United States: SDNY Rejects Innovator Liability

May 10 is an important day in the history of the law. On this date, way back in 1893, the Supreme Court ruled that the tomato is a vegetable, not a fruit. The case was called Nix v. Hedden, 149 U.S. 304 (1893). The issue concerned application of the Tariff Act of 1883, which imposed a tax on vegetables, but not fruits. The appellant was one of New York City's biggest produce sellers. He imported lots of tomatoes, and was looking to dodge the tax. He cited dictionaries defining tomatoes, in a technical/botanical sense, as the "'fruit' as the seed of plants, or that part of plants which contains the seed, and especially the juicy, pulpy products of certain plants, covering and containing the seed." But, alas, the High Court ruled that "[t]hese definitions have no tendency to show that tomatoes are 'fruit,' as distinguished from 'vegetables,' in common speech, or within the meaning of the tariff act." Science be damned, people eat tomatoes in their salads, not desserts, so they are vegetables, not fruits. Because common parlance prevailed, the taxpayer did not.

* * * * *

We'll exploit this historical legal oddity and its exaltation of common understanding as a semi-ironic preface to a case where a pro se plaintiff went down in flames in a product liability case. In Coleson v. Janssen Pharmaceutical, Inc., et al., , 2017 U.S. Dist. LEXIS 68072 (S.D.N.Y. May 3, 2017), the plaintiff filed a pro se complaint against the defendants in New York state court (the Bronx, to be specific) , which alleged that he developed gynecomastia as a result of taking Risperdal and generic risperidone. The defendants removed the suit to federal court. Things were already heading in the right direction for the defense. After discovery, during which the plaintiff apparently never found an expert on causation, the defendants moved for summary judgment. The defendants won. The plaintiff lost. Common sense also won: the court rejected innovator liability for an alleged failure to warn by a generic competitor. Finally, we are reminded of that most common of courts, The People's Court, where Judge Wapner routinely blasted plaintiffs for not having the requisite paperwork to back up their claims.

After the plaintiff in Coleson had been diagnosed with bipolar schizophrenia around 2009 or 2010, physicians prescribed Risperdal and risperidone. Risperdal is the brand name product and was manufactured/sold by the defendants. Since at least 1996, Risperdal's FDA-approved disclosures stated that Risperdal is associated with endocrine-related side-effects, including gynecomastia. Risperidone is the generic version. It had been available since 2008. Medicaid paid for all of the plaintiff's prescriptions. New York's Medicaid program excludes coverage of brand-name drugs when there is an FDA-approved generic equivalent on the market unless one's healthcare provider specifically requests an exemption for the patient. So it looks as if the plaintiff was probably taking risperidone. That is, he took risperidone until sometime in 2013-14, when he switched to an entirely different atypical antipsychotic, which was also associated with gynecomastia. The plaintiff was diagnosed with gynecomastia in 2015.

Despite his usage of generic risperidone and a different antipsychotic, the plaintiff sued only the Risperdal brand manufacturer. As with most pro se complaints, the theories of the case were less than pellucid. The defendants and the court construed the causes of action as failure to warn and design defect against the brand manufacturers. The plaintiff alleged that the side-effect information in the generic risperidone was different from the FDA-approved Risperdal label. The defendants' summary judgment motion argued that the plaintiff's claims failed for lack of any evidence that the plaintiff ingested name-brand Risperdal, as opposed to generic risperdone. The defendants argued that they could not be held liable for either failure to warn or design defect for an injury resulting from a product that they did not manufacture, distribute, or sell. The defendants also argued that the plaintiff could not show medical causation between Risperdal and his gynecomastia.

Yes, we are confronted yet again with the issue of innovator liability. Under Erie, the federal court needed to determine the substantive law of the forum, New York. The New York Court of Appeals has not yet addressed whether a manufacturer of a name-brand prescription drug can be held liable for injuries resulting from another company's generic equivalent. But there is at least one federal case, Goldych v. Eli Lilly & Co., No. 04 Civ. 1477 (GLS)(GJD), 2006 WL 2038436 (N.D.N.Y. July 19, 2006), and one New York state case, Weese v. Pfizer, Inc., 2013 N.Y. Misc. LEXIS 4761, 2013 N.Y. Slip Op. 32563 (Sup. Ct., N.Y. Cty. Oct. 8, 2013), rejecting innovator liability. Those two New York decisions are in accord with the majority of courts to consider the topic: fifty-five other state courts across twenty-one states, in addition to all six circuit courts of appeal, have ruled that innovator liability makes no sense. See our general innovator liability posts here and here. The Conte decision in California, which applied such innovator liability, stands as an egregious, eccentric exception. The Coleson court acknowledged that there are a couple of cases clumsily following Conte, but the Coleson court declined to join the heresy.

