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1 Failure Breach Case 2:12-cv JLL-JAD Document 34 Filed 04/19/13 Page 1 of 6 PageID: 331 UNITED STATES DISTRICT COURT District of New Jersey CHAMBERS OF MARTIN LUTHER KiNG JR. JOSE 1. LINARES FEDERAL BUILDING & U.S. COURTHOUSE JUDGE 50 WALNUT ST., ROOM 5054 Newark, NJ LETTER ORDER April 17, 2013 All Counsel of Record via electronicfiling Re: Andrew Nelson v. Biogen Idec Inc., et al. Civil Action No Dear Counsel: This matter comes before the Court by way of motions to dismiss Plaintiff s Complaint filed by Defendant Biogen Idec Inc. ( Biogen ) and Defendant Elan Pharmaceuticals ( Elan ), respectively. Defendants motions are brought pursuant to Federal Rule of Civil Procedure I 2(b)(6). 1 The Court has considered the submissions made in support of and in opposition to both motions and heard oral argument in connection with said motions yesterday. Having held oral argument, the Court will assume the parties familiarity with the underlying facts contained in Plaintiff s Complaint and summarizes only those facts that are necessary to provide context for this Letter Order. Plaintiff, Andrew Nelson, filed a complaint in this matter on November 28, Plaintiff s Complaint alleges that he sustained injuries stemming from his use of the FDA-approved prescription drug Tysabri, which was prescribed to him for the treatment of multiple sclerosis. Plaintiff s Complaint asserts the following five (5) causes of action against two defendants, Biogen and Elan: (1) Products Liability Act Product, (2) Products Liability Act Implied Warranty, (4) Negligence, and (5) Punitive Damages under common law. This Court s to Warn, (3) Product Liability Act Defective of For a complaint to survive dismissal, it must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. Ashcrofi v. Iqbal, 556 U.S. 662, 678 (2009) (citing Bell At!. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice. Id. 1

2 Defective Case 2:12-cv JLL-JAD Document 34 Filed 04/19/13 Page 2 of 6 PageID: 332 jurisdiction is premised on diversity of citizenship, 28 U.S.C. 1332(a)(1). On January 16, 2013, Defendant Elan Pharmaceuticals filed a motion to dismiss Plaintiffs Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). On February 21, 2013, Defendant Biogen Idec filed a motion joining in co-defendant s motion to dismiss and raising one additional argument in support of dismissal of Count One of Plaintiffs Complaint. Although the Court granted Defendants motions to dismiss Counts One, Three and Four on the record during the April 16, 2013 oral argument, for purposes of clarity, the Court will summarize its holdings below. 1. Count One Products Liability Act (Defective Product) Defendant Biogen seeks dismissal of Count One of Plaintiffs Complaint (Products Liability Act Product) on the basis that Plaintiff fails to adequately plead that a reasonable alternative design existed for the drug Tysabri or that a product existed that was equally effective and capable of preventing the alleged damages. 2 [Tb establish a prima facie case of defect, the plaintiff must prove the availability of a technologically feasible and practical alternative design that would have reduced or prevented the plaintiffs harm. Cavanaugh v. Skil Corp., 164 N.J. 1, 5 (2000) (internal quotations omitted); see also Lewis v. Am. Cyanamid Co., 155 N.J. 544, 571 (1998) ( Plaintiffs who assert that the product could have been designed more safely must prove under a risk-utility analysis the existence of an alternative design that is both practical and feasible. ). Plaintiff does not dispute that it must plead that a reasonable alternative design existed for Tysabri to support a design defect claim under New Jersey law. Rather, Plaintiff directs the Court to paragraph 53 of the Complaint which states: [ajt the time Tysabri left the hands of Defendants, there were safer alternative designs that were economically and technologically feasible by the application of reasonable scientific knowledge. (Compl., 53). However, Plaintiffs Complaint provides no facts, whatsoever, to support this assertion. Thus, the Court agrees with Defendant Biogen that this statement is conclusory and does not benefit from the presumption of truth. See Ashcrojt v. Iqbal, 556 U.S. 662, 678 (2009) ( Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice. ). In light of the foregoing, and for the reasons stated on the record on April 16, 2013, Defendant Biogen s motion to dismiss Count One of Plaintiffs Complaint is granted. Count One is dismissed without prejudice. 2 Defendant Biogen goes on to argue that Plaintiff cannot possibly allege any facts supporting a design defect claim in this case... [because] Tysabri is a monoclonal antibody. By definition, there can be no alternative design of Tysabri, much less a reasonable one. To change a monoclonal antibody would result in a different entity, which would not have the same properties. (Biogen Br. at 2). Because the Court finds that Count One of Plaintiffs Complaint has, in any event, been inadequately pled, the Court need not reach this issue. 2

