Over a quarter of a million heart patients were implanted with Sprint Fidelis leads, wires connecting the heart to a device that slows dangerously fast heartbeats. In many patients, however, the leads were defective and electrocuted them from the inside. Fractures in the leads caused these patients to suffer painful and unnecessary shocks, injuring or killing many of them.
Yet when these victims tried to hold the leads' manufacturer accountable for these injuries, the judge tossed them out of court. Citing a recent Supreme Court decision---decided exactly one year ago today---that grants almost total lawsuit immunity to the manufacturers of dangerous medical devices, the judge declared that he was powerless to help the many people electrocuted by a device intended to save their lives.
This case is not an isolated incident; it is only the most recent skirmish in a campaign by medical device manufacturers, drug companies and health insurers to ensure that, no matter how wrongful or illegal their actions, no person injured by such a company will ever be able to hold it accountable in court. Moreover, in many cases these companies have achieved such immunity by convincing judges to misinterpret laws Congress intended to protect patients, consumers and the insured.
In the 1970s, for example, a contraceptive device known as the Dalkon Shield caused numerous infections and deaths. Congress responded by requiring the FDA to approve new medical devices. Even though Congress enacted this law to protect consumers from dangerous devices, the Supreme Court recently held that the law prevents state tort suits against medical device manufactures. In other words, even though every state's common law obligates defective device manufacturers to compensate people injured by the defect, the Court held that states are powerless to enforce such law.
Similarly, in 1974, Congress passed the Employee Retirement Income Security Act or "ERISA" to ensure workers could rely on their pensions and employer-provided health plans. Yet instead of reading ERISA as Congress intended--to protect workers who receive employee benefits such as health insurance--the Supreme Court has transformed ERISA into a shield protecting health plans which wrongfully deny lifesaving coverage to such workers.
Consider the case of Phyllis Cannon, who died of leukemia after her insurer refused to cover an essential transplant, or that of James Lind, a construction manager with Multiple Sclerosis who was able to continue working, until his insurer suddenly refused to pay for the prescription that kept his MS at bay. Cannon, Lind and many like them were told the same thing by the courts: it does not matter if your insurer broke the law; we cannot help you.
When courts permit the health care industry to ignore the law, the public's health suffers. If insurers know that they are free to deny lifesaving but expensive coverage to their customers, they have no reason to keep their promises to sick patients. Similarly, if manufacturers of faulty devices can continue to market them without consequence, nothing prevents them from injuring future patients.
Thanks to their wildly successful campaign for total lawsuit immunity, health insurers and medical device manufacturers have profited at the public's expense. The new Congress, however, already has a blueprint which will allow it to roll back some of the Supreme Court's worst decisions protecting the health care industry. With progressives now dominating both houses of Congress, the time is ripe to revive the Patients' Bill of Rights, which restores the ability of people like Phyllis Cannon and James Lind to hold rogue health plans accountable in state court. Congress can also ensure the safety of medical devices like the Sprint Fidelis leads by enacting the Medical Device Safety Act, which revives the states' authority to protect their citizens against dangerous medical devices. Indeed, as Congress prepares to consider the President's ambitious health care plan, both bills deserve to be part of their agenda.
Yet, as Cannon and Lind know all too well, the mere fact that Congress intends to protect sick patients does not guarantee that the courts will read the law as Congress intended. Ultimately, the best solution for bad judging is good judges. President Obama must not forget this when he names his first appointments to the bench.