Comments on Pliva v. Mensing


I talk to people every day who suffer very serious side effects from taking prescription drugs. The Supreme Court recently decided a case that affects almost every single conversation I have with a new client.

In Pliva v. Mensing, two plaintiffs took generic Reglan – a drug that speeds up food digestion. Both women took the drug for several years and developed a rare neurological disorder that causes uncontrollable involuntary body movements. People who get it literally cannot sit still. Even though their doctors prescribed Reglan, the pharmacists gave these women the generic version of Reglan. The generic drug is chemically the same, but it is made by a different company.

These women sued the company that made the generic drug and complained that the warning label was not strong enough – that it did not explain clearly that using the drug for a long time would cause uncontrollable body movements for the rest of your life (very serious injuries from taking a drug that helps with food digestion).

The case went all the way to the Supreme Court. The issue was whether the women could sue the company that made the generic drug for an issue with the label.

The FDA has a rule that requires a generic drug’s label to be IDENTICAL to the brand name drug’s label. In Pliva v. Mensing, the company that makes the generic drug argued that it could not make a stronger warning without breaking the FDA’s rule.

The Supreme Court agreed with the company. The way the law is today, generic drug companies cannot change their label – even if they know their drug is killing people or causing people very serious injuries. They can’t change the label and you can’t sue them if you get injured. But what is truly bizarre is that if these women had taken the brand name drug Reglan, they could have sued the company to change to label.

In 2008, the Supreme Court ruled that a Vermont woman who had her hand and forearm amputated because of gangrene after being injected with a brand name anti-nausea drug could sue the manufacturer for not having a strong enough warning label; she won $6.8 million.

Basically, if you get injured by a brand name drug, you can sue a company to pay for your injuries. But if your pharmacist gives you the generic drug instead, the Supreme Court says you don’t have a case.

This is a huge problem because almost 80 percent of prescriptions are filled using generic drugs. The New York Times has picked up on this problem and recently ran a story titled, Generic Drugs Proving Resistant to Damage Suits .

The article talks about how unfair the law is to the people who get injured by dangerous generic drugs.

Your pharmacist may ask if you want to substitute the generic drug because it is much cheaper. But s/he will never tell you that, if you take the generic, you are giving up your legal rights if the drug kills you or seriously injures you for life.

Until Congress steps in to change the law, or until the FDA changes its rules to allow generic drug makers to make warning labels stronger, people who are injured by generic drugs cannot get money from the drug company when they get seriously injured.

The issue is complicated and the laws could change at any time. My job is to help people who get injured by dangerous drugs. I am staying on top of this issue. If you have questions, please feel free to contact me.