Tuesday, July 5, 2011

An Easy Case Makes Good Learned Intermediary Law

Who says one can have too much of a good thing? Yesterday we lost count of the burgers and helpings of potato salad we piled in front of us on the picnic table. (We were doing a Joey Chestnut imitation.) We wanted more pie. More Springsteen on the boombox. More Twilight Zone episodes. (Cable marathon, for those of you not in The Know.) More fireworks. More days off.

Our firm usually gets the hardest cases. We don't often survey the evidence and encounter an embarrassment of riches. Imagine our envy when we read the facts of Legard v. Ortho-McNeil Pharmaceutical, Inc., 2011 U.S. Dist. LEXIS 67997 (N.D. Ohio June 24, 2011). If ever a case called out for application of the learned intermediary doctrine, this was it.

Allow these facts to rain upon you, and grieve that you are seldom so lucky:

- Plaintiff was prescribed the birth control patch in 2002.
- Plaintiff complained of leg pain in May 2006. Upon her doctor's advice, she agreed to discontinue use of the patch.
- Plaintiff was, by the way, a nursing student.
- Plaintiff went to a clinic and complained of leg pain. She advised the clinic's doctor that she had been advised by her personal doctor of the risk of clots and had been told to remove the patch. When she arrived at the clinic, Plaintiff was still wearing the patch.
- Plaintiff underwent a vascular study, with negative results.
- In July 2006, Plaintiff attempted to refill her prescription, but her doctor insisted on seeing her first.
- Plaintiff saw her doctor and told him she wanted to continue using the patch. He agreed after learning of the negative vascular study.
- Plaintiff continued using the patch until Feburary 2007, when she presented at a medical center complaining of leg pain. A new vascular study showed deep vein thrombosis.
- Plaintiff stopped using the patch.
- Plaintiff filed a lawsuit in Louisiana state court. It was removed to federal court and became part of the MDL.

Defendant filed a motion for summary judgment on Plaintiff's failure-to-warn claims based upon application of the learned intermediary doctrine. Plaintiff did not file an opposition. (In criminal cases, this sort of thing is called a 'slow guilty plea.')

Why didn't Plaintiff file an opposition? Here comes another set of bullet points:

- Plaintiff's doctor testified that he was aware of the potential risks of the patch.
- Plaintiff's doctor also testified that "he took into account the information provided by the manufacturer, the patient's medical history, her physical condition, her health as well as the risks and benefits for the particular patient." Legard, 2011 U.S. Dist. LEXIS 67997 at *9.
- Plaintiff "acknowledged the risks of blood clots based upon her reading of the package insert." Id.

The court had little difficulty dismissing the case because Plaintiff had not demonstrated that Defendant failed to warn the doctor of a risk that was not otherwise known to the physician. Id. at * 12. Moreover, "no additional information regarding the patch would have changed the presciber's decision to continue use by the Plaintiff." Id.

That was enough. Plaintiff's own knowledge was extra -- gravy on the spuds, cherry on the ice cream, and bacon on top of more bacon.

So much for easy cases. Now get back to work.

Monday, July 4, 2011

Happy Independence Day

Don't you always feel a surge of patriotism when you return to the United States? Even if the trip abroad was wonderful in every way, and even if the immigration and customs lines are horrific, it's great to be back.

We feel that way now, after spending a good deal of the last couple of months on a case in Europe. We worked with lawyers (solicitors, advocates, etc) from the U.K., the Netherlands, Austria, and Jersey (as in the Isle, not where hot cars are sprung from cages on Highway 9). Those attorneys were skillful and delightful, but the way they practice law couldn't be more different from what we know. They couldn't do even the most ministerial stuff without "receiving instructions." The pace of the litigation abroad seemed slow and the tone tepid. It turns out that even some of the aspects of American litigation that we acknowledge are dopey suit us right down to the ground. By golly, we even missed the tub-thumping plaintiff lawyers who conjure up crazy morality plays. It's like that scene in Patton (sure to be showing on a lot of basic cable channels today) where Patton ruminates on the drama of war: "God help me, I do love it so."

Last year we had an especially contentious meeting with plaintiff lawyers in Houston. It was at their place. Their offices were way more interesting than ours. We have Ansel Adams prints and tacky vanity plaques on our walls. They had antelope heads on theirs. There was a big fight over company documents. At lunch-time, our hosts brought in just about the best barbecue we've ever had. Somehow, over the ribs and corn, we slopped and slobbed our way toward common ground.

Today is a great day for barbecues, of course. And it's a great day to remember all that we love about America, including what it lets us do and those with whom we do it.

Enjoy your Fourth of July.

Friday, July 1, 2011

Another Reason To Like TwIqbal

Not that we need any, but the recent decision in McFarland v. APP Pharmaceuticals LLC, slip op., 2011 WL 2413797 (W.D. Wash. June 13, 2011), is another reason to like TwIqbal.


The wife plaintiff was administered an anticoagulant drug and, lo and behold, her “platelet counts dropped dramatically.”  2011 WL 2413797, at *1.  Unfortunately, that was not a good thing – not at all – and she lost a leg.

She sued.

Boy did she sue.

Specifically, plaintiffs “asserted their claims against 18 named defendants and 75 fictitious defendants.”  Id.

Not only that, plaintiffs blithely alleged that each and every one of these 93 defendants made the drug that caused the injury.  Id.  The complaint did “not specifically identify which, if any, of the defendants manufactured or was otherwise responsible for the product.”  Id. at *2.

Plaintiff fails to allege that her injury was caused by any specific defendant’s product.  Instead, she alleges that all of the 93 defendants “manufactured, supplied and/or sold” all of the doses she received, and that all of those administrations caused her injury.
Id.

Fortunately, after TwIqbal, defendants don’t have to take the kind of scattershot pleading lying down.  As the court stated in McFarland, such “vague and broad allegations fail to meet the plausibility standard” imposed by TwIqbal.  2011 WL 2413797, at *2.

Plaintiffs’ response was essentially, “if we can do it a little; we can do it a lot.”  They relied upon a couple of other cases involving the same drug from New Jersey, where courts had held that “you all made the stuff” allegations were plausible when asserted against three different manufacturers.  Id. The drug is a generic product and those courts supposed it was possible that different manufacturers’ products were used.

We'd take issue with that, but regardless, what might be “plausible” with three defendants, isn’t nearly as plausible with 93:

[A]lleging that 93 defendants all manufactured, distributed, and/or sold all of the products that caused all of plaintiff’s injuries is not plausible.  In addition, plaintiff's allegations are internally inconsistent.  The complaint alleges that “each” of the defendants manufactured the heparin that caused her injuries, but also alleges that each of the 93 defendants “separately manufactured, marketed, distributed, wholesaled, and/or sold” heparin.  The inconsistencies between those allegations, which are not pled in the alternative, further highlight the implausibility of plaintiff's allegations.
McFarland, 2011 WL 2413797, at *3.

Basically, the plaintiffs in McFarland didn’t want to do even the most basic spadework of identifying the correct defendants before bringing suit, so they threw in the kitchen sink in the hope that the defendants would end up having to spend the time and effort to figure things out.  Fortunately, TwIqbal gives our side a chance to stop this sort of funny business and require the plaintiffs to do what they should be doing under Fed. R. Civ. P. 11, but all too often don't.