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Drugs and Medical Devices
Professor Richards, Fall 2002

New - Last Years Exam

This is in PDF format so you can print it just as I gave it. One caveat - last year's course had more informed consent and products liability and much less FDA regulation.

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Course Basics

Course page: http://biotech.law.lsu.edu/Courses/drugsf02/index.htm

Main Page: http://biotech.law.lsu.edu/

(go to online courses on main page header to find the course)

Casebook: Noah and Noah, Law, Medicine & Medical Technology, Foundation Press (2002) ISBN # 1-58778-169-7

My email: richards@lsu.edu (if you need to find me, this is the fastest way)

Course Information

Most of our readings will be from the text, but there will be supplementary materials and news items on the WWW site. You must check the WWW site the evening before class for any revisions.

I reserve the right to lower grades for poor class participation. The course will have a final exam. It will be an in-class essay exam based on the materials we cover in class. You will be allowed to use your book and notes for the exam.

Course Objectives

The course will introduce you to the basic FDA regulatory scheme for drugs and medical devices, how they are dealt with in the torts system, and the policy questions involved in funding new drug development and universal access to drugs and medical devices. The objective of the course is to help you understand the interplay between the regulatory, tort, and political systems. The course focuses on drugs and medical devices because they are a critical part of the health care system, both in the US and internationally.

Current Events

Keep your eye on the news for drugs and medical devices related issues. We will take time at the beginning of each class to discuss issues in the news.

Class Assignments

20 August

General introduction and chalk talk on administrative agencies - no reading assignment.

Executive Order responding to 9/11 - The Office of Homeland Security & the Homeland Security Council

Intro handout on administrative law - part 1 - Word format, right-click to save as file.

22 August

Introduction to Administrative Law - This is the complete handout and replaces the previous part 1. Nothing has changed on the materials we covered on 20 Aug, i.e., prior to the rules.

1 - 36 (These are the reading pages for the day they are under, i.e., 22 Au. We will catch up to the reading in a week or so, after we have finished the intro materials.)

27 August

36-70

Study the definition of a drug on page 8 - how broad could this be, and how have the court's narrowed it? Look at the readings so far as a whole and think about the problem of defining the scope of FDA regulation. What should the FDA regulate? Do you assume that the FDA regulates everything that looks like a drug, i.e., things like food supplements sold in to improve your memory or herbal weight loss remedies? What about all the drugs you can buy on the Internet? FDA regulation depends on controlling the sale of drugs in conventional retail channels, including limit prescription drugs to pharmacies. What problems can arise when the Internet provides an alternative channel?

29 August

There is a change in the schedule - since Professor Malinowski's course in Bioethics is being offered after all, we are going to join Professor Malinowski's class for a discussion of the regulation of clinical trials. We will meet at 9:50 in room 108 on 29 Aug and on 3 Sept, depending on how far the class gets on Thursday. There are materials on clinical trials in our book at pages 137 - 198. You might look over these before class, but you will not be expected to have read them for Professor Malinowski's class. Our readings are the same - 70 - 95.

An interesting article on the debate about the Atkins diet.

3 September

Since Prof. Malinowski finished his materials on clinical trials, we will return to our own class room on the 3rd and continue with our materials. We will finish our discussion of Chapter 1 and begin our own discussion of Chapter 2 next class.

Finish reading chapter 1, 95 - 137.

Update - to better focus your preparation, concentrate on Alabama Tissue Center, US v. 50 Boxes, US v. Ever's, Retkwa v. Orentreich (is this really an FDA case at all?), and the three enforcement cases US v. Alcon, US v. Superpharm, and US v. Universal Management Services.

5 September

I am pushing this assignment to the next class - we are not going to have time to start Chapter 2 until 10 Sept.

10 September

Read 137 - 183. I will review the basics of clinical trial regulation and structure in more detail than our intro with Prof. Malinowski. Review guide in Word format..

Interesting site:

http://www.guineapigzero.com/index.html

12 September

Finish reading chapter 2, 183 - 198. Our class discussion will focus on Section C, securing informed consent, 162 - 183.

