Manufacturing Uncertainty: Plaintiffs’ Strategies to Avoid Their Burden of Proof

Emily Erixson and Leslie Packer, Ellis & Winters LLP


“Profits over safety.” As a defence lawyer, you have probably heard that statement, or something similar, hurled against your clients. Plaintiffs’ counsel try to paint a picture for jurors in which the big, bad drug or device companies, with whom the public entrusts their health, do not really care about their health at all. Those companies care only about the bottom line. And if making a profit requires risking your health and safety, you can bet those companies will take that risk.

In recent years, plaintiffs’ counsel have capitalised on the fear that creeps in when a person believes his or her health or safety is threatened. By now most defence counsel have been exposed to the Reptile theory that is routinely used by plaintiffs’ counsel. Derived from David Ball’s and Don Keenan’s book Reptile: The 2009 Manual of the Plaintiff’s Revolution, the Reptile theory encourages plaintiffs’ counsel to make “rules” that trigger the reptilian instinct to protect oneself. This strategy aims to invoke jurors’ “survival mode” and compel them to protect themselves and their community.

Another tool in plaintiffs’ arsenal is the book Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health, by David Michaels. Like the Reptile theory, this book announces to readers (and potential jurors) that they need to beware, and protect themselves and the public, because their good health, the very thing keeping them alive, is under attack. The plaintiffs’ product liability bar has read the book and its members are employing Michaels’ theories as part of their case strategy; we have seen defence experts deposed and cross-examined with direct reference to Michaels’ book.

According to Michaels, the “product defence industry” employs a strategy of “manufacturing uncertainty” to “prevent or postpone the regulation of hazardous products [or the progression of litigation] by questioning the science that reveals the hazards in the first place.” In Michaels’ view, it is a foregone conclusion that products are causing the public harm, and the “product defence industry” not only refuses to admit that harm, but takes affirmative steps to obfuscate the overwhelming research supporting a causal link between product and harm.

The theory of “manufacturing uncertainty” requires Michaels to make several unsupported assumptions. First, he assumes that the products at issue are dangerous or defective at the outset. Michaels warns the reader of the “polluters and manufacturers of dangerous products”, without setting the groundwork to show that pollution or danger actually exists. This first assumption sets the tone for the remainder of the book, in which Michaels regularly avoids the fact that plaintiffs have the burden of proof on the critical element of causation. 

Second, Michaels assumes that plaintiffs are the only ones employing “respected scientists” to support their position. He argues that scientists who support drug or device companies are “for hire”, and to the extent there are two sides to the causation story, the company’s side “has been bought and paid for”. He further states that defendants’ attempts to challenge or exclude plaintiffs’ “respected scientists” will ultimately cause those scientists to stop advocating as experts and yield a loss for public health. Michaels misses the boat entirely. As every trial lawyer can attest, there is always a price when an expert testifies, no matter on whose behalf. And as every trial lawyer also knows, there will never be a shortage of people claiming to be experts who are willing to testify for either side if the price is right. 

Third, Michaels assumes that every attempt to defend “dangerous products”, or the companies that make them, is driven by a bad motive intended to cover up a known danger or defect. He contends that the industry’s “for-hire” scientists tout “sound science,” but are really promoting what “sounds like science but isn’t”. Michaels then assures readers that “every outrage presented in [the] book is absolutely true”. Readers, therefore, are conditioned at the start to distrust the scientific analysis by anyone associated with an industry; are promised outrage at the conduct of “polluters and manufacturers of dangerous products”; and are promised absolute truth from plaintiffs. In setting this stage, Michaels flips the script. He attempts to do exactly what he claims to stand against – he works to manufacture uncertainty about the methods and reliability of science and scientists associated with the drug and device industry in order to enhance his favoured position.

Michaels injects these assumptions into a discussion about the standards for admissibility of expert testimony in Daubert v Merrell Dow Pharmaceuticals, Inc, 509 US 579 (1993) and its progeny. He takes issue with the rigorous nature of the Daubert standard and advocates for its undoing. His primary dispute with Daubert is that the standard does not fit with scientific study and discourse as applied by scientists in the real world. He claims that “scientists base their judgments on the weight of the evidence because in many instances they have no other choice.” Thus, the “checklists of criteria [considered as part of the Daubert analysis], while appealing in their convenience, are inadequate tools for assessing many scientific issues, certainly including causation.” However, although the “weight of the evidence approach” may be applicable in certain contexts, such as regulatory review and action, Michaels fails to recognise that that approach does not account for the plaintiff’s burden of proof in civil litigation. 

For example, if the weight of the scientific evidence is suggestive, but not conclusive, that a certain exposure level to a drug or chemical may cause an adverse result, then it might make sense, from a regulatory standpoint, for scientists to recommend against a high level of exposure. However, the regulatory process is different from the process for admitting evidence and proving causation in civil tort litigation. In litigation, the burden of proof is on the plaintiff to show that in his or her case, the exposure more likely than not caused the adverse result. See Burst v Shell Oil, No. 14-109, 2015 WL 3755953, at *8 (ED La. 15 June 2015):

The agencies’ threshold of proof is reasonably lower than that appropriate in tort law, which ‘traditionally make[s] more particularized inquiries into cause and effect’ and requires a plaintiff to prove ‘that it is more likely than not that another individual has caused him or her harm’. (Citation omitted, aff’d, 650 F. App’x 170 (5th Cir. 2016)). 

