Woman Can Press Suit Over Hospira Drug Shortage

A federal appeals court has given a green light to a woman to proceed with a lawsuit in which she charges that a drugmaker breached its responsibility to supply patients with a needed medicine. The decision means that, for now, a debate will continue about holding drugmakers accountable for ongoing product shortages that have allegedly caused numerous individuals harm.

In this case, Jennifer Lacognata had been diagnosed with vitamin A deficiency and subsequently prescribed an injectable drug called Aquasol A that is made by Hospira. But shortly afterwards, she was unable to obtain the medicine because Hospira HSP) has had numerous manufacturing problems, which has prompted some Wall Street analysts to speculate the FDA may issue a consent decree (read this).

In filing her lawsuit, Lacognata, who is now blind in one eye due to vitamin A deficiency, highlighted a dilemma resulting from a large and persistent number of shortages over the past two years of numerous medications needed for treating different cancers and attention deficit disorder, among other ailments (see the list).

The crisis has led to patient deaths; gray market price gouging; an increased reliance on compounding pharmacies that have raised safety questions; Congressional probes; calls to fine drugmakers that fail to provide early notice of shortages, and accusations that the FDA has been overzealous in pursuing manufacturing gaffes, a charge the agency has denied. Amid this swirling controversy, Lacognata charged drugmakers that are licensed by the FDA have a duty to maintain supplies of a medication that is required for patient health. Specifically, she argued that Hospira violated its duty by switching manufacturing sites for Aquasol A in late 2010 without stockpiling adequate supplies to avoid what became a significant shortage.

Last summer, a federal district court judge tossed the case by determining that "there is no authority that supports (her) argument that a drug manufacturer, like Hospira, has a duty to continue supplying a patient with a drug that it knows the patient relies upon for his or her medical health" (here is the order).

However, the US Court of Appeals for the 11th Circuit has allowed an appeal to go forward. "The issue of whether drug shortage victims can recover can be decided," says her attorney Allen Black. "It's very fundamental. Is there a duty of someone who takes an FDA license to supply the drug? The doors were shut closed in district court, but were reopened by the circuit court" (here is the appeals court brief).

[UPDATE: A Hospira spokesman sent us this statement: "Hospira recognizes there are patients in need of this product and we are working diligently to return Aquasol A to market as soon as possible."]

21 Comments

Dec 11, 2012 - 9:54am
Seems like a strange legal theory to me. If Hospira can be sued because they run into a manufacturing problem for a drug that nobody else apparently wants to make, can they be sued if they simply decide to stop making it as a business decision? What if there were two manufacturers and one decided to stop making it? It seems to me that any ruling in the plantiff's favor is going to dramatically exacerbate drug shortages.
Dec 11, 2012 - 10:32am
@John - go back to the *precedent* that was set with the scorpion anti-venom case in your favorite free state - Arizona.
Dec 11, 2012 - 11:55am
Hey guys, don't forget that in the land of the blind a one eyed man is king.
Dec 11, 2012 - 1:03pm
I am not sure that suing someone when you need something from them - a drug, goodwill, more competition and choice etc- is a productive strategy.
Dec 11, 2012 - 1:08pm
Like no one is going to notice this ABSURD shell game going on in courts while the *cult* is trying to sneak the entire medicine manufacturing capability in the USA out to slave labor countries.

If there really WAS a *Homeland Security* apparatus, there would be armed guards posted to protect the *HEALTH* of the citizens of USA from this latest industry-wide Vulture Capitalist schtick - medicine is not a *private* toy manufacturing factory in Texas, Bishop...

Dec 11, 2012 - 1:10pm
What would be a good strategy?? Doing nothing?? Saying pretty please to the drug company didn't help. Asking the FDA to intervene did nothing. How long should someone wait?? It has been over two years now. Do you know that cattle can get this drug but humans can't??!!
Dec 11, 2012 - 2:19pm
A Stanford business school student came up with a remarkable strategy for correcting these shortages: Make producing the drugs more profitable by reversing the 2003 Medicare reimbursement cuts that heralded the new era of drug shortages.

http://www.stanford.edu/~ayurukog/shortages.pdf

Dec 11, 2012 - 3:00pm
And the FDA gets off scot-free.....AGAIN!
Dec 11, 2012 - 3:49pm
The solution might involve the government creating a quasi-public company to produce medicines that are simply not profitable enough for private companies to bother with anymore. It would be a little like when Amtrak took over the railroad industry 40 years ago. Obviously people would still need to pay for this product, but Congress would allocate funds to underwrite the difference between production cost & revenue.

I hate this idea. But I hate, hate, hate the Soviet-style approach of the government essentially ordering companies to produce products regardless of profit motive. And obviously it's not acceptable for people to be denied essential meds. There's really no great solution.

Dec 11, 2012 - 3:49pm
We will solve this problem by putting in disclaimers in every package insert that sez we cannot guarantee the continued availability of product, period, end of story. Buh bye, bubbulah.

Should be something anyone can read in plain english, even with one good eye.

