Bayer recently agreed to pay $110 Million to settle 500 Yaz and Yasmin lawsuits (about $220,000 per case average). The prescription, birth control pills Yaz and Yasmin, have been linked to an increase in blood clots, heart attacks and strokes. The FDA determined that there was a 74% increase in blood clots for women taking Yaz and Yasmin compared with birth control pills with a lower level of estrogen. They have recently required Bayer to add stronger product label warnings concerning these risks.
The $110M settlements was the result of a mediation set after an Illinois federal judge postponed the first of a series of trials to determine if Bayer failed to adequately warn of the higher risk of blood clots from its products. This first trial was scheduled for January 9, 2012. There are over 11,000 Yaz lawsuits currently filed across the country.

Lawyers for BP and plaintiffs in the 2010 oil spill in the Gulf of Mexico have reached an agreement to settle their case for approximately $7.8 billion. The settlement was reached on the eve of the first phase of the trial involving the Deepwater Horizon rig that exploded in April 2010 killing eleven rig workers and beginning a spill that for months spewed millions of barrels of oil into the Gulf of Mexico, destroying beaches and wildlife and disrupting the economies of Gulf Coast States. The first phase of the trial was intended, in part, to apportion blame among the defendants, BP, Transocean and Halliburton. The settlement will also provide compensation and medical services to some victims over the next 21 years.

BP’s CEO, Robert Dudley, issued a statement saying, “The proposed settlement represents significant progress toward resolving issues from the Deepwater Horizon accident and contributing further to economic and environmental restoration efforts along the Gulf Coast.” BP has already paid out more than $8 billion to claimants, and has spent some $14 billion in responding to the spill.

The settlement will be paid to thousands of businesses and individuals affected by the spill. But, the agreement does not include the federal government or the state and local governments along the coast which are probably the biggest plaintiffs in the case. The federal government, for example, may still recover billions of dollars in environmental fines.

The proposed settlement will replace the $20 billion Gulf Coast Claims Facility fund created by BP to compensate victims of the spill and to pay natural resources damages and state and local response costs. Thus far this fund has paid out more than $6 billion to approximately 200,000 individuals and businesses.

For more on this story click here.

Medical experts, including those on a recent FDA advisory panel have concluded that Yaz and Yasmin may be more likely to cause blood clots than older types of birth control pills.  A majority of the panel concluded that the products’ label should be changed to warn of the potentially fatal nature of these blood clots.

Bayer promoted these drugs as offering advantages over standard birth control pills, including fewer side effects, alleviating acne and preventing premenstrual symptoms and headaches. In 2009, the FDA found those claims to be exaggerated and forced Bayer to run corrective television ads.

Yaz and Yasmin contain a synthetic version of the hormone progestin called drospirenone. According to a study by the FDA, which reviewed 800,000 women between 2001 and 2007, drospirenone based birth control pills increased the risk of blood clots by 75% when compared to older birth control pills. The study found that these drugs also doubled the risk of arterial thrombotic events such as heart attacks and strokes in some users. FDA studies also found significantly increased risk of blood clots linked to the Ortho-Evra patch and the NuvaRing contraceptive device.

Hundreds of lawsuits have been filed around the country claiming that Bayer failed to adequately warn users of the increased risk of  blood clots, heart attacks, strokes and even death.  Click here for more on this story. 

Propecia (generic name finasteride) has been prescribed to millions of men to help treat male pattern baldness. However, reports indicate that the drug may cause sexual side effects including erectile dysfunction or impotence which can persist even after its discontinued use. Propecia was approved by the FDA in 1997.

Merck & Co., the drug’s manufacturer, admits to the potential for these side effects but claims that they have ”occurred in less than 2% of men and went away in men who stopped taking Propecia.” A Journal of Sexual Medicine reported that about 8% of men taking Propecia reported erectile dysfunction and 4.2% reported reduced libido. Other studies have reported much higher percentages. Apparently the active ingredient in Propecia prevents a certain type of Testosterone to convert into DHT (dihydrotestosterone) in the scalp—reducing hair loss.  However, DHT is critical for male sexual performance and functioning.

Several lawsuits have been filed claiming that Merck failed to warn of the permanency of the sexual side effects. Other reported side effects of Propecia include: anxiety attacks and insomnia which may become chronic and persist even several years after the discontinuation of the drug. Other more severe reported side effects include male breast cancer and prostate cancer.  Click here for more on this topic.

Most of the thousands of hip replacement complaints the FDA has received involve metal-on-metal hips–ones in which the artificial ball and cup are both made of metal.  The majority of these complaints center on the DePuy Hip Replacement System manufactured by Johnson & Johnson.  This system was recalled by the company last year.  As many as 500,000 patients have received metal-on-metal replacement hips.

