This recent expansion of CooperVision’s previous recall of Avaira Toric Contact Lenses affects 6.6 million contact lenses which may cause side effects such as hazy vision, pain, and eye damage.  CBS News reports that the FDA thought CooperVision’s recall didn’t go far enough, and that’s why the FDA has issued “its own urgent warning about Avaira lenses”.

According-+ to the FDA, levels of a silicon oil residue found on the surface of contact lenses causes these eye problems. The world-wide recall involves lenses distributed to several countries including the United States, Canada, Australia, Spain, Hong Kong, Italy, and Germany.  Problems reported by Avaira contact lens wearers include severe eye pain, blurred vision, hazy vision, corneal damage and other vision associated problems.

According to an FDA informational page concerning the recall:

If you wear Avaira Sphere contact lenses and experience any symptoms, CooperVision recommends that you stop wearing the lenses immediately. Contact your eye care practitioner for advice.  CooperVision will launch a recall site  on Wednesday November 16th for wearers to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled.

If you have experienced symptoms as a result of these contacts, check with your eye care practitioner immediately. The FDA requests that you report any problems or symptoms via their MedWatch Reporting program.

Now, it appears that startling new information relating to inappropriate Infuse usage has been discovered. At a national spinal surgeon convention, Dr. Eugene Carragee noted that undisclosed clinical trial data “showed a significantly higher number of cancers in the study group that received Amplify when compared to a control group that received a bone graft as part of a spinal fusion….”

In that same article, Dr. Carragee also noted that Infuse may have been used off-label at higher-than-approved levels, levels possibly higher even than intended for Amplify, resulting in potential cancer risks to recipients.

Medtronic has responded to these claims by forking out $2.5 million to allow Yale researchers to independently analyze the Infuse data. This study has not been released; however, its results will likely provide additional insight into the safety of Infuse.

The result of this un-FDA sanctioned use of Infuse – patients suffering severe medical complications including difficulty breathing, swallowing, speaking, airway compression, respiratory problems, nerve damage, infection, bone loss, unwanted bone growth, sterility in males, and death. Additionally, Policymed.com indicated that reports from the Milwaukee Journal-Sentinel highlighted potentially inappropriate financial links between Medtronic and Infuse researchers. The Senate Finance Committee is currently looking into this claim. Also of note, in 2008, the FDA announced that improper Infuse use could cause medical problems.

According to press releases issued by Cooper, a residue found on the toric lenses causes the eye problems. The world-wide recall involves lenses distributed to several countries including the United States, Canada, Australia, Spain, Hong Kong, Italy, and Germany.  Problems reported by toric lens wearers include severe eye pain, blurred vision, hazy vision, corneal damage and other vision associated problems.

According to an FDA informational page concerning the recall:

On August 19, 2011, the firm sent a recall notification letter to the US and Canadian distributors and health care practitioners. Other foreign distributors were sent the recall letter a week later.

Consumers should return their lenses to their eye care practitioner if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.

If a consumer is wearing Avaira Toric contact lenses and is NOT experiencing symptoms, Cooper Vision recommends going to their recall web page at www.coopervision.com/recall and enter the lot number of their package to determine whether their lenses have been recalled. If the lenses are on the recall list, they should immediately remove their existing lenses, discontinue all lens wear, and return them to their eye care practitioner or point of purchase.

If you have experienced symptoms as a result of these contacts, check with your doctor immediately. If you are uncertain if your contacts were part of this recall, visit the CooperVision website for additional information.

Insight Pharmaceuticals, LLC of Langhorne, Pa., is recalling one lot (34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia.

Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis).  However, the possibility of infection is remote in healthy individuals.

Nostrilla Nasal Decongestant, lot #11G075, UPC Code 6373673005, was distributed nationwide through normal retail outlets and pharmacies. The product comes in a 1/2 ounce, plastic bottle marked with lot #11G075 on the label and with an expiration date of 05/2014 stamped on the side. No illnesses have been reported to date in connection with this problem.

The recall was initiated following internal investigations which determined the potential presence of a microbial contaminant that exceeds the product specifications and may consequently result in a subpar product. This contaminant has been found sporadically throughout only the respective manufacturing lot, #11G075.

