When medical devices or pharmaceutical products are recalled, there is often confusion over who must be held accountable for alerting affected patients. Sometimes, failure on the part of physicians to alert patients can be considered medical malpractice. However, most often it is the responsibility of manufacturers, the government or both to inform patients.
Two relatively new prescription drugs were developed to help patients who suffer from heart conditions. However, they may actually be dangerous medical products as opposed to helpful medicines. One of these drugs, Pradaxa, was approved by the Food and Drug Administration in October 2010 to prevent strokes in patients whose hearts beat irregularly.
Cleveland residents know that the number of things in life that are thought to be dangerous, "all-natural" is generally not one of them. All-natural tends to connote "healthy", but that is not the case as demonstrated by the recent recall of a dangerous yet all-natural erectile dysfunction supplement sold under the name X-Rock. The makers of the X-Rock single-serving dietary supplement recalled all of their products because some of its undeclared active ingredients could interact with prescription medications and result in dangerously low blood pressure.
In February, we wrote about a panel of the Food and Drug Administration's (FDA) vote regarding a highly popular but controversial contraceptive. At that time the FDA panel voted 21-5 to require labels on Yasmin and Yaz to be strengthened by heightening the drugs' warnings related to blood-clot risks.
We began a discussion earlier this week about a report which was recently released on the subject of safety testing for medical devices. Specifically, Consumer Reports has alleged that many potentially defective medical devices are not tested for safety before they enter the marketplace.
From toxic breast implants to metal-on-metal hip implants which can cause severe pain and even paralysis, the media has long reported on medical products which can cause injury and death in American patients. However, Consumer Reports recently released a report indicating that the prevalence of defective medical devices in the marketplace can be attributed to lack of safety testing within the industry.
Last week we wrote about a potential conflict of interest regarding how the Food and Drug Administration (FDA) assesses the safety of pharmaceutical drugs. The controversial drug in question was Yasmin (Yaz), a popular birth control pill that has been shown to put patients at an increased risk of suffering potentially fatal blood clots.
Yaz and Yasmin are two names for one of Bayer HealthCare Pharmaceutical's top selling products. The drug manufacturer sold $1.6 billion worth of the popular contraceptive last year.
There are times at which business practices are so egregious and injure so many residents that states themselves file suit against corporations for causing harm within their borders. While it did not occur here in Ohio, a recent lawsuit could certainly impact Ohio residents, because the defendant is one of America's largest manufacturers of health products.
For decades, Johnson & Johnson (J&J) was a household name synonymous with the most common and effective household medications. Nearly every Ohio resident has taken a product like Tylenol or Motrin at some point in their lives, and millions of parents commonly treat their kids' ailments with medications like Children's Tylenol.