[Drug and Device Law] A Victory Well Won


Today’s case, blogger fanatics, is a good illustration of grinding out a victory.  It’s the story of a defendant calmly and effectively pressing its legal and factual arguments, winning a partial victory before trial, continuing to press its position on the law and facts at trial until it won a directed verdict, and then successfully having it all upheld on appeal.  See Lewis v. Johnson & Johnson, 2015 U.S. App. LEXIS 3150 (4th Cir. Mar. 2, 2015). 

The first part of the victory came via summary judgment.  The plaintiff claimed that defendant failed to warn of risks connected with tension-free vaginal tape (TVT) used in a surgery intended to address plaintiff’s incontinence.  Id. at *1-2.  Given how these cases often go, plaintiff likely pointed to multiple marketing materials and labeling documents as evidence of the defendant’s alleged failure to warn.  But, come the end of discovery, defendant had whittled those documents down to only two: a patient brochure and the instructions for use that came with the device.  Id. at *5-6.  The defendant then eliminated those two documents at the doctor’s deposition.  The doctor testified that she had never read the patient brochure.  There went the patient brochure.  Id. at *5.  And, while the doctor read TVT’s instructions for use, it was years earlier.  She admitted that she did not rely on those instructions when she decided to use the TVT in plaintiff’s surgery.  She relied on her education, experience and evaluation of the patient’s presentation.  Id. at *6.  There went the instructions for use.  Plaintiff was left with no evidence of proximate causation: “When a physician relies on her own experience and examination of a patient in deciding to prescribe a device, and not on the device's warning, the warning is not the cause of the patient's injury.”  Id.

Plaintiff was still able to take a design defect claim to trial.  In pretrial motions, however, the defendant was able to exclude one of plaintiff’s causation experts, Dr. Klinge, a hernia surgeon.  Id. at 7-8.  Dr. Klinge had never performed incontinence surgeries and was not a pathologist.  Yet he purported to be able to opine that pathology slides taken from plaintiff established that the TVT caused plaintiff’s post-surgery pain and discomfort.  Id. at *8-9.  Defendant was able to undermine all of this at Dr. Klinge’s deposition, exposing his questionable qualifications.  Defendant moved to exclude his causation opinion, and the court granted the motion:

Dr. Klinge was a specialist in hernia surgery, not pathology or stress urinary incontinence.  He did not receive training or board-certification in pathology.  Dr. Klinge had never treated Lewis, performed surgery to treat SUI, or collected and studied mesh explants from SUI patients.  The district court was clearly within its discretion in concluding that Dr. Klinge's opinions regarding Lewis's pain and mesh explant were beyond his area of expertise, and so did not abuse its discretion in excluding those portions of Dr. Klinge's testimony.

Id. at *9 (upholding district court’s decision to exclude Dr. Klinge’s causation testimony). 

Plaintiff still called Dr. Klinge as a witness at trial.  And, as you’d expect, plaintiff’s attorneys still tried to elicit causation testimony.  But the defendant stuck to its guns, continually objecting to any testimony on causation.  The court sustained those objections.

Without that testimony, and without causation testimony from any other experts, plaintiff’s case was hobbled.  After plaintiff rested, the defendant moved for a directed verdict and got it.  Plaintiff appealed, and defendant won that too.

This isn’t a situation in which the defendant hit on a Hail-Mary Pass and ended the litigation.  It happened, instead, the way these cases are more often won—by slowly advancing the ball down the field until it crosses the goal line.  The defendant focused on the weaknesses in plaintiff’s warnings and causation evidence, stuck to it from discovery through trial and appeal, and then it won.  That’s how it’s done.    

 


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Posted By John J. Sullivan to Drug and Device Law at 3/09/2015 03:12:00 PM

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