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AAJ quotes Homolash on PA Federal Court Allowing Manufacturing Defect Claims Against Drugmakers

NEWS: Attorney Claudine Homolash quoted by AAJ on PA Federal Court Allowing Manufacturing Defect Claims Against Drugmakers

Alyssa E. Lambert

The American Association for Justice

2013-06-06

A federal district court in Pennsylvania ruled that a consumer who was injured when he took the prescription antidepressant Abilify can bring a strict liability claim against drugmaker Bristol-Myers Squibb Co. for a manufacturing defect. Strict liability is not available for design defect or failure-to-warn claims under Pennsylvania law, but the ruling is the third by a federal judge in less than a year to rule that manufacturing defect claims are permissible, which may open the door for plaintiffs bringing similar products liability actions. (Bergstresser v. Bristol-Myers Squibb Co.2013 WL 1760525 (M.D. Pa. Apr. 24, 2013).)

Pennsylvania has adopted §402 A of The Restatement (Second) of Torts, which imposes strict liability for products sold in “a defective condition unreasonably dangerous to the user or consumer,” but comment k of this section limits a manufacturer’s liability for “unavoidably unsafe” products, such as prescription drugs. Pennsylvania and other state courts have held that comment k applies to failure-to-warn and design defect cases, so such claims are barred.  In Bergstresser, the court held that strict liability claims based on manufacturing defects are not precluded.

Attorney Claudine Homolash: “Under Pennsylvania law, to state a claim for strict liability based on a manufacturer’s defect, the plaintiff must show that the product was defective, the defect was the proximate cause of the plaintiff’s injuries, and the defect causing the injury existed when the product left the seller’s hand.”

In July 2010, Ryan Bergstresser’s treating psychiatrist increased his Abilify dosage from 10 mg to 15 mg, resulting in dystonia, a disorder that causes prolonged involuntary muscular contractions. In July 2012, Bergstresser sued Bristol-Myers in Pennsylvania state court, alleging negligence and strict liability claims for design defect, failure to warn, and manufacturing defect, as well as breach of implied warranties. Bristol removed the case to federal court and moved for judgment on the pleadings in September 2012.

Judge Malachy Mannion dismissed the plaintiff’s failure-to-warn and design defect claims, holding they were prohibited under the Pennsylvania Supreme Court’s decision in Hahn v. Richter and its progeny. But Mannion ruled that strict liability claims based on manufacturing defects are not barred, citing the Eastern District of Pennsylvania’s decision in Doughtery v. C.R. Bard, Inc. (2012 WL 2940727 (E.D. Pa. July 18, 2012).)

In Doughtery, the plaintiff sued C.R. Bard on behalf of her son, who was injured after being implanted with a PerFix Plug, a medical device used in inguinal hernia repair surgeries. Peggy Doughtery alleged that the device was defective and that the manufacturer was aware of the defects. Judge William Yohn dismissed her design defect and failure-to-warn claims, but he held the manufacturing defect claim was permissible and granted her leave to amend her complaint to address pleading deficiencies.

Similarly, in Bergstresser, the court ruled that the plaintiff had not pleaded his claims with factual specificity to satisfy Twombly and Iqbal pleading standards, but it allowed the plaintiff to amend his complaint. Both courts also held that breach of implied warranty claims are permissible to the extent that they are based on a manufacturing defect.

A third Pennsylvania federal court reached the same conclusion in October 2012. In Tatum v. Takeda Pharmaceuticals North America, Inc. (2012 WL 5182895 (E.D. Pa. Oct. 19, 2012)), the plaintiff took Prevacid to treat gastroesophageal reflux disease, and he developed Stage III avascular necrosis, a condition that causes bones to become weak and brittle. David Tatum underwent total hip replacement surgery. He sued Takeda in the Eastern District of Pennsylvania for all three strict liability claims and breach of warranty, alleging that the company was aware of the drug’s risks but did not disclose them. Judge Jan Dubois, citing Doughtery, held that strict liability manufacturing defect claims were permissible.

Philadelphia attorney Claudine Homolash, who represented Tatum, said that the recent decisions could potentially affect plaintiffs suing generic drug manufacturers.

“Under Pennsylvania law, to state a claim for strict liability based on a manufacturer’s defect, the plaintiff must show that the product was defective, the defect was the proximate cause of the plaintiff’s injuries, and the defect causing the injury existed when the product left the seller’s hand,” said Homolash. “It will be interesting to see whether you have a cognizable manufacturing defect claim under Pennsylvania law when a generic label does not conform its warnings with those listed in the brand-name label. This theory could really open the door for plaintiffs since 85 percent of drugs prescribed are generic drugs.

Homolash added that “pharmaceutical companies always claim that most lawsuits are based on a failure-to-warn theory. We are learning, however, that this might not be true.”

Links

“Federal court allows manufacturing defect claims against drugmakers,” The American Association for Justice, June 6, 2013 (password protected)

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