Zimmer wins first US trial over NexGen Flex knee devices

REUTERS: Indiana-based medical device manufacturer Zimmer Biomet Holdings Inc on Friday was cleared of liability in the first of more than 900 U.S. lawsuits to go to trial over claims that its NexGen Flex knee replacements were prone to painful, motion-impairing loosening.

Following a three-week trial in the U.S. District Court for the Northern District of Illinois, jurors returned a verdict for Zimmer in the lawsuit brought by Kathy Batty, according to Zimmer spokeswoman Monica Kendrick. Batty, who suffers from degenerative joint disease, underwent a total knee replacement on both knees in 2009 using Zimmer’s NexGen Flex system. Within a year, she said she began to experience severe pain, leading her to replace the implants in 2011.

She and other plaintiffs had accused the company of designing a flawed product and failing to warn doctors about its potential risks. While the outcome of Batty’s trial will not be binding on other cases, it is a critical early win for Zimmer in the consolidated federal litigation, which currently contains more than 900 cases.

The victory is particularly significant because lead plaintiffs’ lawyers had selected Batty’s case for the first trial, signaling their belief that it was one of the “strongest cases in this litigation,” Kendrick said in a statement. Kendrick said the company was pleased with the verdict and looked forward to defending its NexGen Flex products “in as many trials as are necessary.”

Lead lawyers for Batty did not immediately return requests for comment. Zimmer’s NexGen Flex was cleared for sale by the U.S. Food and Drug Administration in 2007, and was designed to offer greater flexibility than standard knee devices. Plaintiffs said the marketing for the devices falsely implied that patients could engage in activities involving frequent knee flexing, when in fact the devices could not withstand the additional force and strain. They said that a flaw in the NexGen Flex design could cause it to loosen prematurely, requiring additional surgery to fix or replace.

Zimmer has denied that the devices are defective and said they have a successful track record. It argued that Batty’s alleged injuries may have been caused by other factors, such as infection. Zimmer Holdings Inc’s US$14 billion purchase of rival device maker Biomet was approved earlier this year, creating Zimmer Biomet.

The case is Batty v. Zimmer, U.S. District Court for the Northern District of Illinois, No. 12-6279.

(Reporting by Jessica Dye in New York; Editing by Lisa Shumaker)

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Cholesterol levels and tendon pain may be related

(Reuters Health) – People with unhealthy blood cholesterol levels are more likely to have tendon pain or altered tendon structure, according to a new review.

Cholesterol is essential for life, but too much in the blood increases the risk for cardiovascular disease and may also be linked to musculoskeletal problems, such as tendon injuries, said coauthor James E. Gaida of the University of Canberra and Monash University in Australia.

“Tendons connect muscle to bone, and tendinopathy is condition where a person feels pain when using their tendons,” he said. It can affect any tendon including the Achilles tendon in the heel or the rotator cuff tendon in the shoulder, he noted.

“The most interesting finding was that the pattern of cholesterol changes seen with tendinopathy was similar to that which increases cardiovascular disease risk,” Gaida told Reuters Health by email. “It seems that what is bad for your heart is bad for your tendons.”

Gaida and his coauthor reviewed 17 studies that described cholesterol levels or use of cholesterol lowering drugs and participants' tendon structure or pain. Altogether the studies involved more than 2,000 people.

“Cholesterol is deposited within the tendon matrix when its level in the blood is high,” Gaida said. The researchers theorize that cholesterol deposits lead to inflammation of the tendons, and that this leads to structural changes, which make the area vulnerable to injury and pain, he said.

In the studies they analyzed, people with less healthy blood cholesterol levels were more likely in general to have tendon problems, and to have worse pain associated with arm and shoulder musculoskeletal injuries.

But the findings can't prove that high cholesterol causes tendon issues. In fact, tendon injury can limit physical activity, which may affect cholesterol, so the relationship could also go in the opposite direction, the authors note in the British Journal of Sports Medicine.

“The pain is likely due to the accumulation of cholesterol, though the accumulation of cholesterol may very well have a genetic component,” said Louis J. Soslowsky, founding director of the Penn Center for Musculoskeletal Disorders at the University of Pennsylvania, who was not part of the new review.

Obesity can exacerbate both high cholesterol and tendon pain, Soslowsky told Reuters Health by email.

“The association between cholesterol and tendinopathy needs further investigation, including whether lowering lipids through lifestyle changes, such as diet and physical activity patterns, could help treat tendon pain,” Gaida said.

“However, the more important benefit of identifying a link between cholesterol and tendinopathy is the potential for early detection of high cholesterol, and management of cardiovascular disease risk, in those presenting with tendon pain,” he said.

“There is some data that shows statins increase tendon and/or muscle pain so while lowering cholesterol is likely to aid in preventing tendon injury and/or improving tendon healing, its role on pain is not as clear,” Soslowsky said.

Doctors should consider screening people with tendon pain for high cholesterol, and people who increase their physical activity after finding out they have high cholesterol should do so gradually so that their tendons have time to adapt, Gaida said.

SOURCE: http://bit.ly/1NVflx0 British Journal of Sports Medicine, online October 15, 2015.

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