Vetting Pharmaceutical Experts for Product Liability Cases: A Comprehensive Guide

Selecting the right expert witness in pharmaceutical product liability cases is a critical decision that can determine the outcome of a trial. Pharmaceutical litigation often involves complex medical and scientific issues, making it essential to have an expert who not only possesses deep industry knowledge but also has the ability to communicate technical concepts clearly and persuasively in court.

However, inadequate vetting of an expert can lead to disastrous consequences, as seen in the case of Johnson v. Merck & Co., Inc., where a poorly vetted expert witness significantly weakened the plaintiff’s case.

This article provides a comprehensive guide on vetting pharmaceutical experts for product liability cases, focusing on how to address challenges like bias and conflicts of interest, ensuring proper expert preparation, and overcoming vetting difficulties. By learning from past mistakes, such as those highlighted in the Johnson v.

Merck & Co., Inc. case, attorneys can avoid critical errors in expert selection and strengthen their case.

Selecting the right pharmaceutical expert is essential in product liability cases. Learn how to vet experts by verifying expertise, checking for bias, and ensuring the expert is fully prepared for court. Avoid common pitfalls by reviewing the Johnson v. Merck & Co. case, where insufficient expert vetting led to a critical defeat.

Case Study: Johnson v. Merck & Co., Inc. (2011)

In Johnson v. Merck & Co., Inc., the plaintiff filed a product liability claim against Merck, alleging that their osteoporosis drug, Fosamax, caused her to develop osteonecrosis of the jaw (ONJ), a serious medical condition. As with most pharmaceutical product liability cases, expert testimony was central to establishing causation between the drug and the condition. However, the expert selected by the plaintiff’s legal team failed to meet the necessary standards, leading to a significant weakening of the case.

Pharmaceutical Product Liability Expert Witness Issues:

Lack of Specific Expertise: While the plaintiff’s expert was a licensed physician, they specialized in internal medicine rather than in osteoporosis or oral maxillofacial surgery, the fields most relevant to the issues in the case. This lack of specialized knowledge made it difficult for the expert to provide authoritative testimony on the link between Fosamax and ONJ.

Limited Research Experience: The expert had not conducted or published original research on bisphosphonates (the class of drugs to which Fosamax belongs) or ONJ. This gap in research experience weakened the expert’s credibility, especially under cross-examination, where opposing counsel highlighted the expert’s lack of direct involvement in studies related to the drug.

Outdated Knowledge: During the trial, it became evident that the expert was not up-to-date with the latest scientific studies and FDA guidance on Fosamax and ONJ. This lack of current knowledge further undermined the expert’s ability to provide relevant, reliable testimony.

Overreach in Conclusions: The expert made claims about the causal link between Fosamax and ONJ that went beyond what the scientific literature supported. These overreaching conclusions were exposed during cross-examination, damaging the expert’s credibility.

Potential Bias: It was revealed that the expert had a history of testifying almost exclusively for plaintiffs in pharmaceutical cases, raising concerns about bias. This information was used by Merck’s legal team to question the expert’s objectivity and impartiality.

Outcome:

The U.S. District Court for the Southern District of New York found significant issues with the credibility and relevance of the plaintiff’s expert testimony. Under Daubert standards, the court excluded key portions of the expert’s testimony, severely weakening the plaintiff’s case. Without solid expert testimony to establish causation, the plaintiff was unable to meet the burden of proof, and the case was ultimately decided in favor of Merck.

Key Lessons for Vetting Pharmaceutical Experts

The Johnson v. Merck & Co., Inc.,  case underscores the importance of thorough vetting when selecting a product liability expert witness. To avoid similar pitfalls, law firms should take the following steps to ensure their expert is qualified, unbiased, and fully prepared for court.

1. Verify Relevant Expertise

One of the most critical aspects of vetting an expert is ensuring they have specific expertise in the relevant area of the case. In Johnson v. Merck & Co., Inc., the expert’s general background in internal medicine was insufficient to provide credible testimony on osteoporosis or oral maxillofacial conditions related to ONJ.

What to Do:

Focus on Specialty: Ensure the expert has a specific background in the pharmaceutical area at issue. For example, if the case involves side effects related to bisphosphonates, look for an expert with a deep understanding of drug formulation, pharmaceutical devices, or drug evaluation related to those compounds.

Check for Direct Research Experience: An expert who has conducted or published peer-reviewed research on the drug in question or the relevant medical condition will carry far more weight in court.

2. Check Research Credentials

In pharmaceutical cases, an expert’s credibility often hinges on their familiarity with the latest research and regulatory standards. In Johnson v. Merck & Co., Inc., the expert’s outdated knowledge and lack of involvement in recent studies were key factors in the court’s decision to exclude their testimony.

What to Do:

Evaluate Research Involvement: Look for experts who have been involved in clinical trials and pharmaceutical R&D or have published papers on the specific drug or medical condition at the heart of the case.

Review Their Familiarity with Regulatory Affairs: In pharmaceutical litigation, experts must understand FDA regulations, pharmaceutical regulatory standards, and relevant ANDA or NDA processes. Ensure your expert stays updated on the latest regulatory guidance.

3. Assess Current Knowledge

Pharmaceutical research and regulations are constantly evolving, so it’s essential that your expert is current on the most recent studies, clinical trials, and regulatory changes. In the Johnson v. Merck & Co., Inc., case, the expert’s outdated knowledge hurt the plaintiff’s case.

What to Do:

Ensure Continuing Education: Ask the expert about their most recent engagements in the field, such as attending medical conferences, publishing research, or consulting for the industry.

Check for Familiarity with Current Guidelines: The expert should be well-versed in the latest FDA guidelines and pharmaceutical developments related to the drug in question.

4. Evaluate Past Testimony and Potential Bias

As seen in Johnson v. Merck & Co., Inc., an expert’s history of testifying exclusively for one side (e.g., plaintiffs) can raise red flags about potential bias. This is especially critical in pharmaceutical cases, where credibility is often a deciding factor.

What to Do:

Review Past Testimonies: Examine the expert’s litigation history to ensure they have testified for both plaintiffs and defendants. Avoid experts who have consistently testified on one side, as this can suggest bias.

Investigate Conflicts of Interest: Ensure the expert does not have any undisclosed financial or personal ties to pharmaceutical companies or other parties involved in the case.

5. Scrutinize Methodology and Prepare for Cross-Examination

In Johnson v. Merck & Co., Inc., the expert’s overreach in making causal claims unsupported by current scientific literature was exposed during cross-examination, leading to a significant weakening of the plaintiff’s case.

What to Do:

Ensure Methodological Soundness: Ensure the expert uses scientifically accepted methods for forming their opinions and that their analysis aligns with Daubert standards.

Anticipate and Address Weaknesses: Conduct mock cross-examinations to prepare the expert for challenging questions and potential weaknesses in their testimony.

Conclusion: Strengthening Your Case with a Vetted Pharmaceutical Product Liability Expert

The Johnson v. Merck & Co., Inc. case illustrates the critical importance of thoroughly vetting pharmaceutical experts. By ensuring that your expert has the necessary expertise, up-to-date knowledge, and a strong record of credible testimony, you can significantly strengthen your case.

Engaging comprehensive expert litigation support firms, like ExpertConnect Litigation Support, can streamline the process of selecting the right expert, ensuring that they are prepared to withstand cross-examination and deliver reliable, persuasive testimony in court with the ideal pharmaceutical product liability expert.

Source: Johnson v. Merck & Co., Inc., 2011 WL 4915226 (S.D.N.Y. Oct. 14, 2011).