By Thomas M. Burton
Federal authorities reached a proposed consent agreement with
medical device maker Medtronic Inc. over flaws in its SynchroMed
drug-infusion pump for cancer and pain medicine, a device that has
been linked to serious injuries and deaths in recent years.
The Justice Department, working with the Food and Drug
Administration, filed the consent decree along with a legal
complaint alleging that Medtronic and two executives--Chairman and
Chief Executive S. Omar Ishrak and Senior Vice President Thomas M.
Tefft--have distributed "adulterated" devices. The complaint
alleges that the pumps weren't manufactured in accordance with
current good manufacturing processes.
Asked if Medtronic admits the allegations in the government
complaint, a Medtronic spokeswoman, Cindy Resman, said, "We're
addressing these issues, and we're agreeing to these specific
steps" to remedy the problems.
Under the proposed decree, Medtronic agreed to stop
manufacturing and distributing new versions of the SynchroMed II
implantable pump except in extraordinary cases, such as when a
treating physician certifies that the pump is medically necessary.
The device also dispenses medicine to alleviate severe chronic
spasticity.
The government alleges that the Minneapolis device maker
repeatedly failed to correct violations of FDA quality regulations.
Inspections in 2006 and in 2013 uncovered what the government
termed "significant violations" of quality regulations, such as
those related to complaint handling, corrective and preventive
action. Such measures are supposed to ensure that a malfunction
leading to injury or death gets investigated, and that changes are
made.
In 2012, the FDA issued a warning letter to Medtronic that cited
the company for failing to correct problems with the devices,
including their potential to stall due to motor corrosion and to
fail to deliver medication.
The company won't be allowed to resume widely distributing the
SynchroMed II pump system until it gets permission from the FDA.
Medtronic said the SynchroMed system has been used in more than
230,000 patients since it was introduced more than 25 years
ago.
The company stressed that it can continue to provide doctors
with access to the device. "For patients needing a replacement drug
infusion pump, Medtronic is required to collect a physician
certification before providing" the device, Medtronic said. "For
new patients, Medtronic is required to collect physician medical
necessity certification before providing a SynchroMed drug infusion
pump." It said that "efforts are well under way to address issues
included in the consent decree."
In 2013, Medtronic notified physicians of four potential defects
with the pump and said that 14 deaths were associated with
SynchroMed. Most took place when patients either were deprived of
medication and entered withdrawal, or after overdoses.
All four issues with the device were classified by the FDA as
Class 1 recalls, a status meaning that they can lead to serious
injury or death. The company said 11 of the deaths occurred from
1996 through April 2013.
Before the agreement becomes final, a federal judge needs to
sign off on terms of the decree, which was filed in U.S. District
Court in Minnesota. Government officials said in the court filings
that FDA inspectors "repeatedly observed and documented violations"
of federal quality regulations.
"Defendants promised corrections at the conclusion of each
inspection," government attorneys wrote. "FDA has repeatedly
warned" Medtronic and its executives of violations, the government
said.
The government, in court filings, said several responses from
the company promised corrections, but that "none of these responses
contained adequate evidence that Defendants [Medtronic and its
officials] have corrected their deviations."
Write to Thomas M. Burton at tom.burton@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires