Climate Change Project

Table of Contents



Drugs - Products Liability

Guide to: Feldman v. Lederle Laboratories, 479 A.2d 374 (N.J. 1984)

What is the accused drug?

Was it administered as a medical emergency?

What was the alleged complication?

Why didn't plaintiff sue the physician in this case?

What were the two main defenses?

What did the jury do?

Has the case been up to this court before?

What happened last time?

Note on Beshada - this is an extreme case, requiring warnings for things that were alleged not know at the time. It was a reaction to a defense coverup and has been ignored in future cases.

What happened on the first remand?

Who participated as amici?

When did Declomycin go on the market?

What are the advantages of this drug over other tetracyclines?

When was the warning about tooth discoloration added to the PDR?

During what period of time did plaintiff get the drug?

Did it work?

Were there any other adverse side-effects?

What was the effect on plaintiff?

Why were her permanent teeth also discolored, even though they came in later?

Was there dispute over what caused the discoloration?

Summarize plaintiff's presentation on when defendant know about the problem?

How does defendant counter this argument?

What was the problem with defendant's expert's testimony?

When did defendant know for sure that tooth discoloration was a problem?

What warning did defendant want to add to the label?

Why did defendant ask the FDA for permission?

When did the FDA reply?

What did the FDA say about Declomycin?

Why did defendant decide to include the warning on Declomycin as well?

What was the trial court's charge to the jury?

What was the standard for determining if defendant was liable for improper labeling?

Did either side object to the charge?

Stop here for Tuesday - we will discuss products liability before finishing the case on Thursday

When did the defendant raise the application of products liability to drugs?

What did defendant rely on to claim that drugs should not be subject to products liability?

What happened in Magrine?

What were the court's reasons for not holding the dentist liable under 402a?

What happened in Newmark?

Why was the hair salon treated differently from health care practitioners?

What did they same about blood in Baptista?

What happened in Brody?

How does the court distinguish drug companies from doctors and hospitals?

What was the holding in O'Brien?

What were Wade's 7 factors?

What additional information did the court say it would need to see before it could decide that drugs were not subject to products liability?

What did the court want to see about FDA regulation?

Why are these questions about the record important in this case?

What does Comment K apply to?

What example does it give?

What must the manufacturer assure to avoid liability under Comment K?

Why does the court refuse to grant Comment K status to all drugs?

When can there be strict liability under Comment K?

Ignore the discussion of Zirpola and Reynolds in FN6. Most courts do not find liability for extremely rare reactions, but there is no guarantee.

What is the defect in this case?

How did the court say the difference between products liability and negligence is commonly expressed?

How does reasonableness come in as a defense in defective design cases?

What did Suter say the jury could consider?

What does "state of the art" mean?

What time is used to determine what the defendant knew?

What is the Comment J test?

What is constructive knowledge?

What standard is the manufacturer held to as to knowledge about necessary warnings?

What was the standard from Harper and James?

What is the role of complaints by doctors and patients?

Does the court require warning about unknowable risks?

How does the court restrict Beshada?

How does the court justify Beshada?

Who has the burden of proving the availability of the information?


What about risks that come to light after the product is on the market?

When does the manufacturer have to warn consumers as well as physicians?

Why does defendant have a special duty to warn Plaintiff's father?

What should the new jury charge contain?

What did the court say about defendant's claim that it could not warn without FDA approval?

What was the basis of defendant's claim that the FDA regulations preempted the failure to warn claim?

What did the court say about defendant's claim that the FDA regulations preempt cases based on failure to warn?

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