Indiana Injury And Family Lawyer Blog

It is buyer beware when any product label says, “Intended to prevent, treat or cure diseases”. It is particularly buyer beware for the website called www.oxygentherapyprogram.com and its products called Oxygen Therapy (35% Food Grade Hydrogen Peroxide) and Inositol.

Recently, the Food and Drug Administration completed an investigation of 35% Food Grade Hydrogen Peroxide and Inositol and noted several FDA violations. In Fact, the Food and Drug Administration documented that there may be more deficiencies associated with the two products.

First, since the products are intended to diagnose, cure, mitigate, treat, or prevent disease, they fall under the category of classified drugs defined in the Federal Food, Drug, and Cosmetic Act. As such, these products must be recognized as safe and effective for their labeled uses. However, these drugs were not approved by the FDA for safety and efficacy. In addition, new drugs that fall under the classification of the Food, Drug, and Cosmetic Act are not permitted to be introduced to the public until they have been approved. Both 35% Food Grade Hydrogen Peroxide and Inositol have been sold to the public without FDA approval.   The FDA also discovered that the product label did not provide adequate directions for a person to use the product without the advice of a physician. This is a misbranding violation.

The Food and Drug Administration has warned www.oxygentherapyprogram.com to correct their violations immediately or be subject to possible enforcement action, such as illegal product seizure, criminal prosecution, or an injunction against the manufacturer and distributors of www.oxygentherapyprogram.com products.

Buyers of online medical products should be wary of claims stating that a specific product fights off disease, kills viruses, or thwarts off systematic conditions. Before purchasing an online medical product, bring a print out of the product description and any related information to your physician for his or her review and approval.

Burton Padove, Indiana and Illinois lawyer, is available to help those who have been misrepresented. He can be reached at (877) 446 5294.

The Food and Drug Administration conducted an investigation of a OsteoSymbionics plant located in Cleveland, Ohio to learn that the company was manufacturing cranial implants which was not in accordance with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found in Title 21, Code of Federal Regulations (C.F.R.), Part 820.

The Food and Drug Administration determined that these cranial implants are devices which fall under the Federal Food, Drug and Cosmetic Act because the product is intended for the use of disease diagnosis, mitigation, treatment, disease prevention or may affect the structure or function of the body.

Furthermore, the Food and Drug Administration found that the company had inadequate design controls for the development of the cranial implants, did not establish or maintain procedures for ensuring that specific design requirements are met consistently, and did not establish procedures for validation which limited follow up inspections and testing; including an inadequate sterilization process. The company also failed to maintain a device master record for the cranial plate implants and did not adhere to other regulations.

In the warning letter from the Food and Drug Administration, authorities directed OsteoSymbionics to take immediate action to correct the violations.  OsteoSymbionics has fifteen days to tell the Food and Drug Administration what the company has done to correct the violations and what they are doing to avoid violations in the future. The FDA warned that if OsteoSymbionics did not correct the violations, the company may be subject to regulatory action, such as, seizure, injunction, and/or civil monetary penalties.

In the U.S., most anyone can create a medical device and attempt to sell it. Many times, the most appropriate way for new medical companies to sell products to physicians is to participate in medical organization meetings that offer product displays for manufacturers. Medical organizations screen companies interested in exhibiting at medical organization meetings. Medical organizations have the right to refuse any company that the medical organization does not wish to allow participation in their meetings. Physicians also screen products before they make purchases for use in their practices.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

Advanced Bionics took swift action to recall the company’s HiRes 90K cochlear implant device and all un-implantable devices that have been distributed. This hearing aid recall was initiated following two reports from users who experienced excessively loud sounds, shocking sensations and a high level of discomfort. These side effects occurred within eight to ten days of initial use of the hearing aid.

At present, Advanced Bionics does not know why the HiRes 90K cochlear implant device and the company’s unimplantable devices are producing such side effects. The company is working with the Food and Drug Administration to determine the root cause that prompted the hearing aid recall. Typically, flaws in the design of the product or in safeguards of the product are the reasons for malfunction in products.

