Trial Magazine

The hallmark of a large scale drug or device litigation is hundreds—usually thousands—of people with similar injuries. So if you are accepting cases involving certain drugs or devices, you’re likely to be contacted by potential clients with similar injuries but sometimes very different facts. This can make gathering case-specific information and evaluating all the moving parts daunting on a larger scale.

That is why you must first develop objective criteria to evaluate each potential client’s claims. These criteria help you and your team make consistent and objective accept-or-decline decisions during the intake phase and file-or-decline decisions during the investigation phase.

Establish Case Criteria

Case criteria can address a wide variety of factors, but the two most critical ones are product identification and injury. You must prove both for each client to have any chance at a recovery.

Product identification. Compile a list of specific drugs or devices that the potential client must have used to fit the criteria. In cases involving a single drug or medical device, product identification should be straightforward. Most drug and device litigations arise out of new scientific literature, FDA labeling changes, or product recalls that reveal a failure to warn, design defect, or manufacturing defect—so start there.

Your potential clients may have used more than one drug or device that could form the basis for a claim, complicating this process further. For example, the existence of multiple brand-name and generic testosterone drugs, each with its own manufacturer, FDA approval, and labeling history, complicated the testosterone litigation. Each of those drugs had to be evaluated to determine whether a viable claim could be made against the corresponding manufacturer.

Similarly, in the Gilead tenofovir disoproxil fumarate or TDF litigation, five brand-name drugs are at issue made by the same manufacturer. These drugs are designed to treat HIV and have been identified as nephrotoxic, meaning they can cause injury to both kidneys and bones. In each case, firms had to decide which drugs presented a viable claim and then gather information about potential clients’ use of each of those drugs.

If generic or over-the-counter (OTC) versions of the drug exist, also consider whether those will fit your criteria. This requires understanding the differences between brand-name, generic, and OTC drugs. The drugs that present the fewest legal and proof issues are brand-name prescription drugs.

The drugs with the most difficult legal issues are prescription generic drugs, due in part to decisions such as PLIVA, Inc. v. Mensing¹ and Mutual Pharmaceutical Co., Inc. v. Bartlett ² when the U.S. Supreme Court held that federal law preempts failure-to-warn and design defect claims against generic manufacturers.

OTC drugs also present obstacles. Specifically, objectively proving product use, frequency of use, and duration of use can be difficult without medical or pharmacy records.

Some people may not know whether they used the brand-name or generic version of a prescription drug, so be prepared to identify the date generics entered the market. If clients used the drug before generics became available, it is almost certain they used the brand-name drug. If they started after generics became available, you’ll need proof that they used the brand-name drug. For clients who still have the pill bottle, ask them to send you photos—you should be able to identify the manufacturer from information on the bottle.

Usage criteria. Next, identify threshold usage criteria to evaluate whether the nature and extent of the potential client’s exposure to the harmful properties of the drug or device were sufficient for causation. The frequency, duration, and proximity of use of the drug or device to the injury will almost always impact the ability to prove causation and thus the viability of the case.

If you are not sure where to start, look to the scientific literature or FDA labeling describing the mechanism of injury. If these authorities suggest that a particular drug can cause strokes but only after exposure for a certain period of time, consider declining cases when length-of-use is not sufficient or when the potential client took the drug only intermittently. If temporal proximity of use to the injury is critical, you may want to decline cases when the potential client has not used the drug in a long time.

This type of limiting criteria is less likely to be necessary in a device case because the injuries tend to be more local and specific to the device. However, some device-related injuries, especially those caused by an implant, may take time to develop, meaning early onset of those injuries may be indicative of some other problem, such as improper implantation.

You often will not have answers to these questions early in litigation, making case evaluation both tricky and risky. If you are too conservative with your criteria, you may decline cases that will later be viable. If you are too liberal with your criteria, you may wind up with cases you will ultimately have to decline or dismiss. So plan to revisit and refine your criteria as the causation science and expert testimony develop.

One way to evaluate your criteria is to compare it to the criteria other firms are using in the litigation. If cases have already been consolidated, start by asking firms in leadership—they are likely to be the most plugged in and want to ensure that only cases supported by causation experts are included. Do not be shy; coordination among firms in mass torts is both common and encouraged.

Injuries. After nailing down the usage criteria, identify the viable injuries. The key question here is general causation: Limit your list to injuries that have been associated with the drug or device, usually in scientific literature, warning label updates, or a product recall.

