Indemnified Manufacturers: Adam v. GlaxoSmithKline Inc., 2019 ONSC 7066 (CanLII)

This will be a short article, and briefly cover one case: Adam v. GlaxoSmithKline Inc., 2019 ONSC 7066 (CanLII). It dealt with a lawsuit against drug maker, GlaxoSmithKline, and whether they were liable for their products. The point is that the ruling very closely parallels what’s happening now.

To sum it up: no one is responsible for maiming or killing people with experimental drugs. The buck gets passed and passed, so no one has to face it.

Of course, this is of no comfort to people who have lost loved ones. It’s sickening to see that the rules are stacked against the average person.

[17] In the summer of 2009, the WHO called for manufacturers to begin clinical trials for a vaccine to combat H1N1.

[18] GSK developed two vaccines to combat H1N1: Arepanrix and Pandemrix. Both are substantially similar. Pandemrix was manufactured and distributed in Europe. Arepanrix was manufactured and distributed in Canada. Clinical trials for Arepanrix began in 2008 but had not been completed when the pandemic was declared.

[19] The federal Minister of Health authorized the sale of the Arepanrix vaccine pursuant to an interim order dated October 13, 2009. Human trials of the vaccine were still underway. The Minister of Health is empowered to make interim orders if immediate action is required because of a danger to health, safety or the environment. In issuing the interim order, Health Canada deemed the risk profile of Arepanrix to be favourable for an interim order. The authorization was based on the risk caused by the current pandemic threat and its danger to human health. As part of the interim order process, Health Canada agreed to indemnify GSK for any claims brought against it in relation to the administration of the Arepanrix vaccine.

[20] Although human trials of Arepanrix were not finished by the time Health Canada authorized its use, the vaccine was not without clinical history.

The point of this: GlaxoSmithKline was indemnified from any liabilities that their “interim authorized” vaccines might have led to. Guess they don’t really stand behind their work. Does any of this sound familiar?

Does the lack of transparency also sound familiar?

[35] The plaintiffs began their challenge about disclosure with the evidence of Ms. Hyacenth who testified that she was not told that: (i) the vaccine had not been tested through the usual route, (ii) the vaccine had been subject to a hastened approval process by Health Canada, (iii) adjuvants had never been used in children, (iv) the Government of Canada was indemnifying the vaccine manufacturer; and (v) some countries refused to make the vaccine available because of safety concerns. Ms. Hyacenth says that had she been told about these things she would not have risked having her children vaccinated.

[36] Part of the challenge of the plaintiffs’ inadequate disclosure case is that Ms. Hyacenth was not the direct purchaser of the vaccine. Vaccines are administered through a “learned intermediary,” in this case, her family physician. The issue is significant because any disclosures GSK makes are made in product monographs or inserts that accompany each vial of vaccine. The patient getting the vaccine does not receive the box containing the vaccine and whatever disclosure document it contains. It is the physician who receives this.

[37] GSK did disclose in its Product Information Leaflet for the Arepanrix vaccine and in its product monograph that Health Canada had authorized the sale of the vaccine based on only limited clinical testing and no clinical experience at all with children. Dr. Ledesma-Cadhit believes she knew this from the Health Canada website. She was also aware that Arepanrix was authorized through a special process because of the pandemic.

[38] The product monograph for Arepanrix disclosed that there was limited clinical experience with an investigational formulation of another adjuvanted vaccine but no clinical experience with children. In addition, the product information leaflet and product monograph disclosed a number of risks.

[39] Ms. Hyacenth says that Dr. Ledesma-Cadhit did not advise her of these risks. Although Dr. Ledesma-Cadhit was originally a defendant in the action, the plaintiffs released her from the action after being unable to find an expert who would opine that Dr. Ledesma-Cadhit breached her standard of care in administering the vaccine.

It gets interesting since there is in fact no agreement between the drug manufacturer and the patient. By this logic, GlaxoSmithKline wouldn’t be liable even without the indemnification agreement.

Even worse, the “learned intermediary”, the physician, isn’t really responsible either, since they were just following the advice of Health Canada. Remember, it doesn’t matter what your doctors are saying, because they are not responsible for whatever happens to you.

As for Government Officials (such as the Health Minister), they aren’t responsible either. As long as they claim these decisions are made for the good of society, they are pretty much untouchable as well.

Read the entire decision. The case is enlightening, for a few different reasons. If you think you have recourse if a loved one dies or gets seriously injured, think again.

(1) https://www.canlii.org/en/on/onsc/doc/2019/2019onsc7066/2019onsc7066.html
(2) Adam V GlaxoSmithKline 2019 ONSC 7066