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.

“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.

According to an FDA warning, prolonged use of Actos may cause an increased risk of developing bladder cancer.

The seminar will provide an in-depth look at the FDA’s recent update to its health warning regarding Actos, a Type-2 diabetes drug. Through exploration of Actos’ history, as well as recent studies and regulatory action, the faculty will delve into information and strategies that will help plaintiff lawyers understand how to proceed with current litigation.

Arsenault and his firm have filed several lawsuits on behalf of Actos victims who have developed bladder cancer.

To view the agenda, faculty and to register, visit www.justice.org/actos.

• There may be an increased chance of having bladder cancer when you take pioglitazone.
• You should not take pioglitazone if you are receiving treatment for bladder cancer.
• Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain while urinating; pain in back or lower abdomen.
• Read the Medication Guide you get along with your pioglitazone medicine. It explains the risks associated with the use of pioglitazone.
• Talk to your healthcare professional if you have questions or concerns about pioglitazone medicines.
• Report side effects from the use of pioglitazone medicines to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of the page.

The pharmaceutical lawyers at Neblett, Beard & Arsenault are investigating a possible class action lawsuit over the link between Actos and bladder cancer.  If you have taken Actos for a year or more and developed bladder cancer, we’d like to hear your story.

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.

1. Staphaseptic First Aid Antiseptic/Pain Relieving Gel (Tec Laboratories)
2. Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant (JD Nelson and Associates)
3. Dr. Tichenor’s Antiseptic Gel (Dr. G.H. Tichenor Antiseptic Co.)
4. CleanWell All-Natural Foaming Hand Sanitizer, CleanWell All-Natural Hand Sanitizer, CleanWell All-Natural Hand Sanitizing Wipes, and CleanWell All-Natural Antibacterial Foaming Handsoap (Oh So Clean, Inc, doing business as CleanWell Company).

The FDA letters warned each company that their products’ marketing is in breach of federal law and gave them 15 days to correct the violations.

1. Staphaseptic First Aid Antiseptic/Pain Relieving Gel, by Tec Laboratorie
2. Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates
3. Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.
4. Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company.

The FDA is concerned that these products are giving consumers a false sense of protection. Unproven claims found on product labels include, but are not limited to such claims as “kills over 99.9% of MRSA”; “helps prevent skin infections caused by MRSA and other germs”; “is effective against a broad spectrum of pathogens, including MRSA.”

MSRA is a very serious problem. It is a bacterium that can cause severe infections that may become life-threatening. Most troubling is that these infections do not respond to standard treatment with the antibiotic methicillin. According to Edward Cox, M.D., M.P.H., director of the FDA Office of Antimicrobial Products, MRSA is extremely difficult to treat.

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

A veteran of class action and complex litigation, Arsenault’s firm is actively involved in the pending lawsuits against the makers of the recalled painkillers, and continues to investigate additional claims.

Darvon, Darvocet and other forms of propoxyphene where pulled from the U.S. market by the FDA in November 2010 because of serious, potentially fatal heart-related problems and overdose risks, which were determined to outweighed the drugs’ benefit.

The FDA has determined that the drugs’ benefits do not outweigh the serious risks associated with the medications’ side effects, which include heart rhythm abnormalities. Even when taken at recommended doses by healthy patients, the propoxyphene in Darvon and Darvocet can still cause changes in the electrical activity of the heart that can cause serious problems, including sudden death.

Darvon was first introduced to the US market in 1957. However, concerns over the drug’s serious side effects led consumer group, Public Citizen, to petition the FDA in 1978 and 2006 to remove the drug from the market. Darvon and Darvocet have been banned in the UK since 2005, and were banned in Europe over a year ago. Public Citizen estimates that as many as 1,000-2,000 US deaths have been linked to Darvon and/or Darvocet since the drugs were banned in England over 6 years ago.

Our drug injury lawyers know firsthand the pain and suffering that can be caused by unsafe pharmaceuticals. Our firm represented hundreds of Vioxx victims, and our senior partner, Richard J. Arsenault, played a central role in the national litigation against Merck. We’ve been working hard for victims of dangerous drugs for nearly thirty years, and are currently investigating claims on behalf of victims of Darvon, Darvocet and generic propoxyphene painkillers.

