eli lilly

Eli Lilly Attempts to Block Our Firm’s Motion for Class Certification

In August 2013, our law firm submitted several points of law in support of our motion for class certification. The motion was filed in the U.S. District Court for the Central District of California before Judge Stephen V. Wilson – and advanced arguments in support of a finding of class certification in light of the various prerequisites set forth in applicable Federal Rule of Civil Procedure 23.

The Rule begins with a four-prong checklist of factors that must be met in order for certification as a class action (as opposed to individual actions) to be appropriate. In sum, our firm contends that class certification is appropriate because the number of Cymbalta patients is too numerous to practically litigate each individual, representative plaintiffs will adequately protect the interests of all class members, class members have experienced the same course of conduct resulting in the same injuries, and all class members share the same question of law and fact. We further argued that the arguments against Eli Lilly as a whole predominate any individual claims, and a class action is the best way to adjudicate the matters.

On August 26, 2013, counsel for Eli Lilly filed its Opposition to Motion for Class Certification, contending that our law firm met just one of our prerequisites, and the motion should be dismissed.

With regard to the commonality requirement – which mandates a showing that members of the class have common questions of law and fact – Eli Lilly advances the argument that the common issue in the case is one of causation, not deceptive labeling, and each individual plaintiff must advance his or her own causation argument as each was treated by a different physician under a different set of circumstances.

Eli Lilly further asserts that the issue of typicality is not met – which requires a common course of conduct by the defendant, resulting in a common injury for all class members. Eli Lilly advanced the same argument here as in the commonality prong: each plaintiff’s experience with Cymbalta is unique and dependent upon that plaintiff’s personal experience with the drug and its warning label.

Third, Eli Lilly rebuts our firm’s argument that representative plaintiffs can adequately advance the interests of the group as a whole. Relying on the alleged unique nature of each plaintiff’s experience, as outlined in the commonality and typicality analysis, defendants assert that one representative plaintiff cannot possibly advance the interests of potentially hundreds of thousands of Cymbalta plaintiffs.

From there, Eli Lilly further rebuts our position that the over-arching questions of fact predominate against individual claims, asserting that each plaintiff’s Cymbalta experience is patient-specific and reliant upon many factors inherent in the physician-patient relationship. Eli Lilly listed several individual and unique assessments that would have to be considered in each individual case, including whether the treating physician read, digested, and understood the Cymbalta warning label.

In sum, Eli Lilly advances its claim that class certification is improper in this case, and our firm’s motion should be denied for the foregoing reasons.

Our Firms File Motion for Class Certification Under Federal Class Action Rule 23(b)(3)

When it comes to a lawsuit against a large, multinational drug corporation like Eli Lilly, it is not uncommon for plaintiffs to band together in order to consolidate their claims and effectuate a streamlined settlement or litigation process. However, certification as a class action must be granted by the judge assigned to the case, and requires a showing that certain per-requisites are met – which are set forth in Federal Rule of Civil Procedure 23 (and comparable state procedure statutes).

In August 2013, our firm moved for certification as a class before Judge Stephen V. Wilson of the U.S. District Court for the Central District of California. Our motion set forth the various requirements of class certification set forth in the federal law, and explained why each are clearly met under our particular set of facts.

Beginning with the anecdotal reference to founder Benjamin Franklin’s oft-quoted phrase, “[h]alf a truth is often a great lie,” we summarily encapsulated our position that Eli Lilly has for years been able to sell its powerful antidepressant drug at a premium by concealing its life-altering discontinuation side effects.

From there, we defined our classes as [a]ll natural persons within the Commonwealth of Massachusetts and the States of Missouri, New York, and California who purchased and/or paid for Cymbalta manufactured, distributed, and/or marketed by Lilly from Cymbalta’s August 2004 launch until the present, divided into four subclasses. Our subclasses are distinguished between the jurisdictions of Massachusetts, Missouri, New York, and California – and the applicable consumer protection statutes available in each.

