Class Action Lawsuits

June 7, 2010

Toyota Verdict Out and Sienna Mini Vans In

Toyota has agreed to pay $16 million in penalties after the government contended that Toyota knowingly refrained from disclosing the sticky gas pedal defect to the public and did not take action to protect the public from harm. Toyota’s agreement does not mean that the company admits to wrongdoing. However, the company accepted the $16 million penalty within a 24 hour time period. The next legal cases will be those of people that were injured or died because of the sticky gas pedal. Personal injury lawyers are preparing their legal cases against Toyota nationwide. In fact, over 150 lawyers recently gathered in San Diego to bring attention to the high number of reports of people injured by Toyota’s sticky gas pedal. Lawyers may contend that Toyota committed fraud and racketeering in a conspiracy to mislead the government and consumers. People that have been injured because of a sticky gas pedal on a Toyota vehicle may be entitled to financial compensation for their injuries, including: lost wages, medical expenses and pain and suffering. Toyota owners that have lost value in their vehicles because of the extensive recalls may also be entitled to financial compensation.

The Latest Recall: Sienna Mini Vans

Toyota Sienna Mini Vans (1998-2010), totaling 600,000 vehicles, were the latest Toyota recall Toyota model to come to the forefront. The reason for the recall relates to the risk that the spare tire carrier cable can corrode following exposure to road salts. This poses a risk that the cable will fail, leading to the spare tire dismounting from the minivan and a possible car accident. The Sienna Mini Vans are added to the millions of other Toyota vehicles that have been recalled since October of 2009.

June 7, 2010

Guidant to Pay Over $296 Million, Guilty Plea for Withholding Life Threatening Risks

by Burton A. Padove

Guidant, LLC, maker of a cardiac defibrillator, pled guilty to criminal violations of the Food and Dug Administration Cosmetic Act which requires that medical device companies disclose risks of serious injury and death that are associated with their products. The Guidant defibrillator was used in cardiac surgery to produce a shock to restart the heart when the device detects that the heart fails. Guidant apparently was aware that there were short circuit failures in their Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155), but failed to disclose this information to the proper authorities or the public.

The FDA’s Office of Criminal Investigations spent four years investigating this case before determining that criminal allegations must be brought against the manufacturer. The affected Guidant defibrillator models were designed to detect and treat irregular heart rhythms, but when they fail due to short circuiting can result in sudden death momentarily. In the end, Guidant admitted to making a false statement about the Ventak Prizm 2DR device and failing to notify the FDA that the company made a correction to the Contak Renewal devices in order to reduce the risk of sudden death.

Guidant, a wholly-owned subsidiary of Boston Scientific Corporation, has now been presented with the largest criminal penalty imposed on a medical device company that failed to meet FDA requirements in the Cosmetic Act.

June 3, 2010

Toy Company Fined Over $2 million for Hazard Risks

by Burton A. Padove

Stuffed animals, rain ponchos and play jewelry are some of the Toy products that Daiso California LLC had been selling before a recall. The risks associated with their products included strangulation from the rain ponchos, lead poisoning from the jewelry, and choking from the stuff animals.

Since Daiso California LLC has violated federal safety laws, the company has been forced to cease importing children’s toys to the U.S. and must pay fines in excess of $2 million.

The CPSC has a list of safety standards and testing requirements that toy vendors must abide to in order to sell children’s toys in the U.S. Toy companies must also place proper warning labels on their toys so that parents are aware of the risks for children using the toys. However, sometimes the risks are omitted from the label or the manufacturer fails to perform proper testing to identify the risks relating to their toys. Toy manufacturers may also provide a label that informs the parent of the appropriate age of a child to use the toy. This is often done because there is some kind of risk that would apply to a child’s use of the toy that is out of the age bracket identified on the label.

May 18, 2010

Reglan and Tardive Dyskinesia

by Burton A. Padove

Reglan, manufactured by Baxter Healthcare Corporation, has long been used in over 2 million children and adults for the treatment of gastrointestinal conditions such as diabetic gastroparesis disease and gastroesophageal reflux disease. The ill effects of Reglan use has not become fully apparent until recently. The FDA has announced that long term and high dose use of Reglan is linked to Tardive Dyskinesia, a highly disabling medical condition that creates repeated involuntary muscle movements of the face, tongue, eyes, arms and legs. This is particularly disheartening since the drug is only approved for short term use, but physicians have prescribed longer term use for many years. It is recommended that treatment not exceed three months.

Tardive Dyskinesia not only impedes day-to-day life, but is embarrassing because of involuntary body movements that may be rapid and jerky, slow and continuous. The lips may repeatedly grimace, the tongue may protrude irregularly, the eyes may move rapidly, the arms, legs and fingers may be impaired. There is no proven medical treatment for Tardive Dyskinesia, but the symptoms have decreased in a select number of people using Reglan once the medication was not used any longer.

Reglan has not been recalled by the FDA. Instead, there has been a black box warning placed on the drug label that describes the risk of Tardive Dyskinesia, even after the drug is stopped. The risk of Tardive Dyskinesia is greatest with long term or high dose use. This black box warning was placed following a high number of reports of Tardive Dyskinesia in Reglan users. Reglan is considered the most common cause for drug induced movement disorders. Reglan, also known as Metoclopramide, is available in the form of tablets, syrups, and injections.

May 10, 2010

Know What to Consider in the Yaz Recall Bayer Lawsuits

by Burton A. Padove

In November of 2009, Yaz and a similar product Ocella were recalled following reports of serious injury in users as young as thirteen years old. The problems associated with Yaz and Ocella involve the dosage of drospirenone which is known for creating health problems in users that live in European countries. In fact, the use of this ingredient in oral contraceptives was previously banned in several countries.

