Opinion
MDL No. 16-2740
05-27-2020
IN RE: TAXOTERE (DOCETAXEL) PRODUCTS LIABILITY LITIGATION This document relates to: Cases listed on Exhibit A
SECTION: "H" (5)
ORDER AND REASONS
JANE TRICHE MILAZZO, UNITED STATES DISTRICT JUDGE
Before the Court is Defendants’ Motion for Summary Judgment on the Claims of Plaintiffs Whose Taxotere Treatment Started After December 11, 2015 (Doc. 9268). For the following reasons, the Motion is GRANTED .
BACKGROUND
Plaintiffs in this multidistrict litigation ("MDL") are suing several pharmaceutical companies that manufactured and/or distributed a chemotherapy drug, Taxotere or docetaxel, that Plaintiffs were administered for the treatment of breast cancer or other forms of cancer. Plaintiffs allege that the drug caused permanent alopecia—in other words, permanent hair loss. Plaintiffs bring claims of failure to warn, negligent misrepresentation, fraudulent misrepresentation, and more.
Docetaxel is the generic version of Taxotere.
The instant Motion relates to nearly 200 cases. Defendants’ Motion is rooted in the fact that in December 2015, the Taxotere label was updated to specifically warn of the risk of permanent alopecia. Defendants ask the Court to grant summary judgment against these hundreds of Plaintiffs because they were treated with Taxotere after this label change. Defendants argue that these Plaintiffs cannot prove an essential element of their failure to warn claims. Alternatively, Defendants argue that their claims are preempted.
LEGAL STANDARD
Summary judgment is warranted where "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." A genuine issue of fact exists only "if the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Rule 56 of the Federal Rules of Civil Procedure "mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." "If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted."
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).
Anderson , 477 U.S. at 249–50, 106 S.Ct. 2505 (internal citations omitted).
LAW AND ANALYSIS
Defendants first argue that the Plaintiffs at issue cannot create a genuine dispute of material fact on an essential element of their claims. Specifically, Defendants aver that Plaintiffs cannot demonstrate that the Taxotere label, after the December 2015 update, was inadequate. Instead, Defendants contend that the updated Taxotere label was adequate as a matter of law. Indeed, the label made several references to permanent hair loss, which is the very injury of which Plaintiffs allege they were not warned. These references were in three sections of the Taxotere label: the "Adverse Reactions" section, the "Patient Counseling Information" section, and the "Patient Leaflet."
In response, Plaintiffs do not dispute that the December 2015 label addressed the risk of permanent hair loss in these three sections. Plaintiffs argue, however, that the label was nonetheless inadequate because there was no mention of permanent alopecia in the "Warnings and Precautions" section of the label. Notably, Plaintiffs ask the Court to ignore certain testimony from one of their experts, Dr. David Kessler. Dr. Kessler has repeatedly testified (in cases of individual Plaintiffs who received Taxotere before December 2015) that the risk of permanent alopecia should be addressed in either the "Warnings and Precautions" section or the "Adverse Reactions" section of the label. According to Plaintiffs, however, this testimony from Dr. Kessler was case specific and did not contemplate MDL Plaintiffs who were treated after December 2015. Plaintiffs further aver that because none of the roughly 200 Plaintiffs before the Court have been selected as bellwether Plaintiffs, no expert has opined on the adequacy of the label after December 2015.
"It is axiomatic that an essential element of a failure to warn claim is a defendant's failure to adequately warn about the alleged risks associated with its product." In prescription drug cases like this one, the learned intermediary doctrine modifies the adequacy analysis. Under this doctrine, "adequacy in the context of prescription drugs is a function of whether the doctor, rather than the patient, would reasonably understand the risks."
In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., No. 12-cv-492, 2014 WL 2738224, at *8 (D.N.J. June 17, 2014).
Meridia Prods. Liab. Litig. v. Abbott Labs., 447 F. 3d 861, 867 (6th Cir. 2006).
In the MDL context, transferee courts have issued omnibus orders finding a drug label adequate as a matter of law. For example, in In re Fosamax (Alendronate Sodium) Products Liability Litigation , an MDL court held that a drug label was adequate where it was accurate, clear, consistent, and "as a whole convey[ed] an unmistakable meaning as to the consequences of ingesting [the drug]." Considering the evidence in the instant cases before this Court, the Court finds that the Taxotere label after December 2015 was adequate as a matter of law.
