Being the recipient of a lawsuit is unsettling and disruptive to any company. Not only can it be expensive to defend against, but the process itself can be complex, confusing and require much more time and attention than might be fully appreciated. In this article, we will provide a broad overview of products liability litigation in the United States and the various procedural requirements you may encounter. We will walk you through the process by which a typical products liability lawsuit against a life science company unfolds. Our description is general, and the underlying issues of a case―including details unique to the product and the company that makes it―will determine how that particular case evolves. However, most life sciences companies that become involved in products liability litigation generally must grapple with the challenges we describe in this installment of the Litigation 360 series.
The lawsuit, which is typically titled a “complaint” or “petition,” is filed by an individual and names your company as a defendant. The lawsuit alleges that your company provided a product that was defective―likely in its design, its assembly or manufacture, and/or in the sufficiency of its instructions for use or hazard warnings. The plaintiff seeks money damages for permanent physical injuries, past and future pain and suffering, medical bills, and lost wages.
Keep in mind that under the American legal system, the plaintiff does not require proof of facts to file a lawsuit. A lawsuit simply contains allegations, or information the plaintiff’s attorney believes to be true, and your company will have a chance to respond to those allegations through the litigation process.
Filing Versus Service
You become aware of the lawsuit when you are served with the complaint. The procedures by which this is accomplished vary by state but, uniformly, “service of process” triggers the start of the lawsuit.
It is important to note that there is a distinction between the filing and service of a lawsuit. The date of filing is the date the lawsuit was filed with the court by the plaintiff or plaintiff’s attorney. It usually appears in a court stamp on the first page of the complaint.
The date of service is the date the lawsuit was served on your company. In every jurisdiction, a defendant is allotted a certain amount of time in which to make an initial response to a complaint. The date of service is critical because it starts the clock “ticking” for your company’s response. Since time matters, it is important to maintain any documents provided to you upon service of the lawsuit, such as a certified mail receipt or letter.
Time is also of the essence when it comes to notifying your products liability insurance carrier of the lawsuit. You want to inform your carrier of the lawsuit immediately in order to preserve insurance coverage but, as a practical matter, when legal defense is part of your coverage, your first step should be to notify your carrier so that they may assign defense counsel to represent you.
Next, as the defendant, you must respond to the plaintiff’s complaint. Your company’s attorney will recommend an appropriate response that will take the form of an answer or a motion or both.
An answer is a point-by-point response to each allegation in the complaint (or it may be a general denial). The answer may also include certain affirmative defenses, or statements that may provide a defense to the lawsuit, assuming the allegations against your company are true.
Some affirmative defenses that might apply in your case include the statute of limitations, a claim that the plaintiff’s injury was caused by the misuse of the product, or a claim that your product was designed, manufactured, and marketed in accordance with the “state of the art.” (For more specific information about these defenses and others, please consult our Products Liability 360 series, which describes legal principles generally applicable to products liability claims against life sciences companies.)
At this stage, and depending on the jurisdiction of your case, the motion that is likely to be filed is called a “motion to dismiss.” A motion is a legal document setting forth the reasons the complaint (all or portions of it) should be dismissed. A motion to dismiss can be made for various reasons, including failure to state a claim upon which relief can be granted, insufficient process, or lack of personal or subject-matter jurisdiction. (Personal jurisdiction refers to a court's jurisdiction over the parties to a lawsuit, as opposed to subject-matter jurisdiction, which is jurisdiction over the law and facts involved in the suit.)
If the lawsuit was filed in state court, and if your company is not incorporated or does not have a principal place of business in that state, then your defense counsel will likely consider “removal,” which is a procedure where the lawsuit is removed from the state court where it was filed to the federal court.
As a general matter, corporate defendants prefer to litigate cases in the federal system because of the heavier reliance on motion practice, stricter rules on expert discovery, and more predictable timelines. The timing related to removing a case to the federal court is critical because you have only 30 days from the date the lawsuit was served on your company to remove the case. If there are other defendants in your case, they will need to consent to the removal as well.
Once an answer has been filed on behalf of your company and any related issues have been resolved, the process of written discovery begins. Written discovery should be a fact-finding mission, but its scope is quite broad and it encompasses both hard copy (paper) documents and electronic materials.
A court will generally allow broad discretion to the plaintiff’s attorney in seeking a corporate defendant’s information and documents. However, just because information or documents have been disclosed in discovery does not mean that they can be used at trial. As a general matter, courts will allow the discovery of information that may “lead to the discovery of admissible evidence.” In practice, this means many communications that were intended to be private may be disclosed to the plaintiff. At trial, however, a court will apply the rules of evidence (such as how to treat hearsay, what constitutes relevance, etc.) to all testimony and documents to determine whether they can be used during the trial. This will likely result in the exclusion of some information and/or documents disclosed during discovery.
Written discovery can include interrogatories (written questions that typically must be answered under oath), requests for production of documents (a list of documents you will need to collect), and requests for admission (statements that you must admit or deny). A company generally has 30 days to respond to discovery requests, and the defense attorney handling your case will help you develop your responses.
