Law Suits

Baby Rattle Recall: Potential Choking Hazard for Infants
Posted: 16 Jan 2009 12:05 PM CST

The U.S. Consumer Product Safety Commission (CPSC) and Infantino, LLC., have announced that they are expanding a prior baby rattle recall first issued in March 2008, bringing the total number of Infantino Lamb and Lion Rattles recalled to about 131,000.

The baby rattles contain a tail-piece which can detach, potentially resulting in a choking hazard.
In March 2008, approximately 20,000 Infantino Lamb Grabby Rattles were recalled after reports of at least 8 rattles having the tail-piece come off.

Since that time, at least 10 additional reports have been received by Infantino, leading to the expansion of the recall to also include another 111,000 Infantino Lion Grabby Rattles.

The recalled rattles are shaped like a brightly colored lamb or a lion with a body shaped like a ring. An elliptical Infantino logo is stamped on the animal’s front right foot.

Units without tails on the animals and those with production codes 0108 and 0508 are not affected by the recall. The production code is located behind the ear and resembles a dial with the year (08) in the middle of the circle and an arrow pointing towards the number on the circle(01 or 05) indicating the month.

The rattles have been sold throughout the United States since May 2007 at Babies “R” Us, Wal-Mart and other stores for between $3 and $4.

Parents have been urged to take the recalled baby rattles away from their children and to contact Intantino for a free replacement rattle or product of equal value by calling (888) 808-3111 or visiting www.infantino.com.

Fisher-Price Portable Play Yard Recall: Reports of Rails Collapsing
Posted: 16 Jan 2009 11:45 AM CST

The U.S. Consumer Product Safety Commission (CPSC) has issued a Fisher-Price Rainforest Portable Play Yard recall for about 200,000 “pack n play”-like products manufactured by Simplicity, Inc., which was liquidated last year after safety problems with many of their products.

The play yard recall was announced on January 15, 2009, after it was discovered that one or more of the rails could unexpectedly collapse, posing a potential fall hazard or risk of entrapment for children.

The portable play pens contain a bassinet, changing table and mobile features like wheels at one end, with model numbers 5310 RNF, 5310RNFC and 5310RNFW on a sticker under the product. They were sold throughout the United States since January 2007 for about $100, containing the Fisher-Price logo and Rainforest themed artwork.

Simplicity, Inc., which manufactured the pac-n-play type pens, ceased all operations and had all assets sold at a public auction last year following a September 2007 recall of about 1 million defective baby cribs which injured or killed several babies.

All of Simplicity’s assets were purchased by SFCA, Inc., and the U.S. CPSC indicates that neither company has responded to their request that these products be recalled nor have they been responsive to consumer complaints involving problems with the Fisher-Price Portable Play Yards.

About 1,350 reports of problems with the Fisher-Price Rainforest Play Pens have been received involving one or more of the side rails collapsing. Several children have suffered bumps, bruises, cuts, concussions and broken bones.

In August 2008, months after Simplicity ceased operations, the U.S. CPSC issued a warning directly to parents about reports of problems with Simplicity bassinets after learning of at least two infant deaths caused by design defects which created a gap between the bassinett’s metal bars.

At that time, SFCA, Inc., failed to cooperate with the CPSC, but a number of large retailers voluntarily agreed to accept returns of the recalled bassinets, some of which were sold with the Graco label and Disney’s Winnie the Pooh characters.

For the Rainforest Portable Play Yards, Fisher-Price has agreed to replace any of the play pens that contain their logo, even though they did not manufacture or distribute the products.
Consumers have been urged to immediately stop using the portable play pens and to contact Fisher-Price at (800) 432-5437 or at www.service.mattel.com.

Side Effects of Seroquel and Zyprexa Linked to Risk of Sudden Heart Death
Posted: 16 Jan 2009 09:02 AM CST

New research confirms that side effects of newer atypical antipsychotics, such as Zyprexa and Seroquel, nearly double the risk of dying from heart problems, making them no safer than older antipsychotic drugs like haloperidol. The study comes the same week that Eli Lilly agreed to pay $1.42 billion to settle Zyprexa claims brought by the government over their illegal marketing strategies.

Over the past 15 years, atypical antipsychotics have been marketed aggressively as safer alternatives for treatment of conditions like bipolar disorder and schizophrenia, but they have also been widely used off-label for other conditions like treatment of dementia and depression.
Drugs like AstraZeneca PLC’s Seroquel, Eli Lilly & Co.’s Zyprexa, Johnson & Johnson’s Risperdal and Novartis AG’s Clozaril have become the sixth best-selling class of drugs in the world, generating sales of over $20 billion.

In a new study published in the current issue of the New England Journal of Medicine, researchers from Vanderbilt University in Tennessee examined the risk of sudden heart death among users of atypical antipsychotics, typical antipsychotics and those who were not taking either of the drugs.

Results of the study, which involved 44,218 users of older antipsychotic drugs, 46,089 users of atypical antipsychotics and 186,600 in the control group, showed that the newer drugs were not safer than older alternatives, and were still linked to an increased risk of sudden fatal heart attacks, which was roughly double that of those not taking any antipsychotic.

In an editorial which accompanied the study in the New England Journal of Medicine, it was suggested that the use of atypical antipsychotics to treat conditions other than schizophrenia and acute psychosis should be greatly reduced, and continued use among children and elderly patients with dementia was questioned.

Both Eli Lilly and AstraZeneca have faced accusations that they inappropriately marketed Zyprexa and Seroquel for unapproved uses, which the FDA had not established as safe and effective.

On January 15, 2009, Eli Lilly & Co. announced that they have agreed to resolve a long standing government investigation into their illegal marketing and promotion of Zyprexa by agreeing to pay $1.42 billion. The Zyprexa settlement includes $615 million to settle the criminal investigation and nearly $800 million to settle the civil investigation, including $438 million which will go to the federal government and $362 million which will be paid to states.

Lilly has also previously paid more than $1.2 billion to settle over 30,000 Zyprexa lawsuits filed by individual users who alleged that the company failed to warn about serious side effects of Zyprexa, such as an increased risk of diabetes.

For AstraZeneca, the company is still currently facing Seroquel lawsuits filed by over 14,000 people over the diabetes side effects of their atypical antipsychotic, and the first trials in the federal Seroquel litigation are currently scheduled to begin next month.

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