Sabatini and Associates, LLC

The United States Supreme Court held 8-1 that Food and Drug Administration (FDA) pre-market approval of medical devices barred state court lawsuits by patients injured by such devices. The Medical Device Amendments of 1976 called for federal oversight of medical devices, and provided that states were not to establish or continue in effect any requirement “different from, or in addition to, any requirement” applicable to the device under federal law and which relates to, among other things, safety and effectiveness of the device. The Riegel court determined that common law negligence principles, as applied to medical device manufacture and design, constituted impermissible requirements under the statute.

Justice Ginsberg dissented, stating, “Congress, in my view, did not intend 360k(a) to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” However, the majority explicitly stated that this was precisely what the pre-emption, by its very terms, had done.

The Supreme Court’s decision has effectively terminated an injured person’s ability to recover compensation for injuries caused by unsafe and defective medical devices. It will take legislation from Congress to undo this damage to the rights of injured people.

Trees lining the Merritt Parkway make for a scenic commute but those same trees can make a ride dangerous and even deadly if they fall in the road. State of Connecticut crews have been trimming trees after a tree limb fell on a motorist’s car Sunday night near exit 50. The motorist remains in critical condition. Last June, a New York family crashed into a downed tree in Westport. The accident killed two parents and injured their two children. Governor Jodi Rell has called for crews to take a closer look at condition of trees along the state roadway.  Given the latest incident, it appears that more extensive tree inspections are required to ensure the safety of motorists driving on the Merritt Parkway.

The Connecticut�personal injury lawyers of Sabatini and Associates, LLC provide quality legal representation to clients in Hartford, Connecticut, and surrounding cities including: West Hartford, Newington, New Britain, Avon, Canton, Wethersfield, Glastonbury, East Hartford, Norwich, Granby, Rocky Hill, Bristol, Manchester, East Hartford, Plainville, Berlin, Farmington, Windsor, South Windsor, Bloomfield, Enfield and counties including New Haven County, Tolland County, Hartford County, New London County, Litchfield County and Fairfield County..

The FDA has announced that there have been at least 28 reports of consumers getting sick from ciguatera fish poisoning. The fish that were eaten were harvested in the northern Gulf of Mexico. The first reproted case was in November and outbreaks of the illness were confirmed in Washington D.C. and St. Louis.

Symptoms of ciguatera poisoning include nausea, vomiting, vertigo and joint pain. In the most serious cases, neurological problems can last for months or even years. Grouper, snapper, amberjack and barracuda are the biggest threat to consumers.

Ciguatera is common in fish living in tropical and subtropical regions, including the Caribbean Sea, the South Pacific Ocean and the Indian Ocean. But the FDA has considered it rare for fish in the northern Gulf of Mexico to have the toxin.

The fish linked to the ciguatera poisoning were harvested near the Flower Garden Banks National Marine Sanctuary and the FDA is recommending that processors not buy the fish harvested near this sanctuary. The FDA is also warning processors to make sure their hazard control plans are up to date, because failure to take the proper precautions could cause their products to be considered adulterated. Consumers who think they may be ill due to ciguatera poisoning should consult a physician and report their illness to the local health department.

The Connecticut personal injury law firm of Sabatini and Associates, LLC provides quality legal representation to clients in Hartford, Connecticut, and surrounding cities including: West Hartford, Newington, New Britain, Avon, Canton, Wethersfield, Glastonbury, East Hartford, Norwich, Granby, Rocky Hill, Bristol, Manchester, East Hartford, Plainville, Berlin, Farmington, Windsor, South Windsor, Bloomfield, Enfield and counties including New Haven County, Tolland County, Hartford County, New London County, Litchfield County and Fairfield County.

More lawsuits have been filed over bacteria-tainted syringes. Sierra Pre-Filled of Angier, North Carolina makes the syringes, filled with heparin or saline are used to flush IV or catheter lines. In December, bacteria-contaminated pre-filled syringes sickened 20 outpatients of Rush University Medical Center in Chicago. 14 of those patients required hospitalization from five to nine days. All already have compromised immune systems from cancer and other ailments and many were undergoing chemotherapy. Quick investigative work linked the syringes to the bacteria,�Serratia marcescens.  On December 20, 2007, the FDA announced AM2 PAT, Inc., initiated a nationwide recall of one lot of Pre-Filled Heparin Lock Flush Solution USP (5 mL in 12 mL Syringes), Lot # 070926H. Then the FDA in January expanded the recall to include all lots and sizes the company makes of heparin and saline pre-filled syringes after finding they too were contaminated with Serratia marcescens. The heparin IV flush syringe contamination was later confirmed by the CDC after checking several unopened syringes of this product.

A new study said that some over-the-counter drops meant to soften ear wax can damage the ear and shouldn’t be used. “Patients often complain that wax is blocking their ears and is causing discomfort and sometimes deafness,” said Dr. Sam Daniel of the Montreal Children’s Hospital. He said they can cause severe inflammation and damage to the eardrum and inner ear. “Because some of these products are readily available to the public without a consultation with or prescription from a physician, it is important to make sure they are safe to use. Our study shows that in a well-established animal model, one such product, Cerumenex, is in fact, toxic to the cells of the ear,” Daniel said.