Do patients have the right to sue medical device companies when procedures involving FDA-approved devices go awry? The med-tech industry may soon have an answer to that rather vexing question, once and for all.

The U.S. Supreme Court on Monday agreed to hear an appeal involving Medtronic (Minneapolis). The case will be heard in the nine-month term that starts in October.

And 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 angioplasty 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 it released Monday.

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

According to the company 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.

The Riegels are being represented by Allison Zieve and Brian Wolfman of the Public Citizen Litigation Group (Washington).

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 (Medical Device Daily, Nov. 30, 2006).

In a similar legal decision, DePuy Spine (Raynham, Massachusetts) yesterday reported that the U.S. District Court for the Central District of California ruled in its favor and dismissed virtually all claims of product liability relating to its Charit artificial disc, an artificial disc used in the treatment of degenerative disc disease.

“We are pleased with the court’s decision. We think it’s an important decision that recognizes the rigorous testing and evaluation the Charit artificial disc went under before being approved by the FDA,” said Gary Fischetti, president of DePuy Spine. “We will continue to vigorously defend the use of the product for carefully selected patients suffering from degenerative disc disease.”

In April a Massachusetts superior court judge, Susan Garsh, dismissed efforts by the company to throw out four lawsuits filed by patients claiming DePuy’s Charit artificial disc is defective (MDD, April 16, 2007). DePuy had argued that the company should be protected from the legal action since the FDA approved the device (MDD, Oct. 28, 2004).

The plaintiff, a 38-year-old California woman, had claimed that the disc was not designed, tested and labeled properly.

On June 21 the court agreed with DePuy Spine and dismissed all but one of the plaintiff’s claims, stating that “claims alleging a defective design, failure to warn, inadequate labeling of a Class III PMA-approved device are preempted.” The court held the same for breach of warranty claims.

The court explained why a local jury should not be permitted to second guess the judgment of expert evaluators assigned by the FDA to review the safety and efficacy of the Charit artificial disc.

It held that: “were a jury to conclude that the [Charit] was negligently designed, that conclusion would directly conflict with the FDA’s determination that it was safe for use. Similarly, were a jury to conclude that different or additional warnings were required, that would conflict with the device-specific requirements imposed by the FDA.”

The court said it would allow plaintiff to attempt to prove that the particular Charit artificial disc implanted in her body had a manufacturing defect.

DePuy Spine said it would vigorously defend against this one remaining claim and provide factual evidence to dispute the plaintiff’s allegation.

Report from Europe

St. Jude receives CE mark for ‘first-of-its-kind’ pacing lead

A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported receiving the CE mark for its new OptiSense lead, which the company calls “a first-of-its-kind pacing lead designed to offer more accurate sensing in the upper chamber of the heart.”

The lead, introduced at the Europace 2007 meeting in Lisbon, Portugal, incorporates a new tip design that St. Jude said increases the device’s ability to detect and classify electrical signals in the atrium more accurately by avoiding picking up signals from the heart’s lower chambers. According to the company, this improves the pacemaker’s response to sensed signals and the accuracy of device diagnostic reports.

St. Jude said the improved device therapy has now been demonstrated in two completed clinical trials. Results from the International OptiSense Lead Clinical Study were presented at the Europace meeting this past Sunday by Johannes Sperzel, MD, of the Kerckhoff-Klinik (Bad Nauheim, Germany).

The company said that because the design of the OptiSense lead “allows for more accurate detection of impulses from the patient’s atrium,” the lead offers physicians greater flexibility in programming the device’s atrial sensitivity settings while avoiding the sensing of signals from the ventricles.

In the past, physicians sometimes had to program a pacemaker to be less sensitive in order to avoid the detection of interfering signals. While decreasing the sensitivity settings helps to reduce the interfering signals, St. Jude noted that it also can reduce the sensing of important signals, “such as the small signals that can occur during atrial arrhythmias.”

