Judge Upholds $14.3 Million Verdict Against Boston Scientific in Pelvic Mesh Trial

vaginal-mesh-TVM-US District Judge Joseph R. Goodwin upheld $14.3 total verdict in favor of three women who suffered ongoing pain from the Obtrx transvaginal mesh system manufactured by Boston Scientific Corporation.

“There was more than sufficient evidence from which a reasonable jury could find in favor of the plaintiffs on each of their claims,” the judge wrote.

Boston Scientific was found liable of strict liability for defective design, strict liability for failure to warn, negligence and punitive damages. A jury in US District Court in the Southern District of West Virginia in Charleston returned the verdict for the plaintiffs in November 2014. The case is Carol Sue Campbell v. Boston Scientific Corporation, Case No. 2:12-cv-08633 (Oct. 3, 2016).

The case is part of consolidated litigation in MDL 2326, which contains 19,000 individual cases. There are six other MDLs against the transvaginal mesh manufacturers, with more than 70,000 cases currently pending:

  1. Boston Scientific TVM Litigation MDL 2326
  2. Bard TVM Litigation MDL 2187
  3. Ethicon (J&J) Transvaginal Mesh Litigation MDL 2327
  4. Neomedic TVM Litigation MDL 2511
  5. Cook TVM Litigation MDL 2440
  6. Coloplast TVM Litigation MDL 2387
  7. American Medical Systems TVM Litigation
  8. Caldera TVM Class Action In California

Plaintiffs Chris Wilson, Carol Campbell and Jeanie Blankenship had the Obtryx Transobturator Mid-Urethral Sling System implanted between 2009 and 2011. All suffered severe pain in their abdomen, pelvis, vagina, dyspareunia (painful intercourse) and painful urination. Each had unsuccessful revision surgery, which also left them with continuing pain.

  • Wilson recovered $3.75 million in compensatory damages and $1 million in punitive damages.
  • Campbell recovered $3.25 million in compensatory damages and $1 million in punitive damages.
  • Blankenship recovered $4.25 million in compensatory damages and $1 million in punitive damages.

Boston Scienfitif argued that it met the standard of care in the medical community, which did not require clinical trials. “However, as mentioned above, compliance with industry standards is not necessarily proof of reasonable conduct,” the judge held.

A key point of evidence was the Material Safety Data Sheet issued by Chevron Phillips Chemical Company LP with regard to their Marlex polypropylene. The plaintiffs presented evidence at trial that the MSDS included a Medical Application Caution, which stated: “Do not use [Chevron Phillips] material in medical applications involving permanent implantation in the human body . . . .”

Yet after learning this, Boston Scientific never performed any testing of their mesh inside the human body, didn’t halt the release of the Obtryx and didn’t disclose the new information.

The plaintiffs presented evidence related to a study conducted by Dr. Hilary Cholhan and funded in part by BSC. The Cholhan study “identified pariurethral banding as a previously unreported complication” of the Obtryx and noted that “[s]urgeons should be aware of the pariurethral banding and subsequent internal dyspareunia as a potential complication.”

When asked about the study, Alex Robbins, a BSC sales representative and training manager, stated that, because of its negative outcome, the study would not be useful to the sales force and should not be given to physicians.

The judge disagreed with Boston Scientific’s arguments that the verdict was against the weight of the evidence, that jury instructions were confusing, or that in closing arguments a plaintiff attorney improperly tried to appeal to the jury’s sympathy.

Read More

Pelvic Mesh Case Revived Against Boston Scientific

Vaginal-Mesh-POP-331x269-e1370009513525
Some 39,000 pelvic mesh cases have been filed against Boston Scientific.

A Massachusetts appeals court revived a pelvic mesh product liability case against Boston Scientific Corp. (BSC) because the trial court had wrongly excluded three pieces of evidence to rebut the company’s claims that the FDA had “cleared” its Pinnacle pelvic floor repair kit for sale.

A state court jury returned a defense verdict in favor of the company in 2014 in the first product liability lawsuit involving the its pelvic mesh products to go to trial.

Plaintiff Diane Albright of Ohio filed suit in 2012 the Massachusetts Superior Court against BSC, which is based in Massachusetts, seeking damages for injuries after the Pinnacle device was surgically implanted to treat her pelvic organ prolapse (POP) condition.

“The repeated reference to the FDA’s clearance aided BSC’s defense, and handicapped Albright’s case, on the central product safety issue in the case,” the appeals court said. The case is Diane Albright v. Boston Scientific Corporation (PDF), No. 15-P-633 (Sept. 13, 2016).

