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From Products Liability Law Daily, September 10, 2014

Boston Scientific must pay $73.5 million in transvaginal mesh case

By Susan Lasser, J.D.

A Dallas County jury rendered a $73.5 million verdict against the medical device manufacturer, Boston Scientific Corp., after determining that the company was negligent in the design and marketing of one of its transvaginal slings, the Obtryx Transobturator Mid-Urethral Sling. The device had been implanted in a patient who alleged injuries as a result of her use of the product. The largest portion of the award was $50 million, which was for exemplary damages against the device manufacturer (Salazar v. Boston Scientific Corp., September 8, 2014, Molberg, K.).

Background. Martha Salazar had been implanted with Boston Scientific’s Obtryx Transobturator Mid-Urethral Sling after it had been recommended by her doctor as an appropriate and safe treatment for her stress urinary incontinence. The patient’s action, brought by both the patient and her husband, Felix, against the manufacturer alleged that as a result of the implantation of the device, Ms. Salazar “suffered and will continue to suffer serious bodily injuries,” which she alleged included pain, discomfort, pressure, difficulty voiding urine, continued incontinence, discharge, scarring, infection, odor, and bleeding.

Jury findings. The jury first found that Boston Scientific was negligent in designing the Obtryx at the time it left the company, and that it was that negligence that was the proximate cause of injury to the patient. A “design defect” was defined for the jury as a condition of the product that rendered it unreasonably dangerous as designed, “taking into consideration the utility of the product and the risk involved in its use.” In addition, it was required that for a design defect to exist, there had to have been a safer alternative design in January 2011. The jury decided that there was.

Next the jury determined that Boston Scientific was negligent in marketing the Obtryx at the time it left the manufacturer and that this negligence, too, was a proximate cause of the patient’s injuries. The jury instructions defined a “marketing defect” in the product as the failure to give adequate warnings of the product’s dangers that were known or should have been known, or the failure to give adequate instructions to avoid such dangers, and that the failure rendered the product unreasonably dangerous as marketed.

The jury also determined, “by clear and convincing evidence,” that the harm to the patient resulted from gross negligence.

Damages calculated. The breakdown of the jury award for compensatory damages resulting from the defective design or marketing of the device—amounting to nearly $22 million—was as follows:

  • Past physical pain and mental anguish: $1.5 million

  • Future physical pain and mental anguish: $10 million

  • Past physical impairment: $750,000

  • Future physical impairment: $5 million

  • Future reasonable expenses of necessary medical care: $3 million

  • Future loss of earning capacity: $1.7 million

The jury additionally assessed $50 million against Boston Scientific, awarding the sum as exemplary damages for the manufacturer’s gross negligent conduct. The exemplary damages award was apportioned between the patient and her husband as 95 percent for the patient, and 5 percent for her husband.

Finally, the jury found that fair and reasonable compensation for the patient’s husband for the patient’s injuries amounted to approximately $1.5 million:

  • Past loss of household services: $15,000

  • Future loss of household services: $500,000

  • Past loss of consortium: $250,000

  • Future loss of consortium: $750,000

The case number is DC-12-14349-D.

Attorneys: Michael G. Elliott (Shook, Hardy & Bacon) for Boston Scientific Corp. Tim K. Goss (Freese & Goss, PLLC) for Martha and Felix Salazar.

Companies: Boston Scientific Corporation.

MainStory: TopStory MedicalDevicesNews DesignManufacturingNews WarningsNews DamagesNews TexasNews

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