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…
manufacturers of generic drugs are prohibited from making changes to a drug or the already approved label. Analysis The United States Supreme Court adhered that federal law preempts failure-to-warn design defect claims concerning generic drug manufacturers, Mutual Pharmaceuticals Co.
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
preempted. Conclusion The Barlett verdict was upheld on appeal to the First Circuit; however, the Supreme Court reversed and held that when a federal law forbids an action required by state law, the state law becomes ineffective. The appeal resulted in a complete win for the generic manufacturers. Legal Concepts Businesses have to face and abide by substantial federal, state, and local government regulations. These regulations are set for the employer and employee’s safety. “Administrative law is a law that governments enact to regulate industries, businesses, and professionals” (Cheesman, 2013). Mutual Pharmaceutical Company is required to gain Food and Drug Administrative (FDA) approval before marketing a brand name or generic drug. “The FDCA provides the regulations for testing, manufacture, distribution, and sale of food, drugs, cosmetics, and medicinal products” (Cheeseman, 2013). One of the FDCA regulations is the manufacturer of a drug must provide adequate warnings for the drug. The drug label that Mutual Pharmaceutical Company provided for the drug Clinoril did not specifically warn against toxic epidermal necrolysis but did acknowledge the risk of severe skin reactions. The management team from Mutual Pharmaceutical Company was accused of not being in compliance with federal and state regulations. In this case, the management was in compliance with the regulations because it was impossible to be held liable under state law when the federal law did not allow the company to change the warning. Risk-based compliance has to be expected, and the management team has to stay up-to-date on legal regulations.
According to the court case on Pam Huber v. Wal-Mart Stores, Inc., I am in agreement with the fact that the “district court granted summary judgment in favor of Huber” (Morgan, p.413) and that Wal-Mart gave Pam Huber, a maintenance associated job due to her disability. In doing so, I am also in agreement with the fact that Wal-Mart did not breach the American with Disability Act of 1990 due to the fact that Wal-Mart specifically stated what was required of Pam Huber to do on the job. Due to that, I am in agreement with Wal-Mart’s decision to hire a capable candidate in replace of Pam Huber due to their policy.
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.
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
To begin, the Federal Food and Drug Administration does not have the power to regulate supplements like it does with drugs. Once a product is out on the market, the FDA has to prove that it is dangerous or has illegal additives before it can be removed. The FDA has targeted around seventy tainted weight loss products after learning that they had been mixed with undeclared stimulants, diuretics, and antidepressants (Trebilcock 2). The Federal Food, and Drug, Administration is responsible for ensuring that the manufacturers of foods provide safe ingredients and the correct amount of dosages for their products.
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.
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
FDA have been modified completely since 1906. The market itself, the science behind it, and the
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?
"Regulatory Information." Federal Food and Drugs Act of 1906. U.S. Food and Drug Administration, 20 May 2009. Web. 14 Apr. 2014. .
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.
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.
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.
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
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