Pramann v. Janssen Pharmaceuticals, Inc. et al

MOTION for Summary Judgment

E.D. La.March 21, 2017

00401689 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF LOUISIANA RICHARD GLENN PRAMANN v. CIVIL ACTION NO. 16-12413 JUDGE: AFRICK MAGISTRATE JUDGE: NORTH JANSSEN PHARMACEUTICALS, INC., JOHNSON & JOHNSON, JANSSEN RESEARCH AND DEVELOPMENT, L.L.C., PATRIOT PHARMACEUTICALS, LLC, BRENN DISTRIBUTION, INC., AND ENDO PHARMACEUTICALS, INC. DEFENDANTS' MOTION FOR SUMMARY JUDGMENT NOW INTO COURT come Defendants, Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research and Development, LLC (hereinafter "Defendants"), who respectfully request that this Court dismiss Plaintiff's claims against Defendants with prejudice. As explained fully in the accompanying Memorandum in Support, this Motion should be granted because Plaintiff has failed to set forth any evidence — fact or expert — in support of his claims in this case, and the time to produce such expert evidence has passed. Expert evidence is required under the Louisiana Product Liability Act, LA. REV. STAT. § 9:2800.51, et seq. ("LPLA") for claims involving alleged injuries associated with pharmaceutical products. Without it, Plaintiff's claims should be dismissed. WHEREFORE, Defendants respectfully request that this Court grant their motion for summary judgment and dismiss Plaintiff's claims with prejudice, at his cost. Case 2:16-cv-12413-LMA-MBN Document 30 Filed 03/21/17 Page 1 of 2 00401689 Respectfully submitted, IRWIN FRITCHIE URQUHART & MOORE LLC BY: /s/ Gretchen F. Richards________________ JAMES B. IRWIN (La. Bar No. 7172) DOUGLAS J. MOORE (La. Bar No. 27706) MEERA U. SOSSAMON (La. Bar No. 34797) GRETCHEN F. RICHARDS (La. Bar No. 35782) 400 Poydras Street, Suite 2700 New Orleans, Louisiana 70130 Telephone: (504) 310-2100 Fax: (504) 310-2101 jirwin@irwinllc.com dmoore@irwinllc.com msossamon@irwinllc.com grichards@irwinllc.com Counsel for Defendants Janssen Pharmaceuticals Inc., Johnson & Johnson, and Janssen Research and Development, LLC CERTIFICATE OF SERVICE I hereby certify that on March 21, 2017, the foregoing pleading was filed electronically with the Clerk of Court using the CM/ECF system. Notice of this filing will be sent to all counsel of record by operation of the court’s electronic filing system. /s/ Gretchen F. Richards Case 2:16-cv-12413-LMA-MBN Document 30 Filed 03/21/17 Page 2 of 2 00401686 1 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF LOUISIANA RICHARD GLENN PRAMANN v. CIVIL ACTION NO. 16-12413 JUDGE: AFRICK MAGISTRATE JUDGE: NORTH JANSSEN PHARMACEUTICALS, INC., JOHNSON & JOHNSON, JANSSEN RESEARCH AND DEVELOPMENT, L.L.C., PATRIOT PHARMACEUTICALS, LLC, BRENN DISTRIBUTION, INC., AND ENDO PHARMACEUTICALS, INC. MEMORANDUM IN SUPPORT OF MOTION FOR SUMMARY JUDGMENT Defendants, Janssen Pharmaceuticals, Inc., Johnson & Johnson, Janssen Research and Development, LLC (hereinafter “Defendants”), submit this memorandum in support of their motion for summary judgment. For the reasons set forth more fully below, Defendants’ Motion should be granted. Plaintiff alleges that he developed gynecomastia (abnormal enlargement of breast tissue) from the use of the prescription medicine Risperdal ® . However, Plaintiff’s claims brought under the Louisiana Product Liability Act, LA. REV. STAT. § 9:2800.51, et seq. (“LPLA”), should be dismissed for two reasons: (1) Plaintiff has produced no evidence supporting his claim that Risperdal ® is defective within the meaning of the LPLA and (2) even if there were evidence of a defect, the LPLA requires expert evidence to prove medical causation in product liability cases, but Plaintiff has totally failed to produce such evidence. Furthermore, to the extent that Plaintiff’s Complaint includes causes of action that fall outside of the LPLA, those claims are barred by the exclusivity provisions of the LPLA, § 9:2800.52, and must be dismissed. Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 1 of 12 00401686 2 I. RELEVANT FACTUAL AND PROCEDURAL BACKGROUND On July 5, 2016, Plaintiff Richard Glenn Pramann (“Plaintiff”) filed the instant Complaint, claiming that he was prescribed Risperdal ® (risperidone), Risperdal Consta ® (a long- acting injectable form of risperidone), Invega ® (paliperidone) and/or Risperidone by various healthcare providers. (Rec. Doc. 1, at ¶ 6). Plaintiff claims that, as a result of having taken these medications, he developed gynecomastia. (Rec. Doc. 1, at ¶ 7). Although Plaintiff’s medical records demonstrate that his physicians placed him on “Risperdal” between 2012 and 2013, 1 the medicine lost its patent protection in 2008 and was primarily available as generic risperidone at the time that Plaintiff used the medicine. 2 Plaintiff has produced no evidence to establish the manufacturer of the risperidone that he was allegedly prescribed. In fact, the plaintiff’s unsuccessful attempts to dismiss and/or add various manufacturers of the generic risperidone at the beginning of this litigation shows that he is, at the very least, unsure whether he actually used name-brand Risperdal ® or, instead, generic risperidone. (See, e.g. Rec. Docs. 7, 11, 16, 21, 25, 28, 29). Finally, the plaintiff has produced absolutely no evidence to show that he suffered from gynecomastia at any time. Plaintiff’s deadline to submit written expert reports was March 17, 2017. (Rec. Doc. 12). In fact, this Court instructed that Plaintiff’s expert reports could “in no event” be submitted “later than Friday, March 17, 2017.” (Rec. Doc. 12). The time to disclose experts and produce expert reports, however, has passed and Plaintiff has failed to designate a single expert much less furnish an expert report to the defendants. Plaintiff, therefore, has offered no expert evidence on 1 See, e.g., Ex. A: Excerpt of Richard Glenn Pramann’s Medical Records, at RP-PP-00078-84, 145, 156, 176, 178, 180, 185-197. 2 Stephen G. Kunin, Consolidated Listing of Patents Extended Under 35 U.S.C. § 156(e)(1), (June 30, 2003) United States Patent and Trademark Office OG Notices: 29 July 2003, http://www.uspto.gov/web/offices/com/sol/og/2003/week30/patxten.htm (last visited March 21, 2017). Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 2 of 12 00401686 3 the issue of causation nor has he brought a scintilla of evidence – either fact or expert – to support his allegation that Risperdal ® is defective. To further illustrate Plaintiff’s idleness with respect to prosecution of his own case, Plaintiff has failed to propound discovery on Defendants, has failed to respond to the Requests for Products of Documents and Interrogatories issued by Defendants on January 13, 2017, and has failed to provide Defendants with executed HIPAA authorizations so that the defendants may begin collecting medical records from the plaintiff’s medical providers, despite repeated requests for same. Plaintiff’s complete disregard for this matter not only prejudices the defendants who are still bound by this Court’s Scheduling Order, but also implies his awareness that the evidence in support of his claims falls short of that required by Louisiana law. II. LAW AND ARGUMENT Summary judgment should be granted “if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed R. Civ. P. 56(c). Because the burden of proof at trial is on the Plaintiff, Defendants must identify the elements of the opposing party’s claims for which there is an absence of proof. Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 263 (5th Cir. 2002); Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986). In Louisiana, suits for injuries caused by medical products are governed by the Louisiana Products Liability Act ("LPLA"), which is the exclusive theory of liability against product manufacturers for injuries caused by their products. LA. REV. STAT. ANN. § 9:2800.52 (West 2016); Jefferson v. Lead Indus. Ass’n, Inc., 106 F.3d 1245, 1248 (5th Cir. 1997) (“Louisiana law eschews all theories of recovery in this case except those explicitly set forth in the LPLA.”). Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 3 of 12 00401686 4 “To maintain a successful products liability action under the LPLA, a plaintiff must establish four elements: (1) that the defendant is a manufacturer of the product; (2) that the claimant's damage was proximately caused by a characteristic of the product; (3) that this characteristic made the product ‘unreasonably dangerous;’ and (4) that the claimant's damage arose from a reasonably anticipated use of the product by the claimant or someone else.” Stahl., 283 F.3d at 260-61 (emphasis added); see also LA. REV. STAT. ANN. § 9:2800.54(A) (West 2016). Here, as shown below, Plaintiff lacks the requisite evidence to establish any claim under the LPLA. Thus, Defendants are entitled to judgment as a matter of law. A. PLAINTIFF HAS PRODUCED NO EVIDENCE THAT RISPERDAL IS DEFECTIVE WITHIN THE MEANING OF THE LPLA. The Louisiana Products Liability Act (“LPLA”) sets forth the exclusive theories of recovery for product liability claims. LSA-R.S. 9:2800.52 (2010); see also generally, LSA-R.S. 9:2800.51 et seq. (2010). In this case, Plaintiff alleges that Risperdal ® was unreasonably dangerous in construction or composition, design, lacked adequate warnings, and failed to conform to an express warranty. (Rec. Doc. 1, ¶¶ 16-19, 20-23, 24-27, and 28-31). However, Louisiana law is clear that “defects are not presumed to be present by the mere happening of an accident.” Spott v. Otis Elevator Co., 601 So. 2d 1355, 1364 (La. 1992); see also Grenier v. Medical Engineering Corp., 243 F.3d 200, 205 (5th Cir. 2000) (“Louisiana law does not allow a fact finder to presume an unreasonably dangerous design solely from the fact that an injury occurred.”). 1. Plaintiff Has Submitted No Evidence In Support Of His Claims For Defective Composition And Defective Design. In order to prove a claim of defective construction or composition under the LPLA, Plaintiff must “demonstrate not only what a manufacturer’s specifications or performance Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 4 of 12 00401686 5 standards are for a particular product, but how the product in question materially deviated from those standards so as to render it ‘unreasonably dangerous.’” Morris v. United Servs. Auto. Ass’n, 756 So. 2d 549, 558 (La. App. 2 Cir. 02/18/00); see also Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 262-63 (5th Cir. 2002); Reed v. Biomet Orthopedics, Inc., 318 Fed. Appx. 305, 307 (5th Cir. 2009). As stated by the U.S. Fifth Circuit in Stahl, “the plaintiff must demonstrate that, at the time the product left its manufacturer's control, the product deviated in a material way from the manufacturer’s specifications or performance standards for the product or from otherwise identical products manufactured by the same manufacturer.” Stahl, 283 F.3d at 263. In order to make this showing in a case involving a complex medical product, Plaintiff must produce expert evidence sufficient of raising a genuine issue of material fact. Zachary v. Dow Corning Corp., 884 F.Supp 1061 (M.D. La. 1995) (holding that whether or not medical product was defective in construction or composition was not something that could be determined without expert testimony). Additionally, for claims of defective design, Plaintiff must produce expert evidence demonstrating that a feasible, safer alternative design existed that would have prevented Plaintiff’s injury. McCarthy v. Danek Med., Inc., 65 F. Supp. 2d 410 (E.D. La. 1999) (defective design claim failed absent expert evidence as to existing alternative design). Here, however, Plaintiff has offered no expert reports and provided no evidence to support of his claims that Risperdal ® was defective in design or in construction and composition. Accordingly, summary judgment is warranted on these claims. 