IN THE COURT OF COMMON PLEAS HAMILTON COUNTY OHIO LINDA BATES, individually and on behalf of all others similarly situated, ) CASE NO:__________________________ ) ) CLASS ACTION Plaintiff, ) ) -vs) HON. JUDGE:_______________________ ) MYLAN PHARMACEUTICALS, INC. ) a division of Mylan N.V. ) DEMAND FOR JURY TRIAL ) Defendant ) ________________________________________ CIVIL CONSUMER CLASS ACTION COMPLAINT NOW COMES the Plaintiff, LINDA BATES (hereinafter “Plaintiff”), individually and on behalf of other consumers similarly situated, by and through her attorney, THE LEWIS LAW FIRM, INC., LPA, and complaining of Defendant, MYLAN PHARMACEUTICALS, INC. (hereinafter “Mylan” or “Defendant”), and hereby states as follows: NATURE OF THE CASE 1. This consumer class action is brought by Plaintiff, individually and on behalf of putative statewide class in Ohio, (hereinafter “the Class”), for declaratory and injunctive relief, and to recover drug payments and overpayments made from at least the year 2007 through the present (hereinafter the “relevant time period”), as a result of Defendant’s unlawful scheme involving the exorbitant and unconscionable price increase of more than 548% since 20071of its consumer drug product Epinephrine (“EpiPen”), the injection device for children and adults with life-threatening allergies. EpiPen is a lifesaving treatment for millions whose allergies can send them into severe, even life threatening, shock including many schoolchildren who are advised to 1 Wall Street Journal, Mylan Faces Scrutiny Over EpiPen Price Increases, Jonathan D. Rockoff, 08/24/2016 http://www.wsj.com/articles/mylan-faces-scrutiny-over-epipen-price-increases-1472074823 Page 1 of 12 keep an injector handy at all times. Epinephrine, also known as adrenaline, is a medication and hormone that is used for emergency treatment of severe allergic reactions (including anaphylaxis) caused by insect bites or stings, medicines, foods, or other substances. Epinephrine is also used to treat anaphylaxis that is caused by unknown substances or triggered by exercise. It is only available by prescription. 2. The consumer drug products included in this case include all EpiPens manufactured and distributed by Defendant including the following: a. EpiPen®; b. EpiPen Jr.®; c. EpiPen 2-Pak®; d. EpiPen Jr. 2-Pak®; e. My EpiPen®; f. LIFE HAPPENS®; g. Be Pepared®; h. EpiPen4Schools®. i. Never-See-Needle® These consumer drug products are hereinafter collectively referred to as “EpiPen Drugs” 3. In 2007 Defendant, began increasing the price for its EpiPen Drugs to astronomical prices. Last year when all of Defendant’s competition was removed from the market Defendant then became the sole and only manufacturer and distributor of the EpiPen Drugs and the price increased to more than 400%. Plaintiff notes that in 2015 she paid $50.00 for her son’s EpiPen which expires in October 2016 and she has been informed by her pharmacists that the same EpiPen will now costs her $600.00. There is no legitimate, lawful reason for these price increases. Page 2 of 12 4. EpiPen Drugs are “life-saving” drugs that persons suffering with allergies must have and Defendant is aware that no matter what price is set the consumer will endeavor to pay. EpiPen drugs are not normal products that the consumer can elect to do without. They are necessary to the consumers who purchase them and are classed as an “essential medication” by the World Health Organization.2 5. The outrageous, unconscionable and immoral high prices set by Defendant is nothing more than price gouging.. 6. The consumer Class will have to pay more than four to five times the price they paid even in 2015 for the same EpiPen Drugs. JURISDICTION AND VENUE 7. This Court has personal jurisdiction over the defendants in this matter and subject matter jurisdiction over the allegations in the Complaint. 8. The amount in controversy exceeds the jurisdictional minimum for this Court. 9. Venue is proper in this Court per Civ. R. 3(B)(3). THE PARTIES 10. Plaintiff is an individual and resident of Cincinnati, OH who, during the relevant time period, purchased EpiPen Drugs for her now 15 year old son who suffers from peanut allergies which Plaintiff began purchasing for her son when he was 5 years old. As a result, Plaintiff, like other members of the Consumer Class, suffered damages from the unlawful scheme and exorbitant price increase(s) of the same by Defendant, which damages resulted from her being forced to pay the exorbitant prices for EpiPen Drugs or risk the death of her son. 2 http://www.who.int/medicines/publications/essentialmedicines/18th_EML.pdf last accessed 8/30/2016 Page 3 of 12 11. Defendant, Mylan Pharmaceuticals, a subsidiary and/or division of Mylan N.V. a global generic and specialty pharmaceuticals company, is located in Canonsburg, Pennsylvania and makes extensive sales in the State of Ohio. 12. Mylan has grown from the third-largest generic and pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world. Mylan now has approximately 30,000 employees, more than 1,000 separate products, and serves customers in more than 150 countries and territories. Mylan has a global manufacturing output of more than 45 billion doses. FACTUAL ALLEGATIONS A. Defendants Unlawful Scheme to Manufacture, Market and Sell EpiPen Drugs at Outrageous and Exorbitant Prices. 