[Drug and Device Law] Little Reprieve for Prisoner Zyprexa Suit
Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern Romance (1981), Lost in America (1985), Defending Your Life (1991), and a gaggle of other comedies. Brooks also did fine work as an actor in several non-comedies, such as Taxi Driver (1976), Broadcast News (1987), and Drive (2011). But for our money, his best performance is in Out of Sight (1998), where Brooks played a Michael Milken-esque financier-turned-prison-inmate. By the way, Brooks’s birth name was Albert Einstein. Brooks changed his name for obvious reasons. He cracked that the great physicist had changed his name to Albert Einstein simply to sound smart. Finally, happy birthday to Don Henley of The Eagles. Henley sang and co-wrote “Hotel California” (1977), an allegory about SoCal showbiz excess. The best line in the song is “We are all just prisoners here of our own device.”
Does that trio of birthdays suggest a theme? Indeed, it does: drugs and prisoners. Today’s case is Flowers v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS (D. Nevada July 10, 2015), in which a pro se plaintiff prisoner claimed that Zyprexa gave him diabetes. The plaintiff had been prescribed Zyprexa at the beginning of his incarceration in 1997, went off it in 2003, and then back on it in 2009, continuing up through the filing of the lawsuit in 2014. The plaintiff was diagnosed with diabetes in November 2012. After learning of the diagnosis, the plaintiff requested that he be taken off Zyprexa. The request was denied. Remember, the plaintiff was a prisoner. Patient choice seldom matters from a legal point of view in these cases (because of the learned intermediary doctrine, discussed below), but in this case it really, really does not matter. Zyprexa is an antipsychotic drug that can be used to treat very serious conditions such as schizophrenia and bipolar disorder. The court’s opinion does not tell us why the prison wanted the plaintiff to be on an antipsychotic, but odds are there was a very good reason.
There has been a lot of litigation involving claims that antipsychotics cause diabetes. It is unclear what the scientific theory is -- whether the drugs are alleged directly to raise glucose levels, or whether they prompted the patient eat more, leading to obesity, leading to diabetes. People who take antipsychotics grapple with profound, life-disrupting issues. They can be a danger to themselves or others. They might face an inability to do basic, daily things that the rest of us take for granted, such as working, sleeping, or eating. Against those desperate medical issues, the risk of obesity and diabetes might seem like an easy trade-off. Plus, people on antipsychotics often already possess a large number of comorbidities. All of which is to say that a plaintiff in these cases faces an uphill battle when it comes to specific medical causation.
But in Flowers the court did not need to reach medical causation. Instead, the learned intermediary doctrine and warning causation proved to be almost insurmountable barriers. We say “almost” because the court left open the possibility that the case might proceed based on only the early usage by the plaintiff. For that case, if it exists at all, we foresee a specific medical causation problem that will likely doom the case. But let’s not get ahead of ourselves.
The plaintiff’s case was premised on an alleged failure to warn of the risks of diabetes. But in 2003, the FDA required certain antipsychotic drugs, including Zyprexa, to include warnings about the risks of diabetes. That warning language was added to the Zyprexa label in September 2003, and, in March 2004, the defendant sent a letter to doctors informing them of the label change. There is no decent argument that the diabetes warning was in any way inadequate. Moreover, the record in the case showed that all the prescribing doctors were aware of the drug’s potential side-effects. Those doctors decided that those risks were outweighed by the risk of discontinuing the plaintiff’s Zyprexa prescription, which had been more effective than other drugs in treating his psychotic symptoms. There was no evidence that any doctor “would have altered his prescription had the warning that accompanied Zyprexa been different”.
That takes care of any claim premised on usage after the diabetes warnings went into effect. But the plaintiff had used Zyprexa before 2003, as well. What to do about that? At this point the Flowers court considered a Second Circuit case that had confronted a similar chronological issue, Shepherd v. Eli Lilly & Co., 497 Fed Appx. 143 (2d Cir. 2012). In Shepherd, the Second Circuit held that the “Dear Doctor” letter insulated the defendant from liability for failure to warn after 2004. But in Shepherd, as in Flowers, there was also some usage antedating the warning. The Shepherd court concluded that the plaintiff’s claim that his injuries “were caused by residual effects of his Zyprexa usage before 2004” failed because the plaintiff’s own causation expert “concluded that his diabetes was caused by the Zyprexa he took from 2006 to 2009.” Now that’s a helpful expert. By contrast, in the Flowers case, the parties had not yet conducted expert discovery regarding causation from pre-warning usage. Thus, while the Flowers court granted summary judgment as to post-warning usage, it allowed the case to proceed as to pre-warning usage.
But – and this thought seems peculiarly pertinent given that the plaintiff is a prisoner – it’s only a matter of time. Even if the plaintiff is not so cordial as to furnish an expert who disavows the causative effect of the pre-warning usage, it seems incredibly unlikely that the plaintiff will be able to find an expert who can opine with medical certainty that it was the pre-warning usage that caused the diabetes. Why do we think no such plaintiff expert will emerge? First, an opinion connecting usage from a particular period of time to a diagnosis 8+ years later seems simply implausible. Second, the plaintiff is a prisoner. Even if there are experts out there who would sell their scientific integrity, they will not sell it cheap.
--
Posted By Steve McConnell to Drug and Device Law at 7/22/2015 07:30:00 AM --
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To post to this group, send email to drug-and-device-law@googlegroups.com
To unsubscribe from this group, send email to drug-and-device-law-unsubscribe@googlegroups.com
For more options, visit this group at http://groups.google.com/group/drug-and-device-law?hl=en
---
You received this message because you are subscribed to the Google Groups "Drug and Device Law" group.
To unsubscribe from this group and stop receiving emails from it, send an email to drug-and-device-law+unsubscribe@googlegroups.com.
For more options, visit https://groups.google.com/d/optout.
No comments:
Post a Comment