Hearing aids have come a long way from the first ear trumpet style versions of the 1700’s. By the mid 1850’s, a thin metal device was designed to meet specific needs for the hearing impaired. Nearing the 1900’s, ear tubes with speaker connections gained popularity. By the 1940’s, more modern hearing aids were developed and were offered in a variety of sizes to meet the specific needs of individual users. By the end of the 50’s, hearing aid styles were smaller due to advancements in microphone and battery technology.  In the 1990’s, digital processing hearing aids took over the marketplace, which provided greater clarity, a full range of tones and a more discreet appearance.  With the advent of digital technology, designs specifications have changed and hearing aid manufacturers are dedicated to creating advanced design specifications that do not pose risks for consumers.

Hearing aid companies that uncover risks in their products must perform an investigation to determine the reason for the risk. The company must correct the problem in order to sell the product to the public.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

The dietary supplement known as Duro Extend Capsules, manufactured by Intelli Health Products, has been recalled throughout the nation.  Intelli Health Products took this step after the Food and Drug Administration produced results from an analysis of the product showing that it contains Sulfoaidenafil.  Sulfoaidenafil is an ingredient that is FDA approved for the treatment of erectile dysfunction.  The reason why Sulfoaidenafil must be FDA approved is because the drug can negatively interact with other prescription drugs when taken together, such as with nitroglycerin. In addition, Duro Extend Capsules may lower your blood pressure to a high risk level. These two noted risks place people with high blood pressure, diabetes, high cholesterol and heart disease in danger for serious adverse reactions that may be life threatening when taking Duro Extend Capsules with their prescriptions for their medical condition.

Duro Extend Capsules are sold across the U.S. in a blister pack containing one capsule per unit, 12-pack, 24-pack display boxes, or 3 count and 10 count bottles. All lot numbers have been recalled by Intelli Health Products.

People who have experienced an adverse reaction when using the dietary supplement should contact their physician immediately. All consumers using the product should stop using it immediately and return the unused portion to the place of purchase.

Quality assurance testing at Intelli Health Products did not include a test for Sulfoaidenafil so Intelli Health Products was unaware that Sulfoaidenafil was contained in Duro Extend Capsules until the FDA conducted its analysis.

Over-the-counter and online products are not necessarily regulated by the FDA. It is often the manufacturer’s responsibility to ensure the product is safe and effective. In recent years, the FDA has stepped in to conduct testing of over-the-counter and online products. Yet, the number of products available online alone are so high it can be all, but impossible for the FDA to manage over-the-counter regulatory affairs.  Therefore, consumers must proceed with caution when purchasing online products. It is wise to check with your physician before using any over-the-counter or online product.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

Last year alone, roughly 10 million people in the U.S. used propoxyphene, known under the brand names Darvocet and Darvon, to relieve post operative pain.  It is unknown how many people have died or been seriously injured since the drug was approved in 1957. Recently, Public Citizen, a consumer advocacy group, petitioned the Food and Drug Administration to ban the drugs from the U.S. market, stating that the drugs caused over 2000 deaths, are highly addictive, and are not more effective than other safer pain relievers.

In June 2010, Public Citizen alleged that the Food and Drug Administration violated the law by failing to act on a petition that was originally filed in 2006. The FDA discovered over 3000 serious side effect cases involving Darvocet or Darvon. In December of this year, Darvocet and Darvon have been banned from the U.S. market.

The list of life threatening side effects associated with Darvocet and Darvon include: serious or fatal heart arrhythmia, heart attack, cardiac arrest, heart valve issues, myocardial infarction, pacemaker implantation, overdose, and suicide. The Public Citizen group determined that the risks associated with Darvocet and Darvon outweighs the benefit of pain relief, which can be accomplished by other less harmful drugs.

Darvocet has been one of the top twenty five drugs prescribed by physicians in recent years. Darvocet combines the active ingredient in Darvon, known as propoxyphene, with acetaminophen, the active ingredient in Tylenol.

Groups like Public Citizen are taking strides to better protect the public from harm by acting as a watchdog for consumers. Personal injury attorneys assisting people who have been injured by drugs are also part of the check and balance system for protecting the public.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

In October 2010, JP Morgan Chase announced that the company would be temporarily suspending certain foreclosure processes following the discovery that court documents were not being properly reviewed by third party personnel. JP Morgan Chase had allocated some of its foreclosure verification processes to third party foreclosure companies. However, JP Morgan determined that the personnel at the third party companies were not reviewing or properly notarizing foreclosure affidavits before signing off on them.

