This is actually a post from Reed Smith’s Rachel Weil.  While this is not her first post, she is still a mere "guest poster" at this point and takes sole responsibility for the content of her posts.  We have allowed her to use first person plural pronouns, though.

On this unseasonably warm day where we are, as we lament the passage of another summer and the demise of its bounty of strawberries, blackberries and peaches, we rejoice that a recent trip to our local grocery uber-chain revealed a silver lining in the return of perfect clementines.  Clementines, those Lilliputian cousins of the tangerine, represent nature’s engineering at its best.  Easily accessible, their perfect sections are joined in a seamless whole, uniformly sweet and unmarred by “bad spots” or detritus. 

Such are the attributes of a tidy little decision out of the Ortho Evra® MDL.  (We have blogged about other Ortho Evra® decisions, like here and here, for example, but this is the first that was postured in a fashion that facilitated total victory for the defendants in one shot.  Today’s breaking news post, also comes from the Ortho Evra® MDL.)   In Giffen v. Ortho McNeil Pharmaceutical, Inc., No. 3:12 oe 40001, 2014 U.S. Dist. LEXIS 136587 (N.D. Ohio. Sept. 26, 2014), Plaintiff was given samples of the Ortho Evra® birth control patch and used them for one month. Alleging that the patch caused her to suffer a stroke, Plaintiff asserted the standard failure to warn, negligence, design defect, and warranty claims, along with a litany of fraud-based claims. Defendants moved in the alternative (wisely, as you will see) for judgment on the pleadings or for summary judgment on all of the Plaintiff’s claims.  Id. at *1-2. 

Failure to Warn

Defendants argued that the Ortho Evra® package insert was adequate as a matter of Missouri law.   The Court explained that, under Missouri’s learned intermediary doctrine, a warning is adequate if it “properly warns the doctor of the dangers involved in using the medication,” id. at *9-10, and that “Missouri courts have dismissed failure to warn claims where the manufacturer warns of the specific injury alleged.”  Id. at *10 (internal quotation marks and citations omitted).    The Court found that the Ortho Evra® package insert warned of the risk of stroke, and that the “detailed patient labeling document explicitly warned that the product could cause strokes;” Id. at *11, thus, the warning was “sufficient to meet the Defendants’ duty to provide adequate warning to physicians regarding the risks associated with the product.”  Id. The Court also noted that “the record also establishes that [Plaintiff’s prescribing nurse-practitioner] “was aware that the Ortho Evra® birth control patch could cause a stroke [and] . . . was familiar with the language of Ortho Evra®’s FDA approved package insert and detailed patient labeling which warned about the risk of stroke.”  Id.   In addition, Plaintiff “acknowledged receiving a box sample of the Ortho Evra® birth control patch which included the package insert and detailed patient labeling.” Id.

The Court rejected Plaintiffs’ arguments that the Ortho Evra® package insert was “63 pages long;” thus, her prescriber “could not possibly go over every risk with every patient.” In a clear-eyed (and too rare) distillation of the essence of the learned intermediary doctrine, the Court emphasized that “Missouri law does not require a prescriber to go over every risk with every patient.  Rather, Missouri law requires manufacturers to provide adequate warnings to physicians regarding the risks associated with the product. . . . Thus, whether [the prescriber] directly warned Plaintiff is irrelevant.  Defendants have met their burden to [the prescriber], which is all Missouri law requires.”  Id. at *13.

Remaining Claims

The Court denied Defendants’ Motion for Judgment on the Pleadings as to Plaintiff’s remaining claims, holding that Rule 8(a) and Twiqbal were satisfied.  “Nevertheless,” it noted, “these claims fail pursuant to Defendants’ alternative request for summary judgment, which Plaintiff does not oppose.”  Id.  The Court held:

  • Plaintiff could not prevail on a negligent failure to warn claim because, as explained, her failure to warn claim was without merit under Missouri’s learned intermediary doctrine.  Id. *14-15.
  • While Plaintiff alleged a design defect, “she has put forth no facts to support her claim that the design was defective.  Plaintiff must set forth specific facts showing that there is a genuine issue for trial. . . . Because Plaintiff has not demonstrated a defect in Ortho Evra®’s FDA-approved design, she has not met this burden.”  Id. at *16.
  • With respect to Plaintiff’s manufacturing defect claim, she “[a]gain . . . recites factual allegations but fails to put forth any facts creating a genuine issue that shows Defendants’ deviated from manufacturing specifications or otherwise identical units.  Without more, Plaintiff’s allegations fail as a matter of law.”  Id.
  • To prevail on her negligent representation, fraudulent representation, fraudulent concealment, fraud and deceit, and breach of warranty claims, Plaintiff was required to prove “reliance on a false statement or that the goods were not of a certain kind or quality” fit for a particular purpose.  Id. at *16-17 (citations omitted)   Defendants argued that Plaintiff had failed to show that she relied on any statement.   The Court commented, “[T]he root of the issue is much simpler; namely, Plaintiff has failed to show Defendants’ alleged representation was false or that the goods were not fit for a particular purpose.” Id. at *17-18 (emphasis in original).  The Court concluded, “Because Plaintiff has failed to establish she relied on Defendant’s representations, or that such representations were false or unsuitable, these claims fail as a matter of law.”  Id. at *18.

Thus, cutting to the heart of the burdens the Plaintiff was required to sustain and holding that she could not sustain them, the Court closed the door on her claims. Compact, accessible, and uniformly sweet – a worthy model for courts facing these ubiquitous issues.