West Virginia Pharmaceutical Products Law Blog

Earlier this week, we took a brief look at the problems associated with all-metal hip replacement systems and how those defective implants were able to escape meaningful government scrutiny until thousands of patients in West Virginia and other U.S. states had been seriously harmed by them.

Today again, we are going to focus on the U.S. Food & Drug Administration's approval process and why it does such a poor job of keeping defective medical devices out of the American market. This time, however, the defective medical device we're going to use as an example is transvaginal mesh -- another dangerous medical product that has been the subject of countless lawsuits nationwide.

Many of the brand name drugs we write about on this blog also have generic equivalents manufactured by pharmaceutical companies with names that are not as familiar as corporations such as Pfizer or Johnson & Johnson. Unfortunately, a United States Supreme Court holding from last year is proving to be the mother of all windfalls for generic drug manufacturers while having a chilling effect on the defective drug lawsuits of West Virginia plaintiffs who have been harmed by those companies' products.

The industry works like this: Household corporate names like Pfizer do the heavy research and development lifting to put a drug on the market and, in exchange, receive patent protection granting them the exclusive right to manufacture and sell that specific drug and variations of it for many years. When the patent protection runs out, generic manufacturers swoop in with their own copies of the drug. This brings the price of the drug way down for consumers and causes the original manufacturer's profits to take a nosedive. By this time, however, the original manufacturer has most likely made several billion above and beyond their initial investment Everyone walks away happy.

In recent years, many individuals, legislators, government officials, medical professionals and organizations have expressed serious concerns about the U.S. Food & Drug Administration's drug and medical device approval processes. We, too, have voiced our concern about this critical government gateway that consistently allows defective drugs and medical products to make their way on to the American market in countless previous blog posts.

Long story short: There's a fatally flawed system in place and it needs to be fixed. West Virginia residents deserve better. Americans deserve better. It's time for some change we can really believe in.

Last week, the U.S. Food & Drug Administration announced new labeling requirements for birth control pills that contain a synthetic version of the hormone progesterone known as drospirenone. As a result, drug makers will be expected to revise language regarding side effects to more clearly their define blood clotting risks -- which one study suggests are as much as three times greater for women taking drospirenone-based contraceptive pills as opposed to low-dose, estrogen-based alternatives.

Unfortunately, as discussed in a several recent blog posts, this latest example of how pharmaceutical drugs can be harmful to patients is not an isolated event.