Id. (affirming district court's order in MDL that found drug label adequately warned of drug's risk of high blood pressure as a matter of law); In re Chantix (Varenicline) Prods. Liab. Litig., 881 F. Supp. 2d 1333, 1343 (N.D. Ala. 2012) (holding drug label, after certain updates, adequately warned of risk of neuropsychiatric injuries as a matter of law).
2014 Wl 2738224, at *11 (D.N.J. June 17, 2014).
As Defendants note, the Taxotere label at issue here clearly and consistently explained that the drug carried a risk of permanent hair loss. In the "Adverse Reactions" section of the drug, the label stated that "[c]ases of permanent alopecia have been reported." In the "Patient Counseling Information" section, the label instructed doctors to "[e]xplain to patients that side effects such as nausea, vomiting, diarrhea, constipation, fatigue, excessive tearing, infusion site reactions, and hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration." Lastly, the "Patient Leaflet," which is intended for patients, provided a list of the most common side effects of Taxotere, and this list included the following item: "hair loss: in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed." Because the label clearly and consistently warned of the precise injury Plaintiffs suffered, the Court finds that the label was adequate.
Doc. 9268-2 at 9.
Id.
Id. at 10.
Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281, 290 (6th Cir. 2015) ("[P]rescription medicine warnings are adequate when ... information regarding ‘the precise malady incurred’ was communicated in the prescribing information.") (quoting Alston v. Caraco Pharm., Inc., 670 F. Supp. 2d 279, 284 (S.D.N.Y. 2009) ); Kling v. Key Pharm., Inc., 35 F.3d 556 (Table), at *3 (4th Cir. 1994) (upholding district court ruling that label was adequate as a matter of law where "[t]he precise harm alleged to be suffered by [plaintiff], a seizure, was clearly listed as a potential side effect of taking [the drug]"). See also Ziliak v. AstraZeneca LP, 324 F.3d 518, 521 (7th Cir. 2003) (upholding district court ruling that updated label was adequate as a matter of law where plaintiff's injuries were specifically listed as adverse side effects).
To defeat summary judgment, Plaintiffs would need to show expert evidence creating an issue of fact on the adequacy of Taxotere's warning. Plaintiffs have failed to do so. Plaintiffs aver that the language about permanent hair loss should have been included in the "Warnings and Precautions" section of the label, but Plaintiffs present no evidence to support this notion. Indeed, Plaintiffs’ own expert, Dr. Kessler, testified as follows:
See Colville v. Pharmacia & Upjohn Co., LLC, 565 F. Supp. 2d 1314, 1321 (N.D. Fla. 2008) (finding warning adequate as a matter of law and explaining that plaintiff lacked expert evidence on the issue); Benedict v. Zimmer, Inc., 405 F. Supp. 2d 1026, 1033 (N.D. Iowa 2005) ("[T]o show the device was defective because of inadequate instructions or warnings requires expert testimony."). See also Ziliak , 324 F.3d at 521. In Ziliak , the Seventh Circuit affirmed the district court's grant of summary judgment on the adequacy of a drug label. Id. The district court had found that the plaintiff's expert had not sufficiently established his expertise. Id. at 520. The court wrote, however, that even if his expert testimony was considered, he failed to create an issue of fact on the adequacy of the warning but instead advocated for a label that was consistent with the language in the label. Id. The Seventh Circuit agreed. Id. at 521.
My opinion is that it should have been clearly and – the company should have clearly and prominently warned. I think, in the end, there are different sections of the label. I'm happy to discuss that. There is a warning section. It's called Section 5. There is an adverse event section called Section 6. I think in either section, as long as it was clearly and prominently warned of permanent hair
loss, that's what I care about.
Doc. 9268-2 at 14 (quoting transcript).
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Unsurprisingly, Plaintiffs now back away from this opinion. They aver that it is case specific and should not be considered along with the instant Motion. However, Plaintiffs have come forward with no other evidence. They claim that no expert has opined on post-2015 cases because there are no bellwether Plaintiffs who received treatment after December 2015.
