Science and Law
2nd August 2016

3 Use Cases that Highlight the Need For Scientific Publication Monitoring

In December 1990, Connie Chung reported on the alleged dangers of silicone breast implants on her show Face to Face.

3 Use Cases that Highlight the Need For Scientific Publication Monitoring

In a previous post, we outlined the positive impact of comprehensive science monitoring Science in The Courtroom: How to best prepare for a Science-Based Controversy.

In this post, we develop that theme and cover some remarkable use cases demonstrating how critical it is to maintain a robust mechanism to protect organizations from the ever-present threat of a science-based controversy. So, lets get into it.

Example #1: Silicone Breast Implants and Systemic Autoimmune Disease

$11 billion dollars in awards, settlements, and legal fees

In December 1990, Connie Chung reported on the alleged dangers of silicone breast implants on her show Face to Face.

In the decade that followed, over 94,000 adverse event reports were received by FDA from women with silicone breast implants.

As early as 1992, a Texas jury awarded 25 million dollars to a woman who claimed she developed a systemic autoimmune disease as a result of her ruptured silicone breast implant.

Several big verdicts and settlements followed. A few years later, Dow Corning went into bankruptcy and in September 2001, a 3.7 billion dollar multidistrict litigations (MDL) settlement was announced.

When the dust settled, it has been estimated that $11 billion dollars in awards, settlements, and legal fees have been paid.

Scientific Awareness Fail – What could have been…

In 1999, The Institute of Medicine (IOM) came out with a report evaluating the evidence carefully and systematically.

The IOM concluded that the evidence does not support health concern from silicone breast implants. $11 billion dollars in awards, settlements, and legal fees – with no basis for health concerns.

To be sure, it took a while for the requisite scientific studies to be performed and the problem was therefore not merely a gap in scientific awareness.

Nevertheless, there was a great deal of critical scientific information summarized in the IOM report that was essential to their ultimate findings. This included many studies conducted well before the awards, settlements, and verdicts were declared.

It seems reasonable to conclude that a more robust awareness of the science related to silicone breast implants and autoimmune disease would have been beneficial to many of the defendants.

 

Example #2: Contact Lens Solution and `Fusarium Keratitis

Warburg Pincus Acquires Bausch & Lomb for $4.5 Billion

In 2006 a private equity firm, Warburg Pincus, was considering the purchase of Bausch and Lomb that faced hundreds of lawsuits alleging that its contact lens solution was causing a rare fungal disease of the eye known as fusarium keratitis.

The private equity firm recognized that if the science was on its side, the litigation could be properly and effectively managed.

Scientific Awareness Success – Acquisition Protection and Enablement

Warburg Pincus ultimately concluded that there was insufficient scientific evidence to conclude that the injuries were caused by anything fundamental about the product itself.

It turned out that a systematic, objective, robust analysis of the scientific evidence supported that perspective. The private equity firm made the acquisition and 6 or 7 years later, Valeant acquired the Company for 9 billion dollars.

 

Example #3: Serotonin Reuptake Inhibitors (SSRI) and Birth Defects

Paxil and Zoloft, 1 Billion Dollar+ Settlement or MDL collapse

In the mid-2000s, plaintiff lawyers filed complaints alleging that a SSRI, Paxil, caused birth defects when taken by pregnant mothers. A few years later, a large series of cases settled for more than a billion dollars. So, it is interesting to speculate whether or not the available evidence supported the view that Paxil caused birth defects.

Scientific Awareness Success – Data protects the organization

Zoloft is another SSRI in the same antidepressant drug class. Because of the similarity in the mechanism of action, the author of one article asked the question: “Will Zoloft lawsuits equal them?” In April 2016, we learned the answer:  The Zoloft MDL fell apart. And appropriately so.

According to this report, plaintiffs couldn’t find a single causation expert to provide a causation opinion based on reliable scientific evidence that Zoloft caused birth defects when taken by pregnant mothers.

The experts that could be identified by plaintiffs were excluded for all sorts of reasons, including cherry-picking data and double-counting studies in their meta-analyses.

Why do we get it so wrong so frequently?

The Zoloft defense lawyers got it right, but the Paxil defense lawyers didn’t. The original Bausch and Lomb team didn’t recognize the true nature of the science and sold the company prematurely.

