Indiana Injury And Family Lawyer Blog

March 7, 2011

Cardiologists and Risk Managers Advised of Class I Recall

A Class I recall is the most serious type of recall, typically announcing the risk of a life threatening illness due to a defect in a product. Cardiologists and Risk Managers recently received notice that components in the Arstasis One Access System may fracture and/or separate which could result in an emergent life threatening situation.

The Arstasis One Access System is used to support a diagnostic test during upper leg catheterization procedures. The device supports the diagnostic test by providing access to the vascular system so the cardiologist can identify abnormalities in the vascular system. The Arstasis One Access System also offers a means to help halt bleeding from the upper leg artery that is being tested. Cardiologists and Risk Managers will be reporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

The Arstasis One Access Systems involved in this recall include: Models: AAD100, AAD101; Part Numbers: FG-02279, FG-03010; Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334. These products were distributed for five months beginning May 14, 2010.

March 3, 2011

Erectile Dysfunction Drugs Mislabeled as Herbal Dietary Supplements

by Burton A. Padove

The U.S. Department of Justice recently announced a conclusion from the Food and Drug Administration, Office of Criminal Investigations for the owner of JMM LLC, based out of Rhode Island, who smuggled erectile dysfunction drugs that were called Herbal Dietary Supplements from the People’s Republic of China.

The owner of JMM LLC pled guilty to the charges in the U.S. District Court in Providence, Rhode Island. This was after she imported literally thousands of Durasex and Super Sense One capsules that were mislabeled. U.S. District Court Chief Judge Mary M. Lisi accepted the guilty plea. The results were announced by U.S. Attorney Peter F. Neronha, Mark Dragonetti, Special Agent in Charge of the Food and Drug Administration (FDA), Office of Criminal Investigations, and Bruce M. Foucart, Special Agent in Charge of ICE’s Homeland Security Investigations in Boston.

Between last quarter of 2006 and last quarter of 2008, JMM LLC, ordered Durasex and Super Sense One capsules from Chengdu Kang Quan Health Product Company, based out of China. The products had false shipping labels and/or invoices. The shipping label and invoices described the products as “Cinnamon Extract,” “Ginseng Extract,” or “Multivitamin samples”. Then, JMM LLC falsely labeled the packages as “Made in the U.S.A.” The packages bearing the false products were distributed to other distributors and retail stores throughout the U.S.

February 26, 2011

Neuro Resource Group Devices Accessories Recall

by Burton A. Padove

Neuro Resource Group, Inc. manufacturers a variety of medical devices that are sold to people throughout the world. The devices are co-packaged with a variety of accessories, such as, alcohol prep pads, alcohol swabs, and alcohol swab sticks that are manufactured by Triad located in the United States. However, a recall of these accessories was recently announced because of an identified risk that the accessories have been contaminated by Bacillus cereus which is a form of bacteria.

This is especially a concern for people who have had surgery, those with weakened immune systems and those who are frail which elevates the risk of developing a life threatening infection from the bacteria.

There are several ways that the affected lots could be labeled, including the terms “Select”, “Select Medical Products”; “PSS Select”, or “PSS World Medical, Inc”. Consumers are being advised to immediately discard the alcohol wipes, known as Triad Group’s Alcohol Prep Pads, associated with the affected lots. Consumers should go directly to the manufacturer’s website to see lot numbers that are part of the recall or contact the manufacturer directly. Consumers who must discard their alcohol wipes can visit a local pharmacy and can ask the pharmacist about an appropriate replacement so that the consumers can still use Neuro Resource Group’s devices. Consumers may also call Neuro Resource Group direct for replacement wipes at 1-877-314-6500.

February 23, 2011

Indiana and Illinois Food Recall

by Burton A. Padove

St James Smokehouse, Inc. launches a recall for Scotch Reserve Whiskey & Honey Smoked Salmon. The Fresh Market stores in Indiana and Illinois have busy been pulling one of their products off the market this February 2011. Scotch Reserve Whiskey & Honey Smoked Salmon that are 4 ounces have been recalled by St. James Smokehouse, Inc. for Lot code:5797 & batch code: 4759 with UPC# 853729001151. This is because the company has identified a risk of contamination with Listeria Monocytogenes.

Listeria is one of the more common contaminants linked to food recalls and food borne illness every year. Listeria Monocytogenes is an organism that may produce serious health issues and sometimes fatal consequences, particularly in children, elderly, and those with immunity health issues. People who are healthy may still be adversely affected by Listeria Monocytogenes when exposed to the contaminant. Those who are healthy may suffer from short term high fevers, severe headaches, stiffness, nausea, abdominal pain and diarrhea. Those pregnant women infected with Listeria may miscarry and have a stillborn baby.

The company discovered the Listeria link following testing of three sample packages. Only one package tested positive for Listeria Monocytogenes. However, the company has taken precautions by recalling all 600 pounds of the product in that lot that was distributed to sold to The Fresh Market stores.

