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Sometimes the marketplace of ideas actually works

By James M. Beck and Mark Herrmann

Although trial court judges mostly get things right, every once in a while a trial court judge will issue an opinion that just plain stinks. We aren?t simply talking about any old decision in favor of a plaintiff suing a drug or device company. We recognize that some trial court decisions against our clients are legitimate matters of disagreement or, worse, compelled by precedent. The descriptive term ?stinks? is a legal term of art meaning that the trial court has thumbed its nose at the decisions of higher courts. We discussed a prior example of this phenomenon here.

Another example of real stinker of a decision is Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009). We named Hofts one of the worst prescription drug/device decisions of 2009, and we ranted about it here. Hofts skunked two Supreme Court decisions at once: it refused to dismiss claims that were clearly preempted under Riegel v. Medtronic and lacked the specific facts required by Twombly.

In a properly functioning marketplace of ideas, when a judge puts a stinker of a decision like Hofts out in market, the other judges will turn up their noses and not buy it, and that is exactly what has happened to Hofts. See Ilarraza v. Medtronic, Inc., ___ F. Supp.2d ___, 2009 WL 5245630, at *7 (E.D.N.Y. Dec. 28, 2009); Funk v. Stryker Corp., 673 F. Supp.2d 522, 528-29 (S.D. Tex. 2009); Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 283 n.5, 284 n.6 (E.D.N.Y. 2009); Covert v. Stryker Corp., 2009 WL 2424559 at *13 (M.D.N.C. Aug. 5, 2009); In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 2009 WL 1361313, at *3 (D. Minn. May 12, 2009) (all criticizing or disagreeing with Hofts).

The latest example is Anthony v. Stryker Corp., 2010 U.S. Dist. LEXIS 31031 (N.D. Ohio March 31, 2010). Anthony is a fairly typical post-Riegel device claim. Anthony had his hip replaced with a hip prosthesis called the ?Trident System,? but the Trident System allegedly caused him pain and had to be removed. He sued Stryker, claiming that the Trident System was defective, unsafe, etc. To get around Riegel, which held that state law cannot impose requirements different from or in addition to federal requirements, Anthony inartfully tried to assert a parallel violations claim, that is, a claim that his hip was made in violation of federal requirements. His complaint alleged that Stryker deviated from ?manufacturing performance standards.? When Stryker moved to dismiss, his response to the motion referred to FDA warning letters issued to Stryker for certain violations at its facilities, including practices not in conformity with Current Good Manufacturing Practice requirements of the FDA.

The court was not persuaded because those violations were not connected to his allegedly defective hip implant. The court first pointed out that Anthony had not mentioned the FDA or its regulations (or, presumably, the violation letters) in his complaint. But since that defect could be remedied by amending the complaint, the court went on to the heart of the matter: ?Anthony also did not plead any facts that would lead this court to plausibly infer that Stryker?s noncompliance with FDA regulations led to his injury.? Id. at *10. The warning letters did not help Anthony because he did not allege that his injuries were caused by the violations specified in the warning letters. Id. at *12. In a nice turn of phrase, the court concluded: ?Without more detailed factual allegations, Anthony?s complaint does not cross the critical threshold that distinguishes the speculative from the plausible.? Id.

Anthony tried to salvage his claim by urging the court to follow the analysis in Hofts. Perhaps at any earlier point in the life of this decision as precedent, that suggestion would have required a careful review of the reasoning in Hofts to show why it was wrong. By now, however, other judges had reviewed Hofts and said that it stinks, and the Anthony court could simply rely on their unfavorable reviews: ?the cases relied upon in this court?s opinion are found to be more persuasive than the Hofts analysis with regards to the pleading standards in Twombly.? Id. at *13 (citation and quotation marks omitted). The court found that Anthony?s claims were preempted and dismissed the complaint with prejudice.

And that is the life cycle of a bad trial court decision. It first draws rants from people like us and favorable notices from the plaintiffs? bar, which tries to use it. The decision then enters the marketplace as precedent, and other judges test it and write thorough negative reviews. These reviews make the odor readily apparent to other judges, who won?t even go near it and turn up their noses in a sentence or two. Eventually, the stench will become so bad that even plaintiffs? lawyers will shy away from it (anybody remember ?enterprise liability??). We hope that will happen soon to Hofts.

Full post as published by Drug and Device Law on April 13, 2010 (boomark / email).