A group that represents doctors, The Heart Rhythm Society, will publish guidelines to help doctors determine how to respond when a heart defibrillator malfunctions. The publication comes in response to problems experienced by cardiac defibrillator manufacturers,Guidant (recently acquired by Boston Scientific Corp.) and Medtronic. The guidelines call on device manufacturers to develop and use wireless and remote monitoring technology to identify possible malfunctions or problems earlier.
Bausch & Lomb, the maker of ReNu contact lens solution, didn’t bother to notify the FDA or the American public about infections Hong Kong officials found in the product in November 2005. This is important because the product sold in Hong Kong is manufactured at the same Carolina plant that supplies the contact lens solution to stores in the United States.
According to an article published in the Wall St. Journal, the maker of ReNu contact lens solution, was notified of eye infections in November 2005. The number of those infected with the fungus fusarium keratitits has now risen from 176 last week to 186 cases in 29 states. The product distributed in Singapore and Hong Kong is manufactured at the same South Carolina plant as product sold in the United States. The question remains why didn’t Bausch & Lomb publicize this information in November when it first learned of the problem.
In an obviously cynical and calculated move, the attorneys for Monsignor Dale Fushek are now bullying the witness victims of the priest accused of the sexual abuse of numerous boys in Arizona. The defense attorneys are deposing these witnesses and grilling them about their sexual history and their orientation. One witness, Brian Jones, refused to answer the questions citing their utter irrelevance. Fushek’s lawyers filed a motion to compel him to answer the questions.
This is clearly a move calculated to intimidate and prevent further witness testimony against the former founder of Life Teen. It is also a desperate move by a man bent on destroying others. I don’t see anyone on the Fushek side asking the question, “What would Jesus do?”
This afternoon I’ll be filing a civil lawsuit against Bausch & Lomb, the manufacturer of ReNu contact lens solution. I’ll be filing in US District Court for the Middle District of Florida on behalf of a woman who has lost nearly 80% of her vision in her left eye. Unfortunately, she is not a surgical candidate.
As a governmental oversight agency, it should be appalling that the FDA uses experts who have financial interests in the drugs and products about which they provide expert testimony. Yet, in a study conducted by the consumer group Public Citizen, that is exactly what is happening. How can any expert provide unbiased testimony about a product in which they’ve bought stock or have some financial interest? That’s not true oversight, but profiteering at the expense of the consumer.
The Centers for Disease Control and Prevention have confirmed that there are 24 new cases of fusarium keratitis. This brings the total to 54, up from 30 just two weeks ago. In the midst of new cases, Bausch & Lomb, the manufacturer of ReNu remains slow to react to the mounting crisis.
There’s an insightful article in the online version of the Wall St. Journalregarding what jurors think when it comes to the pharmaceutical giant Merck and their drug Vioxx. The article states that three things are important when it comes to prevailing in a lawsuit against the maker of Vioxx: 1)show the victim used Vioxx; 2)a believable plaintiff witness, and 3)risk factors galore.
Now, in my mind, the first two are no brainers for any trial attorney. But the third comes as a huge surprise and goes against the conventional wisdom. Until the latest Vioxx verdict in the McDarby case, it was generally thought that the best case involved a person who had the fewest risk factors. Yet, Mr. McDarby turned that thinking on its head. It just goes to prove that there are certain intangible factors in any trial. The human element always presents the possibility for surprise.
Documents have surfaced in litigation that show Ortho-McNeil has been analyzing the FDA’s death and injury reports on women using the Ortho Evra birth-control patch, and has charts that show a higher rate of blood clots and deaths in women on the patch when compared to women who take birth-control pills.
The Government Accountability Office has published a report sharply critical of the Food and Drug Administration. The report states that the organization is sometimes too slow in recognizing safety problems once drugs have gone to market. The GAO report also says the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings.