil or criminal litigation against an individual for violating 301(k) of the Food and Cosmetics Act, under these circumstances the agency does not seem to have the grounds to do so.

Q2. Why did the Court hold differently in these two cases?

The Riegels alleged that a faulty Medtronic catheter "was designed, labeled, and manufactured in a manner that violated New York common law," but it was affirmed that the Medical Device Amendments of 1976 preempted state law, and the Riegels' claim was problematic because it did not state that Medtronic had violated federal law. The Riegels' suit rested on faulty legal grounds.

In Wyeth v. Levine, the issue in question was whether a state could have higher standards for labeling pharmaceuticals than the federal government. The plaintiff was a musician who had lost her hand due to gangrene after being injected with a drug. Injection, versus an IV drip, was a very risky way of administering the drug but this was not specified on the label. She won a jury verdict in Vermont, after contending that Wyeth did not properly label the medication with a warning about the dangers of injecting it into a patient. On a cost-benefit analysis, she stated, no one would have performed the injection, given the likely side effects (Wyeth, 2008, WSJ). Unlike the Riegel case, the MDA did not apply, as this was a prescription drug not subject to the provisions of the MDA. The U.S. Supreme Court found in favor of Levine, noting that federal law is supposed to be a floor, not a ceiling in terms of setting standards for scrupulous labeling of products.

Q3: Compare FDA Form 483 to an FDA "warning letter."

The intention of a Form 483 is to teach, not to punish, according to the FDA. After it conducts an inspection, the FDA prepares an internal briefing. However, it also presents a Form 483 in private to the establishment which lists all of the institution's violations of FDA regulations (Gyi et al. 2001). This is to better enable the facility to bring its standards up to code and avoid legal sanctions or receiving a publically posted warning letter on the FDA website.

In contrast, "a warning letter is issued for significant regulatory violations that require prompt and adequate corrective actions" (FDA warning letter, 2007, CIRCARE). A Form 483 is almost always issued, given that small breaches of the law are inevitable. It is designed to prevent more serious actions being required. A Form 483 elicits voluntary compliance, while if the directions of a warning letter are not obeyed, then more significant actions are likely to be undertaken in the near future, given the safety risk posed to consumer health. Consumers can also find warning notices on the web, and make decisions regarding their own health, in light of the violations.

Q4. Briefly describe four (4) enforcement actions FDA can take in response to a violation of the FD&C Act.