Review of Informed Consent - Powerpoint;

Review of Informed Consent - HTML

Review of Informed Consent - Word

Leading LA informed consent case:

Informed Consent in Louisiana - Lugenbuhl v. Dowling, 701 So.2d 447 (La. 1997), rehearing denied (Nov 21, 1997)

You are not responsible for this case for 12 September, but you should review it after class. It has a great review of informed consent law in LA. We will see these issues again in the liability chapters.

17 September

(From last class - Notes on 180, 2. Lewis v. Sobol, 710 F.Supp. 506, 53 Educ. L. Rep. 500 (S.D.N.Y. Apr 13, 1989) on page 180, section 2. The context implies that the court found that there was a required religious exemption to vaccination, but that was not at issue. The state law had a religious exemption already, the case was about the definition of religion it used. It does not hold that there must be a religious exception to vaccination law.)

We finish our discussion of chapter 2 with Section D, Access to Experimental Products. Review this carefully and read the notes.

Read Schiff v. Prados, 92 Cal.App.4th 692, 112 Cal.Rptr.2d 171, 157 Ed. Law Rep. 264, (Cal.App. 1 Dist. 2001).

Study Guide to Schiff v. Prados, 92 Cal.App.4th 692, 112 Cal.Rptr.2d 171, 157 Ed. Law Rep. 264, (Cal.App. 1 Dist. 2001) - use this guide when you are reviewing the case. Be prepared to answer the questions in the guide. (For tips on briefing real cases, click here.)

Study Questions - Access to Experimental Products - use this for the cases and materials in the book.

Be prepared to discuss these policy issues:

access outside clinical trials

whether the informed consent for a clinical trial should tell the patient that the drug is available outside the trial

should patients be able to import unapproved drugs for their own use

should the rules be different for patients with terminal or very serious illnesses

how do we prevent charlitans from taking advantage of sick patients

19 September

198 - 230 - Use these study questions to direct your reading.

24 September

231 - 255 - Use these study questions to direct your reading.

26 September

Class Cancelled

1 October

255 - 275 - Use these study questions to direct your reading.

3 October

Storm Day

8 October

Reading day

10 October

Smallpox issues

October 15

Smallpox continued - see: Draft Critique of CDC Smallpox Response Plan - 25 Sept. 02

I will finish my presentation on smallpox and related legal issues, and we will discuss these in class. Be prepared to give me your insights - you will know as much as the pundits do when we are done.

October 17

275 - 313 - Use these study questions to direct your reading. We will concentrate on 293 - 313. Slides on Dissemination of Information.

October 22

FDA seizes products because of drug claims.

Review these package inserts to get a feel for the information and how it is presented: Viagra; Ortho Evra - General Info - Package Insert; and Campath.

We will finish the material from last class, then cover 313-346, as outlined in the study questions.

October 24

346 - 383 - Study questions.

October 29

Introduction to Health Care Products Liability - Introduction to Health Care Products Liability (PowerPoint)

Read 392 - 407. Study Questions. Comment K. § 6. Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices.

October 31

Finish discussion of the materials from last class, in particular how § 6 differs from Comment K.

Read 407 - 444. Study Questions. Slides: Medical Device Law / Medical Device Law - HTML.

November 5

Skip Berkovitz in the book and read this instead: Berkovitz Case , Berkovitz Study Questions. This a case about how and when you can sue the federal government under the FTCA. If your claim does not fit under the FTCA, then the only other remedy is usually a Bivens action. For more information, see: Suing the Government.

Read 449 - 462. Study Questions. We will continue this next class if we do not finish.

November 7

Read 462 - 480 and the carry over material from last class. Study Questions.

November 12

481 - 523, Study Questions, Pictures of Heart Valves

Breaking news on vaccines and autism

November 14

523 - 559, Study Questions

November 19

Class cancelled for Justice Scalia. We will deal with this material next class - come prepared for this and most of the next section.

559 - 597. Study Questions Revised class time - we will meet at 9:40 and quit at 10:15 - be prepared so we can move quickly, and what we do not finish we will put over until next class.

November 21

598 - 633

Rather than a case by case analysis, focus on figuring when docs, hospitals, and pharmacies are liable for drug-related injuries and when they are not, and why.

November 26

General Review Questions

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