The early breast implant verdicts caught the industry flat-footed and unaware. How and why does industry get it wrong so frequently?

Repeating the Mistakes of the Past

First, we don’t necessarily learn from our mistakes. A very recent study on silicone breast implants concluded: “The role of silicone in relation to idiopathic or atypical connective tissue diseases is not clear.

Based on the rigorous IOM report (published more than a decade earlier), this is simply not true. The role of silicone in relationship to idiopathic or atypical connective tissue disease is clear – it is nonexistent.

Unscrupulous Scientists and “Crusaders”

Second, we are sometimes confronted with unscrupulous scientists who view themselves as crusaders.

Here is an official retraction by the Lancet of a 1998 study claiming to find a link between MMR vaccine and autism. It is noteworthy that even the original study was nothing more than a series of cases. A report like this should have been incapable of establishing causal links in the first place.

So, even if there was no unethical activity, we were destined to be misled based on the lack of rigorous scientific methodology.

Cherry Picking

Most often, though, we see the lack of a systematic, objective approach – cherry-picking data to support a particular point of view.

Case studies, adverse drug reaction reports, cross sectional populations, perceived clusters. We have seen these types of errors in most, if not all, of the major mass tort litigations over the last few decades.

It is critical that we start with a well-established systematic review methodology before we start the review process. We must have a protocol-driven approach that defines how the review is going to be conducted in order to do the review properly.

What types of studies will be included in the review? Which will be excluded? How will the review be conducted? And then we must follow this methodology faithfully and rigorously.

There is a term of art for this process: It is called a Systematic Review. And if we want to avoid being misled, it is critical to follow these principles.

The Next Wave of Science-Based Controversy is Imminent

There are many other science-based controversies on the horizon. There are many questions yet to be answered, and science isn’t getting any simpler. These include,

  • Do electronic cigarettes have toxic effects?
  • Does talc cause ovarian cancer or mesothelioma?
  • Does vaginal mesh cause an increased medical complication rate over other devices?
  • Do pesticides cause autism or other birth defects?

As we have written about, with the advent and wide-spread availability of cost-effective and sophisticated genetic techniques, maintaining an awareness of the science is more challenging than ever.

There is no telling how relevant genomic, proteomic, transcriptomic, or epigenetic techniques will be to a case or controversy. These techniques are incredibly powerful. But they are complex, so maintaining your awareness is increasingly challenging.

The key is to take advantage of emerging tools that leverage Big Data and RSS feeds to monitor the science related to legal cases or controversies BEFORE they emerge.

Related Information

Blog Posts:

Did you like this post? We are here to help! Schedule a consult with one of our experts.

Just fill out the form bellow and we will contact you with more information.

  • Hidden
  • This field is for validation purposes and should be left unchanged.

Recent Related Articles

Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]
15 July 2020
Dr. David Schwartz’s IADC Presentation: The Use of Genetic Testing in the Courtroom [Download Slides]

On Wednesday July 8, 2020, Dr. David Schwartz of Innovative Science Solutions presented at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. A complimentary copy of the panel presentation is now available for download. Read more

The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting
02 July 2020
The Use of Genetic Testing in the Courtroom: Dr. David Schwartz will be Presenting at the IADC 2020 Virtual Annual Meeting

Dr. David Schwartz of Innovative Science Solutions will be presenting at the IADC 2020 Virtual Annual Meeting on a panel titled The Use of Genetic Testing in the Courtroom. Read more

WEBINAR ANNOUNCEMENT: What’s in Those Genes?
12 June 2020
WEBINAR ANNOUNCEMENT: What’s in Those Genes?

Genetic Evidence Concerning Causation for Mesothelioma 16 June 2020 at 2pm Eastern Daylight Time. Read more

Talc and Asbestos Defendants Should Monitor and Utilize Published Studies Linking Mesothelioma to Genomic Causes
28 April 2020
Talc and Asbestos Defendants Should Monitor and Utilize Published Studies Linking Mesothelioma to Genomic Causes

Plaintiff experts having been asserting for decades that all mesotheliomas must be linked to some asbestos exposure. Indeed, this has led to the erroneous (but widespread) view that mesothelioma is a signature disease, only caused by asbestos exposure. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us