The first prerequisite to establishing a class is that the members of the class are “ascertainable,” or “administratively feasible for the court to ascertain whether an individual is a member.” Our firm asserts that membership in the class is based on objective criterion: the purchase of Cymbalta – an act clearly provable through medical or financial records.

From there, we address the prerequisites of "numerosity," "commonality," "typicality," and "adequacy" – all of which must be present in order for class certification to be proper.

"Numerosity" requires a showing that separate joinder of the individual actions against Eli Lilly by Cymbalta patients would be impracticable. Our firm asserts that general common sense dictates the numerosity prerequisite is met, considering nine million Americans have purchased Cymbalta over the past ten years.

"Commonality" requires a showing that the members of class share a common interest of law and fact. In other words, the resolution of an issue as to one plaintiff would resolve the issue for all. We advance the argument that our pivotal question of law involves whether each Cymbalta patient is considered a “consumer” within the definitions of the various applicable state statutes, and therefore all plaintiffs share a common interest of law.

"Typicality" requires a showing that members of the class suffered the same type of injury caused by the same course of conduct. We contend that typicality is satisfied because each case shares a universal component: omission of information. As a result, each plaintiff suffered the same injury: “they each paid for a drug whose value was inflated by the omission of material information about the true frequency, severity, and duration of withdrawal.”

Lastly, we addressed the prerequisite of "adequacy," which requires that representative plaintiffs (e.g., Jennifer Saavedra) will adequately address the needs of all members of the class. We contend that there are no conflicts within the class, and our counsel is well-versed in the litigation of complex pharmaceutical cases – thereby adequately protected the interests of all involved.

Our motion further addressed the prerequisites of predominance and superiority, which require common, predominating issues of fact, and a showing that the class action method would be superior to other methods of adjudication, respectfully. Our firm advanced the arguments that each states’ consumer protection statute addresses whether the defendant’s conduct violated the law, thereby alleviating individual analyses of misconduct – establishing the predominance element. We further assert that the class action is the best way to properly adjudicate all putative subclass actions, considering the pool of potential plaintiffs is so large.

Judge Wilson Renders Pivotal Decision on ‘Learned Intermediary Doctrine;’ Holds it Applies in Cymbalta Litigation

One of the main, over-arching issues facing U.S. District Court Judge Stephen V. Wilson in our ongoing class action between drug maker Eli Lilly and scores of former Cymbalta patients involves the applicability of the common law “learned intermediary doctrine.’ This doctrine was developed under the auspices of negligence law to address the common scenario wherein a drug company manufactures a product, doctors learn about the product either through training or conferences, and thereafter describe and prescribe the product to patients presenting with the symptoms or ailments contemplated by the drug during its clinical testing phase. In general, and subject to exception, the doctrine holds drug makers immune from liability to patients for injuries sustained by a drug when those patients were counseled on about the drug by a ‘learned intermediary,’ (i.e., a doctor or healthcare professional).

Our law firm has vehemently denied that the ‘learned intermediary doctrine’ applies to this case, particularly in the context of consumer protection laws. Specifically, our class action – and several subclass actions – involve arguments that Eli Lilly intentionally and purposefully omitted important and life-saving information about the potential side effects awaiting users who abruptly stop the medication. We assert that this practice amounts to deceptive trade, consumer fraud, and various other consumer protection-related arguments.

Eli Lilly asserts that the ‘learned intermediary doctrine’ does not apply in the context of consumer protection because its “consumers” are doctors and healthcare professionals, not patients.

Our firms further rebutted this argument by pointing to Lilly’s eight-figure marketing budget, directed predominantly to potential patients through television, radio, and internet advertisements. We concluded that Lilly’s argument that its consumers are not patients is absurd, and patients are within the direct purview of consumer protection laws as applied to medical products, devices, and especially drugs.

