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From Products Liability Law Daily, May 21, 2018

No amended complaint in pre-natal Zofran® lawsuit

By Robert B. Barnett Jr., J.D.

A motion to amend class action fraud claims regarding the safety of using the drug Zofran® to treat pregnancy-related nausea must be denied as untimely, where the misrepresentations upon which the parents of children born with birth defects relied were known at the time these claims were originally dismissed for lack of specificity, a Massachusetts federal court has ruled. Although new facts were learned in discovery, the alleged off-label misrepresentations upon which the claims were based were available when the complaint was filed, and the parents still failed to allege the specific off-label representations on which they based their claims. The parents’ fraud claims regarding the allegedly false labelling of Zofran, however, have not been dismissed and may continue (In re Zofran (Ondansetron) Products Liability Litigation, May 18, 2018, Saylor, F.).

GlaxoSmithKline LLC manufactures and sells Zofran, an anti-emetic (prevents nausea or vomiting). It was originally approved for the prevention of nausea and vomiting caused by chemotherapy or radiation therapy, as well as post-operative nausea and vomiting. GlaxoSmithKline later sought to expand Zofran’s use to treat pregnancy-related nausea. Various parents and guardians of children who were born with birth defects that they allege were caused by prenatal exposure to Zofran or generic ondansetron filed suit against GlaxoSmithKline. Their suits alleged misrepresentation and products liability claims for both product labeling and for off-label marketing and advertising.

The court dismissed all off-label claims for failing to comply with the heightened pleading standards for fraud. Following additional discovery, the parents moved to amend the master complaint to reassert claims based on off-label misrepresentations that were learned in discovery. The three claims previously dismissed for lack of specificity were for: (1) negligent misrepresentation; (2) fraudulent misrepresentation; and (3) violation of state consumer protection laws prohibiting deceptive practices.

Timeliness. The parents sought to amend their complaint with allegations that GlaxoSmithKline launched a marketing scheme in 1997 to promote Zofran to obstetrics and gynecology health care practitioners and to consumers, as a safe and effective treatment for pregnancy-related nausea and vomiting. As a result, by 2002 Zofran had become the most frequently prescribed drug in the U.S. for treating pregnancy-related nausea and vomiting. Furthermore, the parents alleged, GlaxoSmithKline knew that its statements about Zofran’s safe use were misleading because animal studies had revealed dangers to the fetus. Other than some new details, the court said, the claims were essentially unchanged. The parents, in effect, were seeking to assert the same claims previously dismissed.

The court rejected the argument that the allegations were new because they were based on new facts. The new details about GlaxoSmithKline’s scheme may have provided additional proof of falsity but the new facts never established the contents of the representations themselves. To put it another way, the fact that the parents now know a lot more details about the alleged scheme did not alter their pleading obligations. They still failed to establish the claims in general terms. In the complaint, the parents described the misrepresentations in general terms, allowing individual parents to adopt those allegations that apply to their circumstances. The court found that level of pleading insufficient for fraud.

This motion to amend must therefore fail, the court said, because the parents have still not alleged the specific off-label representations on which they based their claims. Just as importantly, this motion was not timely because the information on what was said was available to the parents from the very beginning. They could have, for example, asked the physicians what GlaxoSmithKline told them. Therefore, the result was not changed by the fact that the alleged misrepresentations were made to the physicians rather than to the parents. "With basic investigative diligence," the court said, the parents "could have uncovered the specific facts underlying their misrepresentation claims." As a result, the motion to amend the three claims was denied.

Further amendments. The decision to deny the parents the right to amend those three claims, the court said, did not mean that the motion to amend the complaint would be denied in its entirety. Consequently, the court allowed the parents to amend the complaint to add the factual assertions they learned in discovery as they applied to the labelling claims. The court also allowed the parents to amend the complaint to clarify that it now asserts only product label claims. In any event, the practical effect of denying this motion, the court noted, was "likely to be fairly limited" because the off-label statements by GlaxoSmithKline may well be admissible even when proving claims not based on fraud.

The court, therefore, denied the motion to amend to the extent that the parents sought to add claims for negligent misrepresentation, fraudulent misrepresentation, and violation of consumer protection laws arising out of alleged off-label misrepresentations. Otherwise, it was granted.

The case is No. 1:15-md-2657-FDS.

Attorneys: Christopher T. Hellums (Pittman Dutton & Hellums, PC) and Kimberly Barone Baden (Motley Rice LLC) for Zofran [Ondansetron] Products Liability Litigation. Amber Davis-Tanner (Quattlebaum, Grooms & Tull PLLC) and Bryan A. Coleman (Maynard Cooper & Gale PC) for GlazoSmithKline LLC. Eva Canaan (Phillips Lytle LLP) and Evan D. Montgomery (Shook, Hardy & Bacon LLP) for GlaxoSmithKline LLC. Erin McCalmon Bosman (Morrison & Foerster LLP) for McKesson Corp.

Companies: Zofran [Ondansetron] Products Liability Litigation; GlazoSmithKline LLC; GlaxoSmithKline LLC; McKesson Corp.

MainStory: TopStory WarningsNews DrugsNews MassachusettsNews

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