If the case is based at least in part on a failure-to-warn theory, focus on the significant risks of harm identified in the scientific literature that were not warned about in the drug’s labeling. In the testosterone litigation, for example, the labels on those drugs were updated to reflect the risk of stroke, heart attack, and pulmonary embolism, so those were the injuries that were pursued.

Injury can be a complicated and evolving piece of your criteria, especially in drug cases when the viable injuries can be numerous and common—think cancer and cardiovascular injuries. Ultimately the viability of various injuries turns on the ability of expert witnesses to offer reliable opinion testimony on causation. If the litigation is in the early stages, consider running your criteria by your expert. Also remember, the more common the injury, the more important frequency and duration of exposure become.

The analysis can be less complicated for devices, which are more likely to cause unique injuries localized to the device. In the absence of a metal-on-metal hip implant, for example, patients generally don’t have significant metal debris in their hips. That said, in an implant case, consider whether cases in which the implant has not been revised or removed meet your criteria. If a surgeon has not already revised or removed a device, it will be much more difficult to prove that it is defective or that the potential client has been damaged by it.

Finally, consider whether you need limiting criteria regarding injuries. Does the potential client have any serious comorbidities, preexisting conditions, or likely alternative causes that could overly complicate specific causation? For example, it could be difficult to convince a jury that a drug caused your client’s kidney failure when the records confirm the client also had uncontrolled diabetes.

Another potential limiting criterion is the date of injury. For example, if your theory is based on failure to warn and a black-box warning was added to the label, you likely will want to decline cases involving use well after that warning was added. The manufacturer’s defense will be that it warned of the injury, and the patient assumed the risk.

Intake

Criteria in hand, you are ready for initial client contact and intake. Before making calls, train your intake team on the specifics of the drug, the injuries, and your criteria. Create a brief questionnaire to use during the initial call with each potential client. The questionnaire should be straightforward, concise, and designed to gather information related to the criteria you just defined.

The initial call. Start the call by letting potential clients tell their stories uninterrupted. Then go back and ask questions to fill in any gaps. Go through your criteria methodically, starting with the person’s product use and ending with the diagnosed injury. The goal is to gather enough information to make the accept-or-decline decision by the end of the call.

If the client is certain he or she did not use the applicable product or did not suffer an injury, you can instruct your staff to orally decline the case on the spot as further investigation is not needed if the case does not involve the correct product or injury. Follow up with a letter that confirms your decision, advises the client to quickly seek a second opinion, and includes general information about applicable statutes of limitations and other potential filing deadlines.

Usually it is not so clear. Often, potential clients may not know exactly what drug or device they used, when or how long they used it, or their exact diagnosis. In any of these situations, reserve an accept-or-decline decision until you can review medical or pharmacy records confirming the product used and the injury. Tell the potential client you would like to investigate the case further.

After the call, send an introductory packet that includes

• a welcome letter
• a fee agreement
• a longer written questionnaire
• HIPAA authorization forms.

The longer written questionnaire should be designed to obtain the client’s full personal information and history and more detail related to your criteria. Ask the client to identify all relevant medical providers by name, address, date, and type of care. You are looking for helpful and harmful information—so don’t hesitate to ask about any criminal history, bankruptcy filings, drug use, workers’ compensation claims, and other lawsuits.

For HIPAA authorizations, you can save time by asking the client to sign but leave the date and provider blank so you can fill them out for each provider or pharmacy identified in the questionnaire.

Ask if you can send the packet electronically. Always streamline the process when possible to avoid delay and the need for follow-up. If you are partnering with another firm, make that clear during the initial call to avoid confusion, and let the client know which firm will be the primary point of contact.

Calendar tentative statutes of limitations and repose. Unless you are going to decline a case during the initial intake call, always ask a potential client these critical questions:

• When did you first start using the drug or device?
• When were you injured?
• When did you first determine that your injury was likely caused by the wrongful conduct of the drug or device manufacturer?

As soon as you hang up with the client, use this information to tentatively calendar statute of limitations and statute of repose deadlines. This can be a complicated analysis in drug and device cases because it’s not always clear what state law will apply. Depending on the circumstances, you may need to identify the applicable deadlines in as few as one but as many as five states: the potential client’s home state, the state where the client purchased and ingested the drug or where the device was implanted or used, the state where the injury occurred (if different), the state where the manufacturer is incorporated, and the state where the manufacturer has its principal place of business. Set the filing deadline based on the earliest date generated by that analysis. If possible, set the date without considering the benefit of a potentially applicable discovery rule.