The court reviewed that this issue was one of “first impression,” meaning it had not been previously considered by other courts, and no direct precedent applied to give precise direction as to the proper outcome. When this occurs, the court is under a duty to use its best judgment – perhaps relying on factually-similar cases – to determine how the relevant state supreme court would decide the issue if presented.

In one case, a Texas District Court expressed anxiety over the notion that litigants could possibly render the doctrine applicable by “casting” it under a different cause of action (i.e., consumer protection as opposed to tort), then the doctrine itself would be essentially meaningless. In other words, if it doesn’t work in tort, it shouldn’t work in consumer protection. Similar holdings were reached in Florida, Missouri, New York, and Massachusetts.

As a result of the seemingly overwhelming willingness of courts to apply the ‘learned intermediary doctrine’ to not only consumer protection cases, but fraud and misrepresentation cases (many of which involved pharmaceutical drug companies), the court in our case was hesitant to outright grant side with the argument that it did not apply against Eli Lilly and its disclosures relating to Cymbalta.

The court concluded that, in order for Eli Lilly to prevail, it must show that it adequately warned physicians and other ‘learned intermediaries’ of the dangers of Cymbalta discontinuation, and granted our firm’s extensive discover requests as set forth in our Opposition to Defendant’s Motion for Summary Judgment.

Cymbalta Plaintiffs Rebut Eli Lilly’s Motion for Summary Judgment

In the ongoing litigation between Indianapolis-based drug maker Eli Lilly and a nationwide class of former Cymbalta patients, our law firm filed a thorough and responsive rebuttal to Eli Lilly’s claims it did not owe a duty to Cymbalta patients directly and, even if it did, there was enough public information available for patients to adequately understand the possible adversities of discontinuing the powerful antidepressant.

Our rebuttal is composed of four distinct inquiries, each of which is drafted to elicit further information from the drug company about its stance on the particular issues of duty and causation.

The first point – captioned as “[w]hom does [Eli] Lilly treat as the consumer?” – seeks additional information from the defendant as to how it can categorize its “consumer” as medically-trained healthcare professionals and not the actual patient taking the drug. Describing the argument as “tortured,” our law firm seeks a more through explanation from the drug maker as to how it defines the term “consumer” outside the context of litigation, primarily with regard to marketing, sales and advertising. In other words, when a television commercial airs touting the effectiveness of Cymbalta, is it directed at medically-trained healthcare professionals? Or directly at potential patients?

Secondly, we request further clarification of whether Eli Lilly’s representations about Cymbalta would have been “misleading to a reasonable lay consumer.” Our argument further attacks Lilly’s “contorted” assertions that its “consumers” are doctors and medical professionals, not patients, and we seek clarification with regard to Lilly’s marketing strategies and its particular internal procedures implemented to determine the nature of the information directly marketed at patients. To further rebut Eli Lilly’s claims that its “consumers” are doctors, we pointed out that it spent $46.7 million in the first three months of 2012 marketing directly to consumers (i.e., patients).

Third, our firm takes aim at Lilly’s application of the “learned intermediary doctrine,” which is a legal doctrine designed to alleviate the duty of a drug company to the ultimate consumer – the patient. Under the doctrine, Lilly seeks to establish that it merely owed a duty of care and disclosure to medical professionals, and not to the patients they treat. In order to gather more information and adequately address this claim, our firm hypothetically assumes this doctrine applies – and therefore seeks additional information in discovery as to the extent to which Lilly informed and trained doctors on the abrupt and severe symptoms associated with the discontinuation of Cymbalta.

Lastly, as a tie-in to all three arguments, our firm inquires as to whether – should Eli Lilly successfully advance its claim that the ‘learned intermediary doctrine’ applies to preclude exposure to liability – that its extensive marketing efforts ultimately derail this line of defense. Specifically, we request detailed information about Lilly’s marketing plans, budgets, studies, analyses, and any correlation between direct-to-consumer (in the traditional sense of the word) and increased sales of Cymbalta.

