MEMORANDUM
RE : PHARMACEUTICAL LAW AND LIABILITY
Dr. Frankenstein may be held liable for products liability in the event that he fails to comply with regulations of the US FDA regulations. There are three theories under the product liability including the Negligence Theory, Strict Liability Theory, and Breach of Warranty Theory.
It can be argued that the Wonkavision device is no longer patentable since it is considered part of a prior art for it has been in the market for almost 40 years. However, the fact that it can provide treatment of patients infected with Ebola will qualify it as a novelty and can considered as a patentable invention. However, it should first be registered with the Intellectual Property Office and it will be the court that will decide whether it is patentable or not. The primary purpose for the invention of the Wonkavision device is to convert a person or object into an energy pattern and later beams it to a target location receptacle.
I will advise Dr. Frankenstein to do an experimental treatment to be administered in the U.S. since there is limited data regarding the safety, efficacy or effectiveness of any experimental drugs or convalescent plasma for treatment of patients with EVD. The Wonkavision is considered as a medical device that should be shielded by law under the medical product device product liability actions and required to obtain FDA approval. The burden of proof lies with Dr. Frankenstein to show that the product is suitable for human consumption. Thus, it shall be the duty of the manufacturer of the final product to undergo the process of acquiring FDA approval. The patients shall allowed by law to recover damages from the manufacturer in the event that the product will malfunction (National Academy of Engineering, 1994). At the same time, 21 CFR 820 explains that the medical device should have an approved design, packaging, labeling, storage and instructions for installation, and to ensure that the finished device is intended for human use.
The negligence theory of liability was derived from the English common law under the law of torts. The principle of tort refers to the civil wrong that provides a remedy for the wrong doing in the form of damages (McCormick and Papadakis, 2003). Under this theory, there is a presumption that the community demands a standard of care among the members, particularly the product manufacturers must comply with this requirement. The plaintiff under the negligence theory case must prove that he or she is entitled to recover damages due to failure of the defendant to observe the required standard of care for its product. This was the ruling enunciated by the Supreme Court in the case of Hollinger v. Shoppers Paradise of New Jersey (1976), where it was held that to be able to successfully file a claim against a defendant, there are four elements that should be present in order to qualify as an ordinary negligence action. The four elements shall include: 1.) The defendant owes a duty of care or obligation to the plaintiff; 2.) There was failure on the part of the defendant to perform such duty; 3.) The failure to perform the required standard of care by the defendant caused the resulting injury to the plaintiff; and 4.) The plaintiff has sustained or suffered actual damage or loss (McCormick and Papadakis, 2003).
As part of Dr. Frankenstein’s defense, he can raise the learned intermediary doctrine by stating that he has given out all the needed information to a learned intermediary, who shall thereafter interact with the consumers of Wonkavision. The learned intermediary doctrine is being used by most of the medical device manufacturers and pharmaceutical companies as a defense for tort claims.
Duty of The Drug Company
Aside from the device, the pharmaceutical drug that is being manufactured by The Drug Company should comply with the registration rules and regulations of the US FDA. I will advise The Drug Company to comply with the US FDA rules and regulations before offering the two (2) drugs that might provide a cure for the Ebola virus. Compliance with the FDA rules and regulations will mitigate the risk of the company and the probability of being held liable under the products liability theory. The Drug Company, with the cooperation of the Blood Plasma Company should work together to ensure that the two pharmaceutical drugs which will be used to treat the symptoms associated with Ebola must register the patent of the discovery of such drugs with the Intellectual Property Office.
I will advise The Drug Company, as manufacturer of the two drugs to be registered with the FDA. It is essential to get the approval of the agency since there had were no controlled clinical trials for an Ebola specific treatment had been conducted to date. Due to the high-risk exposure to Ebola virus of several people all over the world, there is a need to create a vaccine or drug that is approved by the FDA to treat patients who are suspected to be contracted with the Ebola virus.
In case The Drug Company violates any of the rules of the FDA, the agency itself can take action by filing an injunction case before the court in order to address the violations committed by the company. The FDA can also bring a seizure case asking the court to issue an order that will enable the federal officials to possess any of these “adulterated” drugs from the manufacturers and destroy them. It shall be the duty of the agency to immediately prevent any drug company to distribute or sell the drugs to the consumers. The seizure and injunction cases shall stop the drug companies from manufacturing unsafe drugs that can cause detrimental effects to the general public.
The concept of products liability law or products liability theory has been recognized globally (McCormick & Papadakis, 2003). The evolution of this theory can be traced back from the English common law and had developed to the strict products liability theory of recovery which allows the consumers to sue the manufacturers for defective products (McCormick & Papadakis, 2003). The standards of care being applied to the defendant under the products liability case had evolved over time to include the three theories of standard, namely, the breach of warranty standard, strict liability standard and negligence standard.
A valid defense that the drug company can raise is the “learned intermediary doctrine”. Under this doctrine, the company can claim that it had provided with all the needed information to a learned intermediary, who shall be tasked to interact with the consumers of Wonkavision the medical device. The physicians or doctors who shall prescribe the use of these two (2) drugs may be liable for medical malpractice if they shall prescribed the drugs to their patients if they know that these drugs did not obtain FDA approval.
Conclusion
It is the duty of drug manufacturers such as The Drug Company to assure the consumers that every batch of medicines that being taken have complied with the rules on quality standards. The strict compliance to the Current Good Manufacturing Practice regulations (cGMPs) that are enforced by the US FDA shall ensure that the drugs and medicines remain safe and effective to use. It is the duty of the FDA to implement the current good manufacturing practices so that the drug manufacturing processes of the pharmaceutical companies are able to meet the goals of the companies. Under 21 U.S. Code Section 351 on adulterated drugs and devices, poisonous and unsanitary ingredients are prohibited in manufacturing drugs or devices. The preparation and packing of drugs and devices should be under insanitary conditions in order to avoid an contamination that may be injurious to health in conformity with cGMPs. These cGMPs were created in order to develop a system that will provide the right design, monitoring, and control of the manufacturing processes and facilities of every drug company.
Therefore, I will advise Dr. Frankenstein to comply with the rules of the Intellectual Property Office before he releases the Wonkavision to the market. He intends to use the device to transport the two drugs and the convalescent plasma collected from recovered Ebola Virus Disease (EVD) patients to the current patients that are being compassionately quarantined and treated. At the same time, he must also seek the approval of the US FDA before he offers the two (2) drugs manufactured by the drug company before releasing information that it might cure the Ebola virus for he may be liable for the risk of misbranding. He must also comply with the FDA rules and regulations to mitigate his risk and the probability of being held liable under the products liability theory.
References:
Hollinger v. Shoppers Paradise of New Jersey, 134 N.J. Super 328, 340 A. 2d 578
(1976).
Law enforcement by the US FDA lacks conviction. (2006). In pharma Weekly, (1553), 2.
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McCormick, B. W. and Papadakis, M.P. (2003). Aircraft Accident Reconstruction and Litigation.
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National Academy of Engineering (1994). Product Liability and Innovation: Managing Risk in
an Uncertain Environment. Washington: National Academy Press.
Rogers, V.H. and van Boom, W.H. (2004). Unification of Tort Law: Multiple Tortfeasors. U.K.: Kluwer Law International.
Wyatt v. North Carolina Equipment Co. 253 N.C. 355 117 S.E. 2d 21,24 (1960).