2. Plaintiff Has Submitted No Evidence in Support of His Failure to Warn Claim. To maintain a failure to warn claim, a plaintiff must demonstrate that “the product possessed a characteristic that may cause damage and the manufacturer failed to use reasonable Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 5 of 12 00401686 6 care to provide an adequate warning of such characteristic and its danger to users and handlers of the product.” LSA-R.S. § 9:2800.57(A) (2016). The characteristic rendering the product unreasonably dangerous because of an inadequate warning must have existed at the time the product left the manufacturer’s control, or result from a reasonably anticipated alteration of modification of the product. LSA-R.S. § 9:2800.54(C) (2016). In addition, for claims of defective warning, Louisiana applies the learned intermediary doctrine to claims related to prescription medicines, which requires that the plaintiff show that the defendant failed to warn (or inadequately warned) the physician of a risk that was not otherwise known to the physician, and that this alleged failure to warn was both a cause in fact and the proximate cause of the plaintiff’s injury. Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 265-66 (5th Cir. 2002). Here, no evidence has been produced showing that a side effect or adverse effect was not properly warned of based on the available scientific and medical information at the relevant time. In fact, no evidence has been produced showing which warnings were given, what information Plaintiff’s physicians and/or medical providers at the various correctional facilities knew about the medicine, or whether these medical providers would have changed their treatment of the plaintiff if the medicine’s warnings were different. Thus, summary judgment is warranted. 3. Plaintiff Has No Claim For Breach Of Warranty. For breach of warranty claims, the plaintiff must put on evidence that express statements were made that “induced the claimant or another person or entity to use the product and the claimant's damage was proximately caused because the express warranty was untrue.” Aucoin v. Amneal Pharm., LLC, No. CIV.A. 11-1275, 2012 WL 2990697, at *10 (E.D. La. July 20, 2012). Here, Plaintiff has submitted no evidence showing any alleged “warranty” by the defendants, Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 6 of 12 00401686 7 much less the existence of a warranty that was untrue and/or material to the plaintiff’s use the medicine. Because no evidence exists to show that Risperdal ® is defective within the meaning of the LPLA, Plaintiff’s claims fail. B. EVEN IF PLAINTIFF HAD PRODUCED EVIDENCE THAT RISPERDAL® IS DEFECTIVE, PLAINTIFF’S FAILURE TO PRODUCE EVIDENCE AS TO CAUSATION IS FATAL AS TO ALL OF HIS CLAIMS. Courts routinely recognize the necessity of expert testimony to prove medical causation in product liability cases. See Lewis v. Pfizer Pharm. Co., 2010 U.S. Dist. LEXIS 99648, at *1 (Sept. 20, 2010) (granting summary judgment where plaintiff failed to provide evidence of medical causation in product liability claims); Oiler, 2004 U.S. Dist. LEXIS 2481, at *26 (E.D. La. Feb. 16, 2004) (granting summary judgment on LPLA claims in medical device case because “plaintiff has presented no expert testimony that the type of infection [decedent] contracted could have been caused by a contaminated prosthesis”); see also Guinn v. AstraZeneca Pharms. LP, 602 F.3d 1245, 1252 (11th Cir. 2010). The LPLA expressly provides that a plaintiff must demonstrate “proximate” cause, regardless of their theory of liability. LSA-R.S. 9:2800.54. And, in cases involving prescription medical products, Plaintiff must present expert evidence that (1) the product is capable of causing the condition alleged (general causation) and (2) that the product caused the Plaintiff’s specific injuries (specific causation). Pick v. Am. Med. Sys., Inc., 958 F. Supp. 1151, 1173 (E.D. La. 1997). The failure to produce expert evidence on either of these issues warrants dismissal by summary judgment. Id. Here, Plaintiff has produced