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January 01, 2012

Drug Trial Participants

Daniel R. Karon

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To:          File

From:     Daniel R. Karon

Re:          Drug Trial Participants


It seems that GyneTech has caused lots of people some serious problems with its botched drug trials. My challenge is to understand whether these problems create litigation opportunities and, if so, what they are and for whom. Both class- and mass-action opportunities seem possible. But with the drug still in the trial stage, is ramping up either or both litigation efforts premature? If the class or mass claims aren’t yet ripe and I jump on them, I could take a bath. On the other hand, can I afford to wait? If I do wait, might others make off with these opportunities, if opportunities indeed even exist? Alas, this is only the first of many risks inherent in large-scale plaintiffs’ litigation.

In particular, I must wrestle with and manage the following procedural, substantive, political, and financial risks before I can even begin to decide whether to proceed and, if so, how to move toward resolution.


1. Pre-suit investigation and politics. Before suing any claims, whether class or mass, I need to conduct a full factual investigation to ensure as best I can that the potential claims have merit. That involves hiring a medical expert, which isn’t cheap. That also means collaboration. Discussions must begin immediately because a case of this magnitude requires some risk sharing.

But the longer I take to conduct this factual investigation and to assemble my team, the more exposed I become to others suing ahead of me and winning “my” lead position (assuming this is even a case I want to lead). After all, plaintiffs’ lawyers jump the gun all the time just so they can file first. And even though a case might not yet be ripe for filing and lawyers’ pre-suit investigations may be incomplete, nothing attracts a crowd like a crowd.

Because I know I will have company—and plenty of it—it is none too early to begin coalition-building efforts for the inevitable leadership meeting and the fight that will result. To this end, the more important meetings are the ones that occur before everyone gets together: If you walk into the big meeting not knowing who the schmuck in the room is, chances are it’s you.

2. What type of case to sue. Deciding what type of case to sue—class or mass—involves deciding how to sue the case (or cases). Although class claims will give me the biggest bang for my buck, personal-injury-related class claims are nearly impossible to certify given their alleged individual factual questions concerning causation (what really killed you?) and damages (did you die or were you just maimed to some degree?). Moreover, the court must approve my fee in a class claim, and a suitable fee requires a suitable judge who appreciates the risk I took and the work I did to obtain the best possible result for the class. Mass claims, on the other hand, avoid all these persnickety procedural issues but require a lot more public relations. That means nationwide hustling to round up the largest number of victims possible, which not only is expensive, but also likely will require me to pay multiple referral fees that will chip away at what I hope will be my eventual payday.

3. But the drug is still in the trial stage. Although the drug certainly seems to have big problems, I need to remember that it’s still in its trial stage. For that reason, there might not be sufficient personal injuries to qualify for mass-action status, and there might not be sufficient economic losses to qualify for class-action status. What’s more, because personal-injury damages likely involve current and future medical claims, pain and suffering, medical monitoring, and premature wrongful death, they are presently speculative.

Jumping into this case and committing massive resources to these issues before knowing the precise (or close to precise) number of claimants and the extent of—or even how to calculate—their damages is incredibly worrisome. After all, my medical expert will cost me the same whether he or she testifies on behalf of 10 or 100 victims. For that reason, before I invest my time and money, I need to understand the potential rewards better.

4. Special class-based merits considerations. If I go the class route, I’d better pay extra-special attention to the substantive legal claims I will decide to sue. Lots of claims involve elements that necessarily require individualized proof, such as common-law fraud, which asks, “Did you personally rely on defendant’s alleged lies?” So to avoid adding to the already difficult class-certification challenges involving causation and damages (not to mention the tough class-certification standard sweeping the nation that may require the court to decide, when experts are involved, which side’s expert is correct), I need to ensure that my substantive legal theories don’t walk me straight into individual factual questions concerning liability. After all, if a class case is going to wither, it likely won’t be because of lack of numerosity, typicality, adequacy, or superiority: The absence of factual predominance is where class cases go to die.

5. Considering the economic calculus. Whether class or mass, this case will probably take at least five years to resolve. That means that even if we eventually get paid, it won’t be until years from now. Can I ride this out? Do I have the time? Do I have the money? Of course, all this may depend on my level of involvement. I don’t necessarily need to run this case; I can assemble a good team, and we can share the risk and cost. Better yet, my team can be merely one of a number of teams that share the risk and cost. But if others are involved, I’ll need to get a deal in writing because, as they say, “fool me once, shame on you; fool me twice, shame on me.”

The time-and-money commitment raises other questions as well. What does the rest of my caseload look like? What does the emerging law look like? Is the Supreme Court poised to gut my claims—again? And if, despite all these obstacles, I like this opportunity, what does my bank think? This is a big commitment. Will I have the line of credit that I probably will need to stick this out? Do I have the mental, physical, and emotional constitution to stick this out? Does my wife?

Those damned defense lawyers don’t have to worry about any of this stuff. After all, they get paid per hour—I get paid perhaps.

