MachineWatson v. Bayer Healthcare Pharmaceuticals Inc., No. 13-212, 2013 WL 1558328 (E.D. La. April 11, 2013) (Feldman,J.)

Plaintiff failed to state a claim for relief in her Complaint against Bayer Healthcare Pharmaceuticals, Inc. (“Bayer”), the maker of the Mirena intrauterine contraceptive, Id. at *5, and her case was dismissed, without prejudice, pursuant to Rule 12(b)(6) FRCP.

Plaintiff used a Mirena intrauterine contraceptive from 2007 until 2012 when she underwent surgery to have the Mirena removed because it had become embedded in her uterus. Id. at *2. Plaintiff sued Bayer, alleging that the Mirena device was defective under the Louisiana Products Liability Act (“LPLA”), along with theories of negligence, breach of implied warranty, breach of express warranty, negligent misrepresentation, fraudulent misrepresentation, and concealment. Id. Because Plaintiff’s claims arose out of her use of the Mirena product, the LPLA establishes her exclusive avenue of recovery. Accordingly, the court held that Plaintiff could not recover on any theory of recovery besides her claims under the LPLA. Id. at *3.

Next, Judge Feldman considered whether Plaintiff had alleged sufficient facts, if true, that stated a “plausible” claim for relief as required under

Ashcroft v. Iqbal, 556 U.S. 662, 678-79 (2009). The Court found that Plaintiff failed to state a claim under the LPLA because she failed to state how the Mirena device deviated from its intended design, failed to allege how the device was improperly designed, how the alleged defect caused her injuries, and failed to state how any allegedly inadequate warnings caused her injuries. Id. at *4-5. The Court ruled that the Plaintiff could seek leave to file an amended complaint. Id. at *5.

Hargrove v. Boston Scientific Corp., 2014 WL 4794763 (E.D. La. 2014)

Once upon a time, federal court product liability and toxic tort practice involved “notice” pleading: a plaintiff filed a complaint identifying defendant and mentioning a LSA C.C. art. 2315 and maybe a statute or two – and that was all you needed to “notice” plead. Specific facts to support the claims would be developed in discovery.

In 2008-2009, the Supreme Court refined “notice” pleading in the Ashcroft v. Iqbal, 556 U.S. 662 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) cases. Defendants in products and toxic tort cases have used the new “notice” pleading in Rule 12(b)(6) motion to dismiss practice to require a plaintiff to make detailed, fact-specific allegations on technical matters involving the product at issue, e.g., pharmaceutical or chemicals, that historically were developed in fact discovery. The penalty for failure to make these fact-specific allegations is dismissal of part or all of Plaintiff’s suit before discovery even starts.

In Hargrove, Plaintiffs, a husband and wife, alleged that the wife developed chronic pancreatitis after a medical device manufactured by defendant broke apart in her body. Plaintiffs filed suit based on the LPLA in federal court. Defendant filed a motion to dismiss under Fed. R. Civ. P. Rule 12(b)(6), because the Complaint failed to state a claim upon which relief could be granted.

The court first dealt with Defendant’s assertion that Plaintiffs’ claims had prescribed. Noting that federal Fifth Circuit jurisprudence holds dismissal based on prescription under 12(b)(6) is improper if “prescription presents questions of fact that cannot be conclusively resolved on the face of the pleadings,” the court denied Defendant’s motion to dismiss on the basis of prescription. It held that the facts alleged in the Complaint supported application of contra non valentem to toll the running of prescription while Plaintiffs attempted to determine what had gone wrong with the device and by whom it was manufactured.

The court next examined whether Plaintiffs had alleged specific facts for their claims falling under the LPLA. The allegations were sufficient to state a claim that the product was unreasonably dangerous in construction and composition because Plaintiffs alleged that the product was “not properly manufactured,” was “inadequate or insufficient to maintain its integrity,” and was “sold in a defective condition.” But, the court then held that the Plaintiffs failed to specifically allege facts sufficient to state a claim under the other three theories of liability.

On the design defect claim, although the Plaintiffs’ allegations “address[ed] the [product’s] design,” Plaintiffs failed to allege an alternative design existed and could not elevate their allegation above a speculative level by stating that defendants committed “other acts and failures” in the design as would be learned in discovery.

  • Plaintiffs failed to state a claim for inadequate warning based on the “learned intermediary doctrine,” under which manufacturers must only warn the doctor, not the patient. The court held that because Plaintiffs’ Complaint alleged that Defendant failed to warn the “end user” of the risks of using the product, Plaintiffs failed to address whether “a proper warning would have changed the decision of the treating physician” and thus failed to state a claim under the inadequate warning prong of LPLA.
  • On the warranty claim under the LPLA, the Court found no facts alleged to support these claims.

Finally, all of Plaintiff’s non-LPLA claims were dismissed: “to the extent that the [plaintiffs] have alleged independent causes of action for negligence, deceptive practices, ‘inherently dangerous’ product liability, and breach of implied warranty, their claims are not cognizable under the LPLA. And because the LPLA is the exclusive remedy for product liability tort claims under Louisiana law, the [plaintiffs’] tort claims sounding in these theories are dismissed.”

Jenkins v. Bristol-Myers Squibb, 2015 WL 5012130 (E.D. La. 2015)

The Jenkins case illustrates a more traditional, related notice pleading standard.

In Jenkins, Plaintiff alleged that ingestion of the drug Abilify caused him to develop Tardive Dyskinesia, a “neurological disorder characterized by involuntary movements of the face and jaw.” Plaintiff asserted liability under LPLA for failure to warn and defective design.

Defendants moved to dismiss the defective design claim under Fed. R. Civ. P. Rule 12(b)(6), arguing that Plaintiff merely pled that Defendants failed to consider an alternative product design and the LPLA requires that such design exist at the time the product left the control of the manufacturer and that the danger of the damage outweighed the burden of adopting the alternative design. Defendants argued that Plaintiff’s claim for failure to warn should be dismissed because the Complaint failed to mention the adequacy of warnings provided to Plaintiff’s prescribing physician, nor did it allege that the physician would have prescribed a different drug with a different warning.

In opposition, Plaintiff argued that Louisiana law recognizes “much of the evidence in pharmaceutical products liability cases may be in the defendant’s possession, and thus, without the benefit of discovery, stating more specific allegations may be nearly impossible” at the motion to dismiss stage. On the failure to warn claim, Plaintiff argued that his reference to “health-care providers” should be read to include his prescribing physician, but if the court finds this to be unclear Plaintiff requested leave to amend his petition.

Judge Fallon granted, in part, the motion to dismiss based on Plaintiff failing to plead that an alternative design existed that could have prevented Plaintiff’s injuries. The court expressly stated that it did not agree with Defendants’ assertion “that it is necessary at this early stage for Plaintiff to plead specifics about the alternative design,” because “such a requirement would place a near-impossible burden on Plaintiffs in pharmaceutical litigation.” On the element of showing that the burden of adopting the alternative design was outweighed by the danger of using the chosen design, the court recognized that Plaintiff “may be unable to assert specific allegations without the benefit of discovery,” but this Plaintiff failed to “articulate even a bald claim” on this element. The court granted Plaintiff’s motion to amend his Complaint to address factual deficiencies because “[c]ourts should ordinarily grant a Plaintiff at least one opportunity to amend his complaint before dismissing the complaint with prejudice for failure to state a claim.”

On the failure to warn claim, the court applied the learned intermediary doctrine, which requires Plaintiff to “show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product that is not otherwise known to the physician,” and that the failure to warn was the proximate cause of Plaintiff’s injury. The court stated that Plaintiff did not need to identify his treating physician in the pleading, and that the allegation “healthcare providers” included his physician. The court expounded,

To allege a failure-to-warn claim upon which relief can be granted under the LPLA, Plaintiff is not required to detail what an adequate warning would be and how an adequate warning would have caused Plaintiff’s treating physician to act differently. Plaintiff is merely required to allege that Defendants did not adequately warn Plaintiff’s treating physician and that the inadequate warning constituted the proximate cause of Plaintiff’s injuries.