Bayer Yasmin Lawsuit Settlements Climb to $142 Million

Bayer AG (BAYN) said settlements of U.S. lawsuits claiming that its Yasmin line of birth-control pills caused blood clots in women have increased to $142 million.

Bayer, based in Leverkusen, Germany, has resolved 651 cases alleging its Yasmin and Yaz contraceptives caused sometimes- fatal clots that can lead to heart attacks and strokes, the company said today in its Stockholders' Newsletter for the first quarter. The company said it paid $142 million in the settlements, for an average of about $218,000 a case.

The CEO of Johnson & Johnson, William Weldon, recently admitted fault to side-stepping the FDA in attempting to keep quiet nearly half a dozen recalls.  In his apology to the Committee of Oversight and Government Reform, Weldon said, "We made a mistake. We did not notify the FDA…we should have notified the FDA."

Weldon admitted that they had attempted to keep the recalls hush-hush by using private contractors to buy up the faulty drugs before the FDA, physicians, and patients were notified. Apparently, the secretive operation was blown when one of the contractors dropped his instruction sheet, which was later discovered and reported to the FDA.

Avastin, a drug approved in 2008 to treat breast, lung, and kidney cancer, has been under investigation since it's early approval was revoked by the FDA last December. Avastin, designed to treat terminal cancer patients, was reported to have adverse effects that outweighed its benefits.

Numerous women have died when taking Avastin, but an equal number have reported miraculous results. Shannon Morgan, a stage 4 breast cancer patient whose cancer spread to her stomach, has been in remission for 3 years after taking Avastin. Morgan and her husband are scheduled to testify in support of the drug during the FDA's ongoing hearings which began last Tuesday.

The New England Journal of Medicine recently published a study which showed that women taking antidepressants during the first trimester of their preganncy are more likely to give birth to children with birth defects. Although the overall risks are generally small, women should be advised when taking antidepressents, espcially Zoloft, Paxil, Prozac, and Celexa, when pregnant.

These drugs, known as SSRIs (selective serotonin-reuptake inhibitors), are associated with birth defects such as heart defects, omphalocele (where the intestines or other abdominal organs protrude from the navel), and congenital problems such as anenecephaly (where a large portion of the brain and skull is gone) and craniosynostosis (where the connections between the skull bones close prematurely), and intestinal defects.

Bisphosphonates, such as Actonel, Boniva, and Fosamax (a drug already linked to severe musculoskeletal pain and osteonecrosis – a serious bone-related jaw disease), are a widely prescribed class of drugs used to slow bone loss and prevent fractures associated with osteoporosis. In 2010 alone, an estimated 36.5 million prescriptions were dispensed for these drugs. Unfortunately, new research shows that instead of preventing fractures, use of these drugs may actually increase the risk of severe fractures in the femur.

On the heels of yet another major recall involving Johnson & Johnson, the United States government is barring the company from resuming certain operations linked to millions of bottles of defective medicine until met quality standards increase. The U.S. Food and Drug Administration and U.S. Justice Department signed a formal consent decree related to several prescription drug manufacturing sites linked to multiple drug recalls of medications. J&J units have issued 20 drug recalls or medical device recalls since September 2009 covering over-the-counter medicines such as Children's Tylenol, Benadryl, contact lenses, and DePuy hip replacements.

Johnson and Johnson, the world's biggest health products maker, is also facing more scrutiny from U.S. regulators for a unit charged with violating federal laws following multiple recalls in the past year. Legal enforcement from the government and consumer lawsuits over injuries or deaths from recalled products has intensified regulatory pressure on J&J to fix manufacturing problems that have led to the string of drug recalls and medical device recalls in the last year cost at the world's largest health-products company.

"Recent FDA inspections have confirmed that violations persist..." said the United States Justice Department. "This is a strong, but necessary, step to ensure that the products manufactured by this company meet federal standards for quality, safety and purity," said Deborah Autor, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research.

In addition to the Children's Tylenol and DePuy ASR hip implant recall, additional health products recently recalled by J&J include leaking Animas insulin cartridges, cracked syringes of Invega Sustenna for schizophrenia, defective Simponi injectable pens for arthritis and vials of Dermabond skin adhesive. Another J&J unit, Cordis, recently received a Food and Drug Administration warning letter citing manufacturing violations at a factory in Puerto Rico that makes heart stents. Stents are wire mesh tube-like devices that keep diseased arteries open.