February 19, 2011

Strawberry Banana Smoothies Recall

by Burton A. Padove

Strawberry Banana Smoothies sound so healthy who would ever expect that there could be risks associated with drinking such a great Smoothie. However, Strawberry Banana Smoothies have been taken off the market by distributors and manufacturers, f’real® foods and Smith’s Dairy Products Company. The notice for recall the Strawberry Banana Smoothies was sent out after testing by the manufacturer that uncovered a different flavor comparison for the 16 oz. lot number 6/21/2012 Strawberry Banana Smoothies. The result of the comparison was that the level of peanuts contained in one Smoothie lot could lead to a serious or life threatening illness for people that have allergies to peanuts.

f’real® foods is a company that creates, sells and markets milkshakes, smoothies and frozen cappuccino beverages that are made from ” true ingredients”, such as, ice cream, fruit, milk and coffee. They also have a dedicated food safety program in place to monitor and distribute products for the highest quality level. The company contacted the companies who were selling the affected Strawberry Banana Smoothies by phone and in writing to inform them about the risk and the recall.

Consumers who have Strawberry Banana Smoothies should not drink the Smoothies and can contact f’real® at 1-877-367-7325 for a refund.

February 15, 2011

Indiana Medical Malpractice Tips

by Burton A. Padove

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 13, 2011

Nuvigil Drug Linked to Steven’s Johnson Syndrome

by Burton A. Padove

Nuvigil, a drug used to treat jet lag, has been linked to Steven’s Johnson Syndrome which is a life threatening disease signified by skin rashes and skin death that may encompass many areas of the body. Nuvigil, manufactured by Cephalon, was approved by the FDA to fight off fatigue and narcolepsy, but is not FDA approved for use in the treatment of jet lag. In fact, the FDA rejected the request of Cephalon to be approved for jet lag and the end result may be lawsuits.

Nuvigil is also associated with less severe side effects, such as, headaches, insomnia, and nausea. However, the risk of Steven’s Johnson Syndrome is significant and must be considered when interested in using the drug. Typically, a good rule of thumb is that the benefits of a drug have to outweigh the risks in order for the drug to be truly beneficial. So, if you are suffering from jet lag, the suffering of jet lag is less severe than the risk of Steven’s Johnson Syndrome. Steven’s Johnson Syndrome involves skin sloughing and the damage is typically permanent. People often have to be treated in burn units and the final result can be fatal. Some people who have Steven’s Johnson Syndrome and took Nuvigil may be entitled to financial compensation for their pain and suffering and that of their loved ones.

If you, your family or a friend have suffered damages and need assistance in asserting your rights for justice and compensation, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.

February 13, 2011

Indiana Law Trash Modification

by Burton A. Padove

Trash law for depositing electronics in household receptacles has changed, making a change in the protocol for throw away electronics in Indiana. Since the National Safety Council expects that close to 250 million computers in five years and 130 million mobile phones annually will be discarded, the concern about hazardous materials entering the environment from being deposited in landfills or in incinerators has risen. Electronics contain hazardous materials, such as lead, mercury, and hexavalent chromium that when released into the air may cause a variety of diseases like cancer, particularly for high risk people.

For this reason, electronics are now forbidden from being deposited into the trash in Indiana. Instead, residents may take their computers, television sets, and mobile phones to local collection locations and solid waste management facilities. There are also many manufacturers who are happy to take back your unwanted electronics. These options offer a method to properly recycle electronics and reduce the risk that harmful containments will be released into the air, ground and water supply.

While computer monitors, computers, hard drives, scanners, keyboards, televisions and the like may emit harmful chemicals when placed in trash, recycled electronics provide useful materials for mankind. In 1998 alone, over 112 million pounds of recyclable materials were acquired from unwanted electronics. These materials include steel, glass and plastic.

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.

February 6, 2011

Snowmobile Recall for Artic Cat

by Burton A. Padove

Winter is a great time for snowmobiling. Yet, when a snowmobile loses control on its own accord, the personal injuries can be devastating and may result in a host of Indiana and Illinois lawsuits. This may hold true for Artic Cat Snowmobile owners since these cats were recalled recently. The 2010 model Artic Cats manufactured at the company’s Thief River Falls, Minnesota plant were recalled. Owners are advised to immediately stop using the snow mobiles and to contact their local Artic Cat dealer.

In these types of recall cases, manufacturers will often discover flaws in equipment following reports from users. In the case of Artic Cat, there were 13 reports that the suspension arm cracked during use which may lead to loss of control of the vehicle. There were no reports of injury or accidents to date. Yet, engineers will typically design out the flaw to prevent the risk of the malfunction and consequential personal injuries following reports. So, it is wise for owners of all 2010 Arctic Cat Z1, TZ1, F, Bearcat, M, and CF model snow mobiles, including: all model feature and color variations are included in the recall to visit an Arctic Cat dealer for a repair.

Arctic Cat and the U.S. Consumer Product Safety Commission joined together to announce the recall. Owners are typically contacted by mail and through announcements, such as, this announcement. If you have any questions regarding the recall, you may contact Artic Cat direct at 1-800-279-6851.

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