Background
Facts
Jorge Diaz agonized severe harms after consuming Nonflux, a lately permitted medicine drug designated to treat gastroesophageal reflux disease. The package contained a warning of the antagonistic event that he had underwent. The company had endorsed the drug in the media. The spots conformed to the FDA’s guidance on broadcast advertising, but the corporation had not made a copy of a summary accessible in Spanish. Diaz saw such ads though he was not fluent in English. He asked Gloria Gonzalez, a physician, to prescribe the drug for his use. After taking a cursory medical history, Gonzalez gave the patient some samples of Nonflux that one of the manufacturer’s detail reps had left with her.
Issue
The evidence of failure to warn and the intermediary rule by Gonzalez and the manufacturer.
Rule
The applicable rule to this case is the provisions laid under the product liability act (1997). Particularly, the intermediary doctrine and the failure to warn are prevalent. Consequently, the precedent of Perez V. Wyeth Laboratories, Inc., 161 Nj1, and Ramirez V Plough are all critical in determining the issue of the case.
Analysis
According to the product liability, the medical manufacturers and the health care providers must warn the patients about the risks and dangers of the supplied products. Manufacturers and medical care providers are held accountable for the Tort. However, the duty to warn is applicable I the following conditions are met:
- If the medical manufacturer is aware that the product contains substantial risk to the user
- If the manufacturer is aware that the dangers of the product would not be evident to the users
- If the product’s risk or injuries caused by the product justifies the cost of providing a warning.
If the above conditions are met, it is deemed that the manufacturer and the medical care provider have a liability when the consumer or the patient suffers from the product and the manufacturer fails to warn the customer about the risks and dangers of the drug. Consequently, manufacturing defects are the common cause of product liability claims. In such a situation, it is alleged that the original design of the product is entirely safe. Still, something happened in the event of the manufacturing process, which case makes the product unsafe. However, it is a general duty of the manufacturers and the medical care providers to warn the customers and patients about the risk of the product.
The new restatement considers an adequate product warning that a sensible individual in the same state would have offered concerning the dangers and conveys sufficient facts on the hazards and dangers of using the product. If the manufacturer or the physicians are found to be reasonable, they are deemed to have the duty to warn, and failure to warn raises a liability for the drug that causes harm to the patients.
Restatement of Torts: product liability (1997) lays a foundation for establishing whether the defendant is liable for the harm suffered by the plaintiff for the failure to warn. Section 6 and subsections (d)(1) of the product liability act prescribe the customary law of the learned intermediary law that medicine producers are accountable for failing to warn the health care providers of the dangers and risks of the drug. In this case, if the producer warns the health care providers of the risks and hazards of the drug, liability passes to the health care providers for failure to warn if the patient suffers adverse conditions from the drug.
Provisions of the Product Liability Act
Under the new restatement, it is a provision that a warning may be delivered to the health care providers or even to the patients depending on the conditions. This implies that the manufacturer must warn the health care providers and the customers about the risks and dangers of the drug, and the health providers must warn the patients. Depending on the circumstances, either the health care providers or the manufacturers may be held accountable for the defects that the drug may cause to the patients. This shows that the responsibility to warn is passed from the manufacturer to the health care providers and then finally to the patients. On the same note, the obligation to warn also passes directly from the manufacturers to the customers.
The new restatement also acknowledges that the drug companies who market their products directly to the customers must be accountable for the claims by customers if their ads fail to offer a sufficient warning of the risks of the drugs. In this situation, the intermediary rule does not apply to the direct marketing of medicines to the customers. However, the prescription drugs should be labeled and marketed following the FDA specifications in such considerations.This shows that if the prescription of the drugs does not meet the requirements of the FDA, the manufacturer is held accountable for the claims that may arise from the consumers.
According to section 35(n) of the Food, Drug, and Cosmetic Act, advertisements in published journals, newspapers, periodicals, and other advertisement broadcasts in media are allowed. However, making such advertisements does not exclude the manufacturer from the product liability. FDA regulates the authorization of the products, and the manufacturer is expected to provide enough information warning the consumers about the effects and dangers of the product. Section 32 (n) of the Act requires a summary of requirements that the manufacturer should warn the consumers. Failure to provide sufficient information to warn the consumers, the manufacturer is held accountable for the manufacturing defects and therefore responsible for the harms that the consumers may suffer.
