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Lessons from Pharmaceutical Product Litigation: Merck and the Vioxx Withdrawal, Cona & McDarby vs. Merck, Video Supplement Change Management Analysis & Solution
HBR Change Management Solutions
Strategy & Execution Case Study | Margaret L. Eaton
Case Study Description
In 2004, pharmaceutical powerhouse Merck acknowledged potentially harmful side effects and withdrew one of its best selling drugs, Vioxx, an arthritis and pain relief drug, from the market. Withdrawing an FDA approved drug from the U.S. market due to newly-discovered side effects was not so uncommon. What was unusual, however, was that Merck's withdrawal was a voluntary decision by the company after Vioxx had been taken by an estimated 80 million patients during four plus years on the market. While Merck's decision was initially hailed as an example of Merck's well known dedication to ethical business practices, some in the medical community instead accused Merck of intentionally keeping Vioxx on the market even though it was too dangerous. Critics claimed that Merck had put profits ahead of patients and Merck soon faced close to 30,000 product liability lawsuits. This case package consists of a written case, supporting written materials, and an accompanying case video which takes place in the courtroom of a trial against Merck. Tom Cona and John McDarby sued Merck after experiencing heart attacks that they attributed to Vioxx. Using trial footage supplied by Courtroom View Network, this case explores the kinds of wrongful conduct alleged and how companies like Merck defend themselves against such claims. The witnesses testifying in this trial include the patients and their families who are suing, Merck's CEO and senior management, the physicians who prescribed the drug, and those who were called to give expert testimony in support of and against Merck's drug development, regulatory, and marketing activities.Disk 1: Introduction to the trial & Opening statements Disk 2: Testimony in Plaintiffs' Case Disk 3: Testimony in Merck's Defense Disk 4: Closing Statements, Judge Instructions, Verdicts Disk 5: Review copy of case study, supplementary materials and slides from video presentation This material is designed to be used in a one-day seminar or equivalent, with students having read the written case study and watched Disk 1 prior to class. This case is particularly well suited for business, medical, and law students. The written materials and video are sold as a package and are designed to be used together. Academic faculty may request a teaching note. Please contact cases_requests@gsb.stanford.edu for permissions to use the written case each time it is taught.
Change Management, Ethics, Health, Product development, Regulation , Case Study Solution, Term Papers
What is Change Management Definition & Process? Why transformation efforts fail? What are the Change Management Issues in Lessons from Pharmaceutical Product Litigation: Merck and the Vioxx Withdrawal, Cona & McDarby vs. Merck, Video Supplement case study?
According to John P. Kotter – Change Management efforts are the major initiatives an organization undertakes to either boost productivity, increase product quality, improve the organizational culture, or reverse the present downward spiral that the company is going through.
Sooner or later every organization requires change management efforts because without reinventing itself organization tends to lose out in the competitive market environment. The competitors catch up with it in products and service delivery, disruptors take away the lucrative and niche market positioning, or management ends up sitting on its own laurels thus missing out on the new trends, opportunities and developments in the industry.
What are the John P. Kotter - 8 Steps of Change Management?
Eight Steps of Kotter's Change Management Execution are -
- 1. Establish a Sense of Urgency
- 2. Form a Powerful Guiding Coalition
- 3. Create a Vision
- 4. Communicate the Vision
- 5. Empower Others to Act on the Vision
- 6. Plan for and Create Short Term Wins
- 7. Consolidate Improvements and Produce More Change
- 8. Institutionalize New Approaches
Are Change Management efforts easy to implement? What are the challenges in implementing change management processes?
According to authorlist Change management efforts are absolutely essential for the surviving and thriving of the organization but they are also extremely difficult to implement. Some of the biggest obstacles in implementing change efforts are –
- Change efforts create an environment of uncertainty in the organization that impacts not only the productivity in the organization but also the level of trust in the organization.
- Change management is often a lengthy, time consuming, and resource consuming process. Managements try to avoid them because they reflect negatively on the short term financial balance sheet of the organization.
