Category Archives: legal costs

EMRs Impact on Pharmaceutical Litigation

Electronic Health Records or Electronic Medical Records (EHRs/EMRs) are providing information that is impacting risks, risk management and litigation related to pharmaceuticals. I have posted several articles about the legal impact of EHRs at This page provides links with comments about those posts.

My interest in these issues is based on my commitment to reducing costs and improving quality of healthcare. It is supported by my experience with litigation support consulting assignments. I am not an attorney and this material is not offered as legal advice. For legal advice, consult an attorney.

EHR Technology Driving Drug Safety

March 4, 201
Pharmaceutical litigation is where huge lawsuits are common. I predict that this will change and the change will reduce the damage to the bodies and lives of patients, reduce the cost of healthcare, and speed up the process of moving new medications from the laboratory to patients. What will cause that change? …

As a new medication enters the market feedback about its effectiveness and risks will begin to flow very shortly thereafter [in EHRs.] Manufacturers who chose will be able to measure and document effectiveness and will also be able to identify risks. As the patient population using the medication grows, the sample being tracked will also grow. This means that that as risks become significantly large—however significance is determined—the data base will be growing to support both risk assessment and mitigation. Manufacturers, if they chose, will have new opportunities to minimize damage by providing additional information to the medical community and patients and to develop specific responses to specific problems. Timely action will reduce compensatory damages and responsible action will reduce punitive damages. Timely responsible action will reduce damage to the brand in the marketplace.

EHRs Meet Pharma’s Need for Better Risk Management

May 26, 2011
Pharmaceutical product liability lawsuits are notoriously large and represent a major threat to the commercial success of new medications for years after they are introduced. There are new tools available to manage and reduce those risks. … Actual damages provide the basis for lawsuits but punitive damages are often a large part of the final settlement. Early indicators of potential damages offer opportunities to demonstrate concern for patient safety and thereby reduce or avoid punitive damages. … “We didn’t know about the risk,” is no longer a defense, if it ever was one.

EHRs Meet Pharma’s Need for Post-Approval Research

May 23, 2011
Historically, the identification of members of sub-groups and acquisition of additional information has been prohibitively expensive. Rapidly evolving, fully networked, cloud based EMR systems such as Practice Fusion are now being used to collect this data as part of the physician’s normal practice. Data collection, the most costly part of the research process, is now essentially free.

Using data captured by an EHR vendor avoids any real or implied relationship between the doctor who captures it and the pharmaceutical company that uses it. This lends credibility to the outcome by eliminating any appearance of undue influence by the pharmaceutical company on the conduct or outcome of the research.

Personal Health Records Make Care Safer and Cheaper,

April 21, 2011
OTC manufacturers and distributors should find de-identified information about their products and any side-effects or unexpected benefits valuable. … Even a symptom with low frequency can be significant if the harm done to a few individuals is substantial, as it was in that case.

Electronic Health Records and Securities Fraud

April 12, 2011
Can a failure to disclose knowledge about a medication’s side-effects lead to a successful suit for securities fraud? In March 2011 the Supreme Court ruled that it can. … The availability of information from electronic health records with large, near-real-time databases like Practice Fusion’s expands the “total mix of information… available.”

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The Promise of EHRs for Pharmaceutical Companies

Today pharmaceutical companies conduct extensive research to obtain Food & Drug Administration (FDA) approval of a new medication. Typically this pre-approval research is structured in three phases: Phase I, a small (20-100) group of healthy volunteers to assess safety; Phase II, larger groups (20-300) to assess how well the drug works; and, Phase III, randomized controlled trials on large patient groups (300–3,000 or more ) to assess effectiveness vis-à-vis with the current ‘gold standard’ treatment.

Phase IV trials involve the safety surveillance of a drug after it receives permission to be sold. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than is possible during the Phase I-III clinical trials.

There are opportunities to use data from Electronic Health Records (EHR) for Phases II and III, but the larger opportunity, and the one addressed here, is Phase IV, post approval surveillance.

Theoretically it should be possible to use the growing body of data in EHRs to track patients for whom a new medicine is prescribed. However, EHR adoption is still very limited; almost all reports show adoption rates less than 10%. More important, there are more than 200 vendors providing EHRs, all of which are built using limited standards for the information to be acquired, the coding for diagnosis and treatment, and for the exchange of information.

Historically, it has proven very difficult to exchange information among multiple systems within a single organization. The generally accepted solution is an enterprise resources program (ERP) which is complex, costly, and difficult to implement.

The collection and exchange of medical information is simpler in some ways and more difficult in others. The efforts of the Federal Government to develop and implement EHR standards will help but there is a great deal to do and the final definition and implementation of standards will take time—probably several years. Even with standards, there will be minor differences among systems developed independently by a large number of vendors that will limit the industry’s ability to exchange information and will raise questions about the quality of the data.

When a significant body of common data becomes available, pharmaceutical companies should be able to use that data to track a sample of patients using a new medication in “near real time,” perhaps within a week after a doctor sees a patient. This could provide four major benefits.

• First, regulatory agencies may give earlier approval subject to effective ongoing sampling and reporting of any adverse reactions—earlier to market.
• Second, any adverse reactions could be found early and evaluated to minimize damage to patients—minimize patient harm.
• Third, early warning could lead to examination of additional data from existing medical records of patients receiving the medication relatively quickly and at relatively low cost. This will further define the risk and whether or not there are patient, disease, or treatment conditions that create or reduce risk. It may be possible to eliminate a risk just by restricting use based on definable conditions—protection for both the patient and market value of the medication.
• Fourth, timely responses to an identified risk will make it difficult for plaintiff’s attorneys to successively demand punitive damages. Compensatory damages will be smaller and punitive damages will be smaller or non-existent—reduced legal costs.

There is enough information about current and near term EHR systems for pharmaceutical companies to develop strategies to use more and better data they will offer. The time to begin the development of those strategies is now.

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