“Our first priority is always the health and safety of all CooperVision lens wearers and as such we responded quickly to complaints from our customers by initiating a voluntary recall” said Christine Moench, vice president, Global Regulatory Affairs and Quality Assurance. “We want to ensure that all consumers are aware of this action and know where to go for more information.”

If you wear Avaira Toric contact lenses and experience any symptoms, CooperVision recommends that you stop wearing the lenses immediately. Contact your eye care practitioner for advice.

The recall was initiated because of the unintended presence of a residue on certain lots of Avaira Toric lenses, which may cause hazy vision, discomfort, or eye injuries requiring medical treatment. Not everyone experiences the same symptoms. Since the initiation of the recall, the company has received some additional complaints of severe eye pain. Avaira Toric contact lens wearers that experience any symptoms should stop wearing the lenses immediately and speak with their eye care practitioner.

We have ongoing relationships with practitioners to continue to identify all the affected lots in the market. To date, the recall has impacted approximately 600,000 Avaira Toric contact lenses in the U.S.

The Oreck Corporation advertised its Halo vacuum cleaner and ProShield Plus air cleaner as having health benefits, allergy prevention and germ killing properties. During the 2009 holiday season, Oreck began advertising the pair of appliances together under the headline “Introducing the Oreck Flu Fighters.” The ads claimed that the vacuum and air cleaner would “help reduce the flu on virtually any surface and in the air in your home.” The vacuum sold for $600 and the air cleaner for $400.The Federal Trade Commission recently fined Oreck for misleading advertising on those points, however. Oreck agreed to stop making “allegedly false and unproven claims” about the products and agreed to pay a $750,000.00 fine. The consumer protection lawyers at Neblett, Beard and Arsenault are investigating complaints about the Oreck Halo vaccum cleaner and ProShield Plus air cleaner system.

According to Looks Too Good to be True.com, “Bank customers are responsible for the checks [or money orders] they deposit, and victims must repay the bank for bad checks. Federal law requires banks to make the funds you deposit available quickly, but it’s important for consumers to know that, just because you can withdraw the money, it doesn’t mean the check is good. Banks often release funds from a cashier’s check or money order before it clears.”  Meaning, you may be on the hook to pay back the full amount of the bad check or money order.

If you or a loved one believes that they may be  a victim or target of such a scam, contact your local authorities.  You may also contact the Federal Trade Commission Consumer Fraud and Identity Theft Division at 1-877-FTC-HELP or via their website.

Neblett, Beard & Arsenault is a nationally recognized law firm with over 25 years of experience handling toxic tort litigation.  Richard Arsenault, senior and founding partner, has filed a class action lawsuit and is investigating further legal action against DuPont in connection with possible side effects associated with the Imprelis herbicide.

CLEVELAND, OH – July 24, 2011 - (Docket  1:11-cv-01517) Richard J. Arsenault of Neblett, Beard & Arsenault has filed a class action lawsuit against DuPont over reportedly harmful effects linked to their newly introduced “Imprelis” herbicide.  The suit was filed on behalf of victims who claim to have suffered extensive and permanent damage to their trees, lawns and gardens after the use of Imprelis.

According to the lawsuit, Imprelis was applied in accordance with the directions supplied by DuPont.  Despite the care taken by lawn care professionals, the application of Imprelis is alleged to have resulted in serious and permanent damage to non-targeted vegetation, including mature trees.

“We are hearing from landscaping professionals who are fearful that Imprelis could become a tremendous financial problem for the lawn care industry,” said Richard Arsenault, one of the lead lawyers for the plaintiffs. “The troubling dynamic here is that while we don’t yet know how extensive the damage will be, what we’ve seen so far is not encouraging.”

Reports of tree deaths and damage linked to the use of Imprelis began surfacing in late May of 2011.  DuPont has issued a warning letter to landscaping professionals urging them to not apply Imprelis near Norway Spruce or White Pine trees while the company investigates the reports. Additionally, the EPA is launching an investigation into tree death and damage reports in Minnesota, Indiana, Illinois, Ohio, Michigan,  Pennsylvania, Maryland, Delaware and West Virginia. According to the lawsuit, Ohio appears to be the epicenter of the damage, since the chemical has been applied to thousands, if not tens of thousands, of lawns and other properties throughout Ohio.

