Medical Products Liability: Litigation Claims Against Pradaxa

Medical Products Liability

Adopt a Drug or Medical Product/Device

For this assignment you will need to find a drug or medical product/device that is FDA approved (or was FDA approved at some point in time) and has been subjected to litigation claims that the drug or medical product/device caused harm to patients that used the product or device.

The goal of the assignment is to have you work your way through the FDA approval and post-approval processes, and then see how the processes and the information from the processes is incorporated (or not) into litigation.

To complete this paper, you will need to do outside research to find a drug or medical product/device that was approved by the FDA and that was subsequently subjected to litigation. There are a number of resources that you can use to find a drug or medical product/device. One resource is Westlaw to search for cases involving drugs or medical products/devices. There are a variety of databases that will provide information about cases involving drugs or medical products/devices.

There are also some internet websites that may have helpful information including:

• The Findlaw website regarding prescription drug litigation
  http://classaction.findlaw.com/
• PBS Frontline webpage listing prescription drugs that were FDA approved and later withdrawn from the market due to safety problems
  http://www.pbs.org/wgbh/pages/frontline/shows/prescription/etc/dozen.html
• The FDA's webpage on recalls and safety alerts:
  http://www.fda.gov/Drugs/drugsafety/DrugRecalls/default.htm

You are also free to use other websites you may find in your research. These websites can provide you with names of drugs and products that have been subjected to FDA administrative actions or litigation. You can then take the drug or product/devices and search Westlaw to see if any of them were subjected to court cases that you can use for this paper.

After you find your drug or medical product/device, you need to perform the following tasks and answer the following questions:

NOTE TO STUDENTS: you need to select a drug or medical product/device from your research above that will allow you to answer these questions, so it is a good idea to skim through the questions before you start your research and then when you find a drug or product/device you can begin going through the questions to see if you can find enough information about the drug or product/device to answer the questions.

Question #1

Go to the FDA website for Drug or Product/Device approvals. Review the approval documents and labeling for the drug or product/device and answer these questions:

1. What side effects, adverse reactions, or possible risks or dangers associated with the use of the drug or product/device were noted in the approval or in the labeling of the drug or product/device?

2. What did the FDA require the manufacturer to do about them (i.e. conduct post-approval studies, provide warnings, etc.)?

3. Do you think the FDA's approval requirements (the studies, warnings, etc.) seemed to address the possible side effects, adverse reactions, or possible risks or dangers that the FDA was aware of at the time it approved the drug?

Question #2

Search the internet (including the FDA's website) and other sources (like news articles, etc.) and gather information about the problems that started to develop with the use of the drug or product/device after FDA approval. Answer these questions:

1. What problems started to develop with the use of the drug or medical product/device?

2. What harm or injuries were the problems causing patients?

3. Were the problems the same or similar to the side effects, adverse reactions, or possible risks or dangers associated with the use of the drug or product/device that the FDA was aware of when it approved the drug?

Question #3

Search the FDA's website and you may want to search other sites as well and answer these questions:

1. Did the FDA issue any recalls, warning letters, safety alerts, Dear Doctor letters, labeling changes, or take any form of post-approval action regarding the problems noted in question 2?

2. If so, explain what the FDA did and whether you think the action(s) was sufficient to address the problems that the FDA was aware of at the time. Are there any additional actions you think the FDA should have taken?

3. If the FDA did not take any action, explain what you think the FDA should have done given its authority in this area.

Question #4

Find a court case regarding the drug or medical product/device and answer these questions:

NOTE TO STUDENTS: one case may have a number of reported decisions and sometimes the reported decisions on Westlaw or a court database will involve preliminary or collateral issues like jurisdiction, standing, intervention, experts, class action status, etc. You can use these decisions as long as you are able to answer the questions. You may need to find a decision that deals with a substantive issue regarding the plaintiff's liability claims in order to answer the questions. Westlaw now often has the parties' pleadings from the case online and you may need to review those documents to answer some of the questions if the information is not in the decision.

1. What is the decision(s) about? In other words, what issue or issues does the decision discuss and resolve and what is the court's reasoning in resolving the issue(s).

Provide a citation for the decision(s) and be sure to address the following:

A. What were the plaintiff's claims in the lawsuit (failure to warn, design defect, manufacturer defect)?

B. What were the defendant's defenses to the claims?

2. What role if any did the FDA's actions play in the litigation? For this question, be sure to address the following:

A. What arguments, if any, the plaintiff and defendant made regarding the FDA's actions. For example, did the plaintiff assert that the FDA's post-approval administrative actions demonstrate that the product was defective, or did the defendant assert that FDA approval shows that the product is not defective, etc.?

B. Describe how the court addressed and resolved the arguments regarding the FDA's actions. If the court did not address and resolve the arguments, describe how you think the court should have resolved them based on the arguments that were made and what you have learned about these topics in class.

C. What do you think about the parties' arguments and the court's resolution of the arguments? Were they consistent with what you learned in class regarding regulatory standards and products liability and related topics like preemption?

3. If the FDA's actions were not mentioned in the decisions or the parties pleadings, then discuss what arguments could be made given the facts of the case and how the court should have resolved them based on the arguments that were made and what you have learned about these topics in class.

Question # 5

Review the information you have put together to answer the prior questions and answer these questions:

1. If you were to think about all of the information you gathered in the prior questions and throughout this course as describing a process that begins with FDA approval and ends with litigation, how well do you think the current process works to prevent harm to consumers and to provide redress to those who are harmed?

2. What changes do you think could improve the process?

3. What do you think about the role that litigation plays in the process of ensuring the safety of drugs or medical products/devices? In answering this questions consider:

A. Whether litigation and the potential remedies from litigation such as monetary damages or punitive damages provide any incentive for drug and medical product/device manufacturers to make safe drugs and products/devices.

B. Whether litigation provides a sufficient or satisfactory remedy to those that are injured by drugs.

C. Are there other options are there besides litigation that might work better?