13. “The EpiPen, an epinephrine auto injector, has been on the market since 1977. Mylan acquired the device in 2007, when a pen cost patients about $57. Today, patients have to shell out $500 or more to receive a dollar’s worth of the lifesaving drug, according to an article in Forbes. Mylan’s profits from selling EpiPens reportedly hit $1.2 billion in 2015. That success came at a steep price for patients. Even after insurance kicks in, customers can be out $400 or more for a pack of two pens. Current guidelines call for prescribing two doses in case the first one fails, which Mylan used as an opportunity to stop selling single pens and begin selling only two-packs, according to Forbes. Patients do have access to a generic version of a calibrated delivery device for epinephrine, the Adrenaclick, Forbes notes. However, the two devices work differently in ways that result in critical errors if users aren’t properly trained. For example, the EpiPen requires the removal of a single cap for use, whereas the Adrenaclick reportedly requires the removal of two caps. In related news, Bloomberg reports that two senior U.S. senators are looking into Mylan’s price increases for the EpiPen, saying that the company’s practices may have limited competition Page 4 of 12 and access to the treatment. “The substantial price increase could limit access to a much-needed medication,” Senator Charles Grassley (R-Iowa) wrote to Mylan Chief Executive Officer Heather Bresch in an August 22 letter. In a separate letter, Senator Amy Klobuchar (D-Minnesota) asked the Federal Trade Commission to look into whether Mylan had done anything to deny competitors access to the market in order to keep raising prices. She pointed to the Adrenaclick device, which she said is less expensive but has only minimal sales. In October 2015, Sanofi recalled its rival product, the Auvi-Q epinephrine injection, because of reports of device malfunctions and concerns that it wasn’t delivering the correct dose. In February, Teva Pharmaceutical Industries said that the FDA had identified major deficiencies in its application for its own epinephrine injector. Those setbacks have helped Mylan dominate the market, according to Bloomberg.” 3 B. EpiPen Executives Got Huge Pay Raises After Unconscionable, Outrageous and Exorbitant Price Increases. CEO Heather Bresch’s went from $2M to $19M4 14. Makers of the EpiPen gave themselves fat raises as they were increasing the cost of the life-saving device. Mylan CEO Heather Bresch saw her salary leap to $18.9 million from $2.4 million, a 671% increase from 2007 to 2015. That was same period during which Mylan, after acquiring EpiPen, began steadily raising its price by 500%. President Rajiv Malik's base pay jumped 11.1% to $1 million and Chief Commercial Officer Anthony Mauro’s rose 13.6% to $625,000.5 C. The Rights to be free from “Price Gouging”. 15. Ohio consumers are protected by law from the above described price increases. 16. Ohio has adopted sections of the Uniform Commercial Code that prohibit defendants 3 Forbes, August 22, 2016; Bloomberg, August 22, 2016 and http://www.managedcaremag.com/news/mylanhikes-epipen-price-400 . 4 Linda Hervieux, Newser Staff, http://www.newser.com/story/230089/epipen-execs-got-huge-raises-after-pricehike. 5 Id. and Proxy Filings. Page 5 of 12 actions described herein. 6 17. Moreover the Ohio Consumer Sales protection Act classes defendant’s actions as unconscionable. R.C. 1345.03 (B). 18. Defendant has a legal duty and obligation to set a fair, affordable and reasonable Price and not hold consumers hostage by forcing them to pay exorbitant prices for its medically necessary product. CLASS ACTION ALLEGATIONS 19. Pursuant to Rule 23 of the Ohio Rules of Civil Procedure, Plaintiff brings this action on behalf of herself and a Class, defined as follows: All individuals in Ohio who, for purposes other than resale, purchased or paid for EpiPen Drugs from at least 2007 through the present. For purposes of the Class definition, individuals “purchased” these drugs if they paid all or part of the purchase price. 