There are all kind of reasons why 2008 might be on your mind today. For example, that’s when the Hollywood writers' strike ended, importantly ensuring completion High School Musical 3! New York Governor Eliot Spitzer was caught with Client #9. And oh yeah, Barak Obama was elected President!
We all know that presidential and congressional (especially Senate) elections matter for many important reasons not the least of which is the third branch of government. Consider the extraordinary U.S. Supreme Justices chosen by President Obama and (so far) confirmed by the Senate: Sonia Sotamayor and Elena Kagan.
Which reminds me of another reason 2008 is on the brain today. That year, a pre-Obama Supreme Court decided a case of corporate judicial activism at its worst - Reigle vs. Medtronic. The case concerned the FDA’s regulation of dangerous Class III medical devices – the kind that require premarket approval under the Medical Device Amendments of 1976. The Court interpreted this law as preempting (i.e. preventing) claims brought by people injured by such devices. This was even though the law said nothing whatsoever about lawsuits or state tort law. See more here. Representative Henry Waxman (D-CA), then Chairman of the House Energy and Commerce Committee, worried, “If manufacturers face no liability, all the financial incentives will point them in the wrong direction: away from ensuring the safety of their medical devices.”
Yup, he was right on the mark. We recently learned, for example, that, “dosing errors with [Medtronic’s] problem-plagued SynchroMed II infusion pump, an implanted device made in Minnesota that slowly injects pain medications into a patient's spinal canal” have continued to kill people, with two new deaths and “103 affected due to overinfusion of pain drugs." Indeed,
[V]arious problems with the device have been linked to more than a dozen deaths in recent years. The Food and Drug Administration filed a consent decree against Medtronic in 2015 for repeated failures to correct manufacturing problems.…
The consent decree came after a series of FDA recall notices in 2013 about different issues with the device associated with 14 deaths at the time, including one in Minnesota.
Seems like the consent decree isn't working so well.
Medtronic faces a federal false claims and misbranding lawsuit that accuses the company of designing products for one purpose but tricking the U.S. Food and Drug Administration (FDA) into approving them for another to avoid expensive and time-consuming safety testing.
The suit, by a former Medtronic sales representative, alleges that the company designed a family of spinal devices for the neck but told the FDA they were to be used only in the chest and lower spine, where they were almost always too small to work.
The company denies wrongdoing but “Medtronic recently settled a suit making many of the same charges in a California state court.”
Which brings me to a third article this week. While (unlike sales reps) people suffering actual physical injury from Class III devices are blocked from suing, the manufacturers of such devices run straight to court when they don’t like what others say about them. Specifically, device maker St. Jude Medical Inc. has filed a defamation lawsuit against a company that provided research showing that, “hackers can seize control of home remote transmitters to change the settings on pacemakers or to deliver a shock that induces a heart attack.” The company found that St. Jude pacemakers and defibrillators "were easy to penetrate and could be manipulated by outsiders, potentially putting tens of thousands of Americans who use them at risk.”
Yet if that happens, patients will have no recourse in court – that is, unless and until Congress passes (and the President signs) a law to fix the Reigle vs. Medtronic decision.