Consequently, two lawsuits have been filed against JP Morgan Chase regarding their methods for managing foreclosures. The lawsuits were specifically filed against Washington Mutual Bank and JPMorgan Chase & Co in the United States District Court for the Northern District of Illinois, and against Chase Home Finance in California state court.

The allegations in the lawsuit are common law fraud and misrepresentation, as well as violations of state consumer fraud statutes. It is not known who filed the lawsuits at this time. JP Morgan also indicated that the company is being sued for mortgage backed securities by other companies, such as Charles Schwab and Cambridge Place Investment Management. For this reason, class action status seems appropriate to some.

The U.S. mortgage crisis does not cease to exist.  And JP Morgan is not the only bank that has been adversely affected by faulty foreclose processes. Currently, several other banks have lawsuits filed against them, including:

• Bank of America lawsuit involving investors who purchased over $375 million in mortgage backed securities
• Citigroup, Inc. lawsuit, in part, for inappropriate underwriting of residential mortgage backed securities.
• Wells Fargo & Co. has several class action lawsuits filed against them.

Delayed foreclosure processing may open the door for consumers to sue banks on a large scale, potentially leading to another class action lawsuit for banks across the U.S.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

Hostility, irritability and aggressive behavior are the serious side effects that are still being reported by parents whose children take Singular.   This comes as no surprise to the U.S Food and Drug Administration because in March of 2008 the agency reexamined the safety of Singular and required new labeling to disclose the risks associated with the drug for adults and children, including:

• Anxiousness
• Depression
• Bothersome dreams
• Hallucinations
• Insomnia
• Restlessness
• Suicidal behavior and suicide
• Tremors
• Other  neuropsychiatric events

The drug has not been recalled to date. Furthermore, people may not be aware of the risk associated with Singular unless they read the package insert that accompanies the drug when purchased. Knowing that Singular is still Merck’s number one selling drug, with sales at $4.6 billion in 2009, it seems that there could be a good percentage of people who are unaware of the risks associated with the drug.

It does appear that the neuropsychiatric events will cease to occur following discontinuance of the drug. This shows that Singular has the ability to produce unhealthy and life threatening drug induced side effects.  In fact, some children have been misdiagnosed with psychiatric disorders, including ADHD and Tourettes Syndrome. These side effects are a high price to pay when compared the many other types of asthma medications on the market, widely available, that are not linked to serious risks for a high number of people.

This example is another reason why people who are prescribed drugs should ask their doctor about risks and alternatives in treatment. They should also ask the pharmacist about risks and alternatives in treatment.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

A year ago, it was difficult to know who to sue for the health issues and property damage caused by defective Chinese Dry Wall located in homes across the U.S. Recently, a $2.6 million verdict came back in favor of seven Virginia homeowners who were adversely affected by Chinese Dry Wall. This verdict lays the foundation for thousands of others to receive financial compensation for the injuries they have sustained because of the dry wall. The Chinese Dry Wall lawsuit claims are being overseen by a federal judge in New Orleans. This is considered multidistrict litigation (MDL), but you can contact a local attorney if you feel you have been injured by Chinese Dry Wall.

If you have experienced serious respiratory infections, sinus infections, rashes, hair loss, hospitalization or irreparable damage to your home’s air conditioning unit, heating unit, electricity or plumbing, your damages may be linked to Chinese Dry Wall. It is not uncommon for all household members to become ill from Chinese Dry Wall.

People who live in homes with Chinese Dry Wall should evacuate because of the risk of toxicity and unknown long term side effects. There is also no viable means to remedy Chinese Dry Wall toxicity and damage, making the financial loss for property very high.  It is also unknown how Chinese Dry Wall will affect the groundwater supply in areas that have homes built with this type of dry wall.

Between 2001 and 2008, the chance that home were built with Chinese Dry Wall are higher when compared to other years. This is because of the real estate boom in those years which forced some home builders to go outside of the U.S. for dry wall and building supplies. In 2007, home builder incomes rose to nearly $768 billion.  The damage to property from Chinese Dry Wall includes:

• Rotten egg smelling odor
• Failure of appliances, including HVAC systems and coils in air conditioners, stoves and refrigerators
• Corroded electrical wiring

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.