The Court will not allow Plaintiffs to shield these nearly 200 cases from dismissal under this logic. For months now, the parties and this Court have discussed the filing of this "fencepost" (or omnibus) motion. The parties agreed on the briefing schedule. Most striking, however, is that Plaintiffs’ expert testimony regarding placement of the alopecia warning is solely in the possession of the Plaintiffs. Plaintiffs had ample time and opportunity to identify and present expert evidence supporting their argument that permanent hair loss should have been addressed in the "Warnings and Precautions" section of the label. Yet Plaintiffs failed to do so. Accordingly, summary judgment is appropriate.
Because the Court is granting summary judgment due to Plaintiffs’ lack of evidence on the adequacy of the Taxotere label, the Court sees no need to address Defendants’ preemption argument.
CONCLUSION
For the foregoing reasons, Defendants’ Motion for Summary Judgment on the Claims of Plaintiffs Whose Taxotere Treatment Started After December 11, 2015 (Doc. 9268) is GRANTED . The failure to warn claims of the Plaintiffs listed on Exhibit 1 of the Motion are DISMISSED WITH PREJUDICE . Any other claims these Plaintiffs have remain pending. Liaison counsel should provide the Court with a list of any cases that have no claims remaining and should be dismissed as a result of this ruling;
IT IS FURTHER ORDERED that the remaining argument in the Motion for Summary Judgment (Doc. 6186) is DISMISSED AS MOOT .
EXHIBIT 1
Last Name MDL Docket No. First Treatment Date PETRIE 2:18-cv-13643 12/15/2015 ROLAND 2:17-cv-16041 12/16/2015 HENRY 2:17-cv-12780 12/17/2015 JACKSON BIREE 2:19-cv-13256 12/18/2015 PAPAJOHN 2:17-cv-16380 12/21/2015 WHITE 2:18-cv-11593 12/21/2015 FLOWERS 2:18-cv-12439 12/22/2015 CHAVEZ 2:17-cv-07497 12/28/2015 MATSUMURA 2:17-cv-09533 12/28/2015 CHASE 2:18-cv-12941 12/29/2015 BERNHARD 2:19-cv-13649 12/30/2015 COZZA 2:18-cv-03442 12/30/2015 SCOTT 2:16-cv-15472 01/5/2016 SCRUGGS 2:18-cv-08227 01/5/2016 ALLBRITTON 2:18-cv-06530 01/6/2016 BEERMAN 2:18-cv-01879 01/7/2016 MCGAHEY 2:19-cv-11467 01/7/2016 WRIGHT 2:17-cv-14420 01/7/2016 JONES 2:18-cv-12850 01/8/2016 WATKINS 2:18-cv-06462 01/8/2016 FEEHERTY 2:19-cv-09670 01/11/2016 VELASQUEZ 2:18-cv-07208 01/12/2016 REECE 2:18-cv-13515 01/15/2016 TICEY 2:17-cv-15859 01/18/2016 HIGHT 2:18-cv-01854 01/21/2016 RANKINS 2:17-cv-14999 01/25/2016 NANNEY 2:19-cv-09538 01/27/2016
