Design Risks in Personalized Medicine: An Emphasis on Litigation | Diaceutics

Design Risks in Personalized Medicine: An Emphasis on Litigation


This case study will help you understand how personalized medicine will change the legal landscape in ways that are as yet uncharted. It also discusses the importance of reflecting on any potential areas of legal exposure and addressing these in the clinical development program to minimize risks related to the companion diagnostic. It will help you understand:
  • How personalized medicine will change the legal landscape in ways that are as yet uncharted
  • The importance of reflecting on any potential areas of legal exposure and addressing these in the clinical development program to minimize risks related to the companion diagnostic
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1: Case Summary

This case will help you understand:

How personalized medicine will change the legal landscape in ways that are as yet uncharted.

The importance of reflecting on any potential areas of legal exposure and addressing these in the clinical development program to minimize risks related to the companion diagnostic.

Key messages:

Doctors may soon be forced to weigh the risks of performing a new test against the risks of not doing so. 

Personalized medicine and the legal system are already combining to test the justice system.

Developing a therapy using biomarkers, but then not marketing the biomarkers, is a choice that needs to be clearly explained in the design decision-making process.

Understanding physicians’ litigation concerns early on will help inform clinical trial decision-making.

Key actions:

Understand the potential test-related litigation issues that may challenge your key stakeholders.

Consider how 'duty to warn' potentially means more than warning of possible adverse events.

2: Personalized Medicine Could Change the Legal Landscape

 Mean ScoreVery Strongly AgreeAgree SomewhatDisagree SomewhatVery Strongly Disagree
I feel that I can practice medicine as I see fit right now without fear of a medical malpractice lawsuit1.563%12%23%62%
I feel that I can practice medicine as I see fit right now without interference from insurance companies1.824%18%35%44%
I feel that I can practice medicine as I see fit right now without interference from the government2.099%25%33%33%


 
 
I avoid anything 'new' that exposes you to the accusation that you are 'learning' on this patient.
A survey respondent



 
 
I practice defensive medicine by avoiding those procedures which might benefit my patients, but are considered too risky by my malpractice insurer and would increase my premiums to a degree that is prohibitive.
A survey respondent


So What?

Enabled by pharmacogenomics, molecular imaging and other molecular biomarkers, personalized medicine promises to optimize therapy while minimizing side effects. It may also dramatically impact the justice system in ways we are only beginning to understand.

It could change the legal landscape in ways that are as yet uncharted.

Commentary

Personalized medicine teams have paid little attention to the legal issues relating to new therapies and diagnostics, but these issues are on the horizon.

Doctors are already making decisions based on concerns about litigation. More than half of respondents to a US survey said they had delayed adopting a 'medical innovation' due to fear of being sued. Certain specialties were more likely than others to delay adoption of novel therapies. For instance, just 27 per cent of pediatricians were likely to forego new tools, compared to 63 per cent of obstetricians/gynaecologists and two-thirds of surgery subspecialists.

However, doctors may soon be forced to weigh the risks of performing a new test against the risks of not doing so.


3: Tests Provide Malpractice Evidence

So What?

Personalized medicine and the legal system are already combining to test the justice system.

Commentary
Recently, the FDA relabelled some drugs to recommend or require companion tests. In the case of warfarin (brand name Coumadin), for example, it recommended CYP2C9 and vitamin K epoxide reductase complex 1 tests to reduce incidence of bleeding. As a result of the relabelling, if a diagnostic retrospectively reveals that a particular patient was at high risk of bleeding but those tests were not performed, litigation may follow. Lawyers already advertise for cases involving warfarin-related errors and are ready to sue physicians who have not adequately monitored the dosing levels of this drug. Consequently, pharmacogenomics may become part of defensive medicine.

4: An Era Of Personalized Justice

So What?

While the precedents of 'personalized justice' may take time to develop, we can expect landmark judgements in this uncharted area.

Commentary

In a 2010 editorial, Steven Wong, Ph.D., a professor of pathology, psychiatry and behavioural medicine at the Medical College of Wisconsin, and his colleagues, indicated that personalized medicine may dramatically impact the justice system in ways we are just beginning to determine.

They predict the advent of “personalized justice” and how it will complement both personalized medicine and the overlapping practice of translational medicine, which holds that individual differences are caused primarily by genetic and environmental factors.

Although personalized medicine is rapidly taking root among the medical sciences, the authors predict a slower, more begrudging adoption by the legal profession. Nevertheless, they say, the law’s incredibly rich experience with DNA developments may facilitate acceptance.

They caution that personalized justice should be based on sound legal principles as well as reliable and valid evidence-based studies, not on ‘junk’ science and unsubstantiated case reports. With sound scientific and legal principles and correct interpretation, they argue, the emerging concept of personalized justice could enhance patient safety and maintain social justice.

5: The Litigation Burdens of Personalized Medicine

So What?

It is important to reflect on any potential areas of legal exposure and address these in the clinical development program to minimize risks related to the companion diagnostic.

Commentary

Diaceutics worked with the pharmaceutical litigation defense team at Nixon Peabody to review and highlight potential areas of concern in the advent of personalized medicine. They identified several areas where pharmaceutical companies might possibly be sued.

6: Scenarios To Consider: Duty to Warn

So What?

A 'duty to warn' potentially means more than warning of possible adverse events.

For example, in the event of a treatment decision being dependent upon a test, the clinical team should determine what to emphasise and how to educate doctors and the public with regard to the need to test for a condition before prescribing a therapy.

7: Scenarios to Consider: A Design Defect

So What?

Developing a therapy using biomarkers, but then not marketing the biomarkers, is a choice that needs to be clearly explained in the design decision-making history.

Commentary

In the event that biomarkers have been used in therapy development but the treatment has been launched without a test, the clinical team should reflect on the potential future exposure to patients of not educating physicians about any biomarker-related therapy responses before Phase 3 trials.

8: Scenarios to Consider: Prescribing Without Testing

So What?

Understanding physicians’ litigation concerns early on will help to inform clinical trial decision-making.

Commentary

In the event that a targeted treatment has been launched without a test, the clinical team should also reflect, before Phase 3 trials, on physicians’ concerns for litigation. Physicians may face potential future exposure to patients if they prescribe a therapy when there is no test to show that the therapy is appropriate for that patient.

9: Key Messages

Key messages:

Doctors may soon be forced to weigh the risks of performing a new test against the risks of not doing so. 

Personalized medicine and the legal system are already combining to test the justice system.

Developing a therapy using biomarkers, but then not marketing the biomarkers, is a choice that needs to be clearly explained in the design decision-making process.

Understanding physicians’ litigation concerns early on will help inform clinical trial decision-making.

Key actions:

Understand the potential test-related litigation issues that may challenge your key stakeholders.

Consider how 'duty to warn' potentially means more than warning of possible adverse events.

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