The Supreme Court considered whether plaintiff’s lawsuit against the marketers of Accutane was barred by the two-year statute of limitations. Suit was filed about nine years after plaintiff was first prescribed the acne drug as a twelve-year-old. The prescribing doctor did not mention the risk of inflammatory bowel disease (IBD) because he was not aware of it. When the FDA approved Accutane years before, it did not require a warning of possible gastrointestinal side effects such as IBD. Although the brochure plaintiff was provided warned to be on the alert for stomach pain, diarrhea and rectal bleeding, plaintiff did not experience any gastrointestinal side effects during the initial or subsequent times she used the drug. However, about seven
Therefore, for all the foregoing reasons, the ALJ concludes that the Appellant was able to provide verification to substantiate her claim that she had other medical conditions that could qualify her for EMA, therefore; the Appellant’s appeal is SUSTAINED. Subsequently, an appropriate Order will
The fear of medical malpractice lawsuits is an issue faced by all who practice medicine. To avoid public criticism by colleagues or the public from their profession and sometimes lose their ability to practice, physicians, and doctors feel forced to follow published standards of care. These treatments often include prescribing medications made to treat
Facts: On October 25, 2000, the plaintiff, Ellen Levy-Gray visited the head of Infectious Diseases at Mercy Medical Center, Dr. Ronald Geckler, who diagnosed her with Lyme disease. In response to this, he then gave her a prescription for doxycycline. Because Ms. Levy-Gray was concurrently breastfeeding her baby son, Dr. Geckler ordered her to discontinue breastfeeding until the end of her treatment, but did not provide her with any further instructions on how to take the medication. The prescription that Ms. Levy-Gray obtained through the defendant, Rite Aid, came packaged with a patient package insert entitled “Rite Advice.” The pamphlet enclosed instructions on how to take the drugs including its suggestion to consume food or milk with the daily dose if an upset stomach occurs. The “How to take this medication” section of the pamphlet explicitly stated, “Take with food or milk if stomach upset occurs unless your doctor directs you otherwise.”
Relators brought a qui tam action on behalf of the United States and various states against Solvay Pharmaceuticals, Inc. (“SPI”) and its affiliates pursuant to the False Claims Act. Relators alleged that SPI had marketed drugs for conditions other than the conditions for which the drugs were approved by the FDA and offered kickbacks to physicians who prescribed these drugs. Relators moved for summary judgment on a number of SPI’s affirmative defenses,
The Plaintiff (Rector) likely has a strong argument that she should survive summary judgment because there is a question of material fact on product identification. Courts have consistently held that a brand name drug manufacturer cannot be held liable for injuries caused by a generic form of the drug they produce. In re Darvocet, Darvon, and Propoxyphene Products Liability Litig., 756 F.3d 917, 940 (6th Cir. 2014). However, if plaintiffs claim they took the brand name drug itself, then courts have tended to apply a low standard for product identification.
The California Court of Appeals’ decision in Coleman v. Medtronic has made it easier for plaintiffs to pursue medical products liability claims. In the landmark 2014 decision, the court held that the state law tort claims asserted by the plaintiff were not federally preempted. The decision is part of a growing body of medical products liability law regarding the circumstances under which a state law claim can impose "parallel" requirements to those under the Food, Drug & Cosmetics Act (FDCA) and, therefore, avoid federal preemption.
Mis Levine, had taken Phenergan under the care of a physician which led to the her being diagnosed with gang green which led to the amputation of her arm. Levine, filed a medical my practice lawsuit against the physician as well as the manufacturer of the drug Wyeth in the State of Vermont, in the state court not the federal court. Under her claim she argued that Wyeth had prior knowledge that the drug Phenergan entered an artery would lead to gang green with the risk of possible amputation. This risk was not properly disclosed on the warning label required under Vermont state law. Wyeth, position regarding this claim was that under the FDA they admit an adequate disclosure and warning labels that the FDA had approved.
The testimony of Owens stating she was aware of the risks that the plaintiff experienced and that this was not included in the warning labels of the product.
The Medicines Company Case Write-Up: Terence Cho, Felipe Duarte, Aleks Loiko, Robert Shaw, and James Wang
HANP Testimony to Homeopathic Product Regulation: Evaluating FDA’s Regulatory Framework After a Quarter-Century Hearing, April 20-21, 2015, Docket No. FDA-2015-N-0540 Cong. (2015) (testimony of Lisa Amerine, ND, DHANP). Print.
This case is mainly about the pharmaceutical industry and showed the negotiation between Mytex and Food and Drug Administration about Flaxil‘s label of possible side effect. Pharmaceutical industry is special industry which needs quite amount of money in R&D. Also, because of the medical concerns, it is inevitable for companies to have lawsuits of side effects. Meanwhile, FDA posts marketing surveillance and controls on the industry. In this case, when Mytex found an advantage (lower risk of stomach perforation, ulcers a bleeding), they also found an unexpected problem, an increased risk of cardiovascular events. For Mytex, they were not willing to do the research on this side effect because it needed large amount of patients and it would be a wrong signal about company’s confidence to the market，which has a fierce competition.
Brooke is a 47-year-old female who suffers from a long history of Sheehan’s syndrome (E23.0). Brooke’s symptoms include onset growth hormone deficiency was brought on by a pituitary infarction (Sheehan’s Syndrome) resulting from post-partum massive hemorrhaging. Brooke would like to stay on the medications that have proven to work for her, which are the Genotropin Miniquick (DAW), Solu-cortef (DAW), and Vivelle (DAW). To switch to other medications requires months of physical adjustments, additional blood tests and lab work to find a new balanced level of all the medications. Brooke has learned from her doctors that patented drugs cannot be the same in order to be patented drugs. Denying coverage of a therapy when a patient has a significant
The court found in favor of the manufacturer stating “federal law still preempted injured patients from bringing lawsuits in state courts, because the state laws in question require a safer label, not communicating with the FDA about the possibility of creating a safer label,” (Glantz & Annas, 2011, p. 682). Despite this regulatory standing, a controversial issue may entail for the FDA in the allowance of medications to be “interchanged” to promote an additional avenue for savings in prescription medications. Much foresight needs to be included to protect the safety and well-being of patients.
The Court has struggled to define the distinction, if any, between generic and branded drugs in terms of state tort liability and failure to warn claims. In Wyeth v. Levine, the Court decided that the FDA’s drug labeling requirements for brand drugs do not preempt state tort claims related to the dissemination of safety information. In essence, brand name manufacturers will be held liable for failure to update their warning labels in an effective and efficient manner. Just two short years later, the Court contradicts its decision in Wyeth, and defines a distinction for generic drug products, which applies federal preemption principles in Pliva v. Mensing. Finally, in Mutual Pharamceutical v. Bartlett, the Court effectively barred generic failure to warn, and defective design claims in state courts.