To conclude, our firm summarized the above arguments to contend that summary judgment – which requires a finding of no material issue of fact – should be denied, or at the very least deferred pending the submission of the requested discovery materials.

Eli Lilly Seeks to Escape Cymbalta Liability By Motioning for Summary Judgment

Under the Federal Rules of Civil Procedure, a defendant facing liability can seek to have the case dismissed by advancing the argument that there is no reasonable dispute as to any material fact in the case. Known as a motion for summary judgment, this procedural maneuver is often used when the defendant asserts that no reasonable jury could find in favor of the plaintiff, as the facts are so skewed in favor of the defendant that its victory in the lawsuit is virtually inevitable.

Judges facing a motion for summary judgment must weigh the facts in a light most favorable to the plaintiff, particularly since summary judgment motions occur prior to a trial on the merits and the court has not had an opportunity to fully investigate the evidence supporting both sides’ arguments.

In our burgeoning class action against Cymbalta manufacturer Eli Lilly for alleged misrepresentations about the harms of discontinuation of the drug, the defendant asserts that it has been forthcoming all along about the dangers of Cymbalta discontinuation, and there is no way a reasonable jury could conclude that it hid evidence or failed to disclose information about extreme adversities associated with stopping Cymbalta treatment.

Specifically, Eli Lilly – through its counsel Covington & Burling LLP – put forth several reasons why plaintiffs should have been fully aware of the problems lurking in the event of discontinuation. First, it asserts that “discontinuation-emergent adverse events” have been part of public knowledge (i.e., revealed in technical medical journals) since the 1990’s. Secondly, the Cymbalta label has always made mention of possible problems a patient could face following discontinuation – citing its “three paragraph warning” – which is also available on Eli Lilly’s corporate website and is reproduced in the Physician’s Desk Manual. Defendants go on to cite several revisions to its warning label, all of which were allegedly accessible by Cymbalta patients and their healthcare providers at any time.

From there, defendants point to a “widely-disseminated, peer-reviewed medical journal” wherein a study was completed on patients enduring the discontinuation of the drug Cymbalta – pointing to 68 percent of patients who did not report any adverse side effects after the seventh day post-discontinuation.

The next assertion by the defendant is that it regularly publishes “medical information letters” on “discontinuation-emergent adverse events” as pertaining to its antidepressant products, including Cymbalta. While these letters are allegedly thorough resources for information about possible side effects of stopping Cymbalta use, Eli Lilly asserts that these letters are distributed amongst healthcare professionals, researchers and statisticians. It further asserts that the information contained within these letters is available and accessible in four ways: (i) calling 1-800-LillyRX; (ii) asking Lilly sales representatives; (iii) requesting the information from medical personnel at Eli Lilly conferences, and; (iv) submitting a request on www.LillyMedical.com.”

From there, defendants rely on the “learned intermediary doctrine” to assert that a drug company’s duty to warn of adverse side effects is between the company and the doctor. Thereafter, it is the doctor’s responsibility to relay information to the patient, and the drug company should not be held liable for omissions of information. It further relies on this distinction to rebut any claims made under state consumer protection statutes, as the “consumer” in the transaction is the medically-trained professional, not the patient.

Eli Lilly Seeks to Avoid Liability Using Motion to Dismiss in Growing Cymbalta Class Action Lawsuit

In our highly-publicized class action lawsuit involving the potent antidepressant drug Cymbalta, drug maker Eli Lilly sought to avoid conflict earlier by submitting its motion to dismiss in January, 2013. The motion, which directly attacks the validity of plaintiffs’ claims, was filed in U.S. District Court for the Central District of California before Judge Stephen V. Wilson, who is tasked with handling the hotly-contested assertions surrounding unpublished and undisclosed side effects upon the discontinuation of the drug.