“The manufacturers of this product, which was touted as being ‘environmentally friendly’, have some explaining to do,” remarked Arsenault.  “The public deserves to know whether this product is safe and all of the consequences associated with its use.”

According to the lawsuit, victims began to notice trees located in the proximity of Imprelis application sites were yellowing, losing canopy and dying.  They are seeking damages against DuPont in a lawsuit that was filed in the United States District Court for the Northern District of Ohio, Eastern Division.

Most manufacturers have already gotten on board and are providing U.S. families with new and improved safety designs.  However, no one knows exactly how many drop-side cribs are still out there.   Since 2007, over 11 million of these types of cribs have been recalled due to their potential danger, but countless babies may still be at risk because of the use of second-hand or hand-me-down cribs with drop-sides.   If you have questions or concerns, check out the CPSC website for questions and answers about crib safety.

At Neblett, Beard & Arsenault, we have seen first-hand the devastation, pain and destruction that these cribs can inflict on a family.  Please help spread the word about the realities of drop-side cribs and encourage friends and family to make informed decisions when purchasing a new crib.

Triad Group and H&P Industries of Hartland, Wisconsin, are accused of violiating good manufacturing standards and failing to heed FDA inspections and warnings about problems with contamination and sterility.  Today’s actions mean that these groups cannot resume manufacturing and distributing drugs or medical devices until they establish an acceptable Quality Assurance and Quality Control program to ensure that all products manufactured in their facilities comply with federal standards for quality and have the identity, purity, potency and safety they are expected or are represented to possess.  Additionally, about $6 million worth of products were seized by federal health officials over public safety fears.

Triad Group and H&P Industries have been sued by a Houston couple who blame the tainted pads for the death of their two-year-old son.  The boy, who recently underwent surgery, was treated at the hospital with alcohol that were later recalled.  The boy developed an infection with Bacillus cereus, and later died.

JR has gained a national reputation for his skilled representation in consumer protection and class action/complex litigation claims.  He is admitted to practice in all state and federal courts in Louisiana, as well as the United States Fifth Circuit Court of Appeals and the United States Supreme Court. Due to the nature of his practice, J.R. is admitted almost yearly pro hac vice to many courts throughout the country. J.R. was graduated from L.S.U. with degrees in history and political science and was graduated from L.S.U. Law School, where he won the prestigious Flory Trial Competition. In addition to his busy litigation practice, J.R. regularly speaks to other attorneys and students on important legal issues and is a consistent contributor to legal publications throughout the country.

Arsenault and his firm represent owners of 2003-2007 Ford F-series trucks and Excursion vehicles with Navistar 6.0L Power Stroke Diesel engines.  According to class action lawsuits, plaintiffs are alleging these engines are defective and are costing thousands in repair bills, loss of use of the vehicles and loss of resale value.

A veteran of complex and class action litigation, Arsenault has been appointed to serve in leadership positions in some of the nation’s largest litigation.  He currently serves on the Plaintiffs Steering Committees for the litigation stemming from Toyota’s unintended acceleration, Bayer’s genetically modified rice, KABA’s keyless locks, as well as others.  He is frequently quoted in the New York Times, Wall Street Journal and other news outlets for his involvement in major cases, and chairs national litigation conferences on emerging practice areas.

This seems to be what is happening in the case of Ford trucks running the Navistar 6.0L Power Stroke Diesel engine:

• 2003-2007 Ford F250 Super Duty
• 2003-2007 Ford F350 Super Duty
• 2003-2007 Ford Excursion

Investigations have begun into whether the Ford Motor Company and Navistar have knowingly sold their customers trucks with inferior engines that are prone to a litany of costly problems including:

• Loss of engine power
• Blown head gasket
• Warped/disfigured head bolts
• Oil cooler failure
• Engine Gas Recirculation (EGR) cooler failure
• Coolant entering the engine’s ventilation system

In 2007, Ford Motor Company sued Navistar (the maker of the 6.0L power Stroke Diesel Engine), claiming that the 6.0L Power Stroke Diesel Engine was defective and that Navistar had failed to pay its portion of warranty claims filed by Ford owners and lessees.