Supporting its decision, the Coleson court discussed a recent asbestos case that, at first blush (but only first blush) seemed to offer some hope for the plaintiff. Last year, in In re N.Y. City Asbestos Litig., 27 N.Y.3d 765, 59 N.E.3d 458 (2016), the New York Court of Appeals held that manufacturers had a duty to warn of potential dangers resulting from their products' use in conjunction with third party products. To support this interpretation, the asbestos court observed that the manufacturers had "knowledge and ability to warn of the dangers" when consumers used the product with a third party's product. As we discussed at the time, here, that is quite a bit different from being required to warn about use of a competitor's product, when the defendant's own product was not being used at all. The Coleson court reasoned that the asbestos ruling was unlikely to make "the cost of liability and litigation . . . unreasonable" and, moreover, the manufacturers "derive[d] a benefit from the sale of the [other party's] product." This rationale weighed in the opposite direction in Coleson. The brand defendants "had no oversight in the manufacturing of the generic drugs. They earned no profit from the sale of the generic drugs. Given the length of time generic drugs can sell following a patent's expiration, to find a new duty would unforeseeably expand the cost of liability on brand-name drug manufacturers." Coleson, 2017 U.S. Dist. LEXIS 68072 at *10.

Goodbye failure to warn claim. The plaintiff's failure to warn claim was dismissed because he alleged a warning defect as to only risperdone, over which the defendants had no duty of care.

The Coleson plaintiff's design defect claim also failed. He could not show by a preponderance of the evidence that he ever ingested name-brand Risperdal. The plaintiff's declaration and deposition stated that he was prescribed, amongst other drugs, "Risperdal (risperidone)" and that a hospital in 2009 or 2010 dispensed "Risperdal and/or risperidone." The plaintiff also claimed that hospital records proving he actually received Risperdal in the hospital were likely destroyed by a fire in January 2015. [We know some especially nettlesome plaintiff lawyers who would turn this misfortune into a spoliation claim, but the pro se plaintiff lacked either the expertise or chutzpah to pursue that vexatious path.] It was true that the plaintiff's medical records at times recorded his prescription as only for Risperdal. But generic risperidone is regularly written as "Risperdal (risperidone)," a nomenclature even the plaintiff repeatedly adopted in his papers. That a drug is prescribed under its brand-name does not mean that a patient receives that name-brand drug, and it is hardly justifiable to infer that it does. In the absence of real evidence, the Coleson court was unimpressed by the plaintiff's "mere speculation or conjecture" as to Risperdal usage. Coleson, 2017 U.S. LEXIS 68072 at *11.

But let's for the moment speculate that a "fair-minded jury" could speculate that the plaintiff was prescribed brand name Risperdal somewhere in the relevant time-frame. And yet it was undisputed that by 2009, when the plaintiff was first prescribed the medicine, risperidone was a widely available generic to Risperdal. It was also undisputed that all of the plaintiff's prescriptions were paid by Medicaid. Aside from exceptional circumstances the plaintiff never showed, the plaintiff's prescriptions under Medicaid needed to be filled with generic drug equivalents. Thus, from the evidence presented, no jury could draw the "justifiable inference" that the plaintiff received name-brand Risperdal for his prescriptions. There might well have been an inference of injury from ingestion of risperdone, but the Coleson plaintiff had not sued the generic manufacturer. Id. at *12.

Even assuming that the plaintiff had ingested Risperdal, his design defect claim against the defendants would still fail because he could not establish that Risperdal caused his gynecomastia. The Coleson court embraced the requirement in products liability cases that, to establish causation, plaintiffs must offer admissible expert testimony regarding both general and specific causation. The requirement is particularly pertinent where a causal link is beyond the knowledge or expertise of a lay jury. In the Coleson case, there was no such expert in sight. Id. at *13.

The plaintiff suggested he did not need an expert on causation when he had something even better: the Risperdal label. That label contains a warning regarding gynecomastia. The plaintiff also pointed to a July 2015 medical report, which concluded that the plaintiff's gynecomastia "is related to phychiatric [sic] medical ingestion." The court did not buy either of these arguments. First, Risperdal's warning label cannot establish general causation: "Product warning labels can have over-inclusive information on them, often out of 'an abundance of causation or the avoidance of lawsuits.' Coleson, 2017 U.S. Dist. LEXIS 68072 at *14 (quoting In re Mirena IUD Prods. Liab. Litig., , 202 F. Supp. 3d 304, 323 (S.D.N.Y. 2016)). Unless a warning label specifically says that an alleged injury can be caused by a drug, courts have held that a drug's product warning label alone cannot "raise a genuine issue of material fact with respect to general causation." Id. Risperdal's label states merely that it "elevates prolactin levels" and that "gynecomastia . . . ha[s] been reported in patients receiving prolactin elevating compounds." This information is not the same as an admission of "a genuine phenomenon" creating a "material fact with respect to general causation."

Nor did the Coleson plaintiff's July 2015 medical report establish proximate cause. The plaintiff claimed to have taken Risperdal around only 2009-10. Throughout 2010 to 2014, the plaintiff took risperidone. In early 2014, the plaintiff switched to a different antipsychotic, which is also associated with cases of gynecomastia. The plaintiff was diagnosed with gynecomastia only in early 2015, and the medical report to which the plaintiff points indicates the plaintiff had taken both risperidone and the other antipsychotic. This report does not state which, if any, of these drugs was responsible for the plaintiff's injury. Without competent medical expert testimony on the issue of causation, a jury would be left only to "theorize" as to how the plaintiff came to suffer from gynecomastia. Id. Accordingly, the defendants' motion for summary judgment was granted.

So what we have here is a good result from a smart court. That decision was made a bit easier because a pro se plaintiff sued the wrong party, hired no expert who would render some frail opinion on 'substantial causative factor,'' and failed to assemble decent evidence of usage. What's that saying about someone who acts as his own lawyer?

This article is presented for informational purposes only and is not intended to constitute legal advice.

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