Sabatini and Associates, LLC

Nancy Nord, the Consumer Product Safety Commission’s acting chairman, thinks the agencies policies need to be updated, the law is 35 years old and needs to be changed. Earlier this week, her staff had a meeting with a group representing manufacturers and a meeting with several consumer groups to discuss her ideas and proposals.

Nord wants to make it illegal to sell a product that has been recalled after the date of public notice. As of now this practice is still legal. The CPSC also wants to make manufacturers and importers certify that their products meet mandatory and voluntary standards that the commission relies on as effective safety standards. Since there is already a requirement for certification now, this new provision will make the certification more public.

Advanced Medical Optics issued a voluntary recall of its Complete MoisturePlus contact lens solution after epidemiologists at the Centers for Disease Control and Prevention (CDC) in Atlanta linked the product to a rare but serious eye infection known as Acanthamoeba keratitis. Caused by a parasite, Acanthamoeba keratitis can lead to blindness and corneal transplants if left untreated.

 
A woman who says she suffered life-threatening blood clots from a birth control medication wants the Ohio Supreme Court to declare the state’s cap on pain-and-suffering awards unconstitutional.

The court on Tuesday planned to hear arguments in the lawsuit filed by Melisa Arbino of Cincinnati over the Ortho Evra Birth Control Patch, which she contends caused permanent physical damage and threatens her ability to have children in the future.

The challenge to a 2005 law limiting pain-and-suffering awards is the first to reach the court. It is being closed watched across the country by companies who support the concept of caps and attorneys representing injured people.  Read more about the ortho evra birth control patch and the case before the Ohio Supreme Court.

Products liability refers to the liability of any or all parties along the chain of manufacture of any product for damage caused by that product. This includes the manufacturer of component parts (at the top of the chain), an assembling manufacturer, the wholesaler, and the retail store owner (at the bottom of the chain). Products containing inherent defects that cause harm to a consumer of the product, or someone to whom the product was loaned, given, etc., are the subjects of products liability suits. While products are generally thought of as tangible personal property, products liability has stretched that definition to include intangibles (gas), naturals (pets), real estate (house), and writings (navigational charts).

Products liability claims can be based on negligenc, strict liability, or breach of warranty of fitness depending on the jurisdiction within which the claim is based. Many states have enacted comprehensive products liability statutes. These statutory provisions can be very diverse such that the the United States Department of Commerce has promulgated a Model Uniform Products Liability Act (MUPLA) for voluntary use by the states. There is no federal products liability law. 

Connecticut has a state product liability law as set forth in Connecticut General Statute Section 52-572m, et seq.  Pursuant to Connecticut General Statute Section 52-577a, a product liability claim must be brought within three years from the date of injury or death.  There are a few specific exceptions to this 3 year statute of limitations. 

In any jurisdiction, including Connecticut, one must prove that the product is defective. There are three types of product defects that incur liability in manufacturers and suppliers: design defects, manufacturing defects, and defects in marketing. Design defects are inherent; they exist before the product is manufactured. While the item might serve its purpose well, it can be unreasonably dangerous to use due to a design flaw. On the other hand, manufacturing defects occur during the construction or production of the item. Only a few out of many products of the same type are flawed in this case. Defects in marketing deal with improper instructions and failures to warn consumers of latent dangers in the product.

Products Liability is generally considered a strict liability offense. Strict liability wrongs do not depend on the degree of carefulness by the defendant. Translated to products liability terms, a defendant is liable when it is shown that the product is defective. It is irrelevant whether the manufacturer or supplier exercised great care; if there is a defect in the product that causes harm, he or she will be liable for the harm and damages that the defect has caused.

True Man and Energy Max Dietary Supplements are dangerous and defective products.  The Food and Drug Administration (FDA) is advising consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.  FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as “all natural” alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.

“These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products,” said Steven Galson, M.D., MPH, director of the FDA’s Center for Drug Evaluation and Research.”The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.”

The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED.Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.

True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.