Through its counsel, Michael X. Imbroscio of Washington D.C.-based Covington & Burling LLP, Eli Lilly submitted an expansive set of exhibits in support of its Memorandum of Points and Authorities attacking the plaintiffs’ claims each did not know that discontinuing Cymbalta could cause adverse side effects. More specifically, counsel submitted three distinct exhibits: (i) a copy of the November 2007 Cymbalta physician package insert; (ii) a copy of the March 2011 Cymbalta physician package insert, and; (iii) an excerpt from a 2005 article published in the Journal of Affective Disorders, entitled Symptoms following abrupt discontinuation of duloxetine treatment in patients with major depressive disorder.

In sum, Eli Lilly seeks to argue that its patients knew or should have known of the dangers of discontinuation of the drug – and the drug company should not have to further defend any claims stating otherwise.

The November 2007 physician insert, which spans approximately 31 pages, contains purportedly all the information a doctor would need to know in order to properly prescribe Cymbalta to a patient presenting with anxiety disorder or depression. Section 5.6 of the insert addresses the discontinuation of Cymbalta, and describes the possible side effects as “dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis and vertigo.”

The insert further explained that there have been “spontaneous reports” of adverse events occurring upon the abrupt discontinuation of the drug, particularly “dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures.”

Continuing with Exhibit 2, Eli Lilly presented its updated physician insert, which is presumably provided to all healthcare providers planning to prescribe the drug to patients. With regard to discontinuation of the drug, Exhibit 2 lists symptoms very similar to those listed in 2007, however it omits vertigo and nightmares. Its “less common” spontaneous side effects remained unchanged.

Lastly, through its Exhibit 3, Eli Lilly’s counsel seeks to advance the argument that physicians and patients should have been aware of the discontinuation symptoms – which have been described as “brain zaps” by patients having endured withdrawal – due to the fact a lengthy article was published in a psychiatric medical journal in 2005. The study focuses on the widespread reports of dizziness upon discontinuation, and further delves into other symptoms like vomiting, diarrhea, headaches and insomnia.

The study concluded by stating that the discontinuation symptoms for “most” patients were “mild to moderate,” and “reassurance by a clinician may be all that is required.”

The case is Jennifer L. Saavedra v. Eli Lilly & Co., case number 2:12-cv-09366, in the U.S. District Court for the Central District of California.

Amended Complaint Filed Against Drug Maker Eli Lilly

In December, 2012, our law firm filed its Amended Complaint against the Indiana-based drug company Eli Lilly, citing several counts with regard to its Cymbalta product – a powerful antidepressant drug with untold side effects and reports of devastating afflictions in its users. Our legal team advanced counts ranging from breach of warranty to strict products liability, all supported thorough evidence that Eli Lilly knew – or had reason to know – that its product was harmful for consumers and failed to adequately warn vulnerable depression and anxiety patients of the potential hazards.

Eli Lilly touts its Cymbalta product as safe and effective against the effects of major mood disorders, however the experiences of our plaintiffs reveal a darker side to the drug – including severe Cymbalta withdrawal symptoms of which the company failed to disclose. Several parties named in our Amended Complaint briefly describe their experiences with Cymbalta discontinuation, including the universal assertion that it is nearly impossible to achieve a seamless transition off of the drug. However, plaintiffs describe violent shaking, “brain zaps,” tunnel vision, nausea, vomiting, and other tell-tale symptoms of a difficult and painful withdrawal.

According to the Cymbalta package insert, discontinuation symptoms occurring at a rate equal to or greater than 1 percent of duloxetine-treated (non-placebo) patients include dizziness, nausea, headache, fatigue, paresthesia, vomiting, irritability, nightmares, insomnia, diarrhea, anxiety, hyperhidrosis and vertigo. However, our firm contends that the realities of Cymbalta withdrawal are much more severe, and victims would not have undergone Cymbalta treatment had they known the truth.

