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Judge Issues New Rulings Regarding C.R. Bard Lawsuit

Courthouse StepsThe federal judge presiding over a vaginal mesh lawsuit filed against C.R. Bard has struck down a number of allegations while upholding others. Judge Joel H. Slomsky issued the order on July 30, 2014 for the case proceeding in the U.S. District Court for the Eastern District of Pennsylvania.

Judge Slomsky is allowing the plaintiff to proceed with claims of failure to warn and negligent manufacturing with regard to the defendants’ Marlex hernia mesh product.

Patient reported severe mesh complications

This C.R. Bard mesh lawsuit has been years in the making. The plaintiff first underwent surgery in 1996 to repair bilateral ventral hernias. During the surgery, C.R. Bard’s Marlex mesh was used for the repair. At some unspecified point after the surgery, the plaintiff began to suffer from abdominal pain. On February 3, 1997, she went to an emergency room and reported abdominal pain, vaginal bleeding, dizziness, and severe diarrhea. However, the physician at the emergency room was unable to determine the cause of her symptoms.

The plaintiff reportedly suffered from persistent symptoms related to the mesh product for years. She received treatment for irritable bowel syndrome (IBS), fainting, diarrhea, abdominal pain, cramping, and similar symptoms. However, it wasn’t until 2011 that CT scans indicated abdominal abscesses. She subsequently underwent an exploratory surgery, during which the surgeon found that the mesh product had perforated internal structures. Although the surgeon removed some of the mesh, pieces of it were unable to be removed because of the severity of the perforation.

Because of these severe transvaginal mesh complications, the surgeons instead removed the plaintiff’s appendix and performed bowel resection surgery. The plaintiff filed a lawsuit against C.R. Bard upon learning that the product was allegedly expected to cause her continuing medical problems.

C.R. Bard lawsuit allegations

The plaintiff originally filed her lawsuit on August 28, 2013. She filed an amended complaint that alleged manufacturing defect, negligent manufacturing, negligent failure to warn, and breach of implied warranty. Lawyers for C.R. Bard filed a motion to dismiss the entire amended complaint.

Although the Judge agreed with C.R. Bard regarding some of the claims, he upheld the claim of negligent manufacturing, determining that it was sufficiently pled. Specifically, Judge Slomsky determined that the plaintiff’s allegation of failing to produce the mesh in a sterile manner satisfied pleading standards. The Judge further noted that the plaintiff had included sufficient alleged statements of fact in her lawsuit that would reportedly support the association between the pelvic mesh implant and her injuries.

Judge Slomsky also allowed the plaintiff to proceed with her allegation of failure to warn, noting that the C.R. Bard mesh lawsuit lists specific information about risks and defects that should have been provided to her.

However, Judge Slomsky struck down other allegations in the lawsuit, including the claim of manufacturing defect. In his ruling, the Judge discussed the Restatement (Second) of Torts, which states that certain products are not capable of being made fully safe for humans, and that this does not automatically mean they are defective.

Furthermore, the Judge brought up the case of Hahn v. Richter, after which Pennsylvania courts have not allowed strict liability claims on the basis of defects of prescription drugs. The judge determined that it was reasonable to extend the Hahn rule to medical devices. He similarly dismissed the claim of breach of implied warranty of merchantability.