Personal Injury

February 15, 2011

Indiana Medical Malpractice Tips

Indiana law conflicts were suited to reshape the statute of limitations for medical malpractice. According to Indiana statues, a medical malpractice lawsuit must be brought against a party within two years of failure to treat, neglectful injury or wrongful death. Recently, the Indiana Supreme Court weighed in on conflicts for lower court decisions in which the Supreme Court decided that the statue has merit, but cannot be applied in cases when the injured party was not able to learn about the condition until after two year rule. In this exception, injured parties may file a lawsuit within two years after the discovery of the medical malpractice.

This decision served a breast cancer patient well so that she could recoup losses for a physician’s failure to diagnose her breast cancer. Several other medical malpractice victims received proper attention for their complaints under the same exception.

The majority of medical malpractice cases in Indiana fall under the Medical Malpractice Act. However, if the physician does not participate in a state sponsored excess insurance program, other laws may apply. In all medical malpractice cases, there are numerous conditions that just be met in order to qualify for a lawsuit, including, but not limited to:

February 10, 2011

Sanofi Lawsuits When Drug Linked to Liver Damage

by Burton A. Padove

Sanofi lawsuits may shortly be underway since two of its drugs have been linked to seizures and liver damage, resulting in serious personal injury. In 2009, the Food and Drug Administration approved Multaq to treat atrial flutter and atrial fibrillation, also known as, irregular heart rhythms that can result in reduced blood flow throughout the body and consequential strokes. There have been over half million prescriptions dispensed since the drug was approved in 2009. There have also been numerous reports of liver damage and two of these cases involved the removal of the liver for these patients.

Multaq already has a black box warning stating the drug can cause life threatening consequences and death, in people with recent severe heart failure and should not be used in those patients. The common side effects of the drug include: fatigue, loss of strength, diarrhea, nausea and vomiting. Signs of liver toxicity include: nausea, vomiting and fever in which case patients must have their liver enzymes tested and tests may be required to be repeated on a regular basis to ensure that liver toxicity or other harmful consequences do not occur.

The Sanofi-Aventis SA flu vaccine is also being investigated by health officials due to its link to fever related seizures in children less than two years of age.

January 27, 2011

Jury Selection Process Revised?

by Burton A. Padove

After the District Attorney Armando R. Villalobos of Cameron County in Texas announced that he was considering reviewing Facebook profiles as part of the jury selection process, it is suspected that this criterion may eventually become a part of all candidates involved in the jury selection process. Jurors must submit names and basic information, such as employers, religion, and children. Attorneys can also check Google through their smart phones to identify any questionable items.

It’s interesting to see how the Internet has played a role in law. The biggest issue has been fraudulent purchasing activities. Obviously, online purchases are very appealing. A hassle-free purchase experience is highly desirable in today’s market. The Internet offers a great convenience. The Internet also offers a wide variety of items to choose from in varying styles. This allows for a much broader selection of items to select from which provides for a greater shopping experience.

By the same token, the Internet is associated with risks and warnings. The FTC Rules govern Internet purchases. It is known that in Internet purchases the requirement of the FTC states that goods must be shipped at the time that is stated on the website. Goods must be shipped within thirty days of your purchase when there is no time specified for delivery of the purchase.

January 3, 2011

Rolaid, Benadryl and Motrin Recalls

by Burton A. Padove

All lots, totaling 13 million, of Rolaids Extra Strength Softchews, Extra Strength plus Gas Softchews, and Rolaids Multi-Symptom plus Anti-Gas soft chews that were distributed in the United States have been recalled. The reason for the recall is that there have been several complaints that the product is tainted with metal and wood particles. This is the latest in a string of recalls for McNeil Consumer Healthcare, a Division of McNEIL-PPC, Inc.

All lots of Children’s BENADRYL® Allergy FASTMELT® Tablets, in cherry and grape flavors, that were distributed in the United States and some other countries, as well as, Junior Strength MOTRIN® Caplets, 24 count, have also been recalled.

McNeill has voluntarily conducted these recalls in cooperation with the Food and Drug Administration. The company has also investigated why these incidents have occurred. Following a preliminary investigation, it appears that the foreign particles may have been introduced into the product during manufacturing at a third party facility. McNeill has suspended production of the products until a final outcome has been determined and corrective action has taken place to prevent such incidents from happening again.

December 29, 2010

Oxygen Therapy and Inositol Making False Claims

by Burton A. Padove

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.

December 24, 2010

OsteoSymbionics, LLC. Receives FDA Warning about Cranial Implants

by Burton A. Padove

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.

December 20, 2010

Implantable and Un-implantable Hearing Aid Sends Shock Waves to Users

by Burton A. Padove

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.

December 17, 2010

Duro Extend Capsules Recall: Another Dietary Supplement Down!

by Burton A. Padove

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.

December 14, 2010

Darvocet and Darvon are Off the Market, After 32 Years!

by Burton A. Padove

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.

December 10, 2010

Singular Linked to Behavioral Issues in Children

by Burton A. Padove

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