Industrial Knife answered, asserting the statute of limitations as a defense. Two years later, Industrial Knife filed a motion to dismiss based upon the statute of limitations. The District Court denied its motion as untimely and the case went before a jury. The jury found in favor of Coons, awarding him $350,000 in compensatory damages. At the close of Coons’ case, Industrial Knife moved for judgment as a matter of law based upon the statute of limitations; this motion was also renewed before the jury deliberated. The District Court denied these motions without prejudice.

Following the return of the jury verdict, Industrial Knife filed a motion to alter or amend the judgment, arguing that Coons’ claims against it were time-barred. The District Court agreed and entered judgment for Industrial Knife. Coons appealed. The First Circuit first found that since Coons’ claims against Industrial Knife were filed well after three years from the date of the accident — when the cause of action accrued, Coons could only prevail if his amended complaint against Industrial Knife “related back” to his original complaint that was filed within three years of the date of the accident. There are three requirements that must be met for an amended complaint to “relate back” to the original complaint when a new party is added — the claim must arise out of the same conduct, the new party must have had some notice, and new party either must have known or should have known that the action could have been brought against it.

The First Circuit agreed with Industrial Knife that it had no notice of the action within the applicable time frame. Success in making this argument was attained only after defense counsel persisted in making the argument throughout the life of the case. A teaching point for all defense counsel.

Plaintiff Shereen Koch (“Koch”), underwent three arthroscopic shoulder surgeries in 2005 and 2006, which included the “implantation of a pump designed to bathe Plaintiff’s shoulder joint with a local anesthetic after surgery.” Koch alleged that the treatment had not been approved by the federal Food and Drug Administration and resulted in permanent injuries to her shoulder cartilage. Plaintiff filed suit against the manufacturer of the pump as well as the manufacturers of bupivacaine, the anesthetic administered through the pump. She asserted claims against these defendants for I) negligence and negligence per se, II) strict products liability, III) breach of express warranty, IV) breach of implied warranties, V) fraudulent misrepresentation, VI) fraudulent concealment, VII) negligent misrepresentation, and VIII) fraud and deceit.

Bupivacaine is manufactured and marketed under different trade names and prior to filing her complaint, Koch was not able to identify which brand of bupivacaine she received in her pump. As a result, she filed claims, in the alternative, against both manufacturers of bupivacaine. In response, these bupivacaine manufacturer defendants filed a motion to dismiss plaintiff’s claims, Counts I – IV, on the ground that she cannot meet the standard for facial plausibility established by the United States Supreme Court because she could not identify the specific brand that harmed her.

The Court denied this motion to dismiss stating that while Koch must ultimately identify which defendant manufactured the bupivacaine administered to her, she made out plausible claims against each defendant, which was sufficient at this stage of the litigation. On Plaintiff’s fraud and misrepresentation claims, Counts V – VIII, the Court granted defendants’ motion to dismiss based upon Koch’s failure to satisfy Rule 9 by failing to set forth specific and particular facts concerning defendants’ alleged misrepresentations.

This decision instructs that manufacturers of products subject to a products liability action may be required to litigate an action beyond a motion to dismiss even where a plaintiff cannot specifically identify the brand of the product that caused the alleged harm. While this will most likely arise in the medication context, all manufacturers should be aware of this possibility.

Last month, the U.S. District Court for the Southern District of Florida reiterated the significance of litigants’ properly and succinctly setting forth, within their pleadings, the factual and legal bases for which relief should be granted or denied. Gomez v. Pfizer, Inc. — F. Supp. 2d —, No. 09-22700-CIV, 2009 WL 4908937 (S.D. Fla. Dec. 21, 2009).

In Gomez, the plaintiff claimed to have developed severe headaches, body aches, and fever after taking the prescription medication Zoloft. She went to the hospital, where she was administered and prescribed Tylenol and Motrin for pain relief. Her condition allegedly worsened, and she was ultimately diagnosed with Stevens-Johnson syndrome, a life-threatening skin condition that causes the epidermis to separate from the dermis. She then filed suit against multiple defendants alleging theories of negligence and strict liability, and contending that her use of Zoloft, Motrin, and Tylenol – solely or in combination with one another – caused her to suffer the condition.

The defendants filed a motion to dismiss the plaintiff’s complaint. In so doing, they argued that the plaintiff’s negligence theory was insufficient in that it offered “nothing more than a recitation of the elements of duty and breach generally, a general recitation of alleged breaches, untethered to any actual facts, and the conclusion that those alleged breache[s] caused [the plaintiff’s] injury.” Id. The court agreed, holding that the plaintiff failed to set forth in detail each of the defendant’s individualized relationships to the medications in question, individualized duties to the plaintiff, and individualized breaches of that duty.

Second, the defendants attacked the plaintiff’s cause of action for strict liability. They argued that the complaint, which set forth that the products were “defectively designed and/or manufactured because [their] intended use resulted in a substantial and unreasonable likihood of causing Stevens-Johnson syndrome, which rendered [them] unreasonably dangerous for [their] intended use,” constituted nothing more than “bare legal conclusions.” The court agreed, noting that the plaintiff’s failure to set forth a specific theory upon which strict liability should be applied–defective design, manufacture, or failure to warn–prejudiced the defendants because they could not “determine which doctrine is at issue, much less how to frame a proper response.” Id.

The court dismissed the negligence and strict liability causes of action set forth within the complaint as a result of these fatal flaws, holding that a complaint’s allegations must include “more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Id. (internal citations omitted). “Threadbare recitals” of elements of a cause of action for products liability, supported by mere conclusory statements, will not suffice. Id. (internal citations omitted).

As this court demonstrates, a complaint which does not thoroughly and specifically set forth the theories and facts upon which it argues relief should be granted should be attacked for insufficiency. Defendants who are thereafter called upon to establish and foster an appropriate defense are prejudiced by anything less.