• March 13, 2019
• CMZ Law
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In November 2015, a Dallas appellate court reversed a $1.2 million jury verdict against Johnson & Johnson for allegedly designing a defective pelvic mesh product. The plaintiff subsequently filed a petition for review with the Texas Supreme Court. The overarching issue the Court will consider is what evidence is necessary to satisfy the “causation standard” in a product liability lawsuit related to an implanted medical device.

What are the facts in the pelvic mesh case in Texas?

It has been reported that the plaintiff has a “complex” medical history. She had claimed that the defendant, along with its subsidiary, Dallas-based Ethicon, manufactured a polypropylene mesh which caused her to be injured. The trial jury agreed and found that the medical product was defectively designed and awarded the plaintiff $1.2 million.

Johnson & Johnson appealed the judgment, arguing, among other things, that the trial court erroneously excluded all FDA evidence as well as evidence from independent physician organizations that contradicted the plaintiff’s theories of injury. The Fifth Circuit Court of Appeals agreed and ruled that the plaintiff must show that a specific defect in the product caused her injuries.

What is the history of pelvic mesh medical devices?

Pelvic mesh products were initially viewed as a significant technological improvement over traditional surgical methods. Those methods involved the use of stitches and a patient’s own body tissue and had the potential for postsurgical complications. Mesh devices had already been widely used in other types of surgery for decades, particularly for repairing hernias.

Based on the successful history of other mesh devices, The Food and Drug Administration “fast-tracked” approval of pelvic mesh devices — without conducting tests the agency normally requires for new devices. In 2002, the FDA cleared these soft, lightweight porous plastic devices for pelvic organ prolapse. The agency subsequently said in a 2008 public notice that problems were rare. In 2011 the agency reversed itself and said that most common problems occurred in 10 percent of women within one year of surgery.

In light of this finding, about a year ago, the FDA finally ordered a number of medical device manufacturers to conduct “rigorous” studies to determine the complication rates, over time, of surgical mesh.

What impact will the pelvic mesh case in Texas have on product liability?
In her petition, the plaintiff is asking the Supreme Court to clarify whether the appeals court accurately interpreted state common law to hold that a product liability plaintiff must isolate the cause of her injuries to a “specific defect” in a medical device case. The Supreme Court’s decision will have a far- reaching impact on pelvic mesh product liability cases.

If you have been injured by a medical device, you should consult with a qualified attorney who can determine if you have grounds for a lawsuit.