20. Excluded from the Class is Defendant and any entities in which any Defendant has a controlling interest, and its legal representatives, officers, directors, assignees and successors. Also excluded from the Class are any judges or justices to whom this action is assigned, together with any relative of such judge(s) or justice(s) within the third degree of relationship, and the spouse of any such person. A. NUMEROSITY 21. B. The Class is so numerous that joinder of all members is impractical. TYPICALITY 22. The claim of the representative Plaintiff is typical of the claims of the Class, in that Plaintiff, like all consumer Class members, purchased, EpiPen Drugs not by choice or for 6 Including but not limited to: UCC 1-201(20) at R.C. 1301.201; UCC 1-304 at R.C. 1301.304; and UCC 2-302 at R.C. 1302.15 Page 6 of 12 convenience but out of medical necessity and are all subject to the unlawful pricing imposed by the Defendant. C. SUPERIORITY 23. The class action is superior to other available methods for the fair and efficient adjudication of the controversy. D. ADEQUACY 24. Plaintiff will fairly and adequately represent and protect the interest of the Class and have retained Counsel experienced in complex litigation and in class litigation. E. COMMONALITY 25. Common questions of law and fact exist as to all members of the class and predominate over any question solely affecting individual members of the class, including but not limited to that each class member purchases the EpiPen Drug out of medical necessity and has no reasonable way to access a more cost efficient alternative. 26. This case is maintainable as a class action under Ohio Rule of Civil Procedure 23(b)(1) because prosecution of actions by or against individual members of the class would result in inconsistent or varying adjudications and create the risk of incompatible standards of conduct for Defendants. 27. Class certification is appropriate under Ohio Rule of Civil Procedure 23(b)(3) because questions of law and fact common to the class predominate over any questions affecting only individual members of the class, and because a class action is superior to other available methods for the fair and efficient adjudication of this litigation. Defendants’ common and uniform policies and practices were applied to all members of the class and violated the Ohio Consumer Sales Practices Act, and constituted breach of contract, breach of duty of faith and fair dealing, Page 7 of 12 and fraud. The damages suffered by the individual class members are small compared to the expense and burden of individual prosecution of this litigation. In addition, class certification is superior because it will obviate the need for unduly duplicative litigation that might result in inconsistent judgments of Defendants’ practices. 28. Plaintiffs intend to send notice to all members of the class to the extent required by Rule 23. The Names and addresses of the class are readily available from Defendants. CLAIMS FOR RELIEF COUNT I Violations of the Ohio Consumer Sales Practices Act 29. Plaintiff incorporates by reference all preceding paragraphs, as well as the paragraphs that follow in this Complaint, as if fully set forth herein. 30. The Ohio Consumer sales Practices Act (“CSPA), in R.C. § 1345.03(A), provides that no supplier shall commit an unconscionable act or practice in connection with a consumer transaction. 31. A “consumer” is a person who engagers in a consumer transaction with a supplier. R.C. 1345.01(D). 32. A “supplier” is a person engaged in the business of effecting or soliciting consumer transactions, whether or not he/she deals directly with the consumer. R.C. 1345.01 (C). 33. A “consumer transaction” is a transaction in which an item is purchased for the purposes that are primarily personal, family, or household. R.C. 1345.01 (A). 34. The CSPA prohibits a supplier from knowingly taking advantage of a consumer’s inability to protect their own interest due to, inter alia, physical infirmities. R.C. 1345.03(B)(1). Page 8 of 12 35. The consistent pattern and practice of Defendant Mylan of overcharging consumers such as the Plaintiff and the putative class members for medically necessary epinephrine constitutes an unconscionable act or practice in connection with a consumer transaction, in violation of the CSPA and the Ohio version of the Uniform Commercial Code. 36. Plaintiff and each putative class member are entitled to recover damages and other appropriate relief. WHEREFORE, Plaintiff, on behalf of herself and the members of the Class, respectfully seeks the relief set forth below. COUNT II Breach of the Duty of Good Faith and Fair Dealing 37. Plaintiff incorporates by reference all preceding paragraphs, as well as the paragraphs that follow in this Complaint, as if fully set forth herein. 38. Implicit in each consumer transaction described above was a duty of good faith and fair dealing from Defendants to each consumer. 