“...a defective bottle case where a bottle spontaneously burst in the client's hand shooting a shard of glass into his eye… The defendant bottler, parent company and retailer settled prior to trial for a combined total of $ 588 000” (video credit L. Sun/2013)

Product Liability

Introduction

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           112 pages, 36 MB








“G. testified that he dropped a 32-ounce, glass bottle of C., resulting in an explosion of glass fragments which struck him in the right eye”

Root Cause Analysis (RCA) and Failure Investigation are important tools in: 

  • Product Complaint, 
  • mitigation activities, 
  • Failure Investigation,  
  • non-conformance, 
  • Risk Management,
  • hazard analysis,

and the basic foundation of a satisfactory Corrective And/or Preventive Actions (CAPA) system.  Root Cause Analysis is required to verify and validate the issues including data outliers.  These are often improperly and arbitrarily dismissed.   RCA is required in order to close the logic loops existing on:

  • corrective actions,
  • preventive actions, 

thus allowing a proper impact analysis before to decide any action.  Meaning that failure investigation and Root Cause Analysis are an important element of Current Good Manufacturing Practice (cGMP) regulations compliance, enforced by the US Food and Drug Administration.  When non adequately performed it becomes a key source of problems with respect to the norms of the Regulatory Agencies (i.e., FDA in the US, EFSA in the EU, etc.).   Companies’ resources are frequently scarce exactly in those activities that have the greatest positive effect to the Quality and Safety of their Product.   RCA is meant to reduce fire fighting, thus minimizing compliance problems also.   The expectations for meaningful Corrective And/or Preventive Actions, supported by: 

  • Root Cause Analysis,
  • results-driven Failure Investigation, 

addressing and resolving the hidden product problems, are really growing among the Regulatory Agencies.    Two significative examples are the FDA's QSIT, referred to equipments and the EU’s ISO 14971 thinked for the Device Risk Management.    A valid Corrective And/or Preventive Actions system requires defined failure investigation.  This includes a systemic Root Cause Analysis devoted to the true problem resolution.



Example


Shard of Glass into an Eye 

 “The plaintiff's treating ophthalmologist and emergency eye surgeon testified that the plaintiff underwent several surgical procedures to repair the eye damage, but was left without functional vision of the right eye as a result of the accident. 

The plaintiff's contact lens specialist testified that a special contact lens may have restored some of the plaintiff's vision, but, because of the deformation of the front of the plaintiff's eye caused by the glass fragments, such a contact lens could not be successfully fitted”















In the Beverage Bottling Lines of all of the World, the majority of the packaged beers and part of the mineral waters are notoriously glass bottled. Glass really means Quality when compared to PET but, …it introduces a risk non existing with plastic packagings.  In the Bottling Lines the slightly defective yet cracked bottles explode most frequently in the:

  • Filler Machine, during the pressuring phase;
  • Pressureless Infeed Combiner, before the Labeller Machine.

But it’s a fact they continue to explode, shattering glass splinters wherever in a radius of meters also later, out of the Food and Beverage factory.  Reading the news, we know of occurrences of final Customers injured by exploding bottles. Some of the worse cases referred to the effects of glass fragments which penetrated in the eyes. In the following we’ll present a recent case (quoting text by B. Lupetin, full credits in the Acknowledgements).   The Companies involved in the production of the glass and in the filling and packaging are famous. To protect all Parties’ privacy, we preferred to hide all names, of the Companies who were judged in the Tribunal and of the injured person.  Then, in the following all names appear initialized:

“I am investigating a defective beer bottle case where a C. L. bottle spontaneously burst in my client's hand shooting a shard of glass into his eye.  The NY Post covered a similar story a couple of years ago Beer Blast Case A Matter of C.  To my surprise, there are no shortage of exploding bottle cases that have been tried by a jury in Pennsylvania.  Once case I stumbled upon in my verdict research was the matter of G. v. O., Inc., et al.

The plaintiff, G. 18 years old at the time of incident, filed a products liability action against the defendant glass bottle manufacturer, the parent soda company, the bottler and the retailer who sold the bottle of C. which exploded when dropped, shooting shards of glass into the plaintiff's face resulting in functional blindness of the right eye. The defendant bottler, parent soda company and retailer settled prior to trial for a combined total of $ 588,000, and the case proceeded against the defendant bottle manufacturer as the sole defendant.

