New Verdicts: Prempro and Premarin - $134.1 Million Against Wyeth for Menopause Drug

by Sandra Cassidy

Wyeth has been ordered to pay 134 million including 99 million in punitive damages for its “conscious indifference to patient safety" for failure to warn of the risk of breast cancer from Prempro and Premarin its hormone replacement drugs.  In 2002 a study sponsored by the U.S. National Institute of Health found that women who received a combination of estrogen and progestin had a 24 percent higher risk of invasive breast cancer.  Rowatt, et. al., v. Wyeth Pharmaceuticals Inc., 04-01699, Second Judicial District Court, State of Nevada ,October 12, 2007.

Jurors considered ordering Wyeth to pay over $1 billion in punitive damages before settling on the lower amount.

Prempro contains the hormones estrogen and progestin, Premarin is an estrogen only pill. The pills were manufactured to treat menopause symptoms such as hot flashes and mood swings. Both pills were taken by as many as 6 million women before the 2002 study linked the drugs to cancer. 

To date there are approximately 5,300 suits against Wyeth in connection with  the menopause drugs.  The verdict is the company’s fourth loss in litigation over the hormone replacement drugs since trials began in August of 2006.  This verdict is the largest to date and represents the eight largest  verdict of any kind this year.   

Charite Spine Disc

Lawsuits grow over Johnson & Johnson’s Charite Spine Disc

The Charite artificial spinal disc was approved for use in October of  2004  to replace damaged discs and avoid lumbar spinal fusion surgery. Since its approval some 5,000 people have received the implant. 
Within two years of its approval, the FDA has received over 130 reports of serious adverse events connected with the Charite Spinal Disc. The disc was meant to last a lifetime but many patients now have to undergo life-threatening surgeries after disc failure.  The discs migrate resulting in the need for subsequent fusion surgery. The discs are also prone to pedicle fractures which settle and migrate resulting in nicking of a veins or arteries.  Surgeons predict that over the next 10 to 15 years there will be an influx of patients suffering from these product failures.

One of the major concern with the Charite Spinal Disc is that the clinical trial used to obtain FDA approval was only a two year study involving only 304 patients. A study the trial lawyers claim is far to limited for a devise intended to remain in the body for a lifetime.  Many patients are claiming they experienced greater pain after the surgery than they had before.  Johnson & Johnson is being accused of failing to warn about the short clinical trial period as well as the low success rate-only 57%. In May of 2006 Medicare stopped paying for the device in patients over the age of sixty.

Last April a Massachusetts superior court judge, Honorable Susan Garsh, denied the defenses request for a preemption dismissal of four lawsuits over this alleged defective product. The Houston law firm of Pulaski and Middleman leads a group of firms that represent over 350 injured patients.

Sources
Prempro, Premarin Judgement against Wyeth 2-20-08
Prempro Lawsuits, Litigation and Lawsuits -What You Should Know
First of Over 4,000 prempro cases set for trial
Public Citizen reveals on worstpill.org HRT unsafe

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