6. How to get retained? Once I’ve decided to go for it, I need to consider the class-versus-mass route fully. That raises a host of considerations. If I go the class route, how many clients are necessary to make this case fly effectively? Do I need clients from all 50 states? Granted, that would help avoid arguments concerning individual legal standards among the various states, but my judge would hate me forever. Maybe I could get retained by only a couple of victims and make a run at having GyneTech’s home state’s law apply. But that is sometimes a tough proposition to push through. So instead, perhaps I should try a middle ground: getting retained by victims in, say, six or seven populous states with good product-liability laws. That might work well.

As for a mass case, that would really require ramping up: TV and radio spots, Internet placements, press releases, earned-media results, town halls at community centers or nursing homes, activating my nationwide network of plaintiffs’ lawyers to see whether they have any clients and hoping they will want to collaborate—the list goes on. A mass case will require a lot more logistics, but because it avoids class-certification hurdles, it may well be worth it.

7. Where to sue? If ever there were a multidistrict litigation (MDL) calling, this is the case. But once in MDL, where is the best place for the cases to go? I need to identify that place and sue my case or cases there—or do I? What does “the best place” even mean? The best judge? You never know that before you sue; you only know that afterward. Maybe “the best place” means the place with the best class-certification law? The best substantive law? What if, despite all these technical concerns, “the best place” is already chock-full of other lawyers—and bad ones at that (at least in my estimation)? Should I then try somwhere different, even if only for leverage?

If I go the mass route, some of these concerns will disappear, but that doesn’t mean the politics will. So whatever course I choose, I will need to coordinate with my colleagues (whoever they are) to make sure we don’t botch the venue—although with the MDL panel, you never can really know what’s going to happen anyway.

8. How do class and mass counsel coexist? Regardless of which type of claim or claims I pursue, the other claim or claims will be out there as well. For that reason, I need to consider a work-sharing arrangement with the other group or groups. This will involve coordinating deposition dates and dividing the time for conducting them, sharing documents, and other logistical issues. And we will want to discuss not only how to share this work but also how to share its cost. Maybe one group feels good about the risk and will want to run discovery. For reducing the risk, maybe the other group will then agree to pay to the first group a percentage of any judgments or settlements the second group obtains. Or maybe the groups will simply split the cost according to a set formula on the front end to avoid any additional risk to anyone. Then, within the class and mass groups respectively, we will need a system (likely documented in a pretrial order) that vests lead counsel with the authority to request litigation assessments not only for depositions and documents but for experts, too.

9. Uninvited company. The Department of Justice or state attorneys general always could decide to show up and seek restitution, which would crush any economic-loss class case. Although economic-loss class claims present fewer (yet still considerable) class-certification challenges than personal-
injury class claims, economic-loss class claims remain fraught with risk. It would be no different if I were to sue a car case and, three years and $500,000 in expenses later, the National Highway Traffic Safety Administration orders a recall. I must definitely factor that into the equation.

10. Collectability. Before getting too far down the road, I also need to think about a crucial practical question: With all that’s swirling about, is a judgment against GyneTech even collectable? If it is, will there be a limited fund that will be divided among all victims? If GyneTech is broke, what claims will trigger insurance coverage? What are the available limits? Will defense counsel be dipping into this policy for their costs and fees as well? If so, I can see this becoming an even longer and tougher slog.

Collectability isn’t a concept or theme they teach in law school. But in the real world, the best case is worthless if there is no prize for your victims at the end of the process. So how do I answer these questions before committing time and money to an investigation? Do I hire investigators? Do I cull public sources? Do I search for former employees? I’d best pull out all the stops—carefully—because unless a judgment is collectable, this entire effort is a non-starter.

Procedural issues. Political issues. Financial issues. Still more issues that simply are impossible to assess, much less anticipate, this far ahead of suit. The case-evaluation process is all about predicting and managing issues and their concomitant risks before knowing anywhere near all the facts necessary to make a sound and reasoned decision about them. But in this business, doing nothing is not an option: If I don’t consider the efficacy of suit, the next guy will, and then where will that leave me, my reputation, my career?

So therein lies the challenge: balancing the zeal for helping victims with the ability to do so, financially and otherwise. The right choice—and, just as important, how to make it—often comes down to judgment and experience, but luck certainly doesn’t hurt either. In plaintiffs’ cases of this sort, the profession (perhaps regrettably) morphs quickly into a business, a good part of which involves financial, psychological, and emotional constitution—issues that defense attorneys need never consider.

But with this increased risk, on multiple levels, can come increased rewards, whether personal (helping my clients), societal (righting a wrong in need of redress), or financial (making a meaningful living by doing so). All these issues, considerations, pressures, anxieties, torments, and tensions go into the necessary—and the necessarily less-than-fully-informed—calculus required before deciding to sue any case, which, once taken, must be pursued with unquestioned zeal and unwavering commitment.

Such is my mission and goal as a plaintiffs’ attorney, whether on a class-action or mass-action basis. Like all my clients, the victims of GyneTech are the people I’ve sworn to serve. Perhaps my experience, good judgment, and a little luck will guide this worthy mission to a favorable conclusion.


Daniel R. Karon

The author is with Goldman Scarlato & Karon PC, Cleveland.