Replacement hips are supposed to last 15 years or more, but according to the 2011 Annual Report by the National Joint Registry of England and Wales, more than 25% of the J & J Depuy hips documented in its database are failing after only six years. This compares with a 9.5% failure rate for all metal-on-metal hip implants during that time period. The report also stated that 17% of the Depuy hips were replaced after only five years.  In addition to pain and potential revision surgeries, problems may include injuries caused by particles of metal shed by the devices as they wear.  J & J currently faces more than 2000 lawsuits related to its hip implants. For more on this story click here.

The FDA has received more than 5,000 complaints this year about failed hip replacements. Most of the complaints concern metal-on-metal hips–ones in which the artificial ball and cup are both made of metal.  Most of the complaints center on the DePuy Hip Replacement System manufactured by Johnson & Johnson.  This system was recalled by the company last year.  Other manufacturers include Wright Medical, Zimmer, Biomet and Encore Medical. As many as 500,000 patients have received these types of replacement hips.

Replacement hips are supposed to last 15 years or more, but the complaints state that the hips often fail after only a few years.  In addition to pain and potential revision surgeries, problems may include injuries caused by particles of metal shed by the devices as they wear.  For more on this click here.

The US Supreme Court ruled that generic drug makers cannot be sued for failing to warn of their drug’s dangerous side effects even where the brand name makers can be held liable. In the  Court’s 5–4 decision, it determined that failure to warn claims against generic drug manufacturers are preempted because it’s impossible for the generic manufacturer to comply with both federal and state standards.

In dissent Justice Sonia Sotomayor wrote, “As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.”  Justice Clarence Thomas, writing for the majority, acknowledged that  it ‘makes little sense’ that, based on court interpretation of varying US regulations, people who are injured by generic drugs have no state failure-to-warn claim but those injured by brand-name drugs do.” It’s now up to Congress to pass remedial legislation to remedy this absurd result; which in the current political climate may be unlikely to happen anytime soon. For more on this story, click here.

Cholesterol lowering drugs, called statins, are the most widely prescribed drugs in the United States. A new study appearing in the Journal of the American Medical Association indicates that individuals taking statins such as Pfizer’s Lipitor and AstraZeneca’s Crestor have a greater risk of developing diabetes than those taking a placebo.  The risk of diabetes is greater for those taking higher dosages of the statins.

The study involved an analysis of five earlier trials with 32,752 patients and indicated that high doses of these drug can increase the risk of developing Type 2 diabetes by about 12%a twelve percent.  Click here for more on this story.

Pfizer, the world’s largest drug maker, has reportedly agreed to settle one-third of the approximately 10,000 pending cases in which plaintiffs’ have alleged that Pfizer failed to properly warn of the risk of taking Prempro, a hormone replacement therapy (HRT) drug that was prescribed to women to treat symptoms of menopause.

In an SEC filing, Pfizer stated that it set aside $772 million to resolve these cases and noted that this reserve provided “the minimum expected costs to resolve all of the other outstanding” lawsuits over its  HRT drugs.  Pfizer has refused to comment on average settlement amounts but reportedly settled 2200 cases in February for about $330 million representing an average settlement of about $150,000.

An extensive 2002 study revealed that HRT therapy was found to pose serious health risks such as stroke, heart attack and breast cancer. Over six million women took Prempro and related menopause drugs to treat symptoms such as hot flashes and mood swings before this study highlighted their links to cancer. For more on this story click here.

In a case that will greatly impact the future of mass tort drug litigation, the US Supreme Court considered whether generic drug manufacturers have the same duty as the brand name manufacturer to warn of potential harmful side effects of their drugs. 

Attorneys for the generic drug manufacturers argued that the current federal regulatory scheme did not allow their clients to add warnings on their labeling that differed from those of the brand name labels even if they became aware of additional potential risks.  They claimed that the FDA required that their labeling exactly match that of the brand name drug’s labeling. Plaintiffs argued that the generic manufacturer has a responsibility to initiate a labeling change when it has reasonable evidence that its current label is inadequate, otherwise  consumers injured by generic drugs will be without a remedy.

This case involved plaintiffs who took the generic version of the brand name acid reflux drug –Reglan, for stomach ailments and developed a serious neurological disorder called tardive dyskinesia . The lower court ruled against the generics and determined that the federal regulatory scheme did not prevent them from requesting a label change when they became aware of additional risks. Louis Bograd, who argued for the plaintiffs, told the justices, “The central issue in this case is that [the manufacturers], in the face of considerable information that the warnings on their products were inadequate, did nothing.” Michael Johnson, a Minneapolis attorney representing two of the plaintiffs stated:“If the Court sides with the plaintiffs, physicians and patients will receive adequate warnings about the prescriptions they take, and hundreds of thousands—if not millions—of injuries will be prevented.” For more on this story see click here.