no medical or scientific evidence on the issue of causation. In fact, assuming arguendo that the plaintiff actually used Risperdal ® , he has still produced no medical record showing that he was diagnosed with and/or suffered from gynecomastia. The word “gynecomastia” is not even mentioned in Plaintiff’s medical records. As such, Plaintiff has Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 7 of 12 00401686 8 failed to produce any evidence to establish medical causation, and summary judgment is warranted. C. PLAINTIFF HAS NO CLAIM AGAINST DEFENDANTS FOR HIS USE OF GENERIC RISPERIDONE. As stated above, the scant medical evidence submitted by Plaintiff fails to demonstrate the specific manufacturer of the medicine that he was prescribed while being treated at various Southeast Louisiana correctional facilities. In fact, by 2008, the patent for the tablet form of Risperdal ® had expired, and the medicine has been generic ever since. 3 As such, there is no evidence that Plaintiff was receiving name-brand Risperdal ® in 2012 or 2013. And, to the extent that Plaintiff’s claims are based on his use of generic risperidone, the Defendants are not the manufacturer of those tablets and cannot be liable under Louisiana law for any alleged injury associated with their use. Stanley v. Wyeth, Inc., 2007-2080 (La. App. 1 Cir. 5/2/08), 991 So.2d 31. D. PLAINTIFF’S NON-LPLA CLAIMS ARE BARRED BY THE EXCLUSIVITY PROVISIONS OF LA. REV. STAT. ANN. § 9:2800.52. Plaintiff has alleged several claims falling outside the scope of the Louisiana Products Liability Act: negligence (Rec. Doc. 1, at ¶¶ 32-35); redhibition (Rec. Doc. 1, at ¶¶ 36-39); breach of warranty of fitness for ordinary use (Rec. Doc. 1, at ¶¶ 40-43); breach of implied warranty of merchantability and fitness (Rec. Doc. 1, at ¶¶ 44-47); strict liability (Rec. Doc. 1, at ¶¶ 48-51); and violation of federal regulations (Rec. Doc. 1, at ¶¶ 52-56). In Louisiana, suits for injuries caused by products are governed by the Louisiana Products Liability Act, which is the exclusive theory of liability against product manufacturers for injuries caused by their products. LSA-R.S. § 9:2800.52 (2016) (“A claimant may not recover from a manufacturer for damage 3 Stephen G. Kunin, Consolidated Listing of Patents Extended Under 35 U.S.C. § 156(e)(1), (June 30, 2003) United States Patent and Trademark Office OG Notices: 29 July 2003, http://www.uspto.gov/web/offices/com/sol/og/2003/week30/patxten.htm (last visited March 21, 2017). Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 8 of 12 00401686 9 caused by a product on the basis of any theory of liability that is not set forth in [the LPLA]”); see also Stahl v. Novartis Pharm. Corp., 283 F.3d 254, 261-62 (5th Cir. 2002); Jefferson v. Lead Indus. Ass’n, Inc., 106 F.3d 1245, 1248 (5th Cir. 1997) (“Louisiana law eschews all theories of recovery in this case except those explicitly set forth in the LPLA.”). As this Court has recognized, “[e]ven though an action under the LPLA is predicated on principles of strict liability, negligence, or warranty, these theories are not available as independent theories of recovery against the manufacturer.” Watson v. Bayer Healthcare Pharm., Inc., Civil Action No. 13-212, 2013 WL 1558328 at *3 (E.D. La. Apr. 11, 2013) citing Stahl v. Novartis Pharma. Corp., 283 F.3d 254, 261 (5th Cir.2002) (emphasis added). The LPLA also precludes implied warranty claims in product liability actions under Louisiana law. See LSA-R.S. §§9:2800.52, 54 (2016); see also, e.g., Grenier v. Medical Eng’g Corp., 99 F. Supp. 2d 759, 763 (W.D. La. 2000), aff’d, 243 F.3d 200 (5th Cir. 2001) (dismissing, inter alia, plaintiff’s implied warranty claims). Courts routinely dismiss product defect claims against manufacturers that do not arise under the theories of liability established in the LPLA. See, e.g., Stahl, 283 F.3d at 261-62 (5th Cir. 2002) (stating that negligence is no longer viable as an independent theory of recovery against