The medical device market is famously litigious, but legal disputes appeared to come even faster and more furiously in the cardiovascular sector over the past month, all likely to either maintain or shift market positions in some key areas of the sector.

Following is an overview.

Supreme Court will hear product liability case vs. Medtronic

Do patients have the right to sue medical device companies when procedures involving FDA-approved devices go awry? The med-tech industry may eventually get a answer to that rather vexing question, once and for all. The U.S. Supreme Court last month agreed to hear an appeal involving Medtronic (Minneapolis). The case will be heard in the nine-month term that starts in October.

If the high court rules against Medtronic, the decision certainly would have broad implications for the med-tech industry.

The appeal stems from a New York case that began as an agioplasty procedure gone wrong in 1996. After Charles Riegel suffered a heart attack, a doctor inserted a Medtronic catheter into his badly blocked right coronary artery. But when the catheter’s balloon was expanded to restore blood flow to the heart, it burst. Riegel lost consiousness and developed a complete blockage, forcing emergency bypass surgery.

In the case, Riegel vs. Medtronic, an FDA-approved balloon catheter was used, contrary to labeling instructions by the patient’s doctor, Medtronic said in a statement

Rob Clark, a Medtronic spokesman, told Cardiovascular Device Update that the company would not comment on the case beyond what is in the statement.

According to that statement, the decision to take up the case means that “for the first time the Supreme Court will decide whether a patient is precluded from seeking state court remedies against the manufacturer of a device approved by the FDA through its rigorous Pre-Market Approval (PMA) process.” The issue has arisen in many other lawsuits against Medtronic and other device makers, with most lower courts thus far shielding the companies from liability, based on product approval by the agency.

In the Riegel case, an Evergreen balloon catheter — no longer made by Medtronic — was inflated by the patient’s physician beyond the labeling restrictions and the patient was not a proper candidate for a procedure involving the device, the company noted.

Riegel and his wife, Donna, sued the company, but a trial court in Albany, New York, dismissed the case, finding that the patient was not entitled to state law remedies in light of the prior FDA approval of the device. The Second Circuit Court of Appeals upheld that decision.

All but one of the seven federal circuit courts that have addressed the question of medical device preemption of PMA devices has upheld the doctrine, Medtronic said.

In briefing to the Supreme Court on the Riegel case, the FDA and the Solicitor General of the U.S. argued that the Second Circuit decision in Riegel was correct, the same position argued by Medtronic.

Medtronic also used the preemption argument in another high-profile case that stems from its February 2005 recall of heart defibrillators. Several hundred lawsuits against the company have been joined in a single case in U.S. District Court in Minneapolis.

In November, U.S. District Judge James Rosenbaum denied the company’s motion to dismiss the case, writing that it “defies logic” to contend that Congress meant to preempt device makers from lawsuits after they received FDA approval for a product.

Boston Scientific must face trial over problems of Guidant

A federal judge has ruled that some product-liability claims against Boston Scientific (Natick, Massachusetts) over implantable heart defibrillators can proceed, rejecting the device maker’s motions to dismiss them. Guidant (Indianapolis), which Boston Scientific bought last year, continued to sell heart rhythm-management devices after learning of possible defects, Judge Donovan Frank of the U.S. District Court in Minnesota said in a ruling on Tuesday.

“This case concerns the issues of whether, how and to whom information was shared... about a device with an alleged defect,” Frank wrote in his ruling. The ruling clears the way for a July 27 trial.

The first lawsuit against Guidant is being pursued by Leopoldo Duron, a California man who had one of the devices removed. Duron seeks punitive damages over Guidant’s failure to adequately warn doctors and consumers about problems with the defibrillators.

Despite the purported benefits of Boston Scientific’s $27.2 billion acquisition of Guidant last year, the company said in March that it continues to see lawsuits piling up over problems with Guidant’s heart rhythm devices. At that time the company faced more than 1,100 individual and 75 class action lawsuits over recalls and safety warnings issued in 2005 and 2006 involving Guidant’s implantable defibrillators and pacemakers. Guidant has acknowledged that the defibrillators have been linked to seven deaths.

