Fentanyl Patch Lawyer, Lawsuit, and Side Effect News

Another Motion to Compel Filed Against Mylan in a Fentanyl Patch Lawsuit

Mylan is again attempting to play "hide the ball" by refusing to turn over important information relating to their fentanyl pain patches.  Every time the plaintiff is forced to file a motion to compel, it (a) increases the plaintiff's costs, and (b) delays the proceedings.  It's therefore in Mylan's best interests to force the plaintiff to have to file numerous motions to compel.

These nineteen requests relate to the testing, studies, and analysis of “Mylan Products.” Plaintiff defines “Mylan Products” as “any of the transdermal fentanyl patch system products designed, manufactured or distributed by Defendants.” The Mylan Defendants' testing of the transdermal fentanyl patch systems and the results of that testing is critical information that is likely to lead to admissible evidence relating to Plaintiff's negligence and product liability claims. As other courts have noted, in product liability actions this type of testing and clinical trial data “is likely to lead to evidence relating to the design, manufacture, and implantation of [the product] that will be relevant to plaintiffs' allegation that the [product] is defective.” See Timberlake v. Synthes Spine Co., Civil Action No. V-08-4, 2008 U.S. Dist. LEXIS 44256, at *7-8 (S.D. Tex. June 4, 2008); See also In re Prempro Prods. Liab. Litig., MDL Docket No. 4:03-CV-1507-WRW, 2006 U.S. Dist. LEXIS 24931, at *11-15 (E.D. Ark. Mar. 20, 2006) (compelling disclosure of the “meeting minutes and reports of any ... committees ... that relate to the ... clinical trials”); Groundberg v. Upjohn Co., 137 F.R.D. 365, 367 (D. Utah 1991) (overruling objections to the production of the raw data of drug protocol reports used to record the reaction of persons given the medication used in a clinical trial).

Plaintiff has limited these requests to testing and studies of transdermal fentanyl patch systems, the product at issue in this case, and thus the Requests are not overly broad or unduly burdensome. Moreover, due to the nature of the case, these requests are limited in time to a reasonable period. Mylan Inc. announced final FDA approval for its fentanyl transdermal system on January 28, 2005. Thus, obtaining documents relating to the testing, studies and analysis of fentanyl transdermal patches will not require Mylan to comb through decades of documents. Most of the testing will have been done within the last five years. Accordingly, these requests are narrowly tailored to lead to evidence directly related to Plaintiff's claims, and production should be ordered. See FED. R. CIV. P. 26(b).

The Mylan Defendants assert that no documents can be produced without a protective order. Plaintiff disagrees. Plaintiff believes the vast majority of the documents sought by Plaintiff are not “trade secret[s] or other confidential research, development, or commercial information” subject to protection under Federal Rule of Civil Procedure 26(c)(1)(G). Certainly, the Mylan Defendants have the burden of justifying the confidentiality of each and every document sought to be covered by a protective order, which they have not done. See Cipollone v. Liggett Group, Inc., 785 F.2d 1108, 1122 (3rd Cir. 1986.) Accordingly, the Mylan Defendants should be required to produce documents responsive to these requests, and seek protection only for “trade secret or confidential research, development, or commercial information” protected by Rule 26(c)(1)(G).[FN2]

Motion to Compel Filed Against Mylan in Fentanyl Patch Lawsuit

After someone sues a fentanyl patch manufacturer, he or she is entitled to inspect documents in the possession of the manufacturer.  The process in which both sides exchange information is called, appropriately enough, "discovery."  Many of the fiercest legal battles are fought over discovery.  Mylan is fighting very hard not to have to reveal information about their fentanyl patches.  Because of Mylan's efforts to keep things secret, the plaintiffs in this case have had to file a motion to compel, which asks the court to order Mylan to produce the documents:

REQUEST NO. 11: Any and all documents related to the maximum concentration of serum fentanyl intended to be delivered through use of Mylan Products.

REQUEST NO. 12: Any and all documents related to the concentration of serum fentanyl intended to be delivered through use of Mylan Products.

REQUEST NO. 22: Any and all documents submitted to the FDA in connection with efforts to obtain FDA approval of any Mylan Products or the labeling for same.

REQUEST NO. 82: All documents that set forth the process by which decisions were made as to which Mylan Patches, or lots or batches of patches, were accepted or rejected at the Mylan Facility during the period January 1, 2003 to the present.

REQUEST NO. 126: Copies of any and all documents or written communication provided or sent by you to the FDA in connection with its investigation referenced in the FDA's July 15, 2005 Public Health Advisory regarding fentanyl transdermal patches.

REQUEST NO. 148: All Batch Records related to the lot or batch of the patch(es) the subject deceased had on at the time of his or her death.

REQUEST NO. 149: All Batch Records related to the three lots manufactured immediately prior to the lot of the patch(es) the subject deceased had on at the time of his or her death.

Without these documents, it will be very difficult for the plaintiff to win.  No wonder Mylan wants to keep them secret.

Plaintiff’s Motion to Remand in Watson Fentanyl Patch Lawsuit

Whether it is true or not, many corporate defendants believe that they’re better off in a federal court than in a state court.  So when someone sues them in a state court, they often "remove” the lawsuit from the state court and put it in a federal court.  The plaintiff can challenge that removal by filing a motion to remand the lawsuit back to state court.  This is an example of such a motion filed in a fentanyl lawsuit in California:

In the early morning of February 10, 2008, Nicole was discovered unresponsive in her home by her boyfriend. Paramedics were quickly called to the scene and Nicole was taken to the hospital where, after several unsuccessful attempts at revival, she was declared dead. On February 19, 2008, Los Angeles County Medical Examiner Vladimir Levicky performed an autopsy on Nicole's body. A 75 meg/hour Watson patch was present on her inner left arm and the toxicology tests revealed that Nicole had an elevated level of fentanyl in her blood of 15 ng/mL. Fentanyl has proven lethal at concentrations as low as 3.0 ng/mL and the fatal level of fentanyl averages 8.3 ng/ml.

The patch found on Nicole's body was designed, manufactured and marketed by Defendant Watson Laboratories, Inc. Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. (collectively, the “Watson Defendants.”) Defendants Watson Pharmaceuticals, Inc. and Watson Laboratories, Inc. have home offices in California.

On January 21, 2009, Plaintiffs, Nicole's surviving parents, filed suit against the Watson Defendants in California state court alleging strict product liability and negligence in the design, manufacture and marketing of the Watson patch(es) that were used by Melissa near or at the time of her death. Plaintiffs also alleged breach of warranty.

One day after the Complaint had been filed, the Watson Defendants--who had obviously been monitoring the state court docket--filed a Notice of Removal (the “Notice”). The sole removing party, Watson Pharma, Inc., contends that despite the forum defendant rule, removal was proper under 1441(b) because the forum defendants had not been “served” with the Complaint at the time the Notice was filed. (Def. Mot. at 4). On February 6, 2009, Plaintiff Chris Bristol, a California resident, joined the action as a Plaintiff. For the reasons set forth more fully below, this Court does not have diversity jurisdiction, Watson Pharma's Notice of Removal was improper and this case should be remanded back to California state court. This motion is made following the conference of counsel pursuant to Local Rule 7-3 which took place on or before February 19, 2009.

Whether to file in state or federal court is one of the decisions a fentanyl lawyer must make before he or she files a lawsuit.