In reducing the detection of unwanted signals, the OptiSense lead also provide greater freedom in lead placement options. Physicians may be able to place leads lower in the atrium — a potentially optimal location for pacing that previously created challenges because of interfering signals from the heart’s lower chambers.

“Accurate atrial sensing is especially important when using pacemaker therapy for patients with atrial tachyarrhythmia,” said Sperzel. “In clinical studies of the OptiSense lead, we had greater freedom in lead placement and were able to use higher atrial sensitivity settings to more readily detect even very fine atrial signals.”

St. Jude said the improved sensing performance of the OptiSense lead is a result of compressed spacing between the lead’s tip and ring. The 1.1 mm tip-to-ring spacing reduces oversensing of far-field R-wave signals.

In addition to the OptiSense lead, St. Jude also debuted its newest pacemakers — the Zephyr family of devices — at Europace 2007. The Zephyr pacemaker is designed to save clinic time by automatically performing all standard follow-up testing before the patient arrives in the clinic. The stored diagnostics, trends and measurements from the automatic tests are displayed for evaluation.

The company said the Zephyr device also is the first pacemaker that can, in about 90 seconds, tell physicians which device timing settings are optimal for each patient’s needs, via the QuickOpt Timing Cycle Optimization feature.

Grant moves toward in-license

Grant Life Sciences (Los Angeles) reported that it has signed a memo of understanding with Alphagenics Diaco Biotechnologies (Trieste, Italy) to exclusively in-license the manufacturing and marketing rights to Alphagenics’ molecular diagnostic test for human papilloma viruses (HPVs) in China and the U.S. and non-exclusively in Europe, India, Australia and Japan.

The Alphagenics HPV test is a DNA-based diagnostic that uses standard molecular diagnostic equipment found in most commercial laboratories.

Alphagenics’ test complements the HPV blood test — a serum-based immunological test to detect cervical dysplasia — that Grant Life Sciences has been developing.

Of the more than 100 types of HPV, about 10 have been linked to cervical cancer. Grant Life Sciences said that, while a serum-based test to detect pre-cancerous evidence and cancer of the cervix is still viewed as the preferred test-methodology to address the needs of the developing world, molecular, or DNA, testing is currently the approved test protocol in both the U.S. and Europe.

“Our introduction of the Alphagenics HPV test not only allows commercial laboratories to provide molecular testing but also complements the current introduction of vaccines against HPVs,” said Dr. Hun-Chi Lin, president and chief scientist of Grant Life Sciences. “The current approved vaccine in the U.S. provides for inoculation against four types of HPV for use in girls and women 9 to 26, who presumably have not been exposed to the viruses.”

Women who have reached sexual maturity and have not been exposed to one of the four HPV-types may benefit from the vaccination, according to the Advisory Committee on Immunization Practices. Thus, the Alphagenics test can be used by the balance of the female population to determine exposure and the possible use of the vaccine if found negative.

Lin said that the Alphagenics test can be used in the current gynecological regimen to help qualify Pap test results in the case of ambiguous readings, at a cost less than the current approved molecular test. Grant said it expects to launch the Alphagenics HPV DNA-based test in the Asian and Indian markets during 4Q07.

UK distribution pact for Genomic Health

Genomic Health (Redwood City, California) said it has signed an exclusive agreement with Medical Solutions , a UK healthcare and diagnostics business specializing in diagnostic pathology and cytology services and products, to distribute the company’s Oncotype DX breast cancer assay in the UK.

“We view this partnership as an important milestone in making our Oncotype DX breast cancer assay more widely available,” said Chu Chang, Genomic Health’s vice president of business development. “We plan to continue to realize opportunities to broaden access to our test to patients outside of the U.S. who may benefit from the individualized information Oncotype DX results provide.”

Oncotype DX is currently offered for sale in Israel under a testing and services agreement with Teva Pharmaceutical Industries and in Japan under an agreement with SRL . Patient tumor samples from these and other countries are analyzed in Genomic Health’s reference laboratory in Redwood City.

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