Earlier this year, DePuy Orthpaedics, a division of Johnson & Johnson, initiated a worldwide recall of its ASR hip replacement products because of higher-than-expected failure rates. It has been reported that 1 in 8 patients implanted with the recalled hip systems will have to undergo revision surgery within 5 years. A veteran of complex and class action litigation, Arsenault is a frequent speaker and chair of legal conferences. Arsenault’s firm has filed a lawsuit against Johnson & Johnson DePuy and continues to investigate other claims against the makers of the recalled ASR hip replacement systems.

Most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners. The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.

The CPSC has posted this warning on its website:

* STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
* NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
* ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.

The lawyers are Neblett, Beard & Arsenault are currently investigating claims against manufacturers of faulty or defective childrens’ products.  We have worked hard for families whose infants and children have been injured or killed as a result of defective products, and are closely following this recent warning from the FDA & CPSC.  We will updated this information as it becomes available. Stay tuned.

Alexandria, LA (PRWEB) July 1, 2010 — The U.S. Food and Drug Administration should adopt a proactive approach to food safety such as the one outlined in a new report by the Institute of Medicine and National Research Council, says Louisiana food safety advocate Richard J. Arsenault.

The 500-page report, requested by Congress 18 months ago after a rash of foodborne illness outbreaks, states that the FDA’s current “reactive” model makes inefficient use of its limited resources and relies on a case-by-case approach to gathering and using information on risks.

By switching to a “risk-based” approach outlined in the report, the FDA could better identify problems in the food supply and distribution chain, efficiently direct resources to high-risk areas and catch problems before they turn into widespread outbreaks, the report says.

“More than 300,000 people need to be hospitalized and over 5,000 people die from foodborne illness in America every year, and that number of victims is unacceptable when many of these illnesses could have been prevented,” says Arsenault, whose firm, Alexandria-based Neblett, Beard & Arsenault, has represented hundreds of foodborne illness victims throughout Louisiana and across the country.

“The IOM report, for the most part, sets out a vision for how local, state and federal officials can work together to catch problems before they spread and harm innocent consumers, and I think Congress and the FDA should give serious consideration to its recommendations,” Arsenault says. “It’s not a perfect plan, but it serves as a good blueprint.”

The FDA is charged with ensuring the safety of approximately 80 percent of the nation’s food supply, including seafood, fruits, vegetables and dairy products. The federal agency shares food safety responsibility with the U.S. Department of Agriculture, which oversees meat, poultry and egg products, as well as state and local agencies, which inspect food production facilities.

According to the IOM report, the FDA needs to adopt a system that would increase coordination with those other agencies, and it needs more authority to carry out its mission through amendments to the federal Food, Drug and Cosmetic Act – much of which is currently contained in proposed legislation before the Senate.

The report calls for establishing a centralized food safety data center that would collect information, quickly assess risks and take steps to address food safety problems without competing with other agencies for resources.

To enhance its efficiency, the FDA could also delegate food facility inspections to states and establish national standards for the intensity and frequency of those reviews, the report says.

According to the report, this change would build on current practices in which roughly 60 percent of inspections are already conducted by state inspectors, and it would increase the quality of inspections and avoid duplication of efforts.

The report also asks Congress to consider legislation that would specify the FDA’s authority in facility registration, preventive controls, risk-based inspection, mandatory recall, reporting of adulteration and banning of certain food imports if the public’s health is at risk.

“What is significant to me about this report is that a committee of experts has clearly stated that our current food safety system is inadequate and in dire need of change,” Arsenault says. “Improvements need to be made.”

Lifesoy entered into a consent decree of permanent injunction that requires them to immediately stop manufacturing and distributing food products until the sanitary requirements are met and certified by the FDA. Lifesoy makes sweetened and unsweetened soy milk, fresh tofu, fried tofu, soybean pudding and other soy products for human consumption.

This action by the FDA signals faster action against food manufacturers and distributors in efforts to protect consumers from foodborne illnesses.