Judge’s ruling on artificial discs causes pain for Medtronic

[iSpine-Admin]

September 15, 2009
Publication: Finance & Commerce (Minneapolis, MN)
Judge’s ruling on artificial discs causes pain for Medtronicby Arundhati Parmar Staff Writer

People with lower back pain who are mulling a total artificial disc replacement operation may have to wait a while to get some choice in the marketplace.

Currently, two artificial-disc products are approved in the United States by the Food and Drug Administration: Johnson and Johnson's Charite and Synthes' ProDisc. Fridley medical device company Medtronic had been expecting an FDA approval to come for its competing Maverick line of products sometime by the beginning of the year. But that hasn't happened, and a lawsuit brought against Medtronic related to its Maverick products bodes ill for its final introduction in America.

In late August, a Tennessee judge ordered Medtronic to pay the plaintiff in the suit - West Chester, Pa.-based Synthes - more than $21 million for willful patent infringement and ordered Medtronic to stop making and selling Maverick immediately. Although they are sold in Europe, where Maverick is approved, they are manufactured domestically and the judge's order effectively prevents Medtronic from manufacturing it.

Medtronic is appealing the case and has already filed a motion that would allow it to continue to make and sell Maverick while it prepares for the Federal Circuit Court of Appeals in Washington, D.C., to hear its appeal.

"We are disappointed in the order but will abide by the order as we work to have the decision reversed on appeal," said Marybeth Thorsgaard, a Medtronic spokeswoman, via e-mail. " Medtronic believes that the Federal Circuit Court of Appeals will see this case differently than the Tennessee court. "

But in the meantime, Synthes has gotten what it wanted when it brought the lawsuit back in 2007.

"Ultimately, the goal at the time of litigation was to get (Maverick) off the market," said Gilgian Eisner, a spokesman for the medical device firm.

Similar technique

The lawsuit involves how the discs made by Synthes and Medtronic are attached to the bone. While Johnson & Johnson's Charite uses securing pins to attach the disc to the vertebrae, Synthes's ProDisc product uses a single anchor, or keel, to attach the disc to the adjacent bone. Medtronic's Maverick product also uses this single anchor, or keel, to attach to adjacent bone and that has led to charges of patent infringement.

Synthes acquired this single anchor technology when in 2003 it bought the company that developed it, and it was patented in 2005.

"We paid $350 million to acquire Spine Solutions and if there is a product that infringes on the technology, then we are going to sue," Eisner said.

That means that right now, patients looking for artificial disc replacements to relieve lower back pain or injury have to pick between either ProDisc products or J&J's Charite. (Other companies have studied lumbar discs, but they are not federally approved, though patients may be implanted with those products if they are part of a study).

But neither Johnson and Johnson nor Synthes have been very successful in getting insurance companies to cover those products. That is one reason the lumbar disc replacement market is such a small portion of the overall spine market - the U.S. spine market last year was about $5.8 billion, and a Twin Cities spine consultant estimates the lumbar disc market to be roughly $30 million to $40 million.

"Charite was the first disc to market and it hasn't been successful," said Rick Phillips, founder of Minneapolis-based consultancy Spine Market. "The insurance reimbursement for the product hasn't been there - a lot of insurers have issued non-coverage decisions for that product. "

Decision time

Spine Market's Phillips said that Synthes has been marginally more successful in selling its artificial lumbar discs but still does not have broad coverage.

And this is where Medtronic might have made a difference.

"If Medtronic had received approval and was now marketing a lumbar total disc arthroplasty, they would probably bring more pressure on some of the payers and might have more of a positive effect than right now than J&J and Synthes," said John Sherman, an orthopedic surgeon with Twin Cities Orthopedics. "Most patients don't have $30,000 or $40,000 checks that they can write to get their disc replacements done. " (Sherman is not a consultant for Medtronic and has no financial ties with the company, which has come under scrutiny for its relationship with doctors.)

Phillips, the local spine market consultant, agreed.

He said Medtronic has historically been more successful in getting payers to cover different kinds of products. Infuse is one example - it is a bone graft product and was approved in 2002 to treat lumbar degenerative disc disease and has been a hugely successful though controversial product for Medtronic.

"They have the experience and the internal resources to push insurance companies and gaining broad coverage," Phillips said.

Ultimately, if Synthes prevails on appeal and stands by its goal of getting Medtronic's Maverick off the market, Medtronic is faced with two decisions, both expensive. They could move manufacturing outside the U.S. so that it can continue to sell the products in Europe - Synthes so far has not filed patent infringement lawsuits in Europe, although it may decide to later. The second decision that Medtronic will have to make is whether to acquire a company that has an artificial disc technology in the lumbar region or maybe start from scratch on a new lumbar disc altogether.

"I think that it'll be interesting to see what Medtronic's decision is ... and whether or not they ultimately decide to shelve the Maverick and maybe acquire a disc and thereby entire the lumbar market in a more rapid fashion," Sherman said.