The judge overseeing a class action against Johnson & Johnson over allegedly defective vaginal mesh products has asked the applicants to weigh in on a recent UK High Court ruling that found there must be an abnormal risk in order for a product to be considered defective.
Justice Anna Katzmann asked the applicants to file a note on the UK judgment — Gee v DePuy International Limited  EWHC 1208 — which the judge said was referred to in Johnson & Johnson’s submissions on “Scientific Knowledge at Time of Supply”.
The UK High Court issued the ruling in May in a group action brought against DePuy over its Pinnacle hip implants, finding the plaintiffs had failed to prove the products were defective. The judgment, which provided a detailed analysis of the meaning of “defect” in product liability matters, said the inherent tendency of hip implants to shed debris could not be considered a defect just because the shedding caused an adverse reaction in some patients.
Products must pose an abnormal risk in order to be considered defective, the UK judgment found, saying safety was “inherently and necessarily a relative concept, because no product, and particularly a medicinal product, if effective, can be absolutely safe”.
Plaintiffs in the class action are awaiting judgment in the case, after closing submissions concluded February 22. The class action seeks hundreds of thousands of dollars in compensation from J&J Medical Australia and subsidiary companies Ethicon Inc. and Ethicon Sarl.
In April, the applicants won court approval to expand the size of the class and seek an order blocking the sale of devices that don’t include a proper warning.
Over objections from Johnson & Johnson, Judge Katzmann granted the request by the applicants, lodged after the 89-day trial concluded, to expand the class definition to include women implanted with the device after the case was filed and those who were implanted earlier but only suffered complications after the case commenced.
The applicants, represented by Shine Lawyers, wanted to set the end date for class eligibility for whenever the court delivered its judgment or a settlement was reached, but Judge Katzmann said it was “inappropriate and impractical” to use an uncertain date for the cut-off, and instead chose July 3, 2017, the day before trial commenced, as the end date.
The judge shot down Johnson & Johnson’s argument that extending the eligibility period would alter the claims it faces, saying there would be no material change to the claims and that all the relevant evidence had been introduced at trial.
“There is no reason to believe that the respondents would have conducted their case any differently if the group members included women who had received implants and suffered complications after the commencement of the proceeding,” Judge Katzmann said.
The applicants also won approval to seek a declaration that Johnson & Johnson engaged in misleading and deceptive conduct by marketing the devices without the “proper warning”, as described by the applicants, and to seek an injunction of devices that do not include the proper warning.
Jusdge Katzmann disagreed with Johnson & Johnson’s argument that the applicants were trying to usurp the powers of the Therapeutic Goods Administration by prescribing what the proper warning should include and seeking the injunction.
“The contentions that the job of regulating the sale of the products should be left to the regulator and that any such order could not be made without adding the regulator as a party are spurious. The TGA does not have an exclusive role in protecting the safety of consumers,” Justice Katzmann said.
The judge also granted the applicants’ request to add a claim that Johnson & Johnson failed to provide adequate warning that those with autoimmune or soft tissue disorders could suffer inflammation when implanted with the devices.
The case already includes more than 1,000 Australian women who allege one or more pelvic mesh implants surgically inserted since 2005 for stress incontinence or pelvic organ prolapse caused catastrophic injuries to their internal organs and ruined their sex lives.
Shine Lawyers represents the lead applicants in the class action. Clayton Utz represents Ethicon Sarl, Ethicon Inc and Johnson & Johnson Medical Pty Ltd.
The case is Kathryn Gill & Ors v Ethicon Sarl & Ors.
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