Issue In the case of Mutual Pharmaceutical Co., Inc v. Bartlett 133 S. Ct. 2466 (2013), the plaintiff Karen Bartlett was prescribed a medication named Clinoril for shoulder pain. Mutual Pharmaceutical dispensed the prescription in the generic form. The drug caused Karen Bartlett to develop toxic epidermal necrolysis. At the time of the incident, the label of the drug did not specify development of toxic epidermal necrolysis as a possible side-effect. For Karen Bartlett not adequately labeling the medication caused her medical damages. Was Mutual Pharmaceutical Co guilty of noncompliance with consumer protection and product safety laws? Rule “The Federal Food, Drug and Cosmetic Act (FDCA) establishes standards to prohibit misleading labeling.” (Gresham, 2013) “The FDCA also requires that manufacturers of drugs gain approval from the Food and Drug Administration (FDA) prior to engaging in interstate commerce.” (Gresham, 2013) Any new drug is submitted under a New-Drug Application (NDA) for approval. The Hatch-Waxman Act was created for generic drugs. In addition, under the Hatch-Waxman Act …show more content…
v. Barlett, 133 S. Ct. 2466 (2013). The Supreme Court based its decision in part on PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), believed federal law prohibited generic manufacturers from implementing unilateral label changes and that a drug company strengthen its warnings. State law secured U.S. Supreme Court decision assuring that the Hatch-Waxman Act preempts state-law tort claims pointing to the design/composition of generic drug products. Of particular relevance, the Supreme Court also stated that the drug in question was “chemically incapable of being redesigned.” (133 S. Ct. at 2475) The Supreme Court fell short of holding that design defect claims against brand manufacturers were
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Generic drugs must be equal to the brand-name drug. The FDA requires generic drugs to contain the same active ingredient, the dosage form must be identical, strength must be the same, and route of administration must be the same as the brand-name drug in order to obtain FDA approval (Food and Drug Administration, 2013). The manufacturer must also prove the generic drug delivers the same amount of the active ingredient as the brand-name drug. This bioequivalence assists in drawing the conclusion that the generic and brand-name drug will produce therapeutic results that are very similar (Food and Drug Administration, 2012).
FTC requires the manufacturer must provide all ingredients, their quantity, and their significant relationship with the health condition. They must scientific proof, reliable evidence to support their claim. The product has to be clinically tested on humans. It has to be undergone through various placebo controlled and experimental group. Finally the data is collected and conclusion is made based on numerous evidence and support. After that the theory has to be reviewed by experts in the same field to be granted as a scientific proof. US food and drug administration board permits some claims on the product label, with some restrictions. There are four general categories of claims made. Firstly, health claims, which have numerous study and evidences to support them. Secondly, Preliminary claims like on phytochemicals, which have some evidences but no proper research ha...
The case of Sara Montague et al., Plaintiffs and Appellants, v. AMN Healthcare, INC., Defendant and Respondent, was taken up and decided in the appellate court. The case was first granted a standard review of a summary judgment, which failed, the plaintiff then appealed this motion. After the appeal it then went to court to be heard in a normal trial. Just to be a bit more precise, it was heard and decided as case No. D063385. in the Court of Appeals of California, Fourth District, Division One, on the 21st of February in 2014. In this court case, representing Sara Montague, the plaintiff and appellant, was the law office of
Expert testimony, when it is offered within a trial, is a crucial element in trials. When there is expert testimony offered there are steps that need to be taken to ensure that the person giving the testimony is an expert, as we saw in the case of the United States v. Paul (1999). However, there is a procedure to enter this testimony and to determine its admissibility. This matter will be discussed as we review the case of Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993). First there needs to be a little background on the case itself.
The food and Drug Act passed in 1906, at this time advertising was a rather small enterprise with no federal regulation. The act did not really affect advertising directly only the labeling of products (Stole, 2012. p.3). Even though the law did not partain to the advertising of the product, the makers of patent medicine still had to change their method of advertising. They could not lie in the advertisement, only to be caught when the consumer read the label on the product. Even though there was this risk, there was still a need to have something regulated what advertisers were allowed to do. Eight years later, the Federal Trade Commission Act was established and “provided the FTC with regulatory powers over advertising, but the agency was
FBNH wins the challenge of the government’s right to seize the tablets, because the FDA does not have express right to do so. However, the FDA does have over the “manufacture, distribution, or sale of adulterated or misbranded cosmetics,” (p. 201-202). Effectually, the FDA cannot seize the tablets but they can control the distribution and sale of them. Conclusively, FBNH wins the challenge of the government’s right to seize the tablets, but the government does retain the right to stop distribution and sales of the tablets.
In the case of Burger v. Blair Medical Associates, Inc. (BMA), we can see the need for extensive legal knowledge on the part of a health information management (HIM) director. BMA tried several times to have the courts revisit their case based on the statute of limitations. Here the Superior Court declared, “the torts of invasion of privacy and breach of physician-patient confidentiality are distinct, such that the former is expressly governed by the one-year statute of limitations and the latter falls within the catch-all two-year limitations period” (Burger v. Appeal, 2009). Because of this breach, BMA had to pay out over $60,000 to Burger. In this case the Superior Court identified the breach of physician-patient confidentiality and the
In 2008, CVS/Caremark found itself with more legal problems when it was accused of deceptive business practices. A lawsuit was filed implicating CVS/Caremark stores in 28 different states of deceptive practices, when they directly recommended to Doctors that they write their patients prescriptions for name brand drugs instead of generics. CVS/Caremark led the doctors to believe that their patients would save money by using the brand name drug, when in fact, the opposite was true and it was costing their patients more money.
There are many infamous cases where damages were awarded to consumers due to a personal injury resulting from what is claimed to be negligence, failure to warn or a product defect. According to public opinion, some of these lawsuits are frivolous and are causing the decline of our civil justice system. An examination of cases against tobacco companies will provide us with some conflicting information regarding product warning labels. Do they provide manufacturers with adequate protection against this type of lawsuit?
Frye v. United States and Daubert v. Merrell Dow Pharmaceuticals are both legal decisions that set forth standards as they pertain to the admissibility of scientific or forensic evidence, and the admissibility of expert witness testimony. Both cases deal with the admissibility of evidence in judicial proceedings, and prevent prosecutors from abusing the use of expert witnesses and testimony. Due to a loophole that dismisses recent scientific advances when applying the Frye Rule, the Supreme Court revisited Frye, and “took the occasion to issue guidelines for deciding the admissibility of scientific evidence” (Gaensslen, Harris, & Henry, 2008, p. 53). The decision resulted in a five-prong approach called the Daubert Standard.
This is something that happened in Jacobs Pharmacy Co. v Gibson. In this case, the plaintiff presented a prescription for Zephiran Chloride Aqueous Solution 1:750 to a pharmacy technician. The technician informed the plaintiff she did not need the prescription since there was an over-the-counter (OTC) product that was the "same as" the prescription product.
The FDA does state that generic medications are always modeled after the brand medicine, but there is a slight difference in the chemical makeup of the medicine itself. The only way a generic can get approved is if it works similarly enough to the brand medicine. The FDA mentions that there will always be a slight variation between generic and brand drugs, but it is not medically important. They claim that a drug could even change per batch that is created regardless of if it’s brand or generic (Extra Articles #8). This could result in a patient not receiving the best possible dosage of medicine. In situations where patients are taking more serious, life changing medicines, it could be more important for them to get medication that is best suited for