SKELTON 2:18-cv-04810 01/27/2016 LEWIS 2:18-cv-00401 01/28/2016 PERRY 2:18-cv-03417 01/28/2016 ALLEN 2:18-cv-05776 01/29/2016 KING 2:18-cv-12856 02/??/2016 MARTIN 2:17-cv-16355 02/??/2016 RANDALL 2:18-cv-12883 02/??/2016 ROBSON 2:18-cv-06695 02/??/2016 MITCHELL 2:18-cv-10906 02/2/2016 USHER WILLIAMS 2:17-cv-11194 02/4/2016 PIERRE CANEL 2:18-cv-02818 02/5/2016 MILLER 2:18-cv-11729 02/12/2016 WOZNY 2:18-cv-07202 02/15/2016 CADIERE 2:18-cv-06171 02/17/2016 PETTIS 2:19-cv-09443 02/18/2016 CUNNINGHAM 2:19-cv-11930 02/23/2016 MASSIE 2:18-cv-10110 02/23/2016 GROVES 2:17-cv-15595 02/25/2016 IEROKOMOS 2:18-cv-14249 02/26/2016 JONES 2:18-cv-01662 02/26/2016 ROBINSON 2:17-cv-13918 02/28/2016 COWAN 2:17-cv-12540 02/29/2016 MCGAUGHEY 2:17-cv-15967 03/??/2016 JOHNSON 2:17-cv-11214 03/6/2016 BAFFO 2:18-cv-11311 03/7/2016 BLUMLO 2:16-cv-17972 03/8/2016 CONE 2:19-cv-01898 03/9/2016
TOLAN 2:18-cv-03946 03/10/2016 WEST 2:19-cv-14084 03/14/2016 STOOPS 2:17-cv-13921 03/15/2016 MAJOR 2:19-cv-12303 03/17/2016 CHAGAS 2:20-cv-00022 03/23/2016 SCHULTZ 2:18-cv-00498 03/25/2016 FLOYD MOTTER 2:18-cv-02109 03/28/2016 HUGHES 2:19-cv-01903 03/31/2016 GILMORE 2:19-cv-01900 04/5/2016 DYER 2:19-cv-00730 04/6/2016 LENCREROT 2:19-cv-00365 04/6/2016 FREEMAN 2:18-cv-05554 04/8/2016 NEWMAN PARKER 2:18-cv-10882 04/12/2016 HEGENBART 2:18-cv-09084 04/14/2016 BENIGNO 2:18-cv-10566 04/19/2016 LOPES 2:17-cv-14143 04/19/2016 WILLIAMS 2:18-cv-13268 04/21/2016 CURLEYMORABITO 2:18-cv-05986 04/22/2016 HOLMES 2:18-cv-06700 05/1/2016 MINOR 2:19-cv-00037 05/??/2016 BAILEY 2:17-cv-13942 05/2/2016 JONES 2:18-cv-14329 05/3/2016 CAULKER 2:17-cv-17150 05/6/2016 PROCTOR 2:17-cv-16662 05/6/2016 WEST 2:19-cv-11271 05/6/2016 MCMULLEN 2:17-cv-17056 05/11/2016 DENBY 2:18-cv-07609 05/12/2016
SINGER 2:19-cv-12536 05/13/2016 CASTLE 2:19-cv-10055 05/19/2016 WOMACK 2:17-cv-15744 05/23/2016 BERRY 2:18-cv-06173 05/24/2016 ROBERTSON 2:18-cv-06092 05/26/2016 WARREN 2:18-cv-13070 05/26/2016 SHADLE 2:18-cv-03292 05/27/2016 JOHNSON 2:17-cv-12544 05/31/2016 HORNE 2:18-cv-04434 06/2/2016 PRZEKURAT 2:18-cv-12913 06/2/2016 BLACKMON 2:19-cv-09973 06/3/2016 ROCHA 2:18-cv-11723 06/9/2016 SMITH 2:18-cv-05556 06/9/2016 JONES 2:18-cv-04465 06/14/2016 WILLIAMS 2:19-cv-11947 06/14/2016 WEEKS 2:17-cv-15119 06/15/2016 HUTCHINSON 2:18-cv-11496 06/16/2016 IRVING 2:18-cv-07846 06/22/2016 SIMPSON 2:17-cv-15575 06/22/2016 MCCULLUM 2:18-cv-06177 06/27/2016 ADKINS 2:18-cv-12307 07/8/2016 MARTIN 2:18-cv-13104 07/11/2016 WILLIAMS 2:18-cv-02391 07/13/2016 WINGATE 2:18-cv-10321 07/13/2016 WHITEHEAD 2:19-cv-12878 07/20/2016 RHEA 2:17-cv-15421 07/21/2016 MATTHEWS 2:17-cv-17055 07/25/2016