While Ford certainly thought it only fair that they be compensated for these seemingly inferior engines; Ford did not see it quite as fair to stop advertising their trucks with the 6.0L Power Stroke as superior vehicles. Ford also did not see it fit to share any of the money they recouped in their lawsuit against Navistar with the owners of these vehicles, or to issue a recall on their vehicles with 6.0L Power Stroke Diesel Engine. Owners would just have to wait until their vehicles broke down and hope they could afford the costly repairs.

When individuals rely on their vehicles for work and business, problems equal time and money. In turn, a defective truck hurts the small business person who relies on their vehicle for much more than transportation to and from work. The 6.0L Power Stroke Diesel is a powerful engine. It is used by people to haul large loads. As such, the vehicles that run on the 6.0L Power Stroke Diesel are the trucks that haul and move large weight.

People responsible for building our country’s homes and infrastructure need their vehicles to be reliable, which is why many choose brands like Ford, for their typically reliable vehicles. But in the case of the Navistar 6.0L Power Stroke Diesel, it does not seem that a lifetime of quality is what these engines are providing, but rather a laundry list of problems and ever growing repair bills.

A small business owner cannot simply absorb the additional cost of purchasing a new truck or constantly paying for repairs to a truck that simply can never be truly fixed. Many of these trucks have expired or expiring warranties, meaning the shift in financial responsibility for these vehicles is moving to the owners. For many individuals, this added cost could be devastating.

But the costly repairs are not the only fallout from owning a vehicle with a known problematic engine, resale of these vehicles has been greatly affected by the reputation of trucks with the 6.0L Power Stroke engine. Many expect that their vehicle will be an asset in the future that can be sold for a reasonable price, which may not be the case for these Ford trucks. Owners could be stuck with a costly truck that cannot perform its work duties and also cannot be sold for any recovery in monies.

You can’t go onto a truck-related message board without hearing the war stories many 6.0L Power Stroke diesel owners have been through. Some of these sites flat out advise viewers NOT to buy one of these vehicles. For a vehicle that can cost upwards of $60,000, that is simply unacceptable for the hardworking individuals who own these trucks.

Our attorneys don’t think it is fair, either. That’s why we’re investigating claims against Ford and Navistar for owners with 2003-2007 F-250s, F-350s and Excursions. Read more about it here.

TPN is liquid nutrition fed through an IV using a catheter. Use of contaminated products may lead to bacterial infection of the blood.

ADPH requested assistance from the Centers for Disease Control and Prevention. CDC’s initial investigation identified TPN produced by a single pharmacy, Meds IV, as a potential common source and has determined that these hospitals received TPN from this pharmacy. Affected hospitals are Baptist Princeton, Baptist Shelby, Baptist Prattville, Medical West, Cooper Green Mercy and Select Specialty Hospital in Birmingham.

Meds IV was notified and informed its customers of the possibility of contamination. ADPH has been informed that impacted hospitals immediately stopped using TPN received from this pharmacy and that the pharmacy discontinued all production. On March 24, Meds IV recalled all of its IV compounded products. The U.S. Food and Drug Administration is aware of the voluntary recall. The pharmacy and the hospitals are cooperating with the investigation.

At this time, ADPH is aware of 19 cases in these six hospitals of Serratia marcescens bacteremia related to this outbreak.

ADPH will provide updates as more information becomes available.

Product List

• Bronch Procedure Kit
• Bupivacaine Epidural Bag
• Cardioplegia Solutions
• Cefazolin 2 gm Syringe
• Dialysate Solution
• Fentanyl /Ropivacaine Epidural Bag
• Fentanyl/ Bupivacaine Epidural Bag
• Folic Acid 1mg/0.2ml Syringe
• Glycopyrrolate 0.2mg/ml 1ml in 3ml Syringe
• Heparin IV Bags
• Hydromorphone Intravia Bag
• Hydromorphone PCA Syringe
• Ketamine Syringe
• Labetalol syringe
• Lorazepam 2mg/ml syr
• Meperidine 10mg/100ml NS(Intravia Bag)
• Morphine 1mg/ml PCA 100ml Intravia Bag
• Neostigmine 3mg Syringe
• Nitroglycerin IV Bag
• Nitroglycerin Syringe
• Norepinehrine IV Bag
• Oxytocin Bags
• Sodium Chl 23.4% (4meq/ml) 10ml Syr
• Succinylcholine 20mg/ml 5ml Syringe
• TPN Solution
• Vancomycin IV Bag