Boston Scientific to Face the Music

Unfortunately, the tune is likely to be a dirge.

Hundreds of patients who then had their Model 1861s (defibrillators) removed are now suing the company for emotional distress and punitive damages and for failing to warn them of the flaw. Three patients died because of the flaw, but the plaintiffs at issue in the ruling didn't experience a malfunction themselves.

The ruling, by Judge Donovan Frank of the U.S. District Court in Minneapolis, means the cases will proceed to trial. The first case is scheduled to start in July.

Last month, Boston Scientific argued in court that Guidant didn't need to inform doctors because the rate of failure was extremely small -- about one in 500 over a three-year period. Lawyers for the company said it had already informed doctors that the devices were imperfect, and had told the Food and Drug Administration that the rate of failure could be as much as one in 20.

The company argued that patients whose devices weren't faulty shouldn't be able to sue the company for punitive damages. In yesterday's ruling, the court rejected those arguments, stating "the law is not furthered by allowing a manufacturer to escape liability for a defective product simply because a plaintiff elected to remove a medical device."

Was the rate of failure one in 500 (as Guidant told us doctors), or one in 20 (as the plantiff's lawyers contend Guidant reported to the FDA)?

Here's what Guidant's "Dear Doctor" letter said:

There have been 28 reports of this failure worldwide, in 26,000 devices built prior to the April 2002 change. This includes an event reported in March of 2005 in which a device was returned after a patient death. The device was found to have experienced this failure in conjunction with attempted delivery of at least one high-voltage therapy. To date, no such failures have been observed in the
devices built after the April 2002 change (including the approximately 11,000 devices built after the April 2002 change and before the November 2002 change). Approximately 13,900 devices built before the April 2002 change remain in service in the United States.

This would put the failure rate at 28/26000 = 0.1% (or 1 in a 1000 devices). If we double that (to pick up some that might not have failed), then 1 in 500 seems reasonable. But the "one-in-20" incidence, as the plantiff's lawyers contend, seems a bit grandiose given the data...

This ruling makes things more difficult for Boston Scientific, since there is less likelihood that the cases can be dismissed before going to trial on the basis that the claims could be preempted by a federal regulatory scheme (e.g., the FDA cleared our device, so it's not our fault). Further, and perhaps just as importantly, it permits the punitive damages portion of the trials (where big cash judgements to be levied against the device manufacturer) to also be brought forward. Boston Scientific's lawyers might be looking more seriously at settling given this turn of events.

This ruling may also have implications for the other device manufacturers (Medtronic and St. Jude) since now they may also have a hard time keeping their cases from going to trial for similar reasons.

-Wes