Washington Consumers Beware of Big Pharm Marketing

Johnson and Johnson has agreed to pay $2.2 billion for its illegal marketing and kickback program.  At first blush, that seems like a tremendous blow.  But when you dig deeper, you see that this is a penalty that J & J will gladly pay. The drug at issue is Risperdal, a drug approved by regulators to treat schizophrenia in adults. But from 2003 to 2010 when J  & J was pitching off label uses of the drug for things ranging from dementia to anxiety, J & J sold $24.2 billion of  Risperdal alone. In August J & J proclaimed that the resolution with the federal government would not have a material adverse effect on J & J’s finances. They were right: as reported in Bloomberg Businessweek, the $2.2 billion agreement represents just 12.5 percent of J & J’s revenue in this quarter alone.  If there’s a lesson here for our Washington State readership, it’s to be very leery of Big Pharm marketing. From the time a drug is first marketed to the time it is prescribed, it’s a business process. Big Pharm is big business. We all know that. But even knowing this, sometimes we let our guard down when it comes to getting our prescription drugs.  You can never be too careful - you  can't ask your doctor too many questions (what alternatives are there? is this an off-label use?).  You need to keep your eyes wide open when it comes to the business of prescription medicine.

Dangerous Drug Alert: FDA puts "black box" warning on anti-seizure drug Potiga for risk of vision loss and skin problems.

The FDA required "black box" label changes to the anti-seizure medication Potiga (ezogabine),  These are the most serious label changes the FDA can require.  The drug, manufactured by GlaxoSmithKline, carries "risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent."  The FDA recommends that patients have eye exams both before starting the dangerous drug and every six months during treatment. See this FDA press release for more information.

Defective Product Alert: "Breathable Baby" Wearable Blankets Recalled due to Choking Hazard

BreathableBaby has issued a recall on its BreathableSack wearable blanket for infants because the blankets can be a choking hazard to small children. According to the recall, "The zipper pull tabs and sliders can detach posing a choking hazard to infants."  Federal law requires that these items be removed from shelves and are prohibited from being sold. BreathableBaby has urged customers to immediately discontinue use of the defective product and contact them for a replacement.

Cycling: Good for you, but not without risk

  This blog does cover matters of interest to cyclists.  I recommend an interesting article in yeterday's New York Times titled "How Safe is Cycling? It's Hard to Say?"  There are valid arguments on both sides.  But for me the take away is to try to do everything you can to be a safer cyclist.

Sudden Acceleration Litigation Moves Forward

Toyota's recent victory in a California sudden acceleration trial is noteworthy.  But it's only good as far as it goes.  The case involved a new theory, relying not on an electronic defect but instead pointing towards the absence of a brake override system.   The incident occurred when a driver crashed into Noriko Uno, which propelled Uno's car into a sudden acceleration.  The jury placed blame at the hands of the driver, to the tune of $10 million, while hearing Toyota's theory that having been hit by a car, Ms. Uno must have inadvertently slammed on the gas pedal instead of the brake.

It's easy to offer opinions after the dust has settled, but one can't ignore that this case was not  an easy one for the plaintiffs.  The plaintiffs faced obstacles  that aren't ordinarily present in the electronic defect sudden acceleration case.   For example, they faced at least three significant challenges:  They have to convince the jury that the driver who crashed into Ms. Uno wasn't too blame; they had to overcome the theory about hitting the wrong pedal; and they had to convince the jurors that this wasn't a defect, but a failure to have the safer override system.  It was a valiant effort. They fought the good fight. And by taking a case that faced such challenges, you have to hand it to them for trying.

But all is not lost for plaintiffs injured as a result of sudden defect acceleration. In November, Toyota heads back to trial, this time in a bellwether case that they selected for trial. The plaintiff's case is the more straightforward electronic defect case. If Toyota loses this trial, it may be time for them to start thinking about a settlement strategy.