3 Case 2:12-cv JLL-JAD Document 34 Filed 04/19/13 Page 3 of 6 PageID: Counts Three and Four Breach of Implied Warranty and Negligence Defendant Elan moves to dismiss Counts Three (breach of implied warranty) and Four (negligence) of Plaintiff s Complaint on the basis that said claims are subsumed by the New Jersey Products Liability Act ( PLA ) and thus cannot be maintained as separate claims. As stated on the record at oral argument, Plaintiff concedes that Counts Three and Four are subsumed by the New Jersey Products Liability Act. This Court agrees. With the exception of breach of warranty claims, the PLA is the exclusive remedy for harm caused by a product regardless of the theory underlying the claim. Sinclair v. Merck & Co., Inc., 195 N.J. 51, 62 (2008); see also Repola v. Morbarklndus., Inc., 934 F.2d 483, 492 (3d Cir. 1991). And, under the PLA there are only three causes of action manufacturing defect, failure to warn, or design defect. See N.J.S.A. 2A:58C-2. [T]he PLA no longer recognizes negligence or breach of warranty (with the exception of an express warranty) as a viable separate claim for harm[,] [including personal injury,] caused by a defective product or an inadequate warning. Koruba v. Am. Honda Motor Co., Inc., 396 N.J. Super. 517, 531 (App. Div. 2007) (internal quotations omitted). In light of the foregoing, and for the reasons discussed on the record at oral argument, Plaintiff s breach of implied warranty and negligence claims are subsumed by the PLA and are not actionable separate from his defect or failure to warn claims under the PLA. Defendant Elan s motion to dismiss Counts Three and Four is granted; these counts of Plaintiff s Complaint are dismissed without prejudice. 3. Count Five Punitive Damages under Common Law Count Five of Plaintiff s Complaint seeks an award of punitive damages under New Jersey common law. Plaintiff concedes, however, that the PLA is the exclusive remedy for harm caused by a product regardless of the theory underlying the claim. Sinclair, 195 N.J. at 62. Defendant Elan moves to dismiss this claim on the basis that, under the PLA, there can be no punitive damages for a claim based on an FDA-approved drug. The PLA provides in relevant part that: Punitive damages shall not be awarded if a drug or device which caused the claimant s harm was subject to premarket approval.. was approved. by the federal Food and Drug Administration and However, where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency s regulations, which information was material and relevant to the harm in question, punitive damages may be awarded. N.J.S.A. 2A:58C-5c. Thus, the PLA provides in no uncertain terms that punitive damages shall not be awarded in a products liability case based on an FDA-approved drug. Plaintiff 3

4 Case 2:12-cv JLL-JAD Document 34 Filed 04/19/13 Page 4 of 6 PageID: 334 does not dispute that Tysabri was subject to FDA approval and was, in fact, approved twice by the FDA. See Compi., 15, 24. Thus, as a general matter, the PLA precludes an award of punitive damages in this case. While the PLA does provide for one exception to the general rule where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency s regulations, which information was material and relevant to the harm in question, N.J.S.A. 2A:58C-5c, the New Jersey Appellate Division subsequently held that the foregoing exception is preempted by federal law because it requires, among other things, a showing of fraud on the FDA. See McDarby v. Merck & Co., Inc., 401 N.J. Super. 10, (App. Div. 2008) ( Although there are differences between the fraud-on-the-fda claim asserted in Buckman and McDarby s punitive damage claim premised on the withholding of information regarding the incidence of myocardial infarctions demonstrated by a meta-analysis, we find the single focus upon fraud on the FDA in each to be sufficiently similar to warrant the application of Buckman to this case. ); see also Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 348 (2001) ( [Wje hold that the plaintiffs state-law fraud-on-the-fda claims conflict with, and are therefore impliedly pre-empted by, federal law. The conflict stems from the fact that the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives. The balance sought by the Administration can be skewed by allowing fraud-on-the-fda claims under state tort law. ). In short, this is a products liability case. Under New Jersey law, the PLA is the exclusive remedy for harm caused by a product regardless of the theory underlying the claim. Sinclair, 195 N.J. 51. The PLA precludes punitive damages in a products liability case such as this one where the alleged harm was purportedly caused by an FDA-approved drug. N.J.S.A. 2A:58C-5c. Although the PLA has provided for one exception to this general rule, id., the New Jersey Appellate Division subsequently found this exception which requires, inter alia, a showing that the product manufacturer committed a fraud on the FDA to be preempted by federal law. See McDarby, 401 N.J. Super. at (citing Buckman, 531 U.S. at ). Defendants motion to dismiss this claim is, therefore, granted. Count Five of Plaintiff s Complaint is dismissed with prejudice. 4. Count Two Products Liability Act (Failure to Warn) Defendant Elan moves to dismiss all counts of Plaintiffs Complaint based upon Plaintiffs purported lumping together of all allegations as to both Defendants. According to Elan, this violates Federal Rule of Civil Procedure 8(a) inasmuch as it fails to provide each defendant with proper notice of the claim(s) asserted against it, thereby preventing defendants from properly responding to each of Plaintiffs causes of action. 4

