In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings

136 F. Supp. 3d 968, 2015 U.S. Dist. LEXIS 132278, 2015 WL 5768574
CourtDistrict Court, N.D. Illinois
DecidedSeptember 30, 2015
DocketNo. 14 C 1748; MDL No. 2545
StatusPublished
Cited by17 cases

This text of 136 F. Supp. 3d 968 (In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings, 136 F. Supp. 3d 968, 2015 U.S. Dist. LEXIS 132278, 2015 WL 5768574 (N.D. Ill. 2015).

Opinion

[970]*970 MEMORANDUM OPINION AND ORDER

MATTHEW F. KENNELLY, District Judge:

In this multidistrict litigation proceeding (MDL), over two thousand individual lawsuits, filed throughout the country, have been consolidated for coordinated pretrial proceedings in this Court. Plaintiffs in the individual cases have jointly filed a master complaint, which sets forth common allegations regarding plaintiffs’ claims against the multiple defendants in the MDL. All of the plaintiffs allege that they suffered injuries caused by defendants’ testosterone replacement therapy (TRT) drugs. Two of the defendants, Besins Healthcare Inc. (Besins Inc.) and Besins Healthcare, S.A. (Besins S.A.), have moved to dismiss all claims in plaintiffs’ second amended master complaint. Both Besins defendants move to dismiss for failure to state a claim. Besins S.A. also moves to dismiss for lack of personal jurisdiction.

Background

For purposes of the motion to dismiss, the Court accepts as true the facts alleged in plaintiffs’ master complaint. Defendant Besins S.A. is a privately held Belgian corporation headquartered in Thailand. Defendant Besins Inc., a wholly owned subsidiary of Besins S.A., is a Delaware corporation that has its principal place of business in Virginia. Plaintiffs allege that both Besins defendants “engaged in the research, ■ development, design, testing, manufacture, sales, marketing, and/or distribution of pharmaceutical products, including AndroGel,” one of the TRT drugs [971]*971at issue in the MDL. Master Compl. ¶¶ 25(a), 26(a). Besins S.A. engaged in these activities “with knowledge and intent that AndroGel would be marketed, distributed and sold throughout the United States____” Id. ¶ 26(a). According to plaintiffs, Besins Inc. holds the United States patent for the pharmaceutical formulation of AndroGel, whereas Besins S.A. owns unspecified “intellectual property rights” to AndroGel’s pharmaceutical formulation as well as the. rights to sell An-droGel in the United States. Id. ¶¶ 25(b), 26(b).

Besins S.A. manufactures AndroGel sold in the United States at its plant in Mon-trouge, France. AndroGel is an exogenous (that is, originating outside the body) form of testosterone that ■ is delivered transdermally and applied to the skin in the form of a gel. AndroGel, like the other TRT products in this case, has been approved by- the United States Food and Drug Administration (FDA) for treatment of hypogonadism, the diminished functional activity of the gonads which may involve the severely diminished production or non-production of testosterone. In 1995, the Besins defendants gave defendant Unimed Pharmaceuticals, LLC (Unimed) the exclusive right to market AndroGel in the United States. Unimed, a co-assignee with Besins Inc. for AndroGel’s United States patent, is a wholly owned subsidiary of defendant AbbVie Inc. and a direct, wholly owned subsidiary of defendant .AbbVie Products LLC (AbbVie Products). Un-imed is a limited liability company organized under the laws of Delaware, AbbVie Products is organized under the laws of Georgia, and AbbVie Inc. is organized under the laws of Delaware. All three have their principal places of business in Illinois.

According to plaintiffs, Besins S.A. manufactured AndroGel “for sale in the United States — ” Id. ¶ 26(c). Sales of Andro-Gel in the United States have been significant; sales revenue for 2013, for example, totaled $1.4 billion. Plaintiffs allege that the defendants in this MDL-have sold and promoted the use of AndroGel and other TRT drugs to treat a condition referred to as “Low T,” which is not a form of .classical hypogonadism and for which, plaintiffs allege, TRT drugs confer little or no benefit. They further allege that Besins S.A. has “derived substantial revenue” from such United States, sales,, and it “expected or should have expected its acts to have consequences within the United States.... ” Id. ¶ 26(d)-(e).

Plaintiffs aver that AndroGel is unsafe and that its design .is defective because it causes those who use it serious injuries and death as the result of the formation of blood clots and other adverse cardiovascular events. Allegations in the master comr plaint describe how and why AndroGel and other TRT products cause these injuries:

392. Testosterone regulates the expression, of platelet TXA2 receptors in humans,; which significantly increases platelet aggregation. I,t causes an increase in hematocrit and-, estradiol in adult males, resulting in thickened blood, the development of blood clots, and. heart damage.. These. effects, if not monitored and .controlled properly, can lead to life threatening cardiac events, strokes and thromboembolic events, including but not limited .to deep vein thrombosis, pulmonary embolism, transient ischemic attacks, ischemic stroke, and numerous types-of cardiovascular injuries.
393. Use of exogenous testosterone can cause an increase in serum levels of estradiol, the primary female sex hormone; through the conversion of excess testosterone into estradiol. -.Increased serum levels of estradiol have been asso-[972]*972dated with the development of blood dots and' with life threatening cardiac events, strokes and thromboembolic events, including but not limited to deep vein thrombosis, pulmonary embolism, transient ischemic attacks, ischemic stroke, , and numerous types of cardiovascular injuries. '

Id. ¶¶ 392-93.

In the master complaint, plaintiffs assert fourteen claims for relief against all defendants. In response to the Besins defendants’ motion to dismiss, plaintiffs concede that some of those claims cannot properly be asserted against the Besins defendants, and they consent to dismissal of those claims. These are claims Two, Four, Five, Six, Seven, and Nine in the second amended master, complaint. Plaintiffs,, however, continue to assert their strict liability claim based on design defect (Claim One), a negligence claim (Claim Three), and a redhibition claim- (Claim Eight), as well as claims seeking damages pursuant to those causes of action.

In support of the three claims at issue, plaintiffs make allegations about the “Defendants” collectively. The relevant collective allegations for the purposes of this motion are as follows. In support of Claim One, plaintiffs allege that the TRT drugs’ defective design made them unreasonably dangerous but that “Defendants”' knowingly-introduced the drugs- into the market and plaintiffs sustained their injury as a direct and proximate cause of “Defendants’ manufacture ... of the defectively designed drugs.” Id. ¶477. In support of Claim Three, plaintiffs allege that “Defendants” had a duty to properly manufacture and design the TRT products, they breached that duty by negligently and carelessly manufacturing and designing the TRT drugs, and this negligence was a proximate cause of plaintiffs’ injuries. In support of Claim Eight, plaintiffs allege that the TRT drugs’ defect rendered them useless or their use so inconvenient that buyers would not have used them had they known of the defect. In the alternative, plaintiffs allege that the TRT drugs’ defect so diminished their value that buyer would have purchased them for a lesser price had they known of the defect.

Discussion

When considering a motion to dismiss for failure to state a claim under' Federal Rule of Civil Procedure

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Bluebook (online)
136 F. Supp. 3d 968, 2015 U.S. Dist. LEXIS 132278, 2015 WL 5768574, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-testosterone-replacement-therapy-products-liability-litigation-ilnd-2015.