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.

Eastern Federal District Court Rules That PA Law Does Not Allow for Strict Liability Claims Against Manufacturers of Medical Devices

In the case of McDonald v. Flowonix Medical, Inc., No. 21-1404 (E.D. Pa. Jan. 25, 2022 Tucker, J.), the court granted in part and denied in part a Motion to Dismiss in a products liability case involving a medical device.  In this case the device was a programmable infusion pump and catheter.

The court in this case found that Pennsylvania law does not allow for strict liability claims against manufacturers of medical devices. The court noted that, under the Restatement (Second) of Torts §402A, comment k applied across the board to bar all strict liability claims against prescription medical products, both drugs and medical devices.  Judge Tucker offered her prediction that, if faced with this issue, the Pennsylvania Supreme Court would extend comment k to prescription medical device cases to find that there is no valid claim for strict liability in that regard.

The court additionally found that the Plaintiff failed to plead any fact to supporting the express warranty claim and also failed to attach any written warranty to the Complaint.

The court additionally found that the claim of a breach of implied warranty was a form of a prohibited strict liability claim under the facts and circumstances presented in this case.

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

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.

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.

Plaintiff's Claims Not Saved By Discovery Rule; Statute of Limitations Applied

In the case of Tily v. Ethicon, Inc., No. 20-2582 (E.D. Pa. Sept. 8, 2020 Quinones Alejandro, J.), the court granted summary judgment in a claim arising out of allegations of liability due to complaints of years of pain and other complications following a pelvic mesh implant surgery. The court found that the Plaintiff’s claims were barred by the statute of limitations and that the Plaintiff’s claims were not saved by the discovery rule. 

The court found that the Plaintiff failed to prove the applicability of the discovery rule. The record revealed to the court that, had the Plaintiff been reasonably diligent, she would have discussed her years of pain and other complications with her doctor. 

It was also noted that, more than two (2) years before suing, the Plaintiff had attributed her problems to the Defendant’s product and had already undergone revision surgery. 

The court found that, as a matter of law, these facts placed the Plaintiff on notice that she should conduct a further inquiry of her injuries and investigate the cause of the same, which the Plaintiff did not do. 

The court also noted that, despite the fact that there was publicly available information on the implant device, the Plaintiff never sought out more information. 

The court additionally rejected any claims of fraudulent concealment asserted against the Defendant. The court found no evidence in the record of any affirmative acts on the part of the Defendant to conceal from the Plaintiff her right to pursue a recovery. 

Anyone wishing to review a copy of this decision may click this LINK.  The Order can be viewed HERE.

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.

Summary Judgment Granted Due to Lack of Expert Testimony in Medical Device Products Liability Case

In the products liability case of Marshall v. Zimmer, Inc., No. 18-3363 (E.D. Pa. Sept. 9, 2020 Pratter, J.), the court granted summary judgment in favor of a Defendant after the Plaintiff failed to produce expert testimony in support of the claims presented.

The case arose with respect to allegations surrounding a medical device, or implant, used for knee replacement surgeries.

The court reaffirmed the rule of law that a Plaintiff cannot establish causation or a defect in a suit against a medical device implant manufacturer without expert testimony. The court noted that a lay juror cannot simply look at a medical device and reasonably determine that the design, or some other aspect of the device, was defective.

The court noted that the Plaintiff had been given multiple extensions to produce an expert report but failed to do so. 

Anyone wishing to review a copy of this decision may click this LINK.  The companion Order can be viewed HERE

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.

Court Rejects Effort by Manufacturer To Expand Protections of Products Liability Law in Medical Devices Case

In the case of Gross v. Coloplast, No. 19-4385(E.D. Pa. Jan. 17, 2020 Baylson, J.), the court reviewed the Pennsylvania Supreme Court’s decision in the case of Tincher v. Omega Flex to reject efforts by the defense to carve out an exception to Pennsylvania’s strict liability law or the makers of prescription medical devices. The court denied the Defendant company’s Motion to Dismiss the Plaintiff’s Complaint.

In this case, the Defendant, Coloplast, had sought to expand the protections afforded to the makers of prescription drugs under comment K to section 402 of the Restatement (Second) of Torts.

Judge Baylson rejected this effort by noting that, under Tincher, the “Pennsylvania Supreme Court has strongly discouraged Pennsylvania courts from carving out certain categories of products for special treatment within the common law of products liability.

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

Source: Article – “US Judge, Weighing ‘Tincher’ Green-Lights Strict Liability Claims Against Med Device Maker,” By Max Mitchell of The Legal Intelligencer (Jan. 21, 2020).

No Strict Liability Claims for Medical Products/Devices

In two separate recent Pennsylvania Federal Court decisions, courts have ruled that Pennsylvania law does not allow for strict liability claims against prescription medical products, including medical devices.

In Cogswell v. Wright Medical Technology, 2015 U.S. Dist. Lexis 92461 (W.D. Pa. July 16, 2015 Bissoon, J.), the court granted in part and denied in part a motion to dismiss and held that Pennsylvania law does not allow strict liability claims against prescription medical products, including medical devices.  The court otherwise noted that strict liability manufacturing defect claims are barred.  Rather, negligence was found to be the only permitted theory.  The court additionally held that express and implied warranty claims were barred. 

In the separate decision of Wilson v. Synthes United States Products, LLC, NO. 2:2015-cv-00295, 2015 U.S. Dist. Lexis 92347 (E.D. Pa. July 15, 2015 Schmehl, J.), the court granted in part and denied in part a motion to dismiss in a products case.  Similar to the Cogswell decision, the court reasoned that Pennsylvania law does not allow strict liability claims against prescription medical products, including medical devices.  This court also noted that strict liability manufacturing defect claims were barred.  However, the negligence claims were found to be adequately pled.  This court also noted that Pennsylvania does not recognize a claim for negligent marketing, except when the conduct rises to overpromotion.

I send thanks to Attorney James Beck of the Philadelphia office of Reed Smith and writer of the great Drug and Device Law Blog for bringing these cases to my attention.


The Cogswell decision can be viewed HERE.


The Wilson decision can be viewed HERE.