{"id":48918,"date":"2014-08-19T14:06:29","date_gmt":"2014-08-19T18:06:29","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=48918"},"modified":"2014-08-19T18:44:24","modified_gmt":"2014-08-19T22:44:24","slug":"intent-to-mislead","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/08\/19\/intent-to-mislead\/","title":{"rendered":"intent to mislead…"},"content":{"rendered":"
I never thought of myself as a "learned intermediary" – someone who is a go-between between patients and the pharmaceutical industry. I think of myself as someone who needs to know a lot about the drugs I prescribe – gathered from the literature, colleagues, and patients. In fact, I resent being seen that way by industry. No matter how hard they push this point, I’m not their "vendor," I’m a doctor who sees sick people. But I could rant on about that topic for hours, and there are other points to be made. So how did I get this designation – learned intermediary<\/a>?<\/div>\n
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Learned intermediary<\/font><\/strong> is a defense doctrine used in the legal system of the United States. This doctrine states that a manufacturer of a product has fulfilled his duty of care when he provides all of the necessary information to a "learned intermediary" who then interacts with the consumer of a product. This doctrine is primarily used by pharmaceutical and medical device manufacturers in defense of tort suits. In a clear majority of states, the courts have accepted this as a liability shield for pharmaceutical companies. Wikipedia<\/em> <\/div>\n<\/blockquote>\n
For example, we just learned that Roche just won the appeal of a judgement<\/a> against Accutane® based on such an argument. The appeal court ruled that Roche had informed the doctor of the possible adverse effect and that ended their obligation. It’s now an essential piece in the lawsuits against Eli Lilly in Cymbalta® withdrawal cases [see Antidepressant discontinuation syndrome<\/a>] where it was rejected in an attempt to have the suit dismissed:<\/div>\n
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2013 class action lawsuit<\/font><\/strong><\/u><\/div>\n
In 2013, a proposed class action lawsuit, Jennifer L Saavedra v. Eli Lilly and Company<\/em>, was brought against Eli Lilly claiming that the Cymbalta label omitted important information about "brain zaps" and other symptoms upon cessation. Eli Lilly moved for dismissal per the "learned intermediary doctrine" as the doctors prescribing the drug were warned of the potential problems and are an intermediary medical judgement between Lilly and patients; in December 2013 Lilly’s motion to dismiss was denied. Wikipedia<\/em><\/div>\n<\/blockquote>\n
The number of suits around this issue of the Discontinuation Syndrome with Cymbalta® are definitely on the rise [they prefer the term Discontinuation Syndrom<\/em>e rather than Withdrawal<\/em> because the patients aren’t drug-seeking]: <\/div>\n
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Lawsuits charge Eli Lilly with misleading consumers about Cymbalta withdrawal effects<\/a><\/div>\n
Salient News<\/font><\/strong><\/div>\n
by Stoff<\/div>\n
August 15, 2014<\/div>\n

Pharmaceutical giant Eli Lilly and Company is facing a growing number of lawsuits charging the company with misleading patients about the risk and severity of the withdrawal effects of its antidepressant, Cymbalta.  Cymbalta, which lost its patent protection last year, was Lilly’s top selling drug in 2013, earning $5 billion, according to the website FiercePharma<\/a>.<\/p>\n

In an August 14 press release, the law firm Baum, Hedlund, Aristei & Goldman reports that nearly two dozen Cymbalta withdrawal lawsuits<\/a> were recently filed in federal courts across the nation, adding to 7 suits filed in 2013, and a class action lawsuit filed in 2012. Plaintiffs in those suits claim they endured serious withdrawal symptoms, lasting in many cases for months, when they tried to stop taking the drug, and allege that Eli Lilly failed to warn them even though it knew, from its own published research, that severe withdrawal effects were commonplace and lasting.<\/p>\n

Central to the charges is the Cymbalta drug label itself, which states that the risk of withdrawal effects is “greater than or equal to 1%.” In 2005, a study designed, conducted and funded by Lilly, and published in the Journal of Affective Disorders<\/em>, found that up to 51% of users experienced discontinuation symptoms, which were severe in 10 – 17% of cases. In over 50% of the patients, withdrawal reactions had not resolved by the end of the study’s two week withdrawal period.<\/p>\n

Cymbalta’s withdrawal effects include severe nausea, vomiting, dizziness, headaches, vertigo, nightmares, and electric-shock-like sensations in the brain. In a declaration filed in, Harvard Medical School psychiatrist Joseph Glenmullen, author of two books on antidepressant side effects, says that the true incidence of withdrawal reactions may be as high as 78%.<\/font><\/strong><\/em><\/p>\n

Plaintiffs in the lawsuits allege that Cymbalta’s label misled them by suggesting that the risk of withdrawal effects was in the range of 1% and that the effects were generally short-term. The Cymbalta label makes no reference to the findings of Lilly’s study, instead referring to “spontaneous reports of adverse events” that are “generally self-limiting.”<\/div>\n
hat tip to<\/font><\/strong> Bob Fiddaman<\/a>…   <\/div>\n<\/blockquote>\n
\"Prozac\"When I read this, I had a d\u00e9jà vu moment. I was reminded of the early days of Prozac® [also from Eli Lilly]. Package inserts aren’t my primary resource when a new drug shows up, but I’ve always read the PDR [Physician’s Desk Reference] which is essentially a book of package labels for all of our drugs. Over my fifty years in medicine, the PDR has gotten much thicker and the print has gotten much smaller, so I have one of those plastic wallet card magnifiers as an always-around book-mark stuck in my copy. Whenever I learn of a new drug I might prescribe, I always check the PDR [package label] for adverse events and drug interactions. I can’t find the original Prozac® label, but I remember reading about the sexual side effects back in the day. And what it said and what turned out to be true weren’t even in the same state, much less the same county. I sure was no "learned intermediary" in that instance. It’s the first time I can recall feeling like I was being gamed <\/em>about a drug. I feel the same thing reading this final label<\/a> for Cymbalta® before it went off-patent this year…<\/div>\n