a manufacturer); Grenier., 99 F.Supp.2d at 763 (holding that plaintiff’s claims for strict liability, negligence, breach of warranty of fitness for particular purpose, breach of implied warranty, misrepresentation/fraud, fraud by concealment, false advertising, negligent infliction of emotional distress, common plan to prevent public awareness of breast implant hazards, and future product failure were not cognizable under the LPLA); Jefferson, 106 F.3d at 1251 (affirming dismissal of plaintiff’s claims of negligence, fraud by misrepresentation, market share liability, breach of implied warranty of fitness, and civil conspiracy due to exclusivity of the LPLA); Brown v. R.J. Reynolds Tobacco Co., 852 F. Supp. 8, 9 (E.D. La. 1994), aff’d, 52 F.3d Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 9 of 12 00401686 10 524 (5th Cir. 1995) (dismissing plaintiff’s claims for fraudulent misrepresentation, concealment, and conspiracy due to the LPLA’s exclusivity). Because the LPLA provides the exclusive remedy against the manufacturers for alleged damages arising from use of their products, Plaintiff’s claims falling outside the scope of the Act must be dismissed. Finally, even though there is no evidence that the plaintiff actually purchased Risperdal ® , he nonetheless argues that he has a redhibition claim. This claim likewise fails because redhibition is the avoidance of a sale because of some vice or defect in the thing sold. It requires the seller to return the purchase price and the buyer to return the thing purchased. Capitol City Leasing Corp. v. Hill, 404 So.2d 935, 939 (La. 1981). In a suit for redhibition, a plaintiff must be able to prove: “(1) the seller sold the thing to him and it is either absolutely useless for its intended purpose or its use is so inconvenient or imperfect that, judged by the reasonable person standard, had he known of the defect, he would never have purchased it; (2) the thing contained a non-apparent defect at the time of sale; and (3) the seller was given an opportunity to repair the defect.” Johnson v. CHL Enterprises, 115 F.Supp.2d 723 (W.D. La. 2000) citing Watkins v. Freeway Motors, No. 29385-CA (La. App. 2 Cir. 4/2/97); 691 So.2d 854, 857; Vincent v. Hyundai Corp., 633 So.2d 240, 243 (La. App. 1 Cir. 1993). A redhibition claim is not allowed under Louisiana law where there is no evidence of a functional failure of the product and the product functioned as intended. See, e.g., Lonkowski v. R.J. Reynolds Tobacco Co., No. 96-1192, 1996 WL 888182, *9 (W.D. La. Dec. 10, 1996) (finding redhibition claim against seller of tobacco was not viable where plaintiff “smoked the products for 40 years without the type of functional failure that is characteristic of a redhibitory defect”); Family Drug Store of New Iberia, Inc. v. Gulf States Computer Services, Inc., 563 So.2d 1324, 1326-27 (La. App. 3 Cir. 1990) (stating that where no features of purchased Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 10 of 12 00401686 11 computer software failed and where software “functioned as intended,” a “remedy in redhibition must be denied”); Robinett v. Sears, Roebuck & Co., 485 So.2d 953, 955 (La. App. 5 Cir. 1986), writ denied, 488 So.2d 204 (La. 1986) (rejecting redhibition claim related to belt sander where there was “no allegation that the sander failed in its intended use”). Here, the plaintiff does not complain of any physical defect or functional failure in the medication he received. The fact that the plaintiff alleges he developed a condition warned about in the product labeling does not render the medicine defective. All prescription drugs have risks, and informing physicians about those risks is the purpose of the warning labels. Further, the plaintiff has failed to show that he offered to return the product to the Defendants so as to give them an opportunity to repair any alleged defect. Thus, Plaintiff’s redhibition claim fails. III. CONCLUSION For the foregoing reasons, Defendants Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research and Development, LLC respectfully request that the Court grant summary judgment in their favor on all of Plaintiff’s causes of action. Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 11 of 12 00401686 12 Respectfully submitted, IRWIN FRITCHIE URQUHART & MOORE LLC BY: /s/ Gretchen F. Richards________________ JAMES B. IRWIN (La. Bar No. 7172) DOUGLAS J. MOORE (La. Bar No. 27706) MEERA U. SOSSAMON (La. Bar No. 34797) GRETCHEN F. RICHARDS (La. Bar No. 35782) 400 Poydras Street, Suite 2700 New Orleans, Louisiana 70130 Telephone: (504) 310-2100 Fax: (504) 310-2101 jirwin@irwinllc.com dmoore@irwinllc.com msossamon@irwinllc.com grichards@irwinllc.com Counsel for Defendants Janssen Pharmaceuticals Inc., Johnson & Johnson, and Janssen Research and Development, LLC CERTIFICATE OF SERVICE I hereby certify that on March 21, 2017, the foregoing pleading was filed electronically with the Clerk of Court using the CM/ECF system. Notice of this filing will be sent to all counsel of record by operation of the court’s electronic filing system. /s/ Gretchen F. Richards Case 2:16-cv-12413-LMA-MBN Document 30-1 Filed 03/21/17 Page 12 of 12 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 1 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 2 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 3 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 4 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 5 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 6 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 7 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 8 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 9 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 10 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 11 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 12 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 13 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 14 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 15 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 16 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 17 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 18 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 19 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 20 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 21 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 22 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 23 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 24 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 25 of 26 Case 2:16-cv-12413-LMA-MBN Document 30-2 Filed 03/21/17 Page 26 of 26 00401697 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF LOUISIANA RICHARD GLENN PRAMANN v. CIVIL ACTION NO. 16-12413 JUDGE: AFRICK MAGISTRATE JUDGE: NORTH JANSSEN PHARMACEUTICALS, INC., JOHNSON & JOHNSON, JANSSEN RESEARCH AND DEVELOPMENT, L.L.C., PATRIOT PHARMACEUTICALS, LLC, BRENN DISTRIBUTION, INC., AND ENDO PHARMACEUTICALS, INC. STATEMENT OF UNCONTESTED MATERIAL FACT IN SUPPORT OF DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT Defendants Janssen Pharmaceuticals, Inc., Johnson & Johnson, Janssen Research and Development, LLC (hereinafter “Defendants”), hereby submit the following statement of uncontested material facts in connection with their Motion for Summary Judgment: 1. On July 5, 2016, Plaintiff Richard Glenn Pramann filed his Complaint. Plaintiff claims in his suit that he was prescribed Risperdal ® (risperidone), Risperdal Consta ® (a long-acting injectable form of risperidone), Invega ® (paliperione), and/or Risperidone by various healthcare providers. 1 2. In his Complaint, Plaintiff alleges that he developed gynecomastia (enlargement of the breasts) as a result of using the medicine. 2 3. Plaintiff’s medical records demonstrate that he was prescribed either “Risperdal” or, the generic alternative, risperidone, between 2012 and 2013 while in the custody of Southeast Louisiana correctional facilities, but do not establish the manufacturer of the medicine that he took at that time. 3 1 Rec. Doc. 1, at ¶ 6. 