If you have never heard of vaginal meshes, it is probably a good thing. Vaginal meshes are medical devices designed to help women whose organs drop from position, a common problem after childbirth. The mesh is designed to hoist the organ back into place (think of a hammock strung between two trees). Unfortunately, unknown to the 1000s of women who agreed to allow them to be implanted, the mesh can erode, cause scarring and has even been alleged to have caused organ perforation. As a result, some women with meshes end up requiring 10 or even more corrective surgeries, and many are told "there is nothing we can do." Thus, they must live with the intense pain, and inability to have intercourse absent extreme pain, not to mention other effects.
Over 650 lawsuits have been filed against the makers of the mesh, and on July 23, 2010, a jury in California awarded $5.5 million to a California couple in one of the first cases to go to trial. Christine Scott, a formerly avid runner, had a mesh installed to correct a leaky bladder. The mesh soon began cutting into her colon and tissue continued to grow through tiny holes in the mesh,causing intense pain. After eight surgeries, she is still in tremendous pain.
As to the fact that the device has been FDA-approved, Ms. Scott's lawyer noted that "[t]hey tested this on 16 rats, 12 rabbits, four sheep and, by their own researcher's admission, the next living being this product went into was women." For its part, the manufacturer continues to rely on the fact that the device is FDA-approved. Good point: do not assume that simply because a medical device or drug is approved the FDA that it cannot be dangerous.
Meanwhile, Ms. Scott who was under a gag order during the trial noted that "[t]he hardest part, I will tell you, though this whole thing, is having to keep quiet,watching women still get hurt." It will be interesting to see what the manufacturer does for the affected women going forward. Admit its mistake, and help them? Or fight, fight, fight?
After 15 years as a trial lawyer, I have realized what a dynamic, yet often misunderstood, field it is. The goal of this blog is to discuss new and interesting issues affecting the civil justice system, generally, with a particular focus on Maryland, Washington, D.C. and Virginia, where most of our cases are tried.
Thursday, July 26, 2012
Friday, July 20, 2012
Anemia Drug Does Little, Harms Much.......But Was Worth Billions
There seems to be a drug for everything these days. Indeed, there is a new drug on the market called Egrifta. Its goal? To treat excess belly fat in persons with HIV. While drugs serve an obviously important purpose, do not forget the pofit motive behind them. The Washington Post recently reported on a trio of anemia drugs (Epogen, Procrit & Aranep) that have been on the market for two decades that while earning their makers multi-billions in profit help very little, and potentially harm some patients. The article is here: http://www.washingtonpost.com/business/economy/anemia-drug-made-billions-but-at-what-cost/2012/07/19/gJQAX5yqwW_story.html
A growing body of research has shown that the benefits of the drugs "were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked." Worse, the companies encouraged health care providers to prescribe larger and larger doses of the drug by incentivizing them with money. How? Simple. They allowed doctors to make the drugs a profit center: They could directly purchase the drugs. The more the doctor bought, the more the pharma companies lowered the cost. The patient, however, could be charged the same regardless of the cost, allowing the health care provider to profit on the "spread." The article quotes the following amazing statement: "An oncologist could make anywhere from $100,000 to $300,000 a year from this alone."
It gets worse. According to the article, when the FDA got wind of what was occurring and tried to crack down on the ever-increasing dosages, the pharmaceutical companies sent in their lobbyists, getting powerful senators and representatives to tell the FDA to back down.
The pharmaceutical companies have moved on to the next "big thing." As for the families of the people who died, the article states it succinctly: "What killed their loved ones -- the disease or the drugs they took to treat it?"
A growing body of research has shown that the benefits of the drugs "were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked." Worse, the companies encouraged health care providers to prescribe larger and larger doses of the drug by incentivizing them with money. How? Simple. They allowed doctors to make the drugs a profit center: They could directly purchase the drugs. The more the doctor bought, the more the pharma companies lowered the cost. The patient, however, could be charged the same regardless of the cost, allowing the health care provider to profit on the "spread." The article quotes the following amazing statement: "An oncologist could make anywhere from $100,000 to $300,000 a year from this alone."
It gets worse. According to the article, when the FDA got wind of what was occurring and tried to crack down on the ever-increasing dosages, the pharmaceutical companies sent in their lobbyists, getting powerful senators and representatives to tell the FDA to back down.
The pharmaceutical companies have moved on to the next "big thing." As for the families of the people who died, the article states it succinctly: "What killed their loved ones -- the disease or the drugs they took to treat it?"