Since 2009, over 1,000 lawsuits have been filed against Bayer, the makers of Yaz. As more consumers become aware of the medical conditions that Yaz can cause, it is suspected that more lawsuits will arise in the case against Bayer. The company’s Yaz product has been linked to fifty deaths in women that experienced blood clots while taking the oral contraceptive.

Women today have many choices available to prevent pregnancy. When a new option is introduced to the FDA, the product must meet specifications such as delivering a higher value to the user or providing an improved choice for the user when compared to other options. Other hormone medications such as Prempro have been linked to breast cancer.

April 19, 2010

Prempro Recall

by Burton A. Padove

Prempro is subject to another cause for alarm because of a recent recall. This drug recall affects two lots of the product, namely Lot C83323 (exp. 3-10) and Lot D82196 (exp. 12-10). Nearly, 50,000 cartons of Prempro are included in this particular drug recall.

Wyeth Pharmaceuticals, the manufacturer of Prempro, began the drug recall in January of 2010 by way of letter notification. However, people that have moved and have not changed their addresses may not be aware of the recall. The Prempro recall was initiated because the level of estrogen in the affected lots did not meet the specifications outlined in the company’s New Drug Application (NDA).

Prempro is used to treat menopausal symptoms. Wyeth also claimed that the drug improved cardiovascular activity.

April 18, 2010

Recall of Roman Shades Due to Strangulation Scare

by Burton A. Padove

Roman Shades have been recalled by several companies over recent months following reports of strangulation in children the used the blind chords. Most recently, Ethan Allen joined the recall to include over 150,000 Roman Blinds. There were no reports of injury. However, all people using the Roman blinds should immediately take them down, store them in a safe place, return to the manufacturer or discard them. This recall affects all models and styles of Roman blinds.

Strangulation Risk

There are several ways that children can be strangled by Roman blinds. Children may place their neck between the inner cord and fabric when trying to look out the window or while playing near the blinds. Children may pull the cord out and wrap it around their neck. There is also a looped cord in which a child’s neck may get caught. Strangulation may involve a struggle which has the potential to tighten more around the neck. The end result may produce the inability to breathe, low blood pressure, chest pain, shock, stroke and death.

April 13, 2010

Cardiac Patients: Class One Medical Device Recall

by Burton A. Padove

Cardiac patients should be aware of the Class I Recall involving Thomas Medical Products with the company’s Transseptal Sheath Introducer Kit, also known as HeartSpan, CHANNEL FX, and Torflex, Braided Guiding Introducer Kit. This medical device is used in cardiac patients to pass a heart catheter from one side of the heart to the other during cardiac surgery. It has reported that the tip of the medical device may break off, move through the heart and arteries as well as penetrate vital organs such as the heart or brain. Consequently, cardiac patients that experience this defect may be subject to emergency open heart surgery or suffer from injury such as heart attack, stroke or death.

Cardiac patients should be aware that cardiologists are in the process of being informed. Class I Recalls are the most serious types of recalls. Such recalls are usually generated following reports of life threatening injury and/or death. It is wise for cardiac patients to be aware of medical device defects. Cardiac patients may inform cardiologists about the defect. Though, it is not the responsibility of cardiac patients to be informed about medical devices or inform physicians. It is the responsibility of the manufacturer to inform cardiologists about medical device defects.

Cardiac patients and their families may not be aware that illness, stroke, heart attack or death may be caused by a defective medical device. This may appear to be an unexpected, but natural occurrence for an individual with heart disease. However, such is not always the case in medical devices that are subject to a Class I recall. Lawyers that focus on illnesses relating to defective medical devices invest in research to identify the true cause for unexpected injuries and death.

April 10, 2010

Dialysis System Recall: Baxter Healthcare Faced with Class I Recall

by Burton A. Padove

Dialysis Systems by Baxter called HomeChoice and HomeChoice PRO are under a medical device recall following reports from physicians that people have experienced serious injury and one known death because of a defect in the product. The specific defect is unknown at this time. What is known is that the Automated PD system which is programmed to repeatedly deliver and remove dialysis solution may produce increased Intraperitoneal Volume (IIPV). Intraperitoneal Volume (IIPV) is described as overfilling of the abdominal cavity.

Intraperitoneal Volume (IIPV) is known to cause serious breathing difficulty, hernias of the abdomen or diaphragm, pulmonary dysfunction, hypertension, hydrothorax, pericardial effusion and peritonitis. Dialysis patients that are children or are seriously ill are at an increased risk of injury from the affected models of Baxter’s Dialysis System.

Some physicians may still be using Baxter’s HomeChoice and HomeChoice PRO. If they are still using Baxter’s Dialysis Systems, they are being advised by the FDA to inform dialysis patients about the risk associated with HomeChoice and HomeChoice PRO.

March 10, 2010

Closed IV Catheter Systems Recall

by Burton A. Padove

Millions of Becton, Dickinson and Company catheter systems are involved in a recall because of a defect in the product that may result in injury or death to a user. The direct flaw of the catheter system involves the risk of an air embolism and leakage of blood or therapeutic fluids. These risks pose an additional risk of serious injury or death.

Becton Dickson received reports that air was entering through the septum disk. Catheter system failures were reported on units that were distributed from November 2009 to November 2009.

Catheters are used in hospitals to treat a variety of medical conditions, including, but not limited to: