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We sometimes read decisions and think we must have already read the same decision under a different caption.  Critical as we are, we might even give a moment’s thought to the possibility that somehow the same decision was reissued under an alias. The more likely explanations for this phenomenon—setting aside glitches in the space-time continuum—are that cases come to our attention through means that lend to similarities in subject matter and results and that courts with coordinated proceedings sometimes issue similar decisions in batches.  As to the former, we cannot really reveal how we get all the cases considered by the blog cabal for our posts.  Suffice it to say that part of the process involves Bexis and a cauldron.  As to the latter, lots of drug and device cases are handled by federal MDL courts, state coordinated proceeding, or courts that otherwise preside simultaneously over many cases with the same core allegations. For various reasons, multiple decisions addressing common issues can issue from those courts over relatively short periods of time.  (For reasons we also cannot explain, we sometimes see common issues addressed in decisions by multiple courts over relatively short periods of time.  This is our fourth post in less than two weeks on decisions involving contraceptives or discussing law based solely on cases with a fertility drug.  Bexis may have changed the ingredients in the cauldron to augur the coming of spring.)

The decision in Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 1:09 oe 40023, 2014 U.S. Dist. LEXIS 47722 (N.D. Ohio Apr. 7, 2014), reminds us quite a bit of the Averhart and Casso decisions we posted about recently.  Maybe any decision about a summary judgment motion on a warnings claim on Ortho Evra from the judge overseeing the Ortho Evra MDL would.  In discussing the prior decisions, we offered that, because knowledge of the risks of hormonal contraceptives is widespread and “the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations . . . . the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.”  If we change the injury at issue from “blood clots” to “stroke,” the injury in Yates, then we still agree with ourselves.  Like Averhart, Yates involved a minor getting an Ortho Evra prescription from a healthcare provider who was not a physician. Like Averhart and Casso, we cannot figure out why the defendant’s motion for summary judgment did not address non-warnings claims, which easily survived an accompanying motion to dismiss.  Even more than the prior decisions, however, the presented facts show that the system in place for prescription drugs worked how it was supposed to work, other than plaintiff experiencing a serious warned-of event while on the drug.

Under New York law, which applied in Yates, the physician’s assistant who prescribed to the plaintiff counted as a learned intermediary based on statutory prescribing authority.  2014 U.S. Dist. LEXIS 47722, *12.  She also qualified as a learned intermediary by any measure because she was knowledgeable about the risks of hormonal contraceptives, including the risk of stroke with Ortho Evra—from the prominent warnings in the label and otherwise—and warned all her patients about those risks in connection with recommending the particular therapy she thought would be best for the particular patient.  Id. at **3-5.  She followed her normal practice with plaintiff, who admitted was warned about the risk of stroke with Ortho Evra.  Id. at **5-6.  (It sounds like the assumption of the risk defense might be available for at least some of those remaining non-warnings claims.) With the options laid out for her intelligently, plaintiff initially chose contraception in the form of an injection given every three months (as opposed to a weekly patch, daily pill, etc.). Id. at *6.  Plaintiff wanted hormonal contraception because she was sexually active and had severe menstrual cramps.  Id. at *5.  When she experienced weight gain and heavy bleeding, known side effects of the shot, plaintiff returned to her physician’s assistant and asked for Ortho Evra, which she received (via free samples with included patient package insert) after again being warned of the risk of stroke and other injuries and the possibility of diminished efficacy because of her obesity.  Id. at **6-7.  Plaintiff apparently did not read the patient package insert, but admitted that she would have used the patch even if she had read the stroke warnings in the patient package insert.  Id. at *7.  We have a hard time thinking of anything about stroke warnings that plaintiff could really criticize under these facts to defeat summary judgment.

Rather than argue about the warning actually given, the effect of a different warning on the prescriber’s actual decision to prescribe, or even her actual decision to pick the patch, plaintiff claimed no warning could be adequate for a prescription to a minor.  Id. at *14.  Before turning to how the court handled this argument, we ponder how it would be if all warnings to physicians who prescribe to minors were deemed inadequate.  Would drug companies seek to limit usage by minors for drugs that had a favorable risk-benefit and therapeutic niche for minors? Would physicians and other healthcare providers who treat minors resist prescribing drugs to their patients even when that was the best option notwithstanding potential liability?  Would signed informed consents be required before any minor—even one, like Yates, who was 17 years old and actively sought out prescription medication twice—received a prescription?  Would medical care of minors suffer?  We will not answer these questions except to say the public policy did not support plaintiff’s argument.  Luckily for minors, the court did not need to consider public policy to reject the argument.

The Yates court started with the fact that New York law (unlike Mississippi law in Averhart) did not have any requirement for parental consent for minors to receive prescription contraception from licensed healthcare providers.  Rather than deciding whether New York would change the operation of its learned intermediary doctrine for a minor receiving a prescription contraception—in an unspoken bit of Erie restraint, we think—the court looked at the facts of the plaintiff’s use and her mother’s consent to it. The defendant wisely elicited testimony from the mother that, we think, reflects a fairly common pattern, at least when relayed honestly.  Plaintiff’s mother drove her to the appointments with the PA, knew she on prescription contraceptives, saw there was a patient package insert provided, and never attempted to learn the risks or benefits of the contraceptive her daughter was using.  Id.  She did, however, agree that she would have let her daughter use Ortho Evra if she had read the stroke warnings.  Id.  Thus, the court held that parental consent was given, whether or not it was required by New York law.  Id. at *15.  This mooted plaintiff’s attempted end run around standard New York warnings law and led to the court’s conclusion that the warnings provided to the learned intermediary of the risk of the condition plaintiff claimed was caused by the drug were adequate.  The court actually said “The Defendants have met their burden to warn.”  Id. at *15.  We quibble with this, because it really was that “plaintiff did not carry her burden to show Defendants inadequately warned.”  We will cut the court some slack on this, though, because the result was right.

We also cut the court some slack for not explaining the expert opinion at issue in the plaintiff’s motion to amend her complaint.  We know—not just feel—that we have commented a few times on how Rule 15’s directive to “freely give leave [to amend] when justice so requires” should not give plaintiffs unlimited bites at the proverbial apple.  In denying the motion, the court stated plaintiff “has had years to be able to amend her complaint.  Discovery has been conducted and any motion to amend the complaint now that the summary judgment motion has been filed would be extremely prejudicial to the Defendants.”  Id. at *18.  That is the kind of statement we would not mind seeing again, particularly if it is part of putting an end to claims that never should have been pursued.