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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

A Myriad of Mylans – Who to Sue in a Fentanyl Case?

Posted in Duragesic / Fentanyl

I just generically refer to “Mylan” when I mean any one of several Mylan companies.  The best information I’ve seen so far about which Mylan is which comes from their own in-house litigation counsel, Brian Cutherbertson.  He filed a three page affidavit on August 13th of 2009 in the case of Boles v. Mylan.  In it, he details the corporate makeup of Mylan:

5. There is no entity presently operating under the name Mylan Laboratories, Inc. In October, 2007, Mylan Laboratories Inc. officially changed its name to Mylan Inc. ("Mr').

6. MI is a holding company incorporated under the laws of the Commonwealth of Pennsylvania, with its principal place of business at 1500 Corporate Drive, Canonsburg, PA 15317.

7. MI is a shareholder of companies involved in the production of quality generic and specialty pharmaceutical products.

8. MTI is a wholly owned subsidiary of MI and is a corporation organized and existing under the laws of the State of West Virginia with its principal place of business in St. Albans, Vermont.

9. On January 28,2005,M TI received approval from the federal Food and Drug Administration (" FDA") for the manufacture of the Mylan Fentanyl Transdermal System ("MFTS''). A true and correct copy of the FDA approval letter issued on January 28,2005, is attached to this Affidavit as Exhibit No. 1.

10. Pursuant to an Abbreviated New Drug Application submitted by MTI, FDA issued approval for MTI's manufacture of the MFTS concluding that the product was safe and effective when used in accordance with its approved labeling.

11. Since obtaining FDA approval on January 28, 2005, MTI has manufactured the MFTS at its production facilities in St. Albans, Vermont. Distribution of the MFTS is handled through MPI, another wholly owned subsidiary of MI. MPI is a West Virginia corporation with its principal place of business in Morgantown, West Virginia.

12. I understand that the Original Petition filed on behalf of plaintiff in this matter claims that Ms. Vail died on July 12, 2006, allegedly as a result of complications stemming from her use of the MFTS.

13. The MFTS was, at all times, developed, formulated, and manufactured by MTI. Since FDA approval of the product, MPI has been the entity responsible for the distribution and sale of the MFTS.

14. The Original Petition alleges, at paragraph 2.8, that MI, MTI, MPI, Mylan Bertek Pharmaceuticals, Inc. ("MBP"), and VDL Laboratories, Inc., are collectively " engaged in [the] business of designing, manufacturing, marketing, distributing, selling, and otherwise placing into the stream of commerce the [MFTS]." This allegation is incorrect.

15. MBP is a registered Texas corporation that is a wholly owned subsidiary of MI. However, MBP ceased all operations in June of 2005.

16. Thus, while MBP exists as a registered Texas corporation, it has no offices, employees, manufacturing facilities, warehouse, or sales staff in Texas or elsewhere. Moreover, MBP was never involved in any aspect of the design, manufacture, marketing, distribution, or sale of the MFTS.

17. Because the operations of MBP ceased in 2005, this entity absolutely was not involved in the development, manufacture, distribution, or sale of the pharmaceutical product allegedly used by Plaintiff's Decedent in 2006.

18. The final entity named in the Original Petition is VDL Laboratories, Inc. VDL Laboratories Inc. is an Illinois corporation with its principal place of business in the State of Illinois. Like MTI, UDL Laboratories, Inc. had no role or involvement in any aspect of the design, manufacture, marketing, distribution, sale, or supply of the MFTS.

If there are any typos in the above, blame my OCR software, not Mr. Cuthbertson.

Hopefully this document will help plaintiffs’ attorneys figure out which corporate entity to sue in a fentanyl lawsuit.