The should have and could have of Paxil

Who knows how much the U.K. pharmaceutical corporation GlaxoSmithKline will pay in settlements and damage awards in 2013 to victims of the antidepressant Paxil?

Even the corporation’s 2012 earnings statement issued Feb. 6 explained that although, as of Dec. 31, 2012, a half-billion British pounds were provided for “legal and other disputes,” there would be “no assurance that any losses that result from the outcome of any legal proceedings will not exceed by a material amount the amount of the provisions reported in the Group’s financial accounts.”

Injured patients may recover damages in Paxil lawsuits in 2013 that will figure into GSK’s legal-cost equation as well as in the corporation’s bottom line. GSK announced in its statement that its total 2012 revenue dropped 1 percent from that of 2011 to 26.4 billion pounds or $42 billion. Moreover, Paxil sales dipped 14 percent in 2012 to 374 million pounds, the equivalent of $595 million, with U.S. sales of the antidepressant finishing $2 million below sea level.

“There have been no significant developments since the Annual Report 2011” from a legal standpoint, according to GSK’s news release recapping 2012. But there might be a key development in 2013.

What could change is the volume of U.S. Paxil lawsuit filings against GSK, primarily by plaintiffs who will be represented by Paxil lawyers, such as the experienced pharmaceutical injury attorneys at Reich & Binstock [www.reichandbinstock.com].

As GSK’s 2011 Annual Report reads, “The Group is currently a defendant in a substantial number of product liability lawsuits, including class actions, that involve significant claims for damages related to the Group’s pharmaceutical and consumer healthcare products. Litigation, particularly in the USA, is inherently unpredictable … Claims for pain and suffering and punitive damages are frequently asserted in product liability actions” that may be filed in U.S. courts.

GSK’s year-old summary of 2011 briefed investors and others on what had been going on in Paxil lawsuits, explaining, “Most of these lawsuits in recent years have alleged that the use of Paxil during pregnancy resulted in the birth of a child with birth defects or health issues. Other lawsuits and claims have alleged that patients who took Paxil committed or attempted to commit suicide or acts of violence…”

Shifting the focus to congenital conditions, the U.S. Food and Drug Administration approved Paxil in 1992. But the science showed relatively late in the game, instead of pre-approval or early on, that Paxil had a defect that the manufacturer should have known and thus should have reported to regulators, assert plaintiffs.

Expectant mothers who took Paxil exposed their newborns to an increased risk of a life-threatening lung condition. Good to know!

Based on a February 2006 study published in The New England Journal of Medicine, the U.S. Food and Drug Administration directed the manufacturers of Paxil — and of other antidepressants in its class of selective serotonin reuptake inhibitors — to “change prescribing information to describe the potential risk for PPHN,” which is persistent pulmonary hypertension.

The study, according to the FDA, showed that such newborns “were 6 times more likely to have persistent pulmonary hypertension than infants born to mothers who did not take antidepressants during pregnancy. … Neonatal PPHN is associated with significant morbidity and mortality. The FDA is updating the prescribing information for all SSRIs with this new information.”

This does not constitute an, “I told you so moment.” This is a, “You should have told us so” moment.

What a dichotomy. Although the outcome of Paxil lawsuits is, using GSK’s own words, “inherently unpredictable,” the increased risk of PPHN in infants whose mothers took Paxil apparently has been as predictable as the sunrise. If the manufacturer had known the latter, it could have precluded the specter of the former. And harm to newborns and to families perhaps could have been averted.

But here we are. Facing monumental health care expenses and other losses, the victims of Paxil and of other SSRIs — Zoloft, Celexa, Lexapro, Prozac, Luvox and Viibryd — turn to counsel for help. Reich & Binstock provides free consultations to people whose injuries may be related to Paxil, Zoloft or any other SSRI antidepressant. Such patients may be entitled to compensation. The law firm may be reached toll-free at 1-866-LAW-2400.