Georgia Injury Law Blog

Earlier this month, we reported on Governor Sonny Perdue’s proposed legislation granting immunity from civil liability to pharmaceutical companies and medical device makers if their products had already received FDA approval. Earlier this month, a bill was introduced outlining many of the same proposals that the governor mentioned, and underscoring the fears of patients, civil justice advocate and Georgia product liability attorneys.

The Bill, Senate Bill 101 grants immunity to these companies from any injury lawsuit brought by Georgia residents if the injury was caused by a pharmaceutical drug or medical device that had FDA approval. It’s clearly aimed at attracting Big Pharma investment into the state with civil liability immunity being the Unique Selling Proposition (USP). What it essentially does, however, is sacrifice patients’ rights to hold these companies accountable for injuries or deaths caused by their products. At the risk of sounding dramatic, we believe victims of device and pharmaceutical injury will be at the mercy of these companies.

The bill relies on a foundation that has been found to be increasingly fragile in recent years. FDA approval of drugs and devices has come under the scanner after several drugs and devices were forced off the market when injuries and risks associated with their use came to light. Do the names Vioxx, Heparin and Medtronic defibrillator leads ring a bell?

In the days since we were first informed that the nationwide salmonella food poisoning outbreak originated at a Peanut Corporation of America plant in Blakely, Georgia, the death toll from the outbreak has reached 9, the number of people sickened from salmonella tainted products has risen to 19,000 and food poisoning lawsuits have been filed.

Last week, Stewart Parnell, president of Peanut Corporation of America was summoned to Washington to testify at a congressional hearing. Meanwhile, skeletons have been tumbling at the PCA.Former employees at the Blakely plant have come forward to sing like canaries about the abhorrent sanitation practices at the plant. According to one employee, he once found baby mice inside a packet of peanuts. The same employee also claims that he has been witness to the practice of pasting new stickers on jars of old peanut paste, and has seen holes drilled by rats in sacks of peanuts. A new FDA report also indicates that management at the Georgia plant continued to ship out products that they knew had tested positive for salmonella contamination. According to the report, the company continued to retest its products until test results showed findings that were more to its liking – that the peanut butter was salmonella free.

The concern over products from the Georgia plant is so intense that the FDA has asked consumers to throw out any peanut butter products made at the plant over the past 2 years.

A new report underscores the importance of car seats in saving infant and toddler lives in the event of an automobile accident. New research by a California group indicates that the chances of toddlers and infants dying in an accident drop by as much as 75 percent when they are strapped into these safety seats.

Of course we’ve always known that car safety seats are very effective at reducing fatality rates in children who tend to be the most vulnerable victims in the event of a collision, but this study manages to hit home just how important these seats can be to protect their occupants.The two researchers who conducted the study, Thomas Rice and Craig Anderson, analyzed data from nearly 6000 accidents between 1995 and 2006, and compared the information to arrive at some startling statistics. In the case of babies below the age of one year, the odds of dying in a crash declined by as much as 73 percent, while in the 1-2 year age group, the odds of dying went down by 76 percent. 2-3 years olds had a reduced risk of fatality that was close to 60 percent if they were properly restrained in a car seat.

Of course, it goes without saying that these benefits are only valid if the car seats are of high quality, and meet all safety standards for children’s products.There’s no point in having a child strapped in a seat with improper buckles that can snap open in the event of a collision, or one that has defective clips that can slip open, releasing the child from the safety of the seat.Child seats also need to be made of safe materials with sufficient padding that can actually cushion a child from the force of impact during a collision.Stricter standards and demands for more safety features by parents have led manufacturers to design and create safer car seats, but safety issues continue to crop up every year. The unfortunate fact is that these issues come to light only when there is an unfortunate accident that exposes the instability of a defective car seat.

The Georgia peanut butter plant at the center of the salmonella food poisoning crisis has a poor sanitation record, and has frequently been cited for health and sanitation violations, the NY Times (via Tort Deform) reports.Judging by the condition of the plant in our very own Blakely, Georgia, the media and food poisoning lawyers should not even be surprised that a nationwide outbreak of deadly salmonella poisoning has originated from this facility.

The Peanut Corporation of America plant has been cited several times since 2006 for health violations. Inspectors have frequently found the facility full of large gaping holes in its food security mechanisms. These include grease accumulation inside the facility, doors with large holes that a rat could easily squeeze through, and dirt and grime everywhere.The plant had areas caked with rust that could easily disperse and fall into food products, and poor sanitization of surfaces meant for food processing.Peanut butter packets were left lying around uncovered. These violations continued even till 2008, when inspection reports continued to mention numerous violations.

Dirty and unsanitary conditions breed rodents and insects.Animal feces are just one of the ways that the salmonellum bacterium spreads.The risk of infectious disease is the reason why food processing and preparation plants and establishments that serve food like restaurants, are put though numerous safety inspections.From the report in the Times, it seems like that the plant was a salmonellosis time bomb waiting to go off.

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues. We await the United States Supreme Court’s decision on this issue. Meanwhile, the FDA is having to answer to these problems.

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."