Articles Posted in Class Action Lawsuits

Prescription drugs are often a target of litigation for a variety of reasons. In some cases, risks relating to prescription drugs are not disclosed to the patient through the drug label so patients cannot truly make an informed decision about the drug to weigh the risks against the benefits. In these cases, a lawsuit may be appropriate if the patient experiences a serious illness when the risk becomes a reality. In other cases, the drugs are not properly manufactured which may lead to an improper dosage that may pose a risk to a patient.   There are other several reasons why a lawsuit may be brought against the manufacturer of a drug when it relates to a life threatening illness that a patient encounters after taking the drug.     So, the following tips are designed to assist in in preventing the risk of a life threatening illness from a prescription medication.

  • Ask your physician to describe the risks and benefits associated with the medications you are being prescribed.
  • View your prescription before you leave your physician’s office. If the names of the drug, dosage or directions are not legible to you, ask the physician to clarify and write it down for your own records.

Class Action Suit for Avandia in Illinois

Avandia is a target for over 40 lawsuits filed in Illinois that were filed in St. Clair County Circuit Court in May 2011. There are many other lawsuits throughout the U.S. against the makers of Avandia, a diabetes medication linked to cardiovascular disease and heart attack manufactured by GlaxoSmithKline. It is contended that GlaxoSmithKline aware of the risk in 2005 but did not properly inform the public. Therefore, people were not permitted to make a well informed decision about the benefits and risks associated with the drug.  The most recent Avandia lawsuits filed in Illinois account for an estimated$600,000 in damages. 

Approximately four years ago, The New England Journal of Medicine released a report demonstrating the risk of cardiovascular issues associated with Avandia. The FDA then issued a black box warning about the risk of cardiovascular issues.   The injuries that people using Avandia have experienced include: congestive heart failure, heart attack, stroke, liver failure, bone fractures, vision loss and death.  Despite the request from several interested parties to remove the drug from the consumer market, Avandia has never been recalled in the U.S. Instead, the FDA issued restrictions on the purchase of Avandia. The restrictions include that Avandia only be available at specific pharmacies. People interested in taking Avandia must participate in an educational program about the drug.

Drug Take Back Day was in April set by The American Association of Poison Control Centers. Yet, Drug Take Back Day can be every time you complete taking medication to help ensure your medications do not get into the wrong hands or are resold to someone who may be at risk of injury if they take the drug. This is particularly true for narcotics which are associated with risks when not closely monitored by a physician.

Pill abuse and theft is more common than you may think. Medications were the leading cause of poisonous death in 2009. The vast majority of deaths were adults. The National Survey on Drug Use and Health in 2009 noted that more Americans abuse prescription drugs than the number of Americans that abuse cocaine, hallucinogens and heroin combined.

Proper disposal of expired, unused or unwanted prescription drugs is critically important to prevent abuse and theft. In fact, all medications should be properly stored in your home while you are taking them to ensure they do not get in the hands of your children or other outsiders that are not familiar with proper use, drug interactions, risks or possible side effects.

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.

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.

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.

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.

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.

Vitamin Water may have associated with healthy living by providing a means for hydration, but the result of its advertising is a lawsuit. Advertisements portraying basketball stars in support of Vitamin Water can lead one to think that Vitamin Water offers health benefits.  Of course, it’s true that Vitamin Water contains less sugar than Coca Cola, the maker of Vitamin Water. Yet, 33 grams of sugar found in Vitamin Water suggest that the beverage is just a step down from the typical soft drink beverage. In fact, many studies suggest that sugar can trigger added caloric intake which contributes to the obesity problem in the U.S. Add to this health care costs for treating the obese, it’s difficult for authorities to accept that a drink, such as,  Vitamin Water containing 33 grams of sugar, offers health benefits.

Authorities weighed in on this topic in a lawsuit brought about by the Center for Science in the Public Interest who alleged that Vitamin Water labels and advertising contain deceptive and unsubstantiated verbiage.  Federal Judge John Gleeson, of the U.S. District Court for the Eastern District of New York, ruled in favor of the allegations through a 55 page ruling.

Coca Cola did not feel that the company’s advertisements for Vitamin Water were misleading or suggestive that the beverage offers health benefits.  Yet, there is a contention that many consumers may feel that the beverage is nutritional and is preventative for obesity, simply because of the name implication alone.

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.

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