A “bellwether” is someone or something that leads others or shows what will happen in the future or is an indicator of trends. In the legal world a bellwether case is very important because it leads the way in how a large number of lawsuits may be litigated or settled.

Too Many Cases, Not Enough Resources

If there are many plaintiffs suing the same defendant for the same reason with similar facts there are different ways all these cases could be handled. They could,

• Go their own separate ways with their own trials,
• Become a class action in which the interests of all the plaintiffs are represented by one plaintiff, or a group or them, or
• Establish a multi-district litigation (MDL) which has advantages of the options above. Cases from all over the country are transferred to a designated court and grouped together. Instead of just one trial in a class action there could be multiple, independent trials with the first ones called bellwether cases.

MDL bellwether cases allow attorneys for the plaintiffs and defendants to work together on preliminary litigation issues and prepare for representative cases that have similarities to many other (untried) cases. Bellwether cases also lessen the chance of inconsistent rulings and verdicts across the country.

The vast majority of civil cases settle before a trial takes place. What should a case settle for? Bellwether trials help the parties understand what value the cases have that are part of the MDL.

• If juries reject the plaintiffs’ claims and find no negligence, they’re not worth much.
• If the plaintiffs are successful and receive verdicts with large money awards, they’re worth a lot.

With the bellwether cases under their belts attorneys and their clients remaining in MDL get a better idea of the challenges they face and have more realistic expectations for settling cases. In an MDL, case after case could go to trial until they all receive verdicts (which could take years or even decades) or they could settle.

Cook IVC MDL

Currently there is an MDL for about 650 plaintiffs from all over the country injured by Cook IVC filters in the federal court for the Southern District of Indiana. In July 2016, U.S. District Judge Richard Young issued an order selecting three bellwether cases for trial. He also identified the specific type of Cook IVC filter that caused the plaintiffs’ injuries,

• Brand v. Cook Medical, Inc. et al., Case No. 1:14-cv-6018 (Celect)
• Gage v. Cook Medical, Inc. et al., 1:14-cv-1875 (Günther Tulip)
• Hill v. Cook Medical, Inc., et al, 1:14-cv-6016 (Celect)

The first bellwether trial will involve Elizabeth Jane Hill, a woman from Florida who was implanted with a Cook Celect IVC filter. The bellwether trials are supposed to start in the spring of 2017.

With hundreds of cases involved and potentially hundreds of millions of dollars at stake, nothing is simple or easy, including selecting the first Cook IVC filter bellwether cases. Attorneys from both sides did what they normally do: argue with each other. Given the obligation to zealously defend their clients’ interests, it’s an occupational hazard.

Both sides want every advantage they can get and that includes which cases will be the bellwether cases because they literally set the example or set the tone for the cases that follow. Each side gave the judge seven cases they thought should be the bellwether cases because they represent the types of claims and legal arguments involved in the MDL.

The plaintiffs’ attorneys didn’t like the cases proposed by the defendants and the defendants didn’t like the cases proposed by the plaintiffs. There were disagreements about:

• The types of filters involved in the cases,
• The fact that in some cases filters broke apart, and
• How many cases should involve claims over filter removal.

In the end Judge Young did what judges do. He used his best judgment to come up with list of the first three bellwether cases which, if all goes well, will show that plaintiffs suffered serious injuries through no fault of their own and that they deserve substantial compensation for what they had to endure because of the defective Cook IVC filters.

As always, I will keep you posted.

In every lawsuit the court issues key rulings which will impact the outcome of the case. By “court” I mean the presiding judge. Some court decisions end the lawsuit (e.g., a judge granting a defendant’s summary judgment motion). Some decisions kick a leg of the stool out from under one party (granting a motion to exclude one side’s key expert witness). As I have written about in this blog, a judge has great power and influence over every court case. One decision has the power to make or break the lawsuit.

Recently, in the Cook IVC filter multidistrict litigation, a federal judge has refused to bar discovery involving an allegation that Cook failed to report to the FDA bad results with the Cook IVC filters.

What Is Discovery?

After a lawsuit is filed, the defendants have the chance to “answer” the complaint (“yes, we admit that happened” or “no, we deny the truth of that statement”). After these “pleadings” are filed, the parties engage in formal discovery. In civil litigation, discovery is the exchange of documents and information between the parties. It is required by the Rules of Civil Procedure. It goes like this: one side will write out questions (Interrogatories) or requests for documents (Requests for Production of Documents). Unless there is a compelling reason to withhold the information, the other side must then prepare written answers and make all requested documents available to the requesting party. From there, the parties can build their cases for trial.

more Cook Medical’s Request for Protective Order

In the Cook IVC filter litigation, the plaintiffs requested discovery relating to the information Cook Medical delivered to the Food and Drug Administration about the outcomes of patients implanted with the Cook IVC filters. The plaintiffs’ group believes that Cook underreported IVC filter device problems to the FDA, and now plaintiffs want all information surrounding what Cook did or did not report to the FDA.

