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Barba v. Carlson

Superior Court of Delaware, New Castle

April 8, 2014

DEBORAH A. BARBA and THOMAS D. BARBA, her husband, Plaintiff,

Submitted: March 12, 2014

On Defendant Boston Scientific's Motion for Summary Judgment Against Plaintiffs Deborah and Thomas Barba DENIED Except that the Breach of Express Warranty Claim is DISMISSED

On Boston Scientific's Motion for Partial Summary Judgment on Plaintiffs' Punitive Damages Claim DENIED

Colleen D. Shields, Esquire (argued), Eckert Seamans Cherin & Mellott, LLC, Attorney for Defendant Boston Scientific

Jonathan D. Orent, Esquire (argued Summary Judgment), Motley Rice LLC, Philip T. Edwards, Esquire (argued Partial Summary Judgment), Lauren A. Cirrinicione, Esquire, Murphy & Landon, Attorneys for Plaintiff




This products liability action alleges that Boston Scientific Corporation ("Boston Scientific") designed and manufactured defective implantable pelvic mesh devices. Plaintiffs Deborah and Thomas Barba contend that the Pinnacle Pelvic Floor Repair Kit and the Advantage Fit Mid-Urethral Sling System ("Devices") caused physical injury to Deborah Barba. Plaintiffs assert causes of action against Boston Scientific for: breach of implied warranty of merchantability, breach of implied warranty of fitness for particular purpose, breach of express warranty, fraud, fraud by concealment, violations of the Delaware consumer protection laws, loss of consortium, and punitive damages.

Defendant John Carlson, D.O. implanted the Boston Scientific Devices during surgery he performed on Deborah Barba. The Devices were used to treat Ms. Barba's pelvic organ prolapse and stress urinary incontinence. Following surgery, Deborah Barba alleges that she suffered pelvic and abdominal pain, urinary dysfunction, urinary infections, urinary retention, dyspareunia, sexual dysfunction, fecal incontinence, urinary incontinence, recurrent prolapse, and erosion. To address these problems, she was required to undergo corrective surgery.

The Devices only are available by prescription issued by a licensed physician. Each Device is accompanied by Directions for Use ("DFU"). The DFUs state certain precautions that must be taken by the surgeon. The DFUs also list possible "Adverse Events."

For purposes of this motion, it is undisputed that Dr. Carlson does not recall reading the DFU for either Device. However, Dr. Carlson testified at deposition that he attended many different training and educational opportunities on implanting pelvic mesh devices.

In addition to the claims against Boston Scientific, Plaintiffs have sued Dr. Carlson for medical negligence and lack of informed consent, and Defendant Maternity Associates, P.A. for negligence.

Boston Scientific has moved for summary judgment. Boston Scientific has made the following arguments:

• All of Plaintiffs' claims premised on failure to warn are barred by the learned intermediary doctrine.
• There is no evidence that either of the Devices departed from their respective manufacturing specification.
• Plaintiffs' negligent product design claim fails to identify a safer alternative design.
• Plaintiffs' claims for breaches of implied warranty of merchantability, implied warranty of fitness for a particular purpose, and express warranty, all fail for lack of notice and evidence.
• Plaintiffs' fraud, fraudulent concealment, and consumer protection statute claims all fail for lack of evidence.
• Thomas Barba's loss of consortium claim must be dismissed because it is derivative of Deborah Barba's claims.
• Massachusetts law should govern the issue of punitive damages because Massachusetts is the location of the alleged misconduct that forms the basis for Plaintiffs' punitive damages claim.
• Massachusetts law prohibits punitive damages in the absence of wrongful death or special statutory provisions, neither of which are implicated in this case.

Oral argument on these motions was held on March 12, 2014. Trial is set to begin in a few weeks. Following are the Court's findings, intended to enable the parties to timely prepare for alternative dispute resolution and trial.


Summary Judgment Standard

Summary judgment is granted only if the moving party establishes that there are no genuine issues of material fact in dispute and judgment may be granted as a matter of law.[1] All facts are viewed in a light most favorable to the non-moving party.[2] Summary judgment may not be granted if the record indicates that a material fact is in dispute, or if there is a need to clarify the application of law to the specific circumstances.[3] When the facts permit a reasonable person to draw only one inference, the question becomes one for decision as a matter of law.[4] If the non-moving party bears the burden of proof at trial, yet "fails to make a showing sufficient to establish the existence of an element essential to that party's case, " then summary judgment may be granted against that party.[5]

Learned Intermediary Doctrine

As a general rule, the manufacturer owes a duty to warn the consumer directly concerning the risks associated with any product. However, where a product is available only by means of a prescription issued by a licensed physician, the physician is deemed a "learned intermediary" between the manufacturer or seller, and the patient. The duty shifts to the physician to become informed about the qualities and characteristics of the prescribed products.

The learned intermediary physician must exercise independent judgment, taking into account the specific needs of the patient. It is presumed that the patient can reasonably rely on the physician's judgment. If the product is properly labeled and is accompanied by instructions and warnings sufficient to fully apprise the physician of the proper procedures for use and the dangers involved, the manufacturer is relieved of any duty to directly warn or advise the consumer patient.[6]

Boston Scientific argues that it warned Dr. Carlson of the precise injuries Plaintiffs now claim. Further, even if Plaintiffs could demonstrate any inadequacy in the warnings, Dr. Carlson's course of treatment would not have been different because he neither read nor relied upon the warnings and instructions contained in the DFUs. Thus, Boston Scientific contends, any alleged failure to warn cannot have proximately caused Plaintiff's injuries.

The Court finds that the proper analysis must begin with whether there is a genuine issue of material fact about whether the warnings were adequate. A manufacturer or seller, who has failed in its duty to warn, cannot insulate itself from all liability simply by the serendipitous circumstance that a learned intermediary is interposed between itself and the ultimate consumer. If the warnings and information are inadequate as a matter of law, the learned intermediary doctrine cannot apply. However, an injured party cannot ...

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