The case of Perez V. Wyeth Laboratories raises questions about medical product liability. The current changes allow the manufacturers to directly market their drugs to clients in media through radio, television, and magazines, among others. However, this gives rise to whether the law should consider such changes in the market. Notably, when mass advertising of treatment medicines pursues to influence a patient’s choice of a drug, it was determined that the manufacturer who makes direct claims to the clients for the effectiveness of its product would not be dismissed from a responsibility to offer appropriate warning of the risks and hazards of the drug. This implies that advertisements on media do not exclude the manufacturers and the medical care providers’ from the duty to warn the patients and the customers about the drug’s risks.
In the case of Perez, the physician has to maintain the obligation to consider the significance and the dangers linked with the drug before determining whether it is suitable for the users. In this case, it is presumed that the physician is liable for any injury or harm suffered by the patient due to the drug if the physician fails to retain the duty to warn. On the same note, a producer’s warning is considered satisfactory when permitted by the FDA. Suppose the FDA does not authorize the warning. In that case, the manufacturer is deemed to contravene the provisions of the product liability act. Therefore, the manufacturer is held accountable for any harm the customers and the patients suffer due to the drug.
Failure to Warn
The warning is usually necessary when the doctor or the health care provider has a moderated duty as an assessor or a decision-maker. The manufacturer would have an obligation to warn patients directly. In such an event, if the manufacturer has warned the physician and the health care providers about the risk of the drug, the manufacturer excludes themselves from any liability that may arise in case of harm caused by the drug. However, depending on some circumstances, the manufacturer would be held accountable for the harm for failure to directly warn the customers of the threats and dangers related with the drug.
Based on the above discussion, it is clear that the manufacturer and Gonzalez, the physicians met the requirements of the product liability act and the new restatement about the intermediary rule. In this case, the manufacturer advertised the drugs through media which is allowed in section 32(n) of the Food, Drugs, and Cosmetic Act. In this case, though, the manufacturer failed to make some copies. In Spanish, the advertisement met the requirements of the FDA. This implies that the manufacturer provided enough information to warn, and therefore the manufacturer had no liability to Jorge Diaz. On the same note, the manufacturer had advertised the product directly to the consumers, and therefore the intermediary rule does not apply in this case.
Notably, as a requirement that a physician should preserve the responsibility to evaluate the benefits and threats related with the drug before determining its appropriateness for the patient, Gloria Gonzalez retained the duty. Before deciding to prescribe the drug to Jorge Diaz, Gonzalez weighed the drug’s risks. After taking a cursory medical history, Gonzalez gave the patient some samples of the drug left by the manufacturer. This indicates that Gonzalez executed his duty to warn, and therefore he has no liability to the patient for the harm suffered.
On the other hand, the decision made in the case of Ramirez V. Plough is significant to the case of Diaz. This case raises an issue about whether the manufacturer’s duty to war requires it to provide a label package warning in Spanish. According to the case scenario, the manufacturer advertised the product in the media, which is allowed. However, the manufacturer failed to make some summary in Spanish as the agency required. The case of Ramirez applies the rule of formulation of the standard of care in establishing whether failure to provide a warning in Spanish raises any liability to the manufacturer. Following this rule, the court must formulate the standard of care. If the standard applies to the facts of the case, it is easier to establish whether the manufacturer violated the duty to warn or not by failing to provide a summary in Spanish.
Founded on the rule applied in the case of Ramirez, the manufacturer had no duty to label the product with Spanish language warnings. In this case, failure to label the product in Spanish does not violate the standard of care required. The urgency required the warning to be in Spanish, but the manufacturer failed to label the package in Spanish. Based on the Tort’s devotions, the prevailing legislative and administrative standards of care on the issue of foreign language do not necessarily need the warning done in Spanish. The regulation under both federal and state laws mandates warnings in English. In this case, the manufacturer did not violate the rule to warn as everything was clear. Though Diaz was not fluent in English, Gonzalez was fluent in English. As a Physician, he retained the duty to warn, in which case, either the physician or the manufacturer violated the duty to warn.
