CASES FOR CLASS N.2
Riegel v Medtronic, Inc.
FACT SUMMARY
Patient brings common law claims against producer of faulty medical device which was FDA
pre approved.
ISSUE
Whether the preemetion clause in the MDA to the food, drug and cosmetic act (FDCA) bars
common law claims challenging the safety and effectiveness of medical device given the
premarket approved by the FDA?
Defendants balloon catheter ruptured en plaintiffs artery while being used during angioplasty.
Common law claims brought by the plaitiffs were preemted by the federal MDA to the
FDCA,
The plaintiffs are advocating that common law causes of action be allowed which would
differ from or add to requirements set forth….(Bars any state from establishing a requirement
for device which is different from or in addition to any requirements established by MDA.)
Here, there were some warnings that catheter could be used only for certain patients
depending on their arteries etc…doctor didn’t follow those instructions. Product itself was nor
defective!!
In this case there is no conflict between state and federal law.
WYETH V LEVIN
Levin sued W. claiming that a company had failed to provide a warning label indicating that
arterial injuries could occur from improper injection of the drug. According to W their
warning were federally sufficient.
ISSUE
Does federal law pre-empt state torts claims imposing liability on drug labelling that FDA has
approved.
FDA provided a way to change. FDA nd tort law required the same conduct. He breached
both!! There was a way to update the information!!
FDA standards represent bare minimum threshold.
States could make more strict regulation against companies.
Federal law does not pre-empt state law in such cases, W was always responsible for the
content of its labels.
In this case there was no conflict between state and federal law!!
Since we are talking about drugs there were no express pre emtion
. there is a difference btw drugs and medical devices!!
PLIVA V MENSING
generic versions of a brand name drug (raglan)
