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.

Crashworthiness Test Applied to Golf Cart in Accident Case

In the case of Suisi v. JH Global Services, Inc., No. 10604-2015, C.A. (C.P. Lawr. Co. Jan. 23, 2024 Hodge, J.), the court addressed issues arising out of injuries sustained by a Plaintiff during a golf cart accident.

According to the Opinion, the golf cart was designed by Defendant, JH Global, and sold to a licensed dealer. Prior to its sale, the golf cart was modified by the dealer with a lift kit designed and sold by another Defendant.

In this matter, the court addressed a Motion for Summary Judgment filed by the manufacturer of the golf cart. 

According to the Opinion, the accident occurred when the Plaintiff was driving the golf cart on a roadway when the components of the steering mechanism, which were altered by the lift kit, failed.  The Plaintiff crashed and the Plaintiff was thrown approximately thirty (30) feet from the golf cart.

The Defendant filed a Motion for Summary Judgment on the grounds that there was allegedly no support for a claim against JH Global as the designer of product that was impermissibly altered by a dealer and where the designer’s original parts were not the parts that failed during the course of the accident.

The Plaintiffs also subsequently filed a Motion for Summary Judgment asserting that the record should demonstrate that the Defendants should have had knowledge that their carts were being modified and sold by their dealers that the Defendant designer did not adequately monitor and reprimand those actions, and that there was no sufficient warning within the warranty itself to convey the dangerous potential results of those modifications. The Plaintiff additionally asserted that the design of the cart invited modifications without appropriate safety mechanisms.

The court applied a 3-factor test for a defective design claim: whether a product could be designed to be safer, whether a design failed to perform as safely as an ordinary consumer would expect when used as intended or in a reasonably foreseeable manner, and if the designed caused the injury, whether the Plaintiff could demonstrate that a challenged feature outweighs the risk inherent in the design.

The court also applied the crash worthiness of a motor vehicle test to the golf cart as a matter of first impression. 

In this regard, the court noted that the crash worthiness of a motor vehicle test required the Plaintiff to prove (1) that the design was defective and that an alternative, safer and practical design existed and could have been incorporated at that time, (2) the injuries the Plaintiff would have received had the alternative design been used, and (3) what injuries were attributable to the defective design.

Here, the court found that the Plaintiff could not identify or offer an available alternative cart design that would have prevented the Plaintiff’s injuries. The alleged defect was that the cart enabled modifications that it was constructed to handle. The court noted that he Defendant’s warranty instructions said that the cart should not be modified.

The court found that a design that permitted modification of a catastrophically flawed lift kit was unintended and unforeseeable. As such, the court found that the Defendant was not responsible for manfuracturing each golf cart to withstand modifications and noted that the Defendant made a golf cart with additional safety measures when it is lifted, but the original purchaser did not buy that model.

As such, the court found that the design defects alleged by the Plaintiff were without merit.

On the claim of an inadequate warning of the possible consequences of modifying the golf cart, the court stated that the Plaintiff was required to provide proof that the lack of warning rendered the cart unreasonably dangerous and that it was approximate cause of the injury. The court denied summary judgment on the failure to warn claim, finding that this claim presented issues to be resolved by the jury.

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


Source: Law.com: “The Legal Intelligencer Common Pleas Case Alert” (May 8, 2024).\

Source of image:  Photo by Cristina Ann Costello from www.Pexels.com.

Strict Liability Failure to Warn Claims Fail Where Plaintiffs Did Not Read Warnings

In the case of Mains v. The Sherwin-Williams Co., 5:20-CV-00112 (E.D. Pa. Nov. 10, 2022 Gallagher, J.), the Eastern District Court of Pennsylvania addressed the validity of a warning defect theory put forth by a Plaintiff in a products liability case.

This matter arose out of an incident during which the Plaintiff's deck caught on fire.  The Plaintiffs alleged that the product they used to stain their deck self-heated and caused a fire on their property.  More specifically, the Plaintiff's alleged that they placed application materials with the product left on it on the lawn next to the dect after which those items spontaneously caught fire.   

The court ruled that the Plaintiff’s warning defect theory failed as a matter of law because the Plaintiff admitted in this case that they never even read the warning label on the Defendant’s product.

The court therefore found that an unread warning could not be a cause of an injury in a products liability claim. 

The court also noted that the Plaintiff did not show any way that a “reminder warning” might have prevented the accident.

In this particular matter, the court also found that the Plaintiff’s failure to warn claim was also preempted by the Hazardous Substances Act because that Act did not require the Defendant to include a spontaneous combusting warning on the label as a principal hazard.