Not only does Michaels advocate for a less rigorous “weight of the evidence” standard in place of Daubert, he doubles down when addressing cases of a newly suggested causal links. As an example, Michaels discusses toxicity of drugs or chemicals. In his view, toxicity data simply may not be available for certain drugs or chemicals because they have never been studied before. In such cases, Michaels contends that there can never be evidence of causation, so, apparently, the jury should be permitted to weigh everything without any gatekeeping by the court. Otherwise, this “scientific ignorance” guarantees “legal bliss” for corporations as courts continue to apply Daubert to exclude expert testimony on causation. 

Michaels’ logic is faulty. If there is no established evidence of causation, and there cannot be any because the science does not yet exist, there can be no legal basis to send the matter to the jury. The more difficult and onerous course of action, and the one arguably required by the rules of evidence, is to wait for the science to evolve in one direction or the other to avoid faulty assumptions based on untested scientific inquiries. Although waiting until the science develops, such that a causal link can be shown through expert analysis, may limit the recourse of some plaintiffs, that approach is consistent with the plaintiff’s burden of proof in civil litigation.

Overall, Michaels advocates for an approach to expert admissibility that would rescind the court’s gatekeeping role, and send experts to testify before the jury. He believes that a group of jurors is better suited than the court to evaluate an expert’s opinion. According to Michaels, “jurors can employ a deliberative process, pool their collective wisdom, discover, and account for their respective biases and limitations”, but a single judge cannot. 

Plaintiffs are using the themes in Doubt is Their Product to lay the blame for their inability to prove causation directly at the feet of the drug and device industries. They have done this in two primary ways. First, plaintiffs use the notion of “manufacturing uncertainty” to undercut, or bypass entirely, the rigours of Daubert. Second, where Daubert challenges prove unsuccessful, plaintiffs attempt to read inflammatory passages from Doubt is Their Product during the examination of experts to cast aspersions on defendant companies and trigger the powerful senses of fear and distrust in the minds of the jurors.

In Daubert challenges, plaintiffs argue that experts hired by drug and device companies are not experts in their fields, but rather are experts at being expert witnesses for the sole purpose of litigation. See, eg, Plaintiffs’ Daubert Motion to Exclude Test of Defence Experts at 1, Gore v 3M Co, case mo. 5:16-CV-716D (EDNC 10 July 2017) (seeking to exclude experts as “unqualified in that all of their relevant experience has been gained for the purpose of litigation”). Drawing from the criticisms levied throughout Doubt is their Product against industry scientists, plaintiffs argue that industry experts create scientific literature for litigation that would not otherwise be given credence in regular scientific discourse. Targets of these motions are often associated with companies such as Chemrisk or Exponent, both of which receive vehement condemnation throughout Doubt is Their Product as leaders in “manufacturing uncertainty”. Michaels describes the work of those companies as follows:

The range of their work is impressive. They have on their payrolls, or can bring in on a moment’s notice, toxicologists, epidemiologists, biostaticians, risk assessors, and any other professionally trained, media-savvy experts deemed necessary. They and the larger, wealthier industries for which they work go through the motions we expect of the scientific enterprise, salting the literature with their questionable reports and studies. Nevertheless, it is all a charade. The work has one overriding motivation: advocacy for the sponsor’s position in civil court, the court of public opinion, and the regulatory arena. Often tailored to address issues that arise in litigation, they are more like legal pleadings than scientific papers. In the regulatory arena, the studies are useful not because they are good work that the regulatory agencies have to take seriously but because they clog the machinery and slow down the process. 

Plaintiffs incorporate similar excerpts from Doubt is Their Product to support their arguments that industry experts are, in fact, unqualified or so biased in favour of the industry that they are unable to provide a reliable expert opinion. See, eg, Plaintiffs’ Memorandum in Opposition at 18, Sarrat v Univar USA, Inc, No. 2:14-cv-01017-MLV-JCW, 2015 WL 4075518 (ED La. 19 May 2015) (quoting from Doubt is Their Product to discredit defendant’s expert witness).

Beyond Daubert challenges, plaintiffs also aim to discredit experts on cross-examination based on the attacks to credibility and associations with industry groups used in Doubt is Their Product. In at least one case, the court allowed plaintiff’s counsel to read inflammatory passages from Doubt is Their Product during cross-examination and directly to the jury in closing. See, eg, Opening Brief for Appellants at 57-59, In re: Depuy Orthopaedics, Inc. Pinnacle Hip Implant Product Liability Litigation, 2017 WL 497131 (5th Cir. 30 January 2017). The book was treated as evidence by the trial court despite the fact that Michaels was not a witness in the case and the defence had no opportunity to cross-examine him. 

Like the Reptile theory, defence counsel must prepare for Doubt is Their Product to become a regular part of the plaintiff toolkit. In some cases, such as where a defence expert has ties to Michaels’ favourite targets – Chemrisk or Exponent – or the expert relies on research materials derived from scientists associated with those companies, counsel should expect questions about Doubt is Their Product in expert depositions. Prepare those witnesses to discuss the origins and methods of their research and their references to an even more exacting detail than might have been previously necessary. And prepare motions in limine on as many bases as possible to exclude reference to the book or Michaels’s opinions therein. If there are no signs that questions about Doubt is Their Product may be on the horizon, and none come during discovery, do not assume you are out of the woods. Object early and often at trial – hearsay, 403, 404(b), etc. Some objections are falling on deaf ears at the trial court level, but cases such as Depuy are on appeal and the outcome is not yet determined, so vigilance in preserving objections every time remains crucial.

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