Biotech Torts - Winter 2002

Informed Consent

What is the prima facie case?

What is the standard for disclosure?

Why and when is causation a difficult issue?

How does fiduciary duty come into the equation?

How does the doc's duty to get informed consent fit with the drug company's duty to warn?

Is the learned intermediary role consistent with informed consent and fiduciary duty?

How would this be different in MO from CA?

FDA Regulation

How is the regulatory process different for drug and devices as it relates to products liability claims?

What are the important differences between preemption and regulatory compliance as a defense?

How does these theories differ for drugs and devices?

Why does the 510K process v. PMA matter?

What is the post-market surveillance and why is it critical?

Products Liability

Why was 402a & b adopted?

How does it affect the traditional DBCD analysis for torts?

What is the difference between a manufacturing defect and a design defect?

How is the proof of the plaintiff's case different?

How are the defenses different?

How does this impact drug litigation differently from device litigation?

What is the product v. service distinction?

How does it play out in cases against docs and hospitals?

How does medical software fit into the product v. service distinction?

What is Comment K and how does it tie into the learned intermediary defense?

Is the learned intermediary defense as strong for devices?

Why or why not?

What is Comment e and why is it important?

What are the special problems posed by vaccines? (Think about all the different legal issues we have discussed from the perspective of vaccines.)

How does the Restatement 3rd modify the Restatement 2nd's Comment K and other drug-related defenses?

Where does negligence per se come into the biotech torts area?

Explain the role of labeling in prescription drugs, over the counter drugs, and medical devices.

What are other ways manufactures convey information to docs and patients and how do these figure into failure to warn cases?

When should patients get a PPI?

What are the legal issues with PPIs?

When can you sue the FDA?

What are the issues posed by suing the FDA or other government entities?

What are the evidentiary issues in cases like Daubert?

How do joint and several liability and other theories of allocation of liability play out in products cases?

What are the special issues posed by implants?

What are the special problems of products that injury kids and the fetus?

Who has post-sale/post-prescription duties and what are they?

Think of every way the Internet affects liability for drugs and devices and physicians and other health care providers.

When are pharmacists liable for injuries cased by the goods they sell?

When does Cafazzo not block liability for hospitals?