The bottle manufacturer contended that the product was not dangerous nor defective and, if found to be defective, the plaintiff's accident was due to the contents of the bottle, not the bottle itself. The defendant also disputed the extent of the plaintiff's eye injury.

G. testified that he dropped a 32-ounce, glass bottle of C., resulting in an explosion of glass fragments which struck him in the right eye. The plaintiff's treating ophthalmologist and emergency eye surgeon testified that the plaintiff underwent several surgical procedures to repair the eye damage, but was left without functional vision of the right eye as a result of the accident. The plaintiff's contact lens specialist testified that a special contact lens may have restored some of the plaintiff's vision, but, because of the deformation of the front of the plaintiff's eye caused by the glass fragments, such a contact lens could not be successfully fitted nor tolerated, according to this expert.


































G. put on two glass safety experts who testified that the bottle was defectively designed for its intended purpose in that the carbonated beverages created a substantial internal pressure causing a danger of high velocity shooting shards of glass in the event of breakage. This danger could have been eliminated through use of a plastic bottle, or by fragment retentive coatings which were known to the industry at the time, according to the plaintiff's experts. The plaintiff introduced deposition testimony of an engineer who worked for the defendant bottle manufacturer for four years and drop-tested pressurized glass bottles to determine the potential of shooting glass. The plaintiff established that the defendant held a patent for a shatter-resistant bottle coating, yet did not use the coating.

The plaintiff introduced deposition testimony of an engineer who worked for the defendant bottle manufacturer for four years and drop-tested pressurized glass bottles to determine the potential of shooting glass. 

The plaintiff established that the defendant held a patent for a shatter-resistant bottle coating, yet did not use the coating.

The manufacturer's glass expert testified that the frequency of injury from flying glass associated with bottle explosion was very low and that, in his opinion, the design of the bottle was not dangerous nor defective.   The defendant argued that it was not responsible for the pressurization of the glass bottle which occurred only after it was filled with the carbonated beverage by the bottling company.  The defendant's expert ophthalmologist also testified that the plaintiff's eye injury could be improved in the future by new technology and surgical procedures.   After a three week trial, the jury found for the plaintiff in the amount of $ 250,000.   Post-trial motions are pending concerning the award of the damage verdict.

The defendant bottle manufacturer in this products liability action pointed the finger at the settling C. bottler and the C., arguing that the glass bottles themselves were harmless and only acquired a potential for propelling glass fragments after they were filled with carbonated drinks.  The plaintiff's attorney, however, was able to successfully overcome this defense strategy by stressing that the intended use of the bottles was clearly to be filled with carbonated beverages.  The plaintiff's argument in this regard was bolstered by evidence that the bottles were pre-labeled by the defendant for C.  The defendant's case was additionally damaged by deposition testimony of a former engineer who drop-tested pressurized bottles for the defendant bottle manufacturer. 

This witness recorded the results of tests performed with fragment retentive coatings on the glass bottles designed to prevent injuries from flying glass fragments, making it difficult for the defendant to argue that it had no knowledge of the potential danger. Finally, it was shown that the defendant held a patent for a protective glass coating which may have prevented the injury, yet failed to utilize its knowledge.  Great lawyering by Plaintiff's counsel in this case.

One caveat in these types of cases concerns loss of the bottle in question.   When a shard of glass obliterates your eyeball the last thing you are thinking of is to preserve the broken bottle.  As a result, many defective bottle cases are compromised by the loss of key evidence.   BUT...never fear, instead of bringing a claim for a defect in that specific bottle, a plaintiff can broaden their allegation to argue that all the bottles in a given batch were defectively designed.   This allows other bottles to be tested in lieu of the missing product and let's the plaintiff's case move forward.”



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This website has no affiliation with, endorsement, sponsorship, or support of Heuft Systemtechnik GmbH, MingJia Packaging Inspection Tech Co., Pressco Technology Inc., miho Inspektionsysteme GmbH, Krones AG, KHS GmbH, Bbull Technology, Industrial Dynamics Co., FT System srl, Cognex Co., ICS Inex Inspection Systems, Mettler-Toledo Inc., Logics & Controls srl, Symplex Vision Systems GmbH, Teledyne Dalsa Inc., Microscan Systems Inc., Andor Technology plc, Newton Research Labs Inc., Basler AG, Datalogic SpA, Sidel AG, Matrox Electronics Systems Ltd. 


                                                                                                                                                                                                                                                                                                                                                                                                                                                         
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