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.