Trial judge Diane M. Kottmyer erroneously excluded key evidence:

  1. A medical application caution in the 2004 material safety data sheet provided to BSC by its supplier of the polypropylene material used to fabricate the mesh in the Pinnacle device. It states, “Do not use this [polypropylene] material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” The appeals court ruled, ” the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that BSC, which had received the MSDS well before 2009, had notice or knowledge of the content of the caution.”
  2. A letter from the FDA ordering BSC to conduct a “postmarket surveillance” study of the Pinnacle device to address concerns as to the safety and efficacy of the device in treating POP.
  3. A second letter from the FDA, agreeing to a request from BSC to suspend its postmarket surveillance study because the company planned to stop the manufacture and marketing of the Pinnacle device.

“Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial,” the appeal court ruled.

The same documents have been allowed into other trials, including one in Delaware that landed a $100 million verdict last year. Boston Scientific has been hit with verdicts of $18.5 million, $26.7 million and $73.4 million in 2014, and the $100 million award, which later was reduced to $10 million.

Some 39,000 pelvic mesh cases have been consolidated in MDL 2327 before US District Judge Joseph R. Goodwin in the Southern District of West Virginia. There are six other MDLS, making it the largest ongoing medical device litigation in the country. The Judicial Panel on Multidistrict litigation lists 75,000 cases in dockets involving different manufacturers.

A surgeon inserted the Pinnacle device into Albright in 2010. Within six months, she experienced pain and discomfort when urinating and other “hardto-describe” pain in her pelvic area. Two other doctors examined her and concluded that Albright was suffering from painful bladder syndrome and other complications due to the erosion and degradation of the mesh in her body.

 

Read More

Family Sues Boston Scientific over Defective IVC Filter that Killed Truck Driver

Boston Scientific makes the dangerous Greenfield Vena Cava Filters.
Boston Scientific makes the dangerous Greenfield Vena Cava Filters.

Federal litigation is building against Boston Scientific Corp. over defects in its IVC filter, a device implanted to control pulmonary embolisms (PE), a sudden blockage in a lung artery.

The family of a woman truck driver from Ohio filed a wrongful death suit after the company’s IVC filter perforated her inferior vena cava vein, killing her.

Even though plaintiffs are filing more cases against Boston Scientific over its Greenfield Vena Cava Filter, today there is no multidistrict litigation docket (MDL) for the litigation. “We believe it is possible that more cases will be filed and a motion for consolidation and transfer may be filed in an effort to form an MDL,” said John Ray, a leading consultant who has advised attorneys who practice in Mass Torts for more than a decade.

Greenfield Vena Cava Filter
Greenfield Vena Cava Filter

Boston Scientific, headquartered in Marlborough, Massachusetts, designed, manufactured, marketed and sold the Greenfield IVC Filter. It is a basket-like structure with 6 struts, each with a curved hook, and is designed to catch blood clots.

FDA warning and recall

The FDA recalled the Greenfield IVC Filter in May 2007 after reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters, causing a risk of cardiac and pulmonary embolization.

It also issued a warning on August 9, 2010 against leaving IVC filters in for extended periods of time, because they have a tendency to cause life-threatening problems.

The FDA reported that since 2005, there were 921 adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved detachments of device components and embolizations, 70 involved perforation of the IVC, and 56 involved IVC filter breaks.

Dangerous medical device

The co-administrators of estate of Cindi K. Ratliff filed a lawsuit in US District Court for the Southern District of Ohio, Eastern Division, alleging product liability, breach of warranty, negligence and wrongful death, Case: 2:15-cv-00076-GLF-NMK.

In 2004 Ratliff, of East Fultonham, Ohio, was diagnosed with deep vein thrombosis (DVT), which occurs when a blood clot (thrombus) forms in one or more of the deep veins in your body, usually in your legs. That year a surgeon implanted a Boston Scientifi IVC filter in her right inferior vena cava.

On May 3, 2013, she was working as a long‐haul truck driver and traveled to Oregon. While stopped at a rest area located on I‐5 in the vicinity of Coburg, Oregon, she suffered a medical emergency.  Shortly afterwards she was pronounced dead by medics who had been called to the scene. An autopsy that day determined the immediate cause of death was “Perforation of Inferior Vena Cava by Greenfield Filter with Retroperitoneal Hemorrhage.”

The lawsuit charges:

  • Boston Scientific knew or should have known that its Greenfield Vena Cava Filter when used as expected and intended, carrie the risk of breaking free from its implantation site, migrating, perforating the vena cava, and causing serious injury and death to patients.
  • Boston Scientific failed to properly design and manufacture Greenfield Vena Cava Filter.
  • Boston Scientific failed to give adequate warnings about the hazards associated with the filter.
  • Boston Scientific violated Ohio’s Product Liability Act.

The next of kin seek damages for loss of support, loss of services, loss of society of the decedent including loss of companionship, loss of prospective inheritance, and extreme mental anguish as a result of her death.

Read More