In response, Cook Medical filed a motion for “protective order.” This was a motion to bar discovery of the reports Cook made to the FDA. The argument did not appear strong, but Cook essentially said that it did not have any duty to produce this information to the plaintiffs based on a few recent court decisions.

Magistrate Judge Tim Baker disagreed. He ruled that this information requested by plaintiffs is potentially relevant to the claims in the case and that Cook has an obligation under the Rules of Civil Procedure to produce this information. Judge Baker denied Cook’s motion for protective order. In a few weeks, Cook will have to produce this FDA reporting information to the team of lawyers representing the plaintiffs in the MDL.

Why Is This Discovery Decision Important?

The court’s decision is important because it allows the plaintiffs to “discover” information Cook sent to the FDA. If the Cook reports to the FDA turn out to be false, or misleading, or incomplete, it could support plaintiffs claim that Cook misrepresented the risks of the device and that Cook failed to warn adequately of the risks involved in the use of the medical device.

Perhaps more importantly, if it turns out that Cook underreported problems with the Cook IVC filter, the defense of the learned intermediary doctrine could be stripped from the case. I have written about the learned intermediary doctrine in this blog, but essentially it goes like this: a medical device manufacturer cannot be liable for negligence if it provides all necessary information to a “learned intermediary” (such as the implanting surgeon), who then must communicate with the patient about the benefits and risks of using the medical device. The manufacturer basically tells the court: we notified the doctor and the patient about the risks involved, so it’s the doctor’s responsibility to explain those risks to the patient. But if the manufacturer underreported problems to the FDA, the learned intermediary doctrine becomes meaningless. How can a physician give an accurate picture of the risks involved to a patient if Cook Medical is underreporting the risks to the FDA and the medical community?

Cook Medical received approval from the FDA to market the Cook IVC filters under Section 510(k) of the Medical Device Amendment, which I wrote about here. The 510(k) process has allowed many flawed medical devices to hit the market without adequate testing.

If you had a Cook IVC filter implanted and now have medical or health problems, give me a call to discuss further: (919) 830-5602.

What is an IVC Filter?

The inferior vena cava (or IVC) is a large vein carrying blood from the lower and middle body into the heart where the blood is pumped into the lungs in order to have oxygen added to it. An IVC filter is a device that’s surgically implanted into the IVC just below the kidneys in cases where there is fear a blood clot from the legs (deep vein thrombosis) may travel from the body into the heart or lungs (pulmonary embolism). If that happens the results can be a serious, if not fatal, injury for the patient.

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An IVC filter is a cone shaped device (looks like a small badminton shuttlecock) made of wire which is supposed to act like a net, trapping or breaking up a clot while allowing blood to flow through it. The use of a temporary IVC filter is supposed to be short term. If left in too long the filter is likely to break apart. Wires from the filter can tear the IVC or migrate into the heart, lungs or other parts of the body. The entire filter may also be pushed into the heart.

Risk Factors

The results can be catastrophic and have caused the deaths of some patients. Some have pieces of filter stuck in areas where surgical removal is too risky and patients live with a potential medical time bomb in their bodies. Others have had pieces of the filters successfully removed.

There are hundreds of lawsuits pending against one manufacturer, the Cook Group, Inc. The lawsuits started in 2012 and have been transferred from around the country and consolidated in federal court in Indianapolis (the company is based in Indiana). These product liability cases claim that the filters are unsafe for their intended use and Cook should be held responsible for the harm they case. According to one study 100% of Cook’s filters fail if left in patients’ bodies for 2½ or more months.

About 250,000 IVC filters are implanted each year. Cook is one of three of the largest manufacturers, in addition to C.R. Bard, Inc., and Cordis which is part of Cardinal Health. Cook sells about 15,000 different medical devices and has about $2 billion in annual sales.

Profits Often Trump Good Intentions

Though medical devices like the IVC filter may have been developed with good intentions, once medical device companies start manufacturing and selling them and the revenues start rolling in they may be more concerned about the return on their investment and keeping shareholders happy than keeping patients safe. The Cook IVC filter is one example of a medical device where some patients are seriously injured or killed, not protected from harm or had their health improved which are reasons why the patient had the IVC filter implanted in the first place.

If you would like to learn more about the IVC filter generally and the Cook IVC filter litigation, feel free to contact me so we can discuss how the law may apply in your case and your best options for obtaining compensation.