Dec 11, 2012 - 4:55pm
Salient, judging by the smashing success of Amtrak, which has been on life support for decades, your idea has as much chance of approval as a skunk at a Sunday picnic.
Dec 11, 2012 - 6:23pm
Omg. Jennifer gives grifters a bad name IMHO. I hope Hospira plans a vigorous defense. First, one does not develop a Vitamin A deficiency in isolation of other deficiencies. If Captain Hook's picture is an actual picture of Jennifer, she clearly has no deficiency of fat soluble vitamins (which is invariably caused by fat malabsorption.)Jennifer appears to absorb her nutrients just fine. Jennifer and her "attorneys" were too smart by half. They figured they had a fool-proof scam that would stand up against private eyes. Jennifer can easily fake an eye exam; yet drive, do needlepoint and read small text and explain it away by saying "I was using my one good eye". Clever, but not foolproof. Serum vitamin A levels can be analyzed which I can predict will not show a deficiency of vitamin A in this plaintiff. The only evidence that can be gleaned to support her partial blindness claim is her bad perm. All IMHO of course. Btw--the suit claims people have died from the dreaded Aquasol shortage. Where is the evidence of that?
Dec 11, 2012 - 7:26pm
@kaputz, "...Serum vitamin A levels can be analyzed which I can predict will not show a deficiency of vitamin A in this plaintiff...."

Really? A precedent was set that SOME labs are NOT "medically credible"....see this conversation:

http://www.pharmalot.com/2012/11/labs-pain-drugs-urine-tests-and-body-bags/

Dec 11, 2012 - 7:27pm
Kerry is right. Jenny, don't forget to dress for court.

http://www.bing.com/images/search?q=pirates+of+the+carribean+eyepatch&view=detail&id=5A453B1688D63012941C08ACDA598A567EBE8A0A

Dec 11, 2012 - 7:36pm
@salient - "...The solution might involve the government creating a quasi-public company to produce medicines that are simply not profitable enough for private companies to bother with anymore...."

I suggest removing the PROFIT *infinity* algorithm that manages FIAT $$$$ distributed through a fractional reserve banking scheme and get back to double entry bookkeeping for Main Street and life-maintenance commerce.

Too radical...?

Profit has a limit. I can't imagine there not being enough *profit* in producing medicine that has a MINOR cost left to its production since the research and building of manufacturing plants has been paid off long ago, partially thanks to all the TAX BREAKS for doing research and building capacity to manufacture.

Dec 11, 2012 - 9:11pm
Dzieko, of what possible relevance is the factoid that "some labs aren't medically credible"? Guess what-- some plaintiffs aren't "medically credible". I would imagine that University of Wisconsin or U of I would be considered "medically credible". Please Hospira--fight this suit. If you settle with this grifter, every idiot looking for a free payday will be buying eye patches at CVS and claiming to be vitamin A deficient.
Dec 12, 2012 - 8:41am
dz, there are five constants per Ben Casey. Infinity is one of them.

http://www.youtube.com/watch?v=juN1mgR3VBQ

Dec 12, 2012 - 9:56am
oii-Well I did say I hate the idea. Just can't think of anything better. It's easy to attack the merits of this one case, but everyone here knows this is a real problem that needs to be dealt with.

dz-Platitudes aside, how does what you're talking about actually, you know, happen? Businesses do a cost-benefit analysis for their endeavors & do more of the ones that are profitable & do less, or stop doing altogether, the ones that aren't. That's basic economics. There's no such thing as "enough" profit just like there's no such thing as "enough" atoms.

So how do you get these guys to make more of this stuff? Incentivize them (with our tax dollars)? Force them (which is almost certainly unconstitutional)? Is there an Option 3? Like I asked, how does this actually happen?

Dec 12, 2012 - 11:59am
@Salient point - When it comes to managing the health of ANY living species - you have a clear goal - good health when alive and the protection of the reproduction environment. But that always gets the *business* wonks involved in a future-looking analysis that is unknown and any speculations and theories derived from the unknown should not be used to manage what is a closed loop, or a cycle of grow-harvest-repeat.

Best example is AIDS/HIV. What is the goal? One team will tell you that it would be to "manage" the virus into *extinction*. And the other team wants to manage having a constant supply of patients for the profit value of anti-virals.

But the thing is, there will always be bacteria and viruses threatening all live species. It's never ending. So best practices - based on biologic health - should trump best practices based on profit.

If the goal is to replace many living species with mechanical contraptions and/or information storing gizmos for a much smaller human population (billions less), then the role that "health authorities" play in achieving that goal will change, and probably already has.

In this case, an agrarian-driven economy could provide this individual with everything she needs (education/tools/"living" wage) to make the specialized product on which her life depends by herself, but not as a *global* corp.

Micro-economy and macro economy might need to live side by side and those two circles may not even intersect, but rather like a watch, they turn each other.

If the goal of the macro economy is to replace living species with dead machines/gizmos, then the specialized product and the person who needs it are SOL...there is no micro economy or a macro one to support the struggle of that one unique life form.

Dec 12, 2012 - 12:09pm
I would not pay this gal one thin dime until I had her examined by a board certified ophthalmologist.

WHY? Vitamin A deficiency is a SYSTEMIC disease. This means that there is no scientifically plausible reason for this woman to be blind in only one eye unless her ocular pathology is due to something entirely different and she is trying to cop a payday.

Take home lesson: Systemic diseases DO NOT produced unilateral pathology in paired organs. I am even more suspicious than before.

Dec 12, 2012 - 1:03pm
Aye, aye matey. In a perfect world this case would have been tossed out immediately and the defendant would have had it's legal fees reimbursed by the grifter. I'm curious how this lawyer in PA got hold of Captain Hook who lives in FL. Did the lawyer take out full page ads in areas with high unemployment soliciting people with fake one-eye blindness? Notice that Jen isn't completely blind. She wouldn't be able to drive or shop or read in public. That's too tough of a scam to pull off.