- Change efforts are often targeted at making fundamental aspects in the business – operations and culture. Change management disrupts are status quo thus face opposition from both within and outside the organization.
- Change efforts are often made by new leaders because they are chosen by board to do so. These leaders often have less trust among the workforce compare to the people with whom they were already working with over the years.
- Change management efforts are made when the organization is in dire need and have fewer resources. This creates silos protection mentality within the organization.
How you can apply Change Management Principles to Lessons from Pharmaceutical Product Litigation: Merck and the Vioxx Withdrawal, Cona & McDarby vs. Merck, Video Supplement case study?
Leaders can implement Change Management efforts in the organization by following the “Eight Steps Method of Change Management” by John P. Kotter.
Step 1 - Establish a sense of urgency
What are areas that require urgent change management efforts in the “ Lessons from Pharmaceutical Product Litigation: Merck and the Vioxx Withdrawal, Cona & McDarby vs. Merck, Video Supplement “ case study. Some of the areas that require urgent changes are – organizing sales force to meet competitive realities, building new organizational structure to enter new markets or explore new opportunities. The leader needs to convince the managers that the status quo is far more dangerous than the change efforts.
Step 2 - Form a powerful guiding coalition
As mentioned earlier in the paper, most change efforts are undertaken by new management which has far less trust in the bank compare to the people with whom the organization staff has worked for long period of time. New leaders need to tap in the talent of the existing managers and integrate them in the change management efforts. This will for a powerful guiding coalition that not only understands the urgency of the situation but also has the trust of the employees in the organization. If the team able to explain at the grass roots level what went wrong, why organization need change, and what will be the outcomes of the change efforts then there will be a far more positive sentiment about change efforts among the rank and file.
Step 3 - Create a vision
The most critical role of the leader who is leading the change efforts is – creating and communicating a vision that can have a broader buy-in among employees throughout the organization. The vision should not only talk about broader objectives but also about how every little change can add up to the improvement in the overall organization.
Step 4 - Communicating the vision
Leaders need to use every vehicle to communicate the desired outcomes of the change efforts and how each employee impacted by it can contribute to achieve the desired change. Secondly the communication efforts need to answer a simple question for employees – “What it is in for the them”. If the vision doesn’t provide answer to this question then the change efforts are bound to fail because it won’t have buy-in from the required stakeholders of the organization.
Step 5 -Empower other to act on the vision
Once the vision is set and communicated, change management leadership should empower people at every level to take decisions regarding the change efforts. The empowerment should follow two key principles – it shouldn’t be too structured that it takes away improvisation capabilities of the managers who are working on the fronts. Secondly it shouldn’t be too loosely defined that people at the execution level can take it away from the desired vision and objectives.
Step 6 - Plan for and create short term wins
Initially the change efforts will bring more disruption then positive change because it is transforming the status quo. For example new training to increase productivity initially will lead to decrease in level of current productivity because workers are learning new skills and way of doing things. It can demotivate the employees regarding change efforts. To overcome such scenarios the change management leadership should focus on short term wins within the long term transformation. They should carefully craft short term goals, reward employees for achieving short term wins, and provide a comprehensive understanding of how these short term wins fit into the overall vision and objectives of the change management efforts.
Step 7 - Consolidate improvements and produce more change
Short term wins lead to renewed enthusiasm among the employees to implement change efforts. Management should go ahead to put a framework where the improvements made so far are consolidated and more change efforts can be built on the top of the present change efforts.
Step 8 - Institutionalize new approaches
Once the improvements are consolidated, leadership needs to take steps to institutionalize the processes and changes that are made. It needs to stress how the change efforts have delivered success in the desired manner. It should highlight the connection between corporate success and new behaviour. Finally organization management needs to create organizational structure, leadership, and performance plans consistent with the new approach.
Is change management a process or event?
What many leaders and managers at the Merck Merck's fails to recognize is that – Change Management is a deliberate and detail oriented process rather than an event where the management declares that the changes it needs to make in the organization to thrive. Change management not only impact the operational processes of the organization but also the cultural and integral values of the organization.
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