Trial Magazine

In any case involving a drug or device, the defendant manufacturer undoubtedly will attack causation. It is imperative to be prepared for this defense and consider all aspects of causation very early on. General causation is often the first hurdle, but don’t overlook fully establishing specific causation as you start building your case.¹ Specific causation must be on your mind throughout the litigation and strategically dealt with during intake, discovery, and depositions to support a strong presentation at trial.

Compile & Review All Medical History

First, get your client’s complete medical history, including conditions and medical care that are seemingly unrelated. This involves talking with your clients about their full medical picture. Start by explaining that both sides will explore their overall health, so you need to have a clear understanding of it.

I often start by asking clients about any medical conditions they have, such as diabetes, high blood pressure, or high cholesterol, and then I try to walk them through a history of all of their medical care for the last 10 years. Make sure you also discuss any surgeries the client had at any time. Many clients are poor historians, so take your time with this process, and try to help them by looking up doctors’ names on the internet as you go along.

Next, gather all of the client’s medical records, including those that may seem unrelated. Again, the client’s entire medical history will be looked at, so collect records for about 10 years before the incident. I prefer not to file a case unless I have all the medical records and, if time permits, have organized them by date so they are easy to locate when preparing reports.

I also prepare a medical chronology that outlines the client’s medical history with the page numbers of the relevant medical records so I can have it handy as a reference to discuss with experts when they are writing their reports and preparing for depositions and trial. If time does not allow for collecting all records due to a filing deadline, do so as soon as the case is filed.

You and another lawyer or a knowledgeable staff person must personally review the records so you are aware of any issues that may arise. It’s crucial to uncover anything in the records that the defense could use to support an alternate theory of causation. Note any medical diagnoses the client received and any lifestyle choices and activities in the records that may somehow relate to the current injury. These records may sometimes be too far back to collect, but talk to the client so you understand what happened. And stay on top of obtaining the medical records the defense collects and reviewing them too.

Pharmaceutical corporations and medical device manufacturers construct entire defenses blaming plaintiffs for their injuries, and defense attorneys will spend countless hours combing the records for any facts to support the fictitious defenses they have constructed. For instance, if your client has a traumatic brain injury (TBI) and had a concussion many years prior, the defense will point to that concussion as a cause of the brain injury, not the defendant’s product.

Engage With Your Experts

Find experts who are knowledgeable about the device or drug at issue. For example, in a transvaginal mesh case, you need a urogynecologist who has used mesh, removed it, or both. However, that does not mean the expert, presumably a physician, must have used the product. Some of the best physician experts are those who have read the literature and have advocated against the use of a product from the outset.

For instance, in the transvaginal mesh litigation, several of the experts who have testified at trial on behalf of plaintiffs advocated against the use of transvaginal mesh and never used it in their practices. The reasons included concerns about the lack of long-term testing, the published complication rates, and the complications they saw in their own practices from patients who had the mesh implanted elsewhere. You might also consider contacting the treating physicians to see whether they are willing to be involved as experts and can support the case.

Consider hiring an additional causation expert to rule out alternative causes for the client’s injury. For instance, if your client has pain from an implanted medical device, you obviously need an expert who is familiar with that device. But you also might consider hiring a neurologist to rule out alternative causes for the pain that the defense may latch onto and a physician who is intimately familiar with your client’s other diagnoses.

For instance, if your client had Lyme disease in the past, the defense likely will argue that any pain she has for the rest of her life is somehow related to the Lyme disease. Hiring a rheumatologist to debunk this defense, in addition to another expert who deals with the device at issue, could be key.

Thorough prep is essential. Your experts need to know the plaintiff’s complete medical history. Experts have to fully explain how the drug or device in question caused the injury, and they can’t do so without knowing everything that has happened to the client medically. Start working with experts early in the litigation so you can review the records and develop a discovery plan together. Expert reports should address any and all medical conditions relevant to the client’s injuries, as well as health conditions, lifestyle choices, and other notations in the records that are seemingly unrelated but that the defense will point to as alternative causes of the injury.

It is your job to discuss with the expert what the injury is beyond the obvious physical condition or medical diagnosis. For instance, if a client has pain, a physician can easily point that out and refer to the notations in the records about the pain. However, a physician who sees hundreds of clients per month and regularly performs or orders certain types of examinations may forget how uncomfortable many medical exams are. Think of the discomfort associated with a colonoscopy, an MRI, or a gynecologic exam.

If the plaintiff had to undergo these exams only because of the injury caused by the device or drug, then these exams are part of the damages, and the expert must be prepared to describe in detail what the exams are and why they could be uncomfortable. Sit down with your client, and go through everything they have endured—which often takes quite a while for a plaintiff to realize and put into words.

Delve into the medical literature. Another part of establishing causation is learning the relevant medical literature that both supports and contradicts your case. This is important for general causation, but also try to find articles that will help your specific plaintiff. Work with the experts to form your case around the literature that supports your theory. Make sure the experts address the literature that does not support the case and have a credible explanation for why the literature does not support your client’s causation argument. Perhaps the authors are biased because they are paid by the manufacturer of the product, perhaps the literature was ghostwritten, or perhaps the study was short term or did not have enough subjects.

Focus on discovery and depositions. Remember that the experts are there to help you: Communicate with them regularly about all upcoming depositions and what information they would like to know or will need for their expert reports. Have your experts speak to each other so everyone is on the same page and the reports are consistent. Make sure your experts have read all of the plaintiff’s reports. Treat every deposition as though it is a trial deposition, and take great care as to what questions you need to ask so your experts have good deposition transcripts to cite to in support of their opinions.

Go through the medical records page by page with your experts before any treating doctor’s deposition so you know what information in the records helps your case and what likely avenues the defense will take to attack causation. That way, during the deposition you can be fully prepared to ask causation questions to debunk the anticipated defenses.

For instance, for the client mentioned earlier with the TBI, establish that she did not have any pain or problems after the concussion 20 years ago. The defense’s approach for undermining specific causation will be obvious after a few depositions.

Presenting the Medical Evidence

Trials are often won by the party who has the most simple, clear-cut explanation for the injury. You want your expert to be the most knowledgeable person in the room—next to you, of course—about the plaintiff’s full medical picture and have the simplest story explaining how the drug or device caused the injury.

Defense attorneys will look at every other thing in the client’s medical history that could have caused the injury, ignoring the principle that the most obvious cause is likely the cause of the injury. On direct it is your job to go through those other causes and rule them out or explain how they are minor contributors to the injury and not the cause. Don’t let the defense paint a picture of your case that suggests your expert was hiding something or ignoring pertinent facts.

Specific causation is a vital component in pharmaceutical and medical device injury claims. Anticipate the likely defense challenges, and be prepared to deflect them with thorough preparation and by involving your experts early.

Kila B. Baldwin is a partner at Kline & Specter in Philadelphia and can be reached at kila.baldwin@klinespecter.com.

Note

1. For more on preparing general causation experts, see Gary DiMuzio, Fortifying Against Daubert, Trial, May 2020, at 18; Tara Tabatabaie, Decoding General Causation Data, Trial, April 2019, at 28; R. Jason Richards, Reflecting on Hill’s Original Causation Factors, Trial, Nov. 2016, at 44.