We have rules at this blog: We don’t criticize drug and device companies, and we don’t criticize defense law firms.
But we’re making an exception here, and we bet you can understand why: Shook Hardy won an interesting case last week involving the sleeping pill Ambien. More than a dozen folks from Shook Hardy subscribe to this blog. Yet none of those subscribers told us about the firm’s victory! We learned about the Ambien decision only when we read about it on the AmLaw Litigation Daily.
Hence our headline: “Shook Hardy’s Asleep At The Wheel.” And hence too this public shaming: In the future, we expect to hear about Shook Hardy’s great victories promptly, and from folks at Shook Hardy. Got that, guys?
Okay, on to business.
On March 12, 2006, Darlene Gibson took an Ambien sleeping pill at about 7:30 at night. Gibson v. Sanofi-Aventis U.S., No. 3:07CV-192-S, slip op. (W.D. Ky. Oct. 27, 2009) (link here, courtesy of AmLaw Lit Daily). Gibson then “applied a cosmetic facial mud mask and put curlers in her hair.” Id. at 2 (although, we must admit, this is really more than we care to know). At 8:19, dressed for bed and still wearing her mud mask and curlers, and without wearing her eyeglasses, she crashed her car into a utility pole a mile from her home. Id. Gibson’s physician at the hospital said that Gibson had decided to drive herself to the hospital for cardiac symptoms and had fallen asleep at the wheel because she had popped a sleeping pill (or maybe two) before she got in the car. Id. Gibson, on the other hand, blamed Sanofi-Aventis, saying that she had been engaged in involuntary “sleep-driving.” Id. at 3.
The package insert for Ambien was pretty good for the defense. It listed somnambulism as a rare event. It warned to “use extreme care while doing anything that requires complete alertness such as driving a car.” Id. at 4. And it instructed: “You should only take Ambien right before going to bed.” Id.
On the other hand, after Gibson’s accident, a March 2007 “Dear Doctor” letter told physicians that Ambien’s labeling had been revised, at the FDA’s initiative, to include a precaution for patients about reported incidents of “sleep-driving.” Id.
Plaintiff’s experts, however, appear to have been asleep at the wheel. Neither one of them “were asked to render nor were they rendering opinions concerning the adequacy of the warning in the Ambien labeling at the time of the accident.” Id. at 5-6. And the FDA’s decision to revise the labeling in 2007 “does not alone establish inadequacy in the prior labeling.” Id. at 6. (Nice quote there. Make a mental note of it for later use.)
Gibson’s prescribing physician testified “that she would have prescribed Ambien for Gibson under either version of the Ambien labeling.” Id. And Gibson herself never read any product materials that accompanied her Ambien prescription. Id. The failure-to-warn claim thus failed.
Additionally, Gibson failed to establish “but for” causation, because she did not “rule out all other possible causes of the accident but the alleged involuntary act.” Id. When Gibson arrived at the hospital, she said that she had tried to drive herself to the hospital because she was experiencing chest pain and shortness of breath. If that were true, then her accident was not caused by “sleep-driving.” Because multiple causes of the accident were possible, Gibson could not blame sleep-driving for her accident under the doctrine of res ipsa loquitur. Id. at 7.
That’s a pretty good decision, but it gets better. The court went on to exclude Gibson’s expert reports under Daubert. Her expert reports said that it was “medically probable” or “highly probable” that her accident was caused by sleep-driving. But “there are no clinical studies linking the ingestion of Ambien to the behavior of sleep-driving.” Id. at 8. And the experts based their conclusions only on “anecdotal reports of a number of other ‘sleep-driving’ experiences.” Id. “There is nothing ‘expert’ about such a conclusion,” so as to require expert testimony, and the opinion that Gibson was sleep-driving was “sheer speculation void of any scientific basis.” Id.
The court thus granted summary judgment in favor of Sanofi-Aventis.
Nice work, Shook Hardy — except for the failure to let us know about this decision promptly. We’re giving you an “A” for legal work, but an “F” for reportage. We don’t expect this to happen again.