Dangerous Products: March 2009 Archives

March 31, 2009

Salmonella Causes FDA to Issue Pistachio Product Recall

The U.S. Food and Drug Administration (FDA) is cautioning consumers in Florida and across the nation to avoid pistachios and any products that contain them.  The latest food product recall stems from Kraft Foods Inc.'s discovery that their Back to Nature Trail Mix was contaminated with Salmonella.  The source of the Salmonella was traced back to Setton Pistachio of Terra Bella, Inc. in California.  The pistachio contamination is said to involve several strains of Salmonella according to the FDA.

Several illnesses related to the pistachio Salmonella contamination have been reported, but it is unclear if any of those cases occurred in Florida.  The FDA investigated whether the strains found in pistachio products were related to the recent outbreak of Salmonella in peanut products which caused one illness in Florida as of March 15, 2009, but have found no link thus far.

The Salmonella bacteria can cause diarrhea, fever, abdominal cramps and other related symptoms.  In people with weakened immune systems, such as the young, elderly, and infirm, Salmonella can at times lead to death.  In nuts, the roasting process is used to kill off the bacteria, but when this process is improperly performed the bacteria can survive in the finished product.

Companies are often held liable for the injuries caused by their products.  Companies have a duty to comply with the various food-safety guidelines applicable to their particular product and to take steps to ensure the safety of their products.  Most recently, these types of claims against food producers have stemmed from the peanut butter Salmonella outbreak which sparked numerous lawsuits against Peanut Corporation of America and other related companies after allegations of unsanitary conditions and code violations.  Thus far, no such allegations have been made against the producers of the pistachio products.

The FDA is advising that consumers avoid eating pistachio products until further information is available.  Because the pistachios were sold in bulk to other companies that packaged and produced other products with the nuts, the extent of exposure has not yet been determined.  Many companies, including Georgia Nut Company, Back to Nature Food Company, and Kroger, are already issuing recalls on some of their pistachio products.
  

Continue reading "Salmonella Causes FDA to Issue Pistachio Product Recall" »

Bookmark and Share
March 6, 2009

Dangerous Drug Injury Victim Scores Big in Supreme Court

In a 6-3 decision on Wednesday, the Supreme Court of the United States held that federal law and regulation does not pre-empt state personal injury actions against drug manufacturers whose products cause injury because of inadequate labeling.  The ruling in essence makes drug companies responsible for the content of their warning labels.  The decision stems from a Vermont lawsuit in which Diane Levine sued Wyeth Pharmaceuticals after she received an IV-push of the drug company's anti-nausea drug, Phenergan, which ultimately led to the amputation of her right arm.  Levine was awarded $6.7 million (after court-ordered reductions) by a Vermont jury that found Wyeth failed to adequately warn of the dangers of it product.

After the verdict, Wyeth appealed and ultimately argued to the Supreme Court that Levine's lawsuit was pre-empted by federal law because "it would have been impossible for it to comply with its state law duty to modify Phenergan's label without violating federal law" and "that requiring it to comply with a state-law duty to provide a stronger warning about IV-push administration would obstruct the purposes and objectives of federal drug labeling regulation." The Court's opinion rejected both arguments basing part of its decision on the fact that Food and Drug Administration (FDA) regulations permit a manufacturer to make certain changes to its label before receiving agency approval, and without evidence that the FDA would have rejected such changes, the court refused to find the claim was pre-empted because of impossibility of compliance.

The Court also rejected Wyeth's obstruction claim that argued "[o]nce the FDA has approved a drug's label, a state-law verdict may not deem the label inadequate, regardless of whether there is any evidence that the FDA has considered the stronger warning at issue."  The Court found that Wyeth's argument was completely contrary to congressional intent and reasoned that "[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision" within the controlling federal law.  The Court also noted that although the FDA has recently taken the position that its regulations pre-empt state law, "[n]ot once prior to Levine's injury did the FDA suggest that state tort law stood as an obstacle to its statutory mission."

In an amazing denunciation of the FDA's 2006 change in philosophy and in support of state tort claims, the Court noted that "[s]tate tort claims uncover unknown drug hazards and provide incentives for drug manufactures to disclose safety risks promptly" and "serve a distinct compensatory fucntion that may motivate injured persons to come forward with information."

The decision helps pave the way for others in Florida and throughout the US to bring suits for injuries sustained as a result of pharmaceutical companies' failures to adequately label and warn of known dangers. 


Continue reading "Dangerous Drug Injury Victim Scores Big in Supreme Court" »

Bookmark and Share