For example, Indiana has a two-year statute of limitations for personal injury claims and a discovery rule.³ Under the discovery rule, the cause of action does not accrue—the two years does not start to run—until the plaintiff knew or should have known that the injury was caused by the defendant’s wrongful conduct. Even if the client just learned that the injury was caused by the product, set the deadline within two years of the injury diagnosis. Note that this may not be possible in latent injury or long-term exposure cases where that date may have passed already.

That is not the end of the analysis. Some states also have a statute of repose, which sets a final filing deadline that may truncate or even negate an application of the discovery rule.⁴ For example, consider a client whose claim is subject to a two-year statute of limitations with a discovery rule and an unconditional 10-year statute of repose. The client used a drug for nine years and was diagnosed with a qualifying injury one week before your initial call. While the statute of limitations may not run until two years after the date of the diagnosis, the statute of repose sets the final filing deadline without consideration for discovery tolling. In that situation, consider setting the filing deadline for less than 10 years from the client’s first use of the drug.

One resource that makes this complicated analysis smoother is a detailed 50-state survey on statutes of repose, statutes of limitations, and discovery rules (which can vary in application). It is best to create this by doing your own research. If you obtain one from another firm, double-check its work, and do not forget to update it frequently, as laws can and do change.

If you identify an expired statute of limitations or repose, notify the client immediately, and decline the case. If you identify a looming filing deadline, also notify the client immediately, and expedite the post-intake investigation phase.

Post-Intake Investigation

Once your client has returned the fee agreement, HIPAA authorizations, and longer questionnaire, you can enter the investigation phase. This is the final “go” or “no-go” phase before filing.

Order records. Start your investigation by obtaining the specific records confirming the product, usage history, and the injury before you order (and pay for) all of the client’s other medical records from the relevant time frame. To save time and costs, consider asking clients to obtain their own records. Some will be able to accomplish this while others will not. When you are not staring down a filing deadline, it’s often easier to just use the information in the questionnaire and the HIPAA authorizations to request the client’s medical records.

If you anticipate needing records that are more than five years old, do not delay—many providers destroy records after five to seven years, and without records you have to rely solely on your client’s memory and testimony, which is not ideal.

For prescription drug cases specifically, product identification can be confirmed with pharmacy records and, secondarily, prescriber or insurance records. For most devices, particularly those implanted or used during or following a surgery, focus on getting the operative report and hospital discharge summary for the surgical procedure. Typically, the operating room team removes the product sticker from the box containing the device and places it directly on the client’s medical records or chart. You can and should specifically request the record containing the product sticker or lot information.

Also obtain records that confirm the injury diagnosis and crucial dates, including the diagnosis date; the date the client learned of the injury; and the date, if applicable, that the client’s doctor identified the drug or device at issue as the potential cause of injury.

Record review. As soon as you receive medical and pharmacy records, immediately review them to confirm that the case meets your criteria. Also immediately confirm the dates the client provided and that you used to calculate the filing deadline are correct. Client memories often can be off, and that filing deadline you thought was next year could be just a few weeks away. If the records sit on your desk for a few weeks, you could end up on the wrong end of a legal malpractice case. If the dates are different, update the statute of repose and statute of limitations deadlines you calendared after the intake call.

If the records confirm that the case does not meet your criteria, for whatever reason, have an attorney call the client to describe the investigation you conducted, the results, and your decision to decline the case as opposed to just sending a form letter. Remember, most of these potential clients will have suffered serious injuries, and they are putting their trust in you to help them. Treat their claim with respect, even if you decline their case.

By taking these steps and completing a careful analysis at the prefiling stage, you’ll increase the chances that the cases you accept and file will stand up to pressure from the defendant.

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Edward (Ned) Mulligan V is a partner at Cohen & Malad in Indianapolis and can be reached at nmulligan@cohenandmalad.com.

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Notes

1. 564 U.S. 604 (2011).
2. 570 U.S. 472 (2013).
3. Degussa Corp. v. Mullens, 744 N.E.2d 407, 410 (Ind. 2001).
4. See, e.g., Ind. Code §34-20-3-1(b)(2); Kan. Stat. §60-513(b).