Doctors owe patients honesty, and it is safe to say that most doctors are not serving up honesty to their patients when they write them prescription drug orders. Sadly, most doctors probably don’t know they’re not being honest. Most doctors would probably be straight-up honest, if they could be, if they knew the potential impact on their patients of one of the most unjust and unreasonable rulings that any U.S. Supreme Court has ever made.
My doctor looked quizzically at me the other day when I insisted on a brand-name drug for my prescription. So I asked if he was aware that generic drug makers were protected from liability when their drugs hurt or kill people. He was not aware. He was astonished to learn of the absurd arrangement codified by the Supreme Court to protect generic drug makers.
I am certain that my doctor – at heart an honest, decent, trustworthy man – is more the norm than the exception. But because most doctors seem entirely unaware of the impact of the Supreme Court’s Mensing decision on generic drugs, they ought to be compelled by law to tell their patients this: “If you fill your prescription with a generic version of a drug, you will not be protected by tort law if that generic drug injures or kills you.” If your doctor won’t tell you that, who will? (Perhaps pharmacists should also be compelled to share this vital information.)
Since the Supreme Court ruled 5-4 in PLIVA v. Mensing in 2010 that generic drug companies are insulated from liability, generic drug makers have little to no incentive to be sure the drugs they make are safe and effective, or that their benefits justify their risks. The highly contentious high court ruling virtually assures generic drug makers of ongoing immunity from prosecution, from proper responsibility, in any drug injury case.
How many people would continue to take generic drugs if they were aware of this absurd arrangement that does not obtain in any other industry? (Car makers, for one, all copy each other’s designs, but they’re all responsible for their own products, not so in the drug industry.) Nearly 84 percent of drug prescriptions in the country were filled by generics in 2012.
Gladys Mensing was just one of thousands of people unlucky enough to have been given the generic form of a drug – metoclopramide, in her case – instead of the brand name drug, Reglan. That drug caused her tardive dyskinesia, an incurable nerve disorder that keeps her face constantly jerking and twitching, making it difficult for her to speak at all, and it also affects the rest of her nervous system, sometimes putting her legs and arms or trunk in uncontrollable spasms lasting for hours or days. Five members of the Supreme Court threw Ms. Mensing’s case out of court in a ruling that also leaves thousands of other generic drug victims out in the cold.
It gets even more absurd. More than 400 drugs are marketed ONLY in generic form because the name-brand company has stopped selling the original. In those cases, no drug maker has ANY responsibility to suggest and implement any label change, unless FDA has found a new risk and ordered revision. The situation is sadly ludicrous in a civilized country.
In addition, a study by Public Citizen found that in the last five years, a black box warning was added to at least 53 drugs which were approved by FDA more than 10 years ago. Of 53 drugs, 11 are available only as generics and 38 are available in both name-brand and generic. The drug that injured Gladys Mensing was approved in various forms way back in 1979 and 1983, yet didn’t get a black box warning until 2009, nearly 30 years later. That such drug “side effects” can take so long to emerge further underscores the absurdity of insulating generics from liability.
So the system is broken. It’s a mess. Fine. At the very least, doctors ought to be compelled by law to explain the generic drug situation to the people most likely to be affected by it. The AMA, even if only to protect its doctor members from liability, ought to compel doctors to share this information, in the event that one day doctors could be considered liable for failing to share it. The people paying for the drugs and suffering when they injure them deserve the right to know exactly what risks they are taking, exactly what they are getting when they decide to save a few bucks by buying generic.
Shown the whole picture, many of us might consider it penny-wise and pound foolish to choose cheap generics over brand name drugs. Whichever we choose, we have the right to be shown the big picture, so that we can make fully informed decisions about our own health.
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by Matthews & Associates