5 Case 2:12-cv JLL-JAD Document 34 Filed 04/19/13 Page 5 of 6 PageID: 335 The Court has carefully reviewed the allegations set forth in Plaintiff s Complaint. Although Plaintiff s Complaint does contain certain facts pertaining to each defendant, 3 the Court agrees with Defendant Elan that, as a general matter, the Complaint fails to: (a) properly identify which particular legal claims are asserted against which particular defendant, and (b) contain specific facts that would allow the Court to draw the reasonable inference that each defendant is liable for the misconduct alleged. This violates the basic pleading requirement of Federal Rule of Civil Procedure 8(a). See Iqbal, 556 U.S. at 678 ( To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. ) (citations omitted). Having already found that dismissal of Counts One, Three, Four and Five of Plaintiff s Complaint is warranted, for other reasons, the Court finds that dismissal of Count Two of Plaintiff s Complaint is also warranted for failure to meet the pleading requirement of Rule 8(a) of the Federal Rules of Civil Procedure. Count Two of Plaintiff s Complaint is, therefore, dismissed without prejudice. 5. Fees and Costs Lastly, Defendant Elan asks the Court to strike Plaintiff s requests for treble damages, attorneys fees, expert fees and costs and expenses of litigation. According to Elan, New Jersey law does not allow for the recovery of litigation expenses unless authorized by statute, rule or contract, and Plaintiff has not identified any support for the requested relief. In support of its position, Defendant cites to New Jersey Court Rule 4:42-9(a) which provides, in pertinent part, that [njo fee for legal services shall be allowed in the taxed costs or otherwise, except [as provided by rule). In opposing this aspect of Defendant Elan s motion, Plaintiff maintains that any argument regarding attorneys fees, costs and expenses of litigation is premature at this time. In addition, Plaintiff cites to New Jersey Court Rule 4:42-8(a) for the proposition that [u]nless otherwise provided by law, these rules or court order, costs shall be allowed as of course to the prevailing party. The Court has considered the parties positions and notes that if Plaintiff does not succeed in this litigation, this entire issue will be moot. Moreover, the parties have failed to convince the Court that addressing this issue, at this juncture, will have any effect whatsoever on the scope of discovery or on the litigation, as whole. Accordingly, the Court denies this aspect of Defendant s motion, without prejudice, as premature. See, e.g., Compl., J 27, 30, 38. 5

6 Case 2:12-cv JLL-JAD Document 34 Filed 04/19/13 Page 6 of 6 PageID: Conclusion For the reasons set forth above and on the record on April 16, 2013, Defendants motions to dismiss Plaintiffs Complaint [Docket Entry Nos. 8 and 21) are granted in part and denied in part. Counts One, Two, Three and Four of Plaintiffs Complaint are dismissed without prejudice. Count Five of Plaintiff s Complaint, seeking an award of punitive damages, is dismissed with prejudice. Defendants request to strike Plaintiffs request for certain costs and expenses of litigation, including attorneys fees, is denied without prejudice as premature. To the extent the pleading deficiencies in Counts One through Four of Plaintiffs Complaint can be cured by way of amendment, Plaintiff may file an Amended Complaint on or before Friday, May 24, Failure to do so may result in dismissal of Counts One through Four of Plaintiffs original complaint with prejudice. IT IS SO ORDERED. Linares, U.S.D.J. 6

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