Annette Ruzicka, director of media relations for Boston Scientific’’s CRM unit, said the company is prepared to defend the defibrillators in court.

Boston Scientific has estimated damages and costs to cover legal expenses will be $732 million, and in March it said it had set aside $485 million for expected legal matters as of Dec. 31, primarily related to products made by Guidant.

“Clearly, Boston Scientific knew they’d be facing litigation... and in any litigation you’re going to have wins and losses,” said David Katz, chief investment officer at Matrix Asset Advisors, which owned 2.3 million Boston Scientific shares as of March 31, 2007. “You have to take them in stride.” Katz said the most important issues for the company over then next three to 12 months are progress in resolving a warning letter with the FDA, a turnaround in the markets for implantable cardioverter defibrillators (ICDs,) and drug-eluting stents (DES), and cutting costs.

Michael Barr, an industry analyst with Victory Capital Management, added, “Boston Scientific definitely wants to get its debt levels down... this is just one more thing that moves this company toward cost cutting.”

Stents at the heart of Medtronic vs. Cordis, Cordis vs. Abbott lawsuits

In the latest patent-infringement lawsuits concerning stents, Medtronic (Minneapolis) is suing Johnson & Johnson’s (J&J; New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit and Cordis is Abbott Laboratories (Abbott Park, Illinois).

Medtronic, which plans to begin selling its Endeavor stent this year in the U.S., sued J&J in Texas. J&J’s suit, filed in a New Jersey federal court, targets Abbott’s Xience V drug-coated stent, expected to enter the U.S. market next year.

The suits are the latest skirmishes in a legal battle among four companies concerning the devices. Abbott and Medtronic are poised to challenge J&J and Boston Scientific (Natick, Massachusetts), which dominate the $5.4 billion global stent market.

For Medtronic, its new lawsuit against Cordis is the second in three months. The first was filed in March. Both suits are in federal court in Marshall, Texas, and relate to patents owned by Medtronic partner EvYsio Medical Devices ULC (Vancouver, British Columbia), a closely held company.

Medtronic and EvYsio signed an agreement in February 2006 and sued Abbott over the patents in federal court in California. Suits over the EvYsio patents between the companies also are pending in Ireland and the U.K. In France, a court blocked Abbott from selling or making its Xience stents there after finding in favor of EvYsio. The Xience stent is available elsewhere in Europe.

Abbott sued J&J last year, seeking a court ruling that its Xience stents don’t infringe the Cordis patents. J&J responded with three lawsuits, including its most recent, accusing Abbott of using its patented technology without permission.

‘Healthline’ operators fail to correctly identify stroke symptoms

Staff at hospital ‘healthline’ stations should recognize stroke symptoms, but many don’t, according to a report published recently in Stroke: Journal of the American Heart Association. Nearly a quarter of hospital or 'healthline' operators mistakenly routed a caller describing classic stroke symptoms to primary care doctors rather than to 9-1-1, according to the study.

Brett Jarrell, MD, lead author and an emergency department (ED) physician at Cabell Huntington Hospital (Huntington, West Virginia), said he saw the problem while working at a stroke center.

"So many of our patients were transferred to our facility more than three hours after their symptom onset — sometimes as late as days after their symptoms started," Jarrell said. "I would ask them why they waited, and many replied that they called their local hospitals, only to be told that they should contact their primary care doctors instead of calling 9-1-1."

To test how prevalent this problem is, Jarrell called the hospitals' main numbers or the help lines/healthlines that many hospitals offer for medical advice, identifying himself as a researcher to the 46 help lines that participated. He described this stroke scenario: a 65-year-old man experiencing weakness in the left arm and leg and having trouble speaking.

Jarrell asked the operators which of these four responses they would give to such a person: wait for symptom resolution, contact a primary care physician, drive to a local urgent care center or call 9-1-1 for ambulance transport.

While 78 percent gave the correct answer — to call 9-1-1 — nearly a quarter of those surveyed said they would tell the person to call their primary care doctor.

The survey also found that 24% of the operators could not name one stroke symptom.

To test how widespread the problem is, Jarrell said he and his research team will conduct similar surveys of primary care physicians, 9-1-1 dispatchers and health maintenance organizations.