Intermediary Doctrine
Based on the verdict made in the Ramirez case, the standard of care was present. In this case, both the manufacturer and the physician followed the duty of standard care. The duty, in this case, applies to the facts of the case, and therefore it can be established that failing to label the package in the Spanish language does not constitute the failure to warn. Federal and state law acknowledges and mandates warnings in English only in many circumstances. Therefore, it can be concluded that the manufacturer met the federal and state law requirements in failing to make the warning in Spanish as required by the Agency. Notably, there is no claim or failing to warn that can be raised against the manufacturer. Gonzalez was fluent in English, and therefore he understood the risks of the drug, in which case he cannot be held accountable for failing to warn the patient.
Conclusion
Based on the new restatement, the intermediary rule does not apply if the manufacturer advertises the product directly to the consumers. In the case scenario, the manufacturer advertised the product directly to the consumers through the media, which met the provisions of section 35(n) of the Food, Drugs, and Cosmetic Act. The advertisement also met the FDA’s requirements, and the FDA approved the product. There is no claim that the intermediary rule was violated in this case. On the same note, the manufacturer cannot be claimed for the failure to warn.
The new restatement considers an adequate product warning that a reasonable person in the same situation would have offered concerning the dangers and that conveys sufficient information on the dangers and risks of using the product. In this case, the manufacturer and the physician were reasonable individuals. Gonzalez retained the duty to warn as he took time in establishing the cursory history of the drug before prescribing it to the patient. For this reason, Gonzalez cannot be held accountable for the harm suffered by Jorge Diaz since he was fluent in English and understood the risks and dangers of the drug since the warning was in English.
Based on the above discussion, it is clear that the manufacturer and Gonzalez, the physicians met the requirements of the product liability act and the new restatement about the intermediary rule. In this case, the manufacturer advertised the drugs through media which is allowed in section 32(n) of the Food, Drugs, and Cosmetic Act. In this case, though, the manufacturer failed to make some copies. In Spanish, the advertisement met the requirements of the FDA. This implies that the manufacturer provided enough information to warn, and therefore the manufacturer had no liability to Jorge Diaz. On the same note, the manufacturer had advertised the product directly to the consumers, and consequently, the intermediary rule does not apply in this case.
Following the decision made in the case of Ramirez V. Plough, the manufacturer failed to make a summary in Spanish as the Agency required. The case of Ramirez applies the rule of formulation of the standard of care in establishing whether failure to provide a warning in Spanish raises any liability to the manufacturer. The manufacturer did not violate the duty to warn since federal and state law mandates that warning should be in English by upholding the verdict made in this case. The manufacturer and the physician followed the standard of care required, and therefore no claim can be made against the two parties.
By considering the provisions of the product liability, Gonzalez, as a health care provider and the manufacturer, had the duty to warn the customers and patients about the risks and dangers of using the product. The manufacturer provided a summary of the warning though it was not in English. However, failing to provide a brief warning in English does not violate the duty to warn. Generally, no manufacturing defect claim can arise from the case, and both the manufacturer and Gonzalez maintained their duty to warn. The intermediary rule does not give rise to any claim since the manufacturer made a direct advertisement to the consumers.
Brannen Jr, Franklin P., P. Michael Freed, Kristen S. Cawley, and Marcus Strong. “Product Liability.” Mercer L. Rev. 69 (2017): 231.
Federal Food, Drug, and Cosmetic Act (FD&C Act) | FDA
Noah, Law, medicine, and medical technology, Cases and Materials 4th Edition, 4th ed. New York, NY: Foundation Press Thomson/West, 2012, p. 1389.
Perez v. Wyeth Laboratories, Inc., 734, A.2d 1245 (N.J. 1999)
Ramirez v. Plough, Inc. – 6 Cal. 4th 539, 25 Cal. Rptr. 2d 97, 863 P.2d 167 (1993)
Restatement of Torts: product liability (1997)
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