A Florida woman who blames cigarette smoking for her emphysema has been awarded $300 million in her lawsuit against Philip Morris, USA.

Richard A. Daynard, professor of law at Northeastern University and chairman of the Tobacco Products Liability Project, told the Associated Press that the large verdict could encourage other Florida juries to reach similar decisions.  “I think Philip Morris has finally met its match in Florida. This gives jurors permission to fully compensate plaintiffs for all the harm they suffered and to express their moral outrage at the industry’s behavior, ” Daynard said. (more…)

Preliminary results from a large study involving  Meridia, Abbott Labs’ popular prescription weight loss medication, have indicated that the drug  may be associated with a higher risk of  heart-related side-effects.  The findings prompted the  U.S. Food & Drug Administration (FDA) issued a Meridia Early Communication over the weekend.

Because of the serious nature of the issue, the FDA said it is conducting an expedited safety review of Meridia.  The agency will communicate its findings to the public as soon as this review is complete. (more…)

A new study published in the October issue of the Archives of Dermatology has found that dialysis patients and kidney transplant patients exposed to  gadolinium contrast dyes face a higher risk of developing the devastating disease, nephrogenic systemic fibrosis (NSF).

The study involved 94,917 patients exposed to gadolinium agents at the Mayo Clinic between January 1, 1999 and December 31, 2006.   Of that group, 3,779 patients were on hemodialysis, 1,694 patients had undergone a kidney transplant, and 717 patients had liver transplants.  A total of 61 patients had a clinical diagnosis of NSF. (more…)

Last month’s massive explosion at a Caribbean Petroleum Corporation facility near San Juan, Puerto Rico was likely the result of a faulty fuel monitor.  According to the U.S. Chemical Safety Board (CSB),  one of the depot’s 40 tanks was accidentally overfilled with gasoline from a ship docked in the San Juan harbor, reported Reuters.  A defective fuel monitoring system allowed for the error, which in turn led to the explosion, said CSB officials.

According to a Reuters report, depot employees did not notice the problem because the depot’s computerized level monitoring system was not working properly. Gasoline spilled from the tank, evaporated, spread across the facility, and resulted in a 2,000-foot vapor cloud, said Reuters. Once the vapor reached an “ignition source,” the blast occurred and the flames followed, added Reuters. (more…)

Three lots of Vicks Sinex nasal spray are  being recalled in  the United States, United Kingdom and Germany because of potential contamination with the bacteria, B. cepacia.   According to a recall notice issued by Proctor & Gamble,  B. cepacia  has been found in some of  the product made at its plant in Gross Gerau, Germany, and in a small amount of Vicks Sinex nasal spray from the recalled lot sold in the States.

There have been no reports of illness.  However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis.  B. cepacia poses little medical risk to healthy individuals. (more…)

Hurricane Katrina flooding victims who claim that the the U.S. Army Corps of Engineers’ failure to properly maintain the Mississippi River Gulf Coast Outlet (known popularly as MRGO) was partly to blame for the flooding that followed the historic storm got a huge win in federal court yesterday.

In a 156-page decision, Judge Stanwood R. Duval, Jr. wrote that  Army engineers are liable for the “negligent operation and maintenance” of the canal and not for faulty design or construction. “When the corps designed the MRGO, it recognized that foreshore protection was going to be needed, yet the corps did nothing to monitor the problem in a meaningful way,” he wrote in a 156-page opinion. (more…)

The label for  OptiMARK gadolinium contrast agent will now warn that it should not be administered to people with severe kidney impairment.  The decision by Covidien to make the label change comes on the heels of a the U.S. Food and Drug Administration review that found that OptiMARK was one of three gadolinium agents with the highest risk of nephrogenic systemic fibrosis (NSF).

In a statement released by Covidien yesterday, the company said it is  implementing its OptiMARK label change in all countries where OptiMARK contrast agent has been approved for sale, in accordance with local regulatory requirements. Covidien also will update its educational materials to help physicians make informed decisions regarding the appropriate use of OptiMARK. Mallinckrodt Inc., a Covidien company, has submitted this label change to the FDA and says it is implementing the new label in the U.S. effective immediately. (more…)

The U.S. Food & Drug Administration (FDA) is seeking label changes for gadolinium contrast dyes after determining that three – Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan,  and Covidien ‘s  OptiMARK -carry a higher risk of nephrogenic systemic fibrosis (NSF) than others.

According to documents released yesterday by the FDA,  the lowest risk was associated with Bracco Diagnostic’s Prohance and Multihance.  However, the agency said “the data do not appear to rule out an NSF risk for each of the agents.” FDA reviewers said the extent of risk from any of the agents was unknown. One study of Omniscan estimated the chances of developing NSF was 4 percent among patients with severe kidney impairment. (more…)

All lots of the ViperSheath Sheath Introducer have been recalled because of a breakage risk.  According to Cardiovascular Systems Inc.’s (CSI) recall notice, there have been three  reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI. The ViperSheath Sheath Introducer is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device (more…)

Plavix users should not take Prilosec and Nexium because these drugs can reduce the anti-clotting effects of Plavix, the U.S. Food & Drug Administration (FDA) warned yesterday.

Patients taking Plavix need to consult their healthcare provider if they are currently taking or considering taking Prilosec, Prilosec OTC or Nexium.  The FDA said it is also very important that patients talk with their healthcare professional about any over-the-counter drugs they are taking before starting or while using Plavix. (more…)