A Medical Device Daily

Patent lawsuits continue to dot the landscape for makers of medical devices, and Cordis (Miami Lakes, Florida) is only one of a number of device firms embroiled in a number of such suits, the pace of which seems to be increasing.

Cordis managed to recently win a partial reversal of a juried court case that awarded Jan Voda, MD, of Oklahoma City, Oklahoma, potentially multiple millions of dollar in damages for what he alleges is an infringement of his design for a catheter. However, a new precedent that was set after the conclusion of that initial trial gave the defendant enough room to blunt some of the effect of the suit.

Voda sued the company in 2003 over the company's XB catheter and won handily with the damages set at 7.5% of gross sales despite the fact that Cordis went to market with the first iteration of the XB before Voda filed a patent for his invention. The crucial change to the original XB was a change in the catheter to a slightly curved design that apparently failed to be curved enough to avoid infringement of a catheter described as "straight," among other things.

The suit alleged that Cordis willfully infringed on the physician's patent and prior to the end of the first trial, Voda expanded the jurisdiction of his suit to four other nations, Britain, Canada, France and Germany.

The Federal Circuit Court of Appeals for the Western District of Oklahoma ruled on Aug. 18 that the lower court's instructions to the jury regarding willfulness were erroneous. The notion of willfulness in this context was affected by a lawsuit involving computer hard drive maker Seagate Technologies (Scotts Valley, California). That suit, which was decided in August 2007, is said to have lowered the bar for defending allegations that a defendant willfully infringed on a patent. The first trial in Cordis v. Voda concluded before the Seagate trial had run its course, but the appeal came after the closure of the Seagate trial, hence the application of that standard for willfulness.

The Circuit Court overturned the jurisdiction claim based on the lack of a provision affirming such a claim in the Paris Convention for the Protection of Industrial Property of 1883. However, the Paris Treaty does not ban such a claim, either. Voda also lost a motion to slap an injunction on Cordis' distribution of the XB.

Cordis' legal affairs department still has a lot on its plate, with the announcement that a suit of the company and third-party manufacturer Norman Noble (Highland Heights, Ohio) will go forward. The plaintiff in that trial is Spectralytics (Dassel, Minnesota), but details of the trial have as yet to emerge.

Cordis can take comfort, however, in the fact that other med-tech companies have more cases on the nation's judicial docket. At the web site Justia.com (look under http://dockets.justia.com), the search term "Cordis" indicates that the company is involved in 10 lawsuits filed between Jan. 1, 2004, and Aug. 13, 2008. Justia.com lists more than 20 lawsuits involving Medtronic (Minneapolis) over the same period of time, all of which deal with patents, while Boston Scientific (Natick, Massachusetts), is also named as part of more than 20 patent lawsuits in that time. Of that number for Boston Scientific, eight were filed in the first eight months of this year.

At press time, Cordis had not responded to a call for comment.

AHRQ says hospital tab jumped in '06

The Agency for Healthcare Research and Quality tracks many things, including how much money the U.S. spends on hospital care, and the most recent numbers suggest a sharp jump in expenditures between 2005 and 2006. According to AHRQ's numbers, hospital charges rose from $873 billion to $943 billion "even though hospitals admissions increased only slightly, from 39.2 million to 39.5 million," according to the agency's Sept. 17 statement.

A quick calculation indicates that the increase in billings was 8% while the increase in admissions comes to seven tenths of a percent.

AHRQ broke down the numbers by payment source and to the surprise of perhaps no one, Medicare was the primary payer of those fees by a hefty margin. However, according to those numbers, the increases in spending were least for those who were privately insured, $272 billion to $287 billion, or 6%.

Billing for Medicare patients rose from $411 billion to $444 billion for a change of 8%, while Medicaid billings rose by 9%, from $124 billion to $135 billion.

However, the largest percentage increase was for those with no insurance, a 15% jump from $38 billion to $44 billion.

The report notes that Medicare and Medicaid accounted for nearly two thirds of the total and the uninsured about 5%, but also noted that diseases of the circulatory system generated about $103 billion of the $943 billion total. Osteoarthritis, which one assumes will become more common in the coming decades, ran a hospital tab of $16 billion. The numbers do not include data on hospital outpatient charges or charges for emergency room care unless the patient was admitted.

New guidance for ultrasound 510(k)s

FDA has published a new guidance for those "seeking marketing clearance of diagnostic ultrasound systems and transducers," and as is so often the case, the guidance almost qualifies as a tome.

The 68-page guidance covers intravascular ultrasound catheters and cardiovascular blood flow meters as well as ultrasonic pulsed Doppler imaging systems. One thing has not changed, the guidance notes, informing the reader that the guidance "retains the two-track approach of the 1997 guidance." Track 1 recommendations "are for devices that do not conform to the output display standard" whereas those for track 3 deal with devices that do conform to that standard.

The agency says that "because laboratory studies have shown the potential for both thermal and mechanical bioeffects at diagnostic acoustic output levels, and because of the particular concern for fetal exposures, prudent use has been advocated by national and international bodies concerned with medical ultrasound use and safety." Because of the difference in display usage, FDA suggests that "for devices that follow the track 1 recommendations, acoustic output information should be included in the operator's manual" whereas "for devices that follow the track 3 recommendations, the system should incorporate the output display and the labeling should include acoustic output information."