Patchwork is a type of needlework that involves sewing together pieces of fabric into a larger design, usually based on some repeating pattern. The fabric pieces can be different shapes and different colors that are then pieced together. Evidence of patchwork was found in Egyptian tombs. We tend to think of it more in terms of a style that came to America with the pilgrims and had a resurgence during World War I and the Great Depression as clothing and other materials were recycled to make blankets and quilts. Today, patchwork is a form of art, in which the designers use precious fabrics to create beautiful textiles. The use of uneven pieces of fabric in particular can result in real masterpieces. Need proof? There’s the National Quilt Museum in Kentucky, the Visions Art Museum in San Diego, or the City Quilter in New York. Just to name a few. To create a beautiful patchwork design, however, requires effort and time.
We say all this because to us the term “patchwork” conjures up something nicer than a “hodgepodge” or a “mixed bag.” Something in which there is a grander design or a prettier outcome when all the pieces come together. A case like Crockett v. Luitpold Pharmaceuticals, Inc., 2020 WL 433367 (E.D. Pa. Jan. 28, 2020) may not be headed for a museum, but we are going to choose to see the good over the bad and find the pretty among the mismatched pieces.
The case involves an injectable medication used to treat iron deficiency anemia in people who are intolerant to oral medications. The particular formulation of this product contains a formulation that is alleged to cause abnormally low phosphate levels which can have serious consequences. Id. at *1. The drug was first marketed in Europe, during which time the low phosphate condition was noted and studied. When the manufacturer submitted a New Drug Application to the FDA to bring the drug to the United States, it was twice rejected. In its non-approvable letters, the FDA cited the low phosphate as a concern. The drug was eventually FDA approved in 2013. Id. at *2. The drug’s labeling since that time has included the condition in its adverse reaction section. Id.
Plaintiff’s complaint alleged 11 causes of action, which we’ll address in the order the court did. First up, strict liability failure to warn and design defect. Defendants argued that these claims were not viable under Pennsylvania law for prescription drug cases citing Hahn v. Richter, 673 A.2d 888 (Pa. 1966). The court agreed. Both claims were dismissed with prejudice. Id. at *4-5. The court went on to dismiss plaintiff’s breach of implied warranty claim for the same reason. Noting that strict liability and breach of implied warranty of merchantability are “parallel theories of recovery,” “[i]t would be inconsistent to exempt a drug manufacturer from strict liability for defective design or failure to warn under Comment k, but allow recovery for the same issue under a breach of implied warranty claim.” Id. at *5.
Next up were plaintiff’s negligence claims – failure to warn, design defect, misrepresentation, and a catch-all claim. This one of the pieces of fabric we could have done without. Defendant moved to dismiss these claims as preempted. That’s an uphill battle in a branded prescription drug case and one we on the defense side should be cautious about bringing. If a defendant can demonstrate that the risk at issue was submitted to the FDA (by defendant or someone else) for evaluation and the FDA did something to demonstrate that it would not have approved a change in the labeling, by all means bring the motion. Given the need for “clear evidence,” this is still a hard issue at the Rule 12 stage due to the limited record. Id. at *7. And, without “clear evidence” or really “any” evidence, bringing the motion is just inviting bad law. Not something we want pieced into the fabric of product liability law.
Here, the court ultimately ruled that deciding the preemption issue on the pleadings would be premature. Id. at *8. But, since the motion was brought, the court did undertake an analysis and found no evidence of any submission to the FDA that demonstrated the FDA considered and rejected a different warning label. Defendants argued that the non-approvable letters were evidence that the FDA was aware of the low phosphate issue and approved the drug with its current labeling. Id. at *7. However, the court did not find that to be evidence that either the defendants proposed a stronger warning or that if presented with a different warning, the FDA would have rejected it. Id. Defendants also argued that plaintiff failed to plead facts supporting an inference that the FDA was not aware of the risk when it approved the drug. Id. at *8. But, because preemption is an affirmative defense, it’s not something on which plaintiff bears the burden and therefore has no obligation to plead around. Id. So, plaintiffs’ negligence claims survive.
Defendants’ next argument was that the learned intermediary doctrine barred plaintiffs’ fraud claim and claim for violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”). While the court did not find the argument persuasive as to common law fraud, it did as to the UTPCPL claim. Both claims require a showing of justifiable reliance by the plaintiff. Common law fraud, however, is governed by Restatement (Second) of Torts which allows third party reliance and therefore permits a plaintiff to prove reliance by showing that her prescribing physician relied on the allege misrepresentations made by defendant. Id. at *9. The UTPCPL, not governed by the Restatement, creates a private right of action for someone harmed as a result of defendant’s “unfair or deceptive” trade practices. It does not recognize third party reliance and therefore, there is no UTPCPL claim where the drug is not sold directly to the plaintiff and defendant does not have a duty to warn the patient. Id. So, the statutory consumer protection claim is barred by the learned intermediary doctrine.
Defendants also moved to dismiss on TwIqbal grounds. Of note in this section of the opinion is the court’s finding that the holding of Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) did not limit negligent design claims to the extreme case of a drug that is “too harmful to be used by anyone.” Id. at *10-11. Such a finding would be inconsistent with Pennsylvania’s adoption of the Restatement (Second) of Torts, § 398 which does not require the design to be unsafe for any use. Id. at *11.
The court did find that plaintiff failed to plead her fraud claim with the particularity required by Rule 9(b)’s heightened standard. Allegations simply recycled from the negligence section of the complaint with the addition of words like “falsely” and “fraudulently” weren’t enough. Id. at *12. And finally, plaintiff’s express warranty claim was dismissed for failure to plead pre-suit notice. Plaintiff tried to argue that had notice of the low phosphate issue and that “should suffice to achieve the same goal as pre-suit notice.” Id. But notice is not that same thing as notifying. Pennsylvania requires plaintiff to notify defendant of the alleged breach to provide an opportunity for resolution before a lawsuit is initiated. Unless plaintiff took that step, this claim is also gone.
Call it what you will, the case has its high points and its low points. If we were designing it, there are some pieces we’d have left out. So, it may not be going on our wall for display, we’ll tuck it away in a drawer because we might need a piece of it to keep us warm down the road.