The court also confirmed that, in any event, the warning label on the product contained the words 'DANGER' and 'COMBUSTIBLE,' and further informed users of the product that 'rags, steel wool, other waste soaked with this product...may catch fire if impropertly discarded.'  Users were advised to discard such waste in a sealed water filled metal container.     

The court additionally noted that the Plaintiff was unable to establish any design or manufacturing defect because the Plaintiff’s lacked any expert evidence that the product, whether it was defective or not, actually caused the fire that injured them.

The court confirmed that the Plaintiff did not identify a cause and origin expert with regards to the fire in question. It was additionally held that lay opinion testimony is speculative and no substitute for expert fire causation testimony, particularly where there were possible alternative origins for the fire in this case. The court also noted that scientific knowledge about the chemical components of the product and their corresponding combustibility was beyond the understanding of a layperson and, therefore, required the testimony of an expert.

The court also found that the Plaintiff could not rely upon a malfunction theory of liability to establish an alleged manufacturing defect because the Plaintiffs did not have the expert testimony necessary to eliminate other possible causes.

The court also found that the Plaintiff’s implied warranty of merchantability claim was similar to a strict liability claim and that this implied warranty of merchantability claim failed because the Plaintiffs were not able to establish a product defect.

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


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

Source of Image:  Photo by Pontius Wellgraf on www. Pexels.com.

Federal Court Addresses Potiential Liability of Drug Manufacturer in Products Liability Case

In the case of DiCair v. Gilead Sci., Inc., No. 21-CV-5486 (E.D. Pa. July 12, 2022 Schiller, J.), the court ruled that negligent failure-to-warn and strict liability product claims against a pharmaceutical manufacturer were barred as a matter of Pennsylvania law.  As such, a Defendants’ Motion to Dismiss was granted in part and denied in part.

According to the Opinion, the Defendant designed and manufactured a prescription medication sold under the trade name of Harvoni which was used to treat Hepatitis C. 

The Plaintiff’s decedent was prescribed the medication and, after taking the medication, was diagnosed with a form of liver cancer. The Plaintiff’s decedent passed away thereafter.

The Plaintiff filed this lawsuit alleging a failure to warn and design and manufacturing defect claims under both negligence and strict liability. The Plaintiffs claimed that the decedent’s development of cancer was caused by his use of the medication.

The court dismissed the negligent failure-to-warn claim, noting that it was well-settled Pennsylvania law that pharmaceutical companies do not owe a duty to warn the public. Rather, manufacturers of medications are only required to warn prescribing doctors of the risk of the medications.  The court cited to the learned intermediary doctrine which holds that drug manufacturers are only required to direct required drug safety warnings to physicians who, in turn, are required to relay the same to patients.

However, the court declined to dismiss the Plaintiff’s negligent design and manufacturing defect theories, finding that the Plaintiff had asserted a valid cause of action that the Defendants had allegedly negligently designed and manufactured the medication.

Lastly, the court did dismiss the Plaintiff’s strict liability claims after holding that strict liability claims against prescription drug manufacturers were barred by Pennsylvania products liability law.

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


Source: “Digest of Recent Opinions.” Pennsylvania Law Weekly (Aug. 12, 2022).

Source of image:  Photo by Anna Shvets on www.pexels.com.

Federal Court Addresses Daubert Motion Relative to Expert Testimony and Motion for Summary Judgment in Products Case

In the case of DiDonato v. Black & Decker (U.S.), Inc., No. 20-CV-4425-JMY (E.D. Pa. Feb. 9, 2022 Younge, J.), the court denied a Motion for Summary Judgment and a Motion regarding the admissibility of expert testimony under Rule 702 in a products liability case.

According to the Opinion, the Plaintiff was allegedly injured while cleaning a vehicle and using a power buffer/polisher manufactured by the Defendant.  

Relative to the issues raised by the defense with respect to the Plaintiff’s expert testimony, the court found that the Plaintiff’s expert’s testimony about an alternative design was admissible under Rule 702. The court noted that the reliability analysis with respect to an expert testimony looks at the reliability of the methodology as opposed to the conclusions of the expert. To be admissible, the expert’s testimony must also assist the trier of fact in resolving a factual dispute.

The court noted that it is not essential that an expert be able to recreate the facts of the accident. The court reasoned in this case that, while the accident in this case happened quickly while the Plaintiff was allegedly distracted while using the Defendant’s power tool, those facts did not preclude the Plaintiff’s expert from opining on the issue of causation.

