Expert Witness, Product Liability and Patent Infringement

When undergoing procedures for the implantation of medical devices, patients have an expectation that the device is both effective and safe. Depending on geographic location and jurisdiction, that expectation may be enshrined in laws that protect patients from devices that may be neither effective nor safe. The determination of whether the manufacturer and / or supplier of a product is liable for ‘injuries’ sustained through defective products is usually carried out by the appropriate courts. If there is a single event, in a single patient, the process is usually simple, and the outcome, while being supervised by a court will be settled without a court hearing. With more complex cases, especially those involving multiple patients who appear to have been injured by one type of device, the cases may be consolidated, in a type of class action, usually referred to as Multidistrict Litigation (MDL) in the USA. Cases that are set for trial involve lengthy periods of ‘discovery’ in which all relevant facts should be ascertained, and then at trials, when both sides, that is plaintiffs and defendants, offer evidence from “fact witnesses” and “expert witnesses”. In theory, anyone could be offered as an expert witness, but in reality, courts have become very wary of allowing poorly qualified individuals to give evidence, and the so-called Daubert Rules are usually followed, where “A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:
(a) The expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;
(b) The testimony is based on sufficient facts or data;
(c) The testimony is the product of reliable principles and methods; and
(d) The expert has reliably applied the principles and methods to the facts of the case.
Either side may lodge an objection to a witness on the basis of these rules; although I have been frequently challenged in this way, they have never been successful.

During ‘discovery’ an expert will usually be deposed, that is, be exposed to an interrogation, under oath, by opposing counsel in order to get a clearer idea of your views. These are often very aggressive sessions, where the actual purpose is not to hear your views but to pressure you into making mistakes, being inconsistent and giving them some sound-bite to use at trial. Depositions are often more stressful than court appearances, but, in my experience, cases are usually settled after most depositions have been concluded, so a trial is unnecessary. In the USA, most trials, at the request of plaintiffs, are heard in front of a jury; they give an opinion and recommend the level of damages if the company is held liable, but expert witnesses get no feedback at all. Occasionally, especially in Federal Court, and in all cases where I have given testimony outside the USA, trials are in front of a judge without a jury. Here it is usual for the judge to provide a very detailed assessment, along with their verdict. I provide here such an assessment of a heart valve class action case in Toronto, Canada, in 2012 (Andersen v. St. Jude Medical, Inc., 2012 ONSC 3660, file 00-CV-195906CV, Toronto, 26 June 2012). My evidence was given over two full days; the extent of the detailed scientific and clinical interrogation can be seen from the Judge’s opinions and commentary.