Monday, November 11, 2013

Court Rules Jury’s Decision “Sound” in Upholding $2Million Verdict vs. C.R. Bard

Judge Joseph Goodwin of the US District Court for the Southern District of West Virginia and the presiding judge in vaginal mesh lawsuits consolidated into six multidistrict litigations (MDL) issued a ruling on October 18, 2013 upholding the jury’s decision in the first bellwether case against C.R. Bard, according to court documents.

The jury, after deliberation, found the defendant C.R. Bard liable for the injuries sustained by Donna Cisson after being implanted with an Avaulta Plus Posterior BioSynthetic Support System for the repair of her pelvic organ prolapse in 2009. After only a few years, the plaintiff started experiencing severe complications which required multiple surgeries and caused her mental and physical pain, permanent injury, and substantial physical deformity.

In handing down his decision, Judge Goodwin declared that the jury’s award was sound and that the plaintiff’s counsel had proven that the device did not function as intended.

Amount of damages awarded to the plaintiff was $2 million which represented $250,000 in compensatory damages and $1.75 million in punitive damages.

Friday, June 28, 2013

Prolift Vaginal Mesh Sold Without Undergoing Clinical Trials

This was the description made by Jonathan Meeks, worldwide marketing director of Ethicon, over the material for the Prolift vaginal mesh. The company painted such scenario in a copy of Meek's internal memo presented during the trial of Linda Gross against Ethicon.

This particular mesh was the petroleum-based synthetic mesh material that was used by Ethicon for its Gynemesh PS, intended for the treatment of hernia disorders. In his email, Meeks admitted that the chosen artificial material was the best of a bad lot regarding integration and retraction and that there was a need to develop grafts that mimic the mechanical properties of human tissue.

In her testimony, Dr. Anne Webber, a doctor presented by the plaintiff, said that Ethicon was aware before the launching of the Prolift that the mesh material used would cause an inordinate number of complications. Yet, even with this knowledge, no clinical trials were made on the Prolift.

 Ethicon officials, despite warning from their researchers, insisted on launching the product in March 2005. It relied on the performance of another product, the Gynecare PS, which led Dr. Weber to conclude that this was unreasonable and may lead to a new set of complications.

Read More: Prolift Mesh Kit Was Never Subject to Clinical Trial 

Friday, June 14, 2013

Chronic Pelvic Pain Affects 39% of Adult Women, Report Shows

Online resources, quoting medical experts, report that chronic pelvic pain in women is a common problem posing a major challenge to medical specialists because of its unclear causes, involvement of complex body organs, and poor response to treatment. This condition has become prevalent in the United States where 39 percent of women are of child-bearing age encounter these symptoms -- with almost a half of them claiming to have decreased productivity at work, according to findings of a recent study. 

Chronic pelvic pain, as distinguished from acute pelvic pain, may be defined as a non-cyclic pain occurring below the belly button which may last from six months or more. This pain which is felt in the pelvic area should be severe enough to affect the woman’s functional ability and may require medical attention. 

The following are among the most common causes of chronic pelvic pain: 

Interstitial Cystitis 
Probably the most common cause of chronic pelvic pain among women is interstitial cystitis or IC which is responsible for over 33 percent of all reported cases. An inflammation of the bladder due to an infection has been traced as cause of this condition which usually affects women in their 30s and 40s. The exact cause of this disease has yet to be established although symptoms may be relieved by the use of antibiotics. 

The disorder is usually indicated by the need to urinate frequently which may be many times in just a span of one hour. This condition may also be manifested in the form of pressure above the pubic area, pain during sex, and painful urination. 

Endometriosis 
Although found in females between the ages of 13 and 50, this condition is usually diagnosed in women in their 30s especially those who may have problems conceiving. Growth of endometrial tissues outside the uterus usually in the ovaries, bladder, fallopian tubes, intestines, and other nearby organs characterizes this condition. 

Even if endometriosis may not be a serious health problem, this may cause extreme pelvic pain particularly during certain periods of the month. Due to the formation of scar tissues, women with endometriosis may find it very difficult to get pregnant. While no cure has yet been discovered for this condition, there are treatments available that may alleviate the symptoms. 

Irritable Bowel Syndrome 
More commonly known as IBS, this condition may not affect the reproductive organs of a woman but may still cause severe and chronic pelvic pains. The exact cause of this medical condition has not yet been known although doctors agree that IBS is associated with digestive disorders. 

Symptoms may differ from one person to another with the most common signs reported to include recurring abdominal pain, bloating, cramps, and diarrhea or constipation. There are medications available to alleviate these symptoms but not to completely cure the disorder. This condition may also be addressed by other strategies such as diet changes and stress management. 

Pelvic Organ Prolapse 
Women who have given birth and those in the advancing years are most commonly affected by this condition. Pelvic organ prolapse or POP occurs when a pelvic organ such as bladder and uterus descends into a lower position. While this disorder may not be considered serious, it may be very disruptive and uncomfortable. 

Among the indications of POP are chronic pain in the pelvic area, pressure against the vaginal wall, a feeling of being full in the lower belly, and pain during sex. Pelvic exercises, lifestyle changes, medical devices and surgeries are among the several options available in the management of this condition. This last option which may include vaginal mesh surgeries has become controversial in recent years due to alleged complications resulting from the use of these devices which have in fact led to numerous vaginal mesh lawsuits. 

References:
  • emedicine.medscape.com/article/258334-overview#a0199
  • uptodate.com/contents/chronic-pelvic-pain-in-women-beyond-the-basics
  • patient.co.uk/health/pelvic-pain-in-women