1. Class 3 – September 8 th, 2009 Health and Medical Research for Lawyers: 524.01 Molly Brownfield brownfield@law.duke.edu

2.  Review of take-home assignment #1  Clip from Side Effects  Legal Issues Surrounding Pharmaceutical Companies  Unethical relationships with medical community  Misleading Advertisements  Improper Labeling/Inadequate Warning of Risks  Research Resources  Federal Statutes and Regulations  FDA Resources  Case Law (* Wyeth and Riegel - the question of federal preemption )  Practice-Oriented Resources  In-class Exercise

3.  Client is a truck driver who was driving down the road at night, claims he falls asleep and loses control of the truck and there’s a big crash in which he’s injured  He wants to claim workers’ compensation from his employer  At the hospital they do a toxicology screen and they find cocaine metabolites  Employer says he’s outside the scope of workers’ comp benefits because he was taking drugs  He said he did snort cocaine a week earlier, but hadn’t touched anything at the time of the accident  Case is in Illinois (state law question – workers’ comp)

4.  Identify a medical resource that would give you more information about cocaine metabolites and whether they could be detected in Mr. Jones’ system after a week [and tell me how and why you selected this source].  Identify and read one secondary source to give you more detailed information about the scope of workers’ compensation benefits to help us see what effect possible drug use/intoxication will have on Mr. Jones’ case. Provide me with the citation [and tell me how you found the secondary source].  Identify any Illinois statutes that you think would be relevant in this case [and tell me how you identified these particular statutes].  Identify any Illinois cases that you think would be relevant in this case (*hint – cases in this area are often heard before a Board of Commissioners) [and tell me how you found these cases].

5.  I chose PubMed as my medical resource  I did a search for "cocaine metabolites" and duration, which led me to this article.

6.  I started with Am.Jur. on Lexis as my secondary source.

7.  I wasn’t sure what sub- topic to select…

8.  So I selected all the Workers’ comp documents and did a search for intoxication – limiting it to the Table of Contents only for those document.

10.  I skimmed the article, then scrolled down to the case citations in the footnotes to see if there were any IL case citations

13.  I’m going to select the statute generally addressing liability of employer to pay compensation to see what I can find out.

14.  I did a “Control F” to see if the term “intoxication” showed up anywhere in the statute or its annotations.  Jackpot!

15.  Could also use Westlaw’s Key Number Digest Outline and browsed the topics under Workers’ Compensation.  I selected k798 – Intoxication as a defense against claims for compensation

20.  Could also start with West’s Topical by Area of Practice for Workers’ Compensation  Might be some precedent in the ILWC-ALL database

22.  This result is a case heard by the IL Workers Compensation Commission  Deals with toxicology screen report  Good insight into how a contradictory expert reports might be read  How might we check out these witnesses’ creds?

23.  Lets try the All Expert Witness CV and Resume materials in the Litigation Database

26.  Legal Issues?  Disclosure/awareness of risks  What other legal issues might pharmaceutical companies face?  How do we research these areas?

79.  Could be an ideal resource for seeing how a major case, law, or regulation has affected this legal area.

81.  More of a Pleading & Practice type of resource with forms, litigation guidance, etc.

82.  Consider using West’s “Find a database” tool  Let’s search for pharmaceutical patent (no quotation marks)

83.  This first result looks interesting  Click on the “i” to see what it contains

84.  Not all that helpful for letting us know what’s in this thing – but we can see that it’s current through the 2009 pamphlet

85.  Use the Table of Contents to browse this resource

86.  Looks pretty useful!  Let’s take a look at the content of a particular section.

87.  Provides references to primary sources, which is extremely useful

88.  Another idea is to keep your eye on the “ResultsPlus” in Westlaw  Remember when we were looking at the citing references to 21 U.S.C.A. 355?  Click on the first result under “ResultsPlus”

89.  Might never have thought to look here otherwise!  Click on Table of Contents to see what else is in here.

93.  Remember, we always want to know what we’re looking at – what does it cover? How current? Etc.

97.  Our client, MajorPharm, is being sued by John Doe in the state of Michigan. Mr. Doe recently attempted to commit suicide. Though he survived, he incurred severe injury and is now permanently disabled.  Mr. Doe had been taking the antidepressant drug, Paxit, which is nearly identical to Paxil CR, and he believes the drug caused his suicidal thoughts and subsequent action. He now plans to sue MajorPharm for not including a strong warning on the label re: suicide risk.

98.  Are there any studies indicating that MajorPharm should have used stronger suicide-risk warnings on the label for Paxit?  What FDA resources should we consult for guidance re: advertising/labeling?  Are there any statutes or FDA regulations requiring postmarking reporting?  Are there similar lawsuits that we can look to?  In the wake of Wyeth, do we have any chance at arguing that Mr. Doe’s claim is federally preempted?  Is there anything particular in the Michigan statutes that might work in our favor for arguing federal preemption?

99.  Starting with a Google Search…

100.  Looks like an interesting lead, but where is it coming from?

101.  Okay…seems like this is pretty legit, though it’s not something to cite to or rely upon without back-up.  Let’s go back and link to that Senate Report it mentions

102.  Takes us to a legitimate U.S. Government site.  Now this is something we can rely on more.

112.  Scroll down to see sources of this regulation, as well as a link to Notes of Decisions.

113.  Could browse these decisions to see if any similar lawsuits

114.  Effect of Wyeth on our case?  Andrews Litigation Reporter could be a good source for this.