Western District Federal Court of Pennsylvania Addresses Products Liability Claims In a Prescription Medical Device Litigation

In the case of Blair v. Abbvie, Inc., No. 2:23-CV-1871 (W.D. Pa. Jan. 9, 2025 Ranjan, J.), the court granted a Motion to Dismiss in a prescription medical device litigation.

In this decision, the Western Federal District Court confirmed that Pennsylvania’s across-the-board application of the Restatement §402A, comment k, as precluding strict liability design defect claims, but not strict liability manufacturing defect claims.

The court also ruled that, similarly, given that the elements of implied warranty claims are identical to strict liability claims, the Plaintiff’s implied warranty claims were dismissed.

The court also ruled in this case that the manufacturing defect claims asseted by the Plaintiff were inadequately pled because the claims did not reveal either any specific problem with the device or how the device allegedly failed. The court noted that the availability of a malfunction theory manufacturing defect claim does not exclude excuse failure to plead the circumstances of the alleged malfunction.

The court also ruled that the negligent design and warning claims were inadequately pled because the Plaintiff did not identify the design defect, anything about the manufacturing process, or what information should have been given to his medical providers.

Based on these issues, the trial court granted the Defendant’s Motion to Dismiss.

Anyone wishing to review a copy of this decision may click this LINK.


I send thanks to Attorney James M. Beck of the Philadelphia office of the Reed Smith law firm for bringing this case to my attention.

Federal Court Addresses Products Liability Claims Involving a Medical Device

In the case of Ford v. St. Jude Medical, LLC, No. 3:21-CV-01765 (M.D. Pa. Sept. 23, 2024 Mehalchick, J.), the court granted in part and denied in part the Defendant’s Motion to Dismiss.

The case involved allegations that the Plaintiff fell when his pacemaker device failed.  

The court ruled that Pennsylvania law does not permit strict liability claims in prescription medical product liability litigation against medical device manufacturers. This prohibition includes strict liability design and manufacturing claims.

Judge Mehalchick additionally ruled that the Plaintiff’s claims of an implied warranty based upon different or additional Pennsylvania medical device standards were preempted. The court additionally noted that, even if these claims were not preempted, such claims would also be barred by the Restatement of Torts (Second) §402a, comment k.

Judge Mehalchick additionally ruled that a loss of consortium claim cannot be based on a contractual claim for breach of an express warranty.

Anyone wishing to review a copy of this decision may click this LINK.  The Court's companion Order can be viewed at this LINK.


I send thanks to Attorney James M. Beck of the Philadelphia office of Reed Smith law firm for bringing this case to my attention.

Federal Court Addresses Viability of Products Liability Claims Involving Medical Devices

In the case of Douglas v. Atrium Medical Corp., No. 3:23-CV-747-JKM (M.D. Pa. Sept. 30, 2024 Munley, J.), the court granted in part and denied in part a Motion to Dismiss after finding that settled Pennsylvania law did not allow for strict liability claims in a products liability litigation relative to claims involving prescription drugs and medical devices.

The case arose out of issues regarding the use of a hernia mesh as treatment.   

Judge Munley also denied the request for a certification of the strict liability issues for an interlocutory appeal because there was no substantial ground for a difference of opinion on this decision.

Anyone wishing to review a copy of this decision may click this LINK.

I send thanks to Attorney James M. Beck of the Philadelphia office of Reed Smith law firm for bringing this case to my attention.

Souce of image:  Photo by Vidatl Balielo, Jr. on www.pexels.com.

Chief Judge Brann of Federal Middle District Court Addresses Variety of Products Liability Issues

In the case of Goodling v. Johnson & Johnson, No. 4:21-CV-00082 (M.D. Pa. Feb. 10, 2022 Brann, C.J.), the court granted in part and denied in part a Motion to Dismiss in a medical device strict liability and negligence claim reagarding pelvic mesh product.

The court found that, although the Plaintiffs’ Complaint provided comparatively little information about the medical procedure and the injuries at issue, the allegations were found to provide adequate notice of the claims and supporting facts and could not be dismissed as an alleged shotgun pleading.

Notably, Judge Brann also ruled that Pennsylvania law did not require an application of the Restatement of Torts (Second) §402A, comment k, across the board to bar strict liability claims against medical devices. 

Chief Judge Matthew W. Brann
M.D. Pa.

Judge Brann noted that Pennsylvania Superior court precedent barring such claims has been undermined by other decisions. Judge Brann felt that comment k applied to medical devices only on a case-by-case basis.

While the court found that the Plaintiff’s strict liability allegations involving a design defects and with respect to warnings were adequately pled, the court dismissed the strict liability manufacturing defect claim because there was no allegation made that the device deviated in some unique way from its intended design.

Judge Brann additionally dismissed the Plaintiff’s negligent misrepresentation and fraud claims as duplicative of the Plaintiffs’ warning claims.

The court also noted that the claim of unjust enrichment did not apply in products liability claims where the Plaintiff actually received and used the product. 

Elsewhere in his decision, Judge Brann also confirmed the rule of law that punitive damages are not to be considered a separate cause of action, but rather, an element of damages.

Anyone wishing to review a copy of this notable decision by Chief Judge Brann of the Federal Middle District Court of Pennsylvania may click this LINK.  The Court's companion Order can be viewed HERE

I send thanks to Attorney James M. Beck from the Philadelphia office of the Reed Smith law firm for bringing this case to my attention.

Third Circuit Court of Appeals Certifies Medical Device Products Liability Questions to the Pennsylvania Supreme Court For a Decision

In the case of Ebert v. C.R. Bard, No. 20-2139 (3d Cir. 2021), the Third Circuit Court of Appeals certified two issues of medical device products liability to the Pennsylvania Supreme Court for a decision.

The court sent the following two issues to the Pennsylvania Supreme Court: (1) what standard the Pennsylvania Supreme Court would apply to negligent design claims against prescription medical device manufacturers, and (2) whether prescription medical device manufacturers are categorically subject to strict liability under Pennsylvania law or may instead be immune from strict liability in certain circumstances.

Anyone wishing to review a copy of this Petition for Certification authored by the Third Circuit Court of Appeals may click this LINK.

Source of image: Photo by Hush Naidoo on unsplash.com.

Does Pennsylvania Recognize Strict Liability Claim for Manufacturing Defect of a Prescription Medical Device?

In the case of Rosenberg v. C.R. Bard, Inc., No. 18-4767 (E.D. Pa. June 25, 2019 Robreno, J.), a products liability pelvic mesh lawsuit, a federal district court noted a need for guidance from the Pennsylvania Supreme Court on a recurring issue in strict liability cases.

In his Opinion, Judge Eduardo C. Robreno noted that he was “presented with an important question of state law that has often been raised but has effectively evaded review by the Pennsylvania Supreme Court:  does Pennsylvania law recognize a strict liability claim for a manufacturing defect of a prescription medical device?”

Judge Robreno predicted “that the answer to this question is ‘no.’”  

However, given the growing debate by trial courts regarding this issue, he certified the issue to the Third Circuit Court of Appeals.

In addition to certifying the issue to the Third Circuit, Judge Robreno dismissed the Plaintiff’s strict liability claims with prejudice, but allowed her to refile her negligence claims.

Anyone wishing to review this decision may click this LINK.

Source:  Article:  “Federal Judge Highlights Lack of Pa. Precedent on Medical Device Strict Liability” by P.J. D’Annunzio of the Legal Intelligencer (June 26, 2019).