Where do you stand on this?

I heard about this case and the findings drove me nuts.

Risperdal (risperirdone) is a drug used to treat schizophrenia and bipolar disorder.  Johnson and Johnson submitted and obtained FDA (Food and Drug Administrative) approval for the drug.  Um, one second- let’s be a little more clear.  The FDA approved its use for adults.

This was true noting the fact that a potential side effect- gynecomastia- prevailed for a certain population.  Gynecomastia means that there is an abnormal swelling of the breasts.

Which population was affected?  Children.  Well, that’s ok, right?  After all, the use of the drug is only approved for adults.

Now, here’s where it gets tricky.  Since the FDA did not approve the drug for children, it was illegal for J&J to list this side effect.   Because the FDA specifically approves all wording of labels on drugs- and this warning would suggest to practitioners that an unapproved or off-label use was acceptable to the FDA.

Now, this is America.  Where, as soon as a drug is approved for a purpose, practitioners are welcome (OK, not welcome, they just aren’t prohibited) to choose to use the drug for any purpose they feel has merit.  (You remember me bringing up this fact when we were discussing Aduhelm, a while ago.  You know, the pharmaceutical that was approved- with no proven clinical benefits- for treatment of early Alzheimer’s patients.  I said then that physicians are free to use it for all Alzheimer’s patients, given the approval.  Thankfully, in that case, the prohibited annual costs – and the controversy stirred up by me and others- is making that far less likely.)

So, what do you think happened with this J&J drug?

Folks prescribed this drug to kids.  And, soon enough, young boys were dismayed because they developed breasts.  And, their parents did the other big American thing.  They sued- Johnson and Johnson- because there was no warning on the label.  And, the media helped the outrage, stating that J&J knew that this side effect existed and didn’t warn anyone about it.

J&J used the defense that it was illegal for them to list that side effect, since the drug was not approved for kids.

But, the Philadelphia jury didn’t find that argument had merit.  It awarded some $ 8 billion in punitive damages.  (The fact that the judge lowered that to $6.8 million provided J&J some comfort.)

Here’s the dilmena…

The US Constitution (Article VI) is absolutely clear on this matter.  It avers that that Federal law is the “supreme law of the land”.

Well, d-uh!   That should mean that the jury and judge awards should be thrown out.  After all, J&J was totally in compliance with Federal law.   They would have violated the law if they added the warning to comply with any state requirement.   (This is known in legal circles as the “impossibility preemption”, which is used by many firms to adjudicate such situations.)

Except, SCOTUS (Supreme Court of the United States) has not been clear on this.   In Wyeth (a pharmaceutical firm) v. Levine, in 2009, SCOTUS rejected the impossibility preemption, stating that the Vermont rules that would have caused Wyeth to change the label to meet the state laws.  Their logic?  Brand name pharmaceuticals can update their labels when new side effects are known via a process called “changes being effected” (CBE).  That means J&J should have changed their label, when they knew folks were using the drugs for kids, approved use or not.

(Just so you know, SCOTUS also holds that generic drugs are NOT held to this ridiculous standard, since they do not have the ability to employ CBE.)

When presented with this case, SCOTUS declined to review the findings.  Which means state law prevails on label warnings for prescription drugs- but not for generic drugs (even of the same medicine).

Is that clear to you?  J&J should use an unapproved label (bringing sanctions from the FDA) or be subject to legal proceedings?