In another important ruling, the court noted that experts are allowed to rely upon the testimony of witnesses, even where that testimony is disputed.

The court ultimately found that, since the Plaintiff’s expert’s testimony was admissible, the Plaintiff’s risk/utility theory of a designed defect survived the Motion for Summary Judgment.  However, summary judgment was granted with respect to the Plaintiff's claims of a manufacturing defect, and with regards to the breach of express warranties and failure to warn claims.

The court additionally noted that the extent to which the Plaintiff’s alleged carelessness and alleged failure to follow instructions caused the accident was an issue for the jury to decide.

Anyone wishing to review a copy of this decision 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.

Source of image (not the device in question):  Photo by Khunkorn Laowisit from 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.

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).

Western Pennsylvania Federal District Court Reaffirms Several Products Liability Principles of Law

In the Western District Federal Court case of Chandeler v. L’Oreal USA, Inc., 2:17-CV-01141 (W.D. Pa. Sept. 14, 2018 Fisher, J.), the court reaffirmed several important principles of products liability law.   

In the end, the court granted summary judgment in favor of the Defendant on the basic rationale that the Plaintiff had failed to prove that the product was defective, which is fatal to claims for strict liability, negligence, breach of warranty, and violations of the Unfair Trade Practices & Consumer Protection Law.  

 The court additionally noted that the Defendant’s warnings on the product warned about the type of injury the Plaintiff suffered. The court also stated that the record before it established that the Plaintiff failed to read the warnings.   Moreover, to the extent that the Plaintiff may have allegedly read the warnings, the evidence was that she ignored the warnings.  

According to the Opinion, this case involved the Plaintiff's use of an at-home hair relaxer product manufactured by the defendant.

Among the notable rulings of the court were the following:

-It is the judge who determines whether warnings are adequate and whether the product is defective for an inadequate warning.

-Negligence and strict liability claims overlap in warning claims.

-A manufacturing defect can be established directly or by circumstantial evidence.

-Circumstantial proof of a product malfunction must rule out any abnormal use of secondary causes of the injury.

-Implied warranty claims and manufacturing defect claims are essentially the same.

-To establish an implied warranty, the Plaintiff must prove a product defect.

-Where a Plaintiff does not retain any of the product at issue, that Plaintiff cannot prove a manufacturing defect directly and must, instead, attempt to rely upon circumstantial
evidence.

-A failure of a Plaintiff to follow warnings is fatal to a malfunction theory case.

-Claims for misrepresentation and the UPTCPL claims can fail for lack of justifiable reliance by the Plaintiff, i.e., these claims may fail where a Plaintiff does not read or rely upon any alleged misrepresentations with respect to the product.

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 and the writer of the excellent Drug and Device Law blog for bringing this case to my attention and providing his above analysis of the same.
 

Summary Judgment Granted in Part and Denied in Part Under Tincher Analysis

In the case of Mercurio v. Louisville Ladder, Inc., No. 3:16-CV-412 (M.D. Pa. May 31, 2018 Mariani, J.), the court granted summary judgment in part and denied it in part in a design defect products liability case. 

The case arose out of a Plaintiff's fall from a ladder.

In this decision, the court noted that the admissibility of the Plaintiff’s design defect expert required a Daubert hearing on the Defendant's Motion in Limine seeking to preclude the Plaintiff's expert from testifying. 

The court additionally found that there was no basis for the Plaintiff’s expert’s opinion that the warnings on the product at issue were defective.  The court noted that the expert’s opinion in this regard was a spur of the moment comment during depositions.    The court additionally found that the Plaintiff’s expert was not qualified to evaluate the warnings at issue.  

Judge Robert D. Mariani
M.D. Pa.

Judge Mariani also concluded that, under the new post-Tincher law, compliance with industry standards by the defense is evidence that a jury may consider as relevant to a product’s risk/utility defect test.  

The court also reaffirmed that the Azzarello case was overruled by the Tincher decision.  

Judge Mariani also confirmed that, under the current status of Pennsylvania products liability law, there is no longer a bright line between negligence and strict liability theories in a given case.  

In the end, the court denied the Defendant's Motion for Summary Judgment relative to the design defect and breach of implied warranty claims.  However, the court did grant the Defendant summary judgment on the claims of a manufacturing defect, inadequate warning, and breach of express warranty.

Anyone wishing to review a copy of this decision may click this LINK.  Here is a LINK to the companion Order entered in the case.

I send thanks for Attorney James M. Beck of the Reed Smith Law Firm in Philadelphia, Pennsylvania for bringing this case to my attention.