Your company’s attorney may prepare objections to the questions or requests for documents. For example, if the plaintiff’s attorney sends a request for production stating, “Produce all documents concerning the design, manufacture, and distribution” of the product alleged to have caused harm, the attorney may object to that request as being overly broad, unduly burdensome, and vague. Given that medical device and pharmaceutical companies are heavily regulated, all documents concerning the design, manufacture, and distribution of a product will be contained in numerous departments and locations, such as quality control, regulatory, research and development, and field assurance. Counsel will assist you in identifying the proper scope of the document request. It may be reasonable to limit your response to certain categories of documents, such as the 510(k) submission(s), quality control testing, and sales documents related to the specific product.
Your company may be asked to verify or certify that the responses to the interrogatories, requests for product, and/or requests for admission are complete and accurate subject to the objections asserted by the company’s attorney, who will work with you to identify the appropriate person to verify or certify the responses. That individual signing may or may not have personal knowledge of the responses, however they should understand the process by which the information and documents were collected to arrive at the response.
Many of your company’s documents likely contain confidential and/or trade secret information. For example, your company’s design and testing documents, unless they are publicly available on the FDA’s website or otherwise, contain sensitive information that may be considered confidential and/or trade secret. Your company’s attorney can ensure that certain documents produced are subject to a protective order that would limit their dissemination to counsel in this matter. Caution should be given to over-designating documents as confidential and/or trade secret, meaning that companies should not automatically designate all documents produced as confidential and/or trade secret in an attempt to limit the reach of discovery, because many courts are taking a narrower view on what can be considered confidential and/or trade secret.
A deposition is a legal proceeding during which questions are asked by attorneys and the person being deposed is required to give testimony under oath. The company’s attorney will be present at all depositions in the case. You should anticipate that employees of your company will be called to give deposition testimony during the lawsuit. For example, if the product that allegedly harmed the plaintiff was returned to your company for evaluation, the individual who performed that evaluation may be called for a deposition to discuss his or her findings. Other depositions may include the plaintiff, the medical provider who prescribed and/or implanted the device, and representatives of other parties. A deposition is an adversarial process and significant time and thought should be given to the preparation and presentation of a witness for deposition.
Experts are critical in the defense of products liability cases. “Retained experts” are outside experts who are hired and paid to provide an expert opinion in your case. You may also have someone internally who is considered the in-house expert. Depending on the allegations in the case, multiple experts in a variety of disciplines may be retained on the company’s behalf. For example, there may be a regulatory expert to opine on the approval or clearance of the product by the FDA, a warnings expert to opine on the sufficiency of the warnings, and an engineering expert to opine on the design and testing of the product.
As a general matter, the plaintiff must disclose his or her experts and provide a summary or report of each expert’s opinions. In some jurisdictions, depositions of those experts will be taken before your company has to offer its defense. This can be beneficial, as the company’s retained experts will have the benefit of exploring plaintiff’s theory of the case through expert discovery before being required to respond.
Motion for Summary Judgment
A motion for summary judgment is a procedural mechanism often utilized by defendants and generally used more frequently in the federal courts. A motion for summary judgment will allow for the dismissal before trial of some or all claims asserted by the plaintiff on issues where there is no genuine dispute of material fact. A material fact is a fact that could lead to judgment in favor of a party. According to the Advisory Committee on the federal rules, “the very mission of the summary judgment procedure is to pierce the pleadings and to assess the proof in order to see whether there is a genuine need for trial.”
A motion for summary judgment is generally filed after the close of discovery (i.e., after all the written discovery and depositions have been completed). This motion will include a statement of facts and a recitation of the law as it is applied to those facts. The motion will refer to the evidence developed in the case, such as deposition testimony and discovery responses. In the case described above, if, after the experts for each side have been deposed, there was no true dispute as to the adequacy of the warnings that accompanied the product, your company may be entitled to summary judgment on that claim. After the motion is filed, plaintiff will file a response, your company may be allowed to file a reply, and the judge will then need to make a decision. This process may take months or years to reach a resolution.
The preparation for trial and the actual trial are time-intensive and costly. It can take years to get a products liability case ready for trial. The decision to take a case to trial should not be made lightly. (The decision whether to take a case to trial or settle will be addressed in a later installment of this series.) For purposes of this article, it is important to know that defense counsel will likely need at least one company representative present for the entire trial. This person will be the “face of the company” and will need to be present during jury selection and the subsequent trial proceedings.
While litigation will likely be a challenging experience for your company, take the opportunity to reflect on ways to improve your company’s response to product issues. Could you easily locate all the documents that were requested during discovery? If not, create a better system for document management. Did the company employees perform poorly at deposition? Make sure that all employees are trained appropriately and are confident in their job duties. Were there concerns about your standard operating procedures? Use the experts’ opinions – on both sides – to evaluate your procedures. Reflecting on these issues, and making appropriate changes, will help minimize litigation risk for the future.
Products liability litigation is a complex and costly endeavor, and it can vary drastically depending upon the jurisdiction, the medical product implicated, and the alleged injury. Companies need expert guidance when navigating these legal challenges and Medmarc, through its experienced claims examiners and in conjunction with its carefully selected defense panel members, endeavors to make the process as smooth as possible for its policyholders.
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Medmarc is a part of ProAssurance Group, a family of specialty liability insurance companies. The product material is for informational purposes only. In the event any of the information presented conflicts with the terms and conditions of any policy of insurance offered from ProAssurance, its subsidiaries, and its affiliates, the terms and conditions of the actual policy will apply.
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