SMITH 2:19-cv-12040 07/28/2016 SANTIAGO 2:17-cv-09131 07/29/2016 DAVIS 2:17-cv-16280 08/??/2016 GHOLAR 2:18-cv-00502 08/??/2016 ARROYO 2:19-cv-07567 08/2/2016 KINSLER 2:19-cv-10627 08/2/2016 NICHOLS 2:17-cv-15204 08/4/2016 FERNANDEZ 2:18-cv-08114 08/11/2016 SMITH 2:18-cv-13890 08/11/2016 BURNS 2:19-cv-11973 08/12/2016 KIMBRELL 2:18-cv-12329 08/17/2016 PRZESTRZELSKI 2:19-cv-01176 08/18/2016 MILTON 2:18-cv-05997 08/19/2016 CREWS 2:17-cv-10525 08/25/2016 GOODMAN 2:18-cv-07244 08/26/2016 ANDRES 2:18-cv-06189 08/29/2016 KNIGHT 2:17-cv-17052 08/31/2016 WEAVER 2:17-cv-15513 08/31/2016 ADAMS 2:17-cv-16210 09/??/2016 KIRBY 2:18-cv-10313 09/13/2016 GILMORE 2:18-cv-05273 09/14/2016 BROWN 2:19-cv-11980 09/20/2016 GREEN 2:17-cv-13902 09/21/2016 BACH 2:19-cv-12357 09/22/2016 MORGAN 2:18-cv-11822 09/22/2016 GLENN 2:18-cv-13020 09/28/2016 MCMILLAN 2:18-cv-10481 09/29/2016
BROWN 2:19-cv-12433 10/??/2016 CASTILLE 2:18-cv-03431 10/??/2016 COX 2:18-cv-12902 10/??/2016 PARSONS 2:19-cv-02174 10/3/2016 SYLVE 2:17-cv-14650 10/11/2016 HAYES 2:18-cv-08308 10/12/2016 HENDRICKS 2:18-cv-07248 10/13/2016 SHAW 2:18-cv-05780 10/17/2016 RAGSDALE 2:19-cv-11266 10/24/2016 BLACK 2:18-cv-02782 11/??/2016 SKILLOM 2:19-cv-11936 11/1/2016 WELLS 2:18-cv-13440 11/??/2016 HOFF 2:19-cv-12700 11/8/2016 DUVALL 2:18-cv-04715 11/11/2016 EIDEL 2:17-cv-06024 11/17/2016 BAREFIELD 2:19-cv-13433 11/18/2016 MILLICAN 2:18-cv-14040 11/18/2016 SPADA 2:19-cv-12775 11/29/2016 GOLDSBORO 2:18-cv-12441 12/2/2016 DAVIS 2:19-cv-12251 12/8/2016 SAMPSON 2:17-cv-15773 12/8/2016 HARRIS 2:19-cv-00504 12/9/2016 PASTORKOVICH 2:18-cv-13186 12/15/2016 ZUPKO 2:18-cv-13465 12/19/2016 ROLLE 2:18-cv-12914 01/2/2017 BARKER 2:17-cv-13272 01/3/2017 TOLBERT 2:18-cv-04463 01/9/2017
MCINTOSH 2:18-cv-13176 01/13/2017 REEVES 2:19-cv-12711 01/19/2017 SMITH 2:19-cv-03290 01/24/2017 WILLIAMS 2:18-cv-12464 02/7/2017 MOODY BEAUMONT 2:17-cv-15956 02/21/2017 MCNELLEY 2:18-cv-03612 02/24/2017 WILKINS 2:19-cv-10869 03/9/2017 HALL 2:18-cv-08717 03/10/2017 ALSTON 2:18-cv-06527 03/14/2017 DENNIS 2:18-cv-06154 03/14/2017 BRYANT 2:19-cv-01292 03/22/2017 MUGLESTON 2:19-cv-02205 03/27/2017 TUTT 2:19-cv-01715 03/27/2017 FRANKLIN 2:19-cv-01947 03/29/2017 LANDERS 2:18-cv-08358 03/29/2017 BALAAM 2:18-cv-08761 04/6/2017 NELSON 2:18-cv-08400 04/18/2017 SHELTON 2:19-cv-09977 04/18/2017 GREEN 2:18-cv-06174 05/4/2017 ALLEN 2:19-cv-13477 06/29/2017 CARTER 2:18-cv-07047 06/29/2017 MONNIN 2:18-cv-08006 07/7/2017 MACDONALD 2:18-cv-05994 07/11/2017 WAGGONER 2:19-cv-11423 07/14/2017 RIGO 2:17-cv-09889 12/13/2017 VIDAL 2:19-cv-12539 12/26/2017 SMITH 2:19-cv-11532 01/23/2018
DORSEY 2:20-cv-00241 07/31/2018 MCCOY 2:18-cv-10424 12/??/2015 VAN DEN VRIJOEF 2:19-cv-01365 12/??/2015