39. This duty is also made explicit by the Ohio version of the Uniform Commercial Code as listed above. 40. Defendant breached each duty by charging an excessive and unjustified price for medically necessary epinephrine to the plaintiff and class members. 41. Plaintiff and the Class have been damaged as a direct and proximate result of Defendant’s conduct and breach. WHEREFORE, Plaintiff, on behalf of herself and the members of the Class respectfully seeks the relief set forth below. Page 9 of 12 COUNT III Unjust Enrichment 42. Plaintiff incorporates by reference all preceding paragraphs, as well as the paragraphs that follow in this Complaint, as if fully set forth herein. 43. By engaging in conduct described in this Complaint, Defendant has knowingly obtained benefits from Plaintiff and the Class under circumstances such that it would be inequitable and unjust for the Defendant to retain them. 44. Thus, Defendant will be unjustly enriched if it is permitted to retain the full amounts paid to them by Plaintiff and the members of the Class. 45. Plaintiff and the Class are therefore entitled to an award of compensatory and punitive damages in an amount to be determined at trial or to the imposition of a constructive trust upon the wrongful profits obtained by, revenues obtained by, and benefits conferred upon Defendant as a result of its wrongdoing and the payments made by Plaintiff and members of the Class. WHEREFORE, Plaintiff, on behalf of herself and the members of the Class, respectfully seeks the relief set forth below. Punitive Conduct 46. Plaintiff incorporates by reference all preceding paragraphs, as well as the paragraphs that follow in this Complaint, as if fully set forth herein. 47. By engaging in the conduct described in this Complaint, Defendant has intentionally disregarded the potential risk of harm that the outrageous and exorbitant prices for the EpiPen Drugs will have on the of millions of children and adults in the United States whose parents and/or guardians of said children and adults who will be forced to pay the outrageous and Page 10 of 12 exorbitant prices or risk a fatal allergic reaction if they don’t have the EpiPen during an allergic reaction. 48. Defendant’s conduct was knowing, intentional, with malice and demonstrated a complete lack of care for its consumers and was in reckless disregard of the rights of the Plaintiff and Class members. Defendant’s conduct has been outrageous and outside the bounds of decency. Defendant should be punished due to its conduct of putting infants, children and adults at risk of serious potential injury and/or death in order to make more profit. WHEREFORE, Plaintiff, on behalf of herself and the members of the Class respectfully seeks the relief set forth below. DEMAND FOR RELIEF WHEREFORE, Plaintiff, LINDA BATES, and the Class respectfully request that this Honorable Court: (a) Determine that the claims alleged herein may be maintained as a class action and issue an order certifying the Class as defined above; (b) Appoint Plaintiff as the representative of the Class and certify the Plaintiff’s class defined herein; (c) Appoint Attorney Cornelius “Carl” Lewis, of The Law Lewis Law Firm as Lead Class counsel; (d) On the claims under the consumer protection statues of Ohio award compensatory damages, treble damages, punitive damages, and any other damages permitted under such statutes, such amounts to be determined at trial, plus Plaintiff’s costs in this suit and reasonable attorneys’ fees; Page 11 of 12 (e) On the claim for unjust enrichment, award recovery in the amount of Plaintiff’s and the Class’ excess payments for these EpiPen Drugs; (f) Award Plaintiff and the Class other appropriate equitable relief, including, but not limited to, disgorgement of all profits obtained from Defendants’ wrongful conduct and declaratory and injunctive relief; (g) Award Plaintiff and the Class punitive damages to appropriately punish Defendants for their extreme misconduct; (h) Award Plaintiff and the Class pre-judgment and post-judgment interest at the maximum rate allowed by law; (i) Award Plaintiff and the Class their costs and expenses in this litigation, including expert fees, and reasonable attorneys’ fees; and (j) Award Plaintiff and the Class such other and further relief that this court deems just and proper under the circumstances. JURY DEMAND Plaintiff demands a jury on all issues so triable. Dated: September 6, 2016 Respectfully submitted, THE LEWIS LAW FIRM, INC., LPA By:___________________________________________ Attorney for Plaintiff Cornelius “Carl” Lewis, Esq. (Ohio Supreme Court Reg. #0055700) THE LEWIS LAW FIRM, INC., LPA 119 East Court Street Cincinnati, Ohio 45202 Phone: (513) 632-9542 Fax: (513) 721-5824 e-mail:CarlLewisLaw@gmail.com Page 12 of 12