Last month, members of the US Congress sent letters to 14 generic drug manufacturers, demanding explanation for the recent, dramatic spike in the price of some 20 generic drugs. The Generic Pharmaceutical Association, a trade group representing the generic pharmaceutical industry, blames the increase on simple market forces, but many are suspicious of that response.
The recent approval of a drug for use in combating leukemia by the US Food and Drug Administration has shed light on the relatively controversial, albeit common practice by that organization of using surrogate markers of efficacy for determining the benefit of a given drug or therapy. Some believe this constitutes a low bar for
In January, 2014, an article published in The Journal of Neuropsychiatry and Clinical Neurosciences titled “Long-Term Duloxetine Withdrawal Syndrome and Management in a Depressed Patient” reported on a depressed patient who used Cymbalta (duloxetine), discontinued the drug, and faced long-term withdrawal symptoms. After using Cymbalta (60mg/day) for one year, the patient, called “Miss B” in
WARNING: Xarelto Linked to Fatal Internal Bleeding, No Reversal Agent Recently, the anticoagulant drug Xarelto (rivaroxaban) has come under increased scrutiny by both the United States Food and Drug Administration and medical professionals alike, citing an increased risk for internal bleeding. Unfortunately, there is as yet no reversal agent for the drug. Due to inadequate
AndroGel (Low Testosterone) Lawyers have filed an AndroGel lawsuit in Illinois
The past decade has seen a rise in lawsuits surrounding gender and sex identity issues. For example, in 2012, the news followed Jenna Talackova, a transgendered beauty queen, as she battled Donald Trump to gain eligibility to compete in the Miss Universe pageant. In 2013, a Colorado court made a historical ruling when it decided
A number of lawsuits have arisen due to the complications caused by the use of intrauterine contraceptive devices (IUDs). It has been shown that with the increase in popularity of IUDs, there has been a notable rise of cases where migration of the devices leads to a need for corrective surgery for the removal of
When is a conservative court not a conservative court? When it expands tort liability, apparently: Last month, in Wyeth v. Weeks, the Alabama Supreme Court adopted an aggressive new theory of tort liability that threatens to return Alabama to a litigation era so hostile to business and industry that the state was dubbed “Tort Hell.” In Weeks,
The New York Times reports on the interesting information being revealed in the first DePuy ASR hip trial: Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation. Depending on the surgical technique and a patient’s build,
Once again, the FDA arrives late to the party: Jan 17 (Reuters) – The U.S. Food and Drug Administration has issued a proposal calling on companies that make all-metal hip replacements to provide additional information proving they are safe and effective before being allowed to continue selling them. The move follows years of concern within