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.
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: 919.546.8788.