Liability and Generic Drug Makers

The Supreme Court is hearing a case that has be really fascinated. 

As you might know, generic drug manufacturers are not allowed to make any changes to the drug composition or labeling of the brand names they are genericizing. 

So what happens (as in this case) if a patient gets severely hurt by the side effects of a generic drug? 

1.  Can they sue the generic company for damages?  The generic company sold them the drug, but was not allowed by law to do anything about it.

2.  Can they sue the original pharma company that designed, tested, and brought the drug through Phase I, II, and III trials?  It was their mistake, but the patient has no connection with this company so where is the standing?

3.  Can they sue the FDA?  The FDA should have made sure that the Phase I, II, and III testing was adequate to catch dangerous side effects.  But of course this is not feasible economically or scientifically. There are too many variations in patient behavior and genes, remote side effects that don't show up, etc.  The drug approval process would be paralyzed.  And the federal government has safe harbor from law suits anyway.

4.  Maybe the patient sues the generic and the original pharma.  The combination is sort of the entity that is responsible. 

5.  Maybe they just can't sue anyone.  If a company gets a drug through FDA trials and approval, perhaps they should be protected from lawsuits.

Then we can imagine some real obfuscation that should add some corollaries to the law.  What if the original pharma company knew about the side effect but suppressed it in their drug application?  What if the generic company knew about the side effects and the fact that they were suppressed, but couldn't do anything about it because of the law handcuffing generics from making changes?  What if these side effects became known after the FDA had granted approval? 

The Supreme Court only has to consider one case this time.  But another one of these variations could come up at any time.  I hope they are ready.