Plaintiffs’ attorneys contend that Eli Lilly systematically lied to consumers throughout the United States about true nature of Cymbalta withdrawal, citing weaning difficulties as uncommon and rare. Counsel also asserts that the drug maker has engaged in fraudulent and deceitful marketing practices in order to push Cymbalta prescriptions; completely and negligently ignoring the duty to fairly and adequately warn consumers about the nature of their anti-depressant prescription medication – and the likely experience upon discontinuation.

The Amended Complaint continues by addresses counts common to all plaintiffs within the class action, as well as counts particular to four distinct subclasses. Class representative plaintiff Jennifer Saavedra, through our firm, advances the claim that she suffering lingering and painfully disruptive symptoms upon halting Cymbalta, lasting longer than one year. Saavedra thoroughly read the warning label as pertaining to discontinuation symptoms, and would not have continued treatment had she known the truth about the drug.

Subclasses raise a number of state-specific arguments about the Eli Lilly product, beginning with a general allegation involving all states’ consumer protection statutes.

Count 1 of the California subclass alleges unfair and deceptive marketing practices in violation of the Consumer Legal Remedies Act. Our firm further contends that Eli Lilly intentionally failed consumers by claiming Cymbalta had certain characteristics, quality standards, and benefits it does not actually have – particularly within the context of discontinuation.

Count 2, also within the California subclass, alleges violations of California’s Unfair Competition Laws, including the unfair persuasion of plaintiffs like Saavedra to choose the Cymbalta product when other, safer, antidepressants may have better protected the plaintiffs’ well-being. Our firm also advanced a third Count on behalf of the California subclass pertaining to violations of California’s false advertising laws.

The Massachusetts subclass includes counts under the Massachusetts Consumer Protection Act, while the Missouri subclass argues that Eli Lilly violated its Merchandising Practices Act. Lastly, the New York subclass addresses plaintiffs’ contentions that Eli Lilly violated New York’s similar anti-deceit laws.

The Amended complaint concludes with allegations of personal injury, breach of warranty, strict products liability and negligence.

The case is Jennifer L. Saavedra v. Eli Lilly & Co., case number 2:12-cv-09366, in the U.S. District Court for the Central District of California.

Class Action Lawsuit Filed Against Eli Lilly and Company Regarding Cymbalta

Keller Rohrback L.L.P., Keller Rohrback P.L.C., Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC filed a class action lawsuit today against Eli Lilly and Company (“Lilly”) (NYSE:LLY). Lilly, an Indiana based pharmaceutical company, is the maker of Cymbalta. The class action complaint was filed in the United States District Court for the Central District of California, in Los Angeles, on behalf of all consumers who purchased Cymbalta at any time since the product’s launch in August 2004 to the present.

Cymbalta is prescribed to individuals that have been diagnosed with generalized anxiety disorder, fibromyalgia, and musculoskeletal pain. Plaintiff alleges that Lilly misrepresented the risks associated with taking Cymbalta and misled consumers about the frequency, severity, and duration of “Cymbalta withdrawal.” Withdrawal symptoms include, among others, headaches, dizziness, nausea, fatigue, nightmares, insomnia, anxiety, and suicidal ideation. Cymbalta withdrawal symptoms can range from mild to severe—the latter consisting of debilitating and painful symptoms that last several months.

If you used Cymbalta or you would like more information regarding the Cymbalta class action, please contact one of the following attorneys: Michael Woerner or Mark Samson, Keller Rohrback at 800-776-6044.

If you used Cymbalta, suffered serious side effects, and want more information about pursuing an individual personal injury claim, please contact Pogust Braslow Millrood LLC and Deskin Law Firm, a PLC via the contact form on this website or at 800-897-8930.

Contact Cymbalta Attorneys

We are no longer accepting new Cymbalta withdrawal cases.

Cymbalta LawyersOur firms are investigating problems with symptoms from the discontinuation of use of Cymbalta. Please use the form below to tell us about your situation. We will contact you by phone or email as soon as possible.



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