2 Rec. Doc. 1, at ¶ 7. 3 See, e.g., Ex. A: Excerpt of Richard Glenn Pramann’s Medical Records, at RP-PP-00078-84, 145, 156, 176, 178, 180, 185-197. Case 2:16-cv-12413-LMA-MBN Document 30-3 Filed 03/21/17 Page 1 of 2 00401697 4. Risperdal® lost its patent protection in 2008 and was primarily available as generic risperidone at the time that Plaintiff used the medicine while in the custody of various Southeast Louisiana correctional facilities. 4 5. This Court’s Scheduling Order initially set Plaintiff’s expert report deadline for March 17, 2017. 5 6. Plaintiff has not requested an extension of his expert report deadline. 7. As of the date of this filing, Plaintiff has failed to produce any expert evidence in support of his claims. 8. Plaintiff’s medical records show no indication of a gynecomastia diagnosis. Respectfully submitted, IRWIN FRITCHIE URQUHART & MOORE LLC BY: /s/ Gretchen F. Richards________________ JAMES B. IRWIN (La. Bar No. 7172) DOUGLAS J. MOORE (La. Bar No. 27706) MEERA U. SOSSAMON (La. Bar No. 34797) GRETCHEN F. RICHARDS (La. Bar No. 35782) 400 Poydras Street, Suite 2700 New Orleans, Louisiana 70130 Telephone: (504) 310-2100 Fax: (504) 310-2101 jirwin@irwinllc.com dmoore@irwinllc.com msossamon@irwinllc.com grichards@irwinllc.com Counsel for Defendants Janssen Pharmaceuticals Inc., Johnson & Johnson, and Janssen Research and Development, LLC CERTIFICATE OF SERVICE I hereby certify that on March 21, 2017, the foregoing pleading was filed electronically with the Clerk of Court using the CM/ECF system. Notice of this filing will be sent to all counsel of record by operation of the court’s electronic filing system. /s/ Gretchen F. Richards 4 Stephen G. Kunin, Consolidated Listing of Patents Extended Under 35 U.S.C. § 156(e)(1), (June 30, 2003) United States Patent and Trademark Office OG Notices: 29 July 2003, http://www.uspto.gov/web/offices/com/sol/og/2003/week30/patxten.htm (last visited March 21, 2017). 5 Rec. Doc. 12. Case 2:16-cv-12413-LMA-MBN Document 30-3 Filed 03/21/17 Page 2 of 2 00401702 UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF LOUISIANA RICHARD GLENN PRAMANN v. CIVIL ACTION NO. 16-12413 JUDGE: AFRICK MAGISTRATE JUDGE: NORTH JANSSEN PHARMACEUTICALS, INC., JOHNSON & JOHNSON, JANSSEN RESEARCH AND DEVELOPMENT, L.L.C., PATRIOT PHARMACEUTICALS, LLC, BRENN DISTRIBUTION, INC., AND ENDO PHARMACEUTICALS, INC. NOTICE OF SUBMISSION PLEASE TAKE NOTICE that Defendants, Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research and Development, LLC (hereinafter "Defendants") will bring on for hearing the accompanying Motion for Summary Judgment on the 5th day of April, 2017, at 9:00 a.m., before the Honorable Lance M. Africk, District Judge of the United States District Court for the Eastern District of Louisiana, 500 Poydras Street, New Orleans, LA 70130. Respectfully submitted, IRWIN FRITCHIE URQUHART & MOORE LLC BY: /s/ Gretchen F. Richards________________ JAMES B. IRWIN (La. Bar No. 7172) DOUGLAS J. MOORE (La. Bar No. 27706) MEERA U. SOSSAMON (La. Bar No. 34797) GRETCHEN F. RICHARDS (La. Bar No. 35782) 400 Poydras Street, Suite 2700 New Orleans, Louisiana 70130 Telephone: (504) 310-2100 Fax: (504) 310-2101 jirwin@irwinllc.com dmoore@irwinllc.com msossamon@irwinllc.com grichards@irwinllc.com Counsel for Defendants Janssen Pharmaceuticals Inc., Johnson & Johnson, and Janssen Research and Development, LLC Case 2:16-cv-12413-LMA-MBN Document 30-4 Filed 03/21/17 Page 1 of 2 00401702 2 CERTIFICATE OF SERVICE I hereby certify that on March 21, 2017, the foregoing pleading was filed electronically with the Clerk of Court using the CM/ECF system. Notice of this filing will be sent to all counsel of record by operation of the court’s electronic filing system. /s/ Gretchen F. Richards Case 2:16-cv-12413-LMA-MBN Document 30-4 Filed 03/21/17 Page 2 of 2