LS&HC Horizons 2023 - Flipbook - Page 59
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Europe
59
Anticipated changes to the EU liability landscape
To adapt the European product liability
landscape to the digital age, in September
2022, the European Commission proposed
new rules to address liability claims relating to
defective products, including life sciences and
health care products, and AI systems:
• revised Product Liability Directive (PLD),
building on the strict liability rules for
defective products known since 1985 while
modernising their scope to encompass digital
products, circular economy business models
and global supply chains; and
• a first of its kind AI Liability Directive
(AILD), targeting harmonization of the
member states’ national fault-based civil
liability rules for AI-enabled products
and services.
With the declared aim of putting consumers on
an equal footing with defendants and to ease
their burden of proof – in particular in cases
where discharging it is excessively difficult
(as arguably in most life sciences and health
care cases) – both Directives introduce novel
procedural mechanisms, such as:
• national courts may grant consumers access
to relevant evidence at the defendants’
disposal (failure to comply with such orders
being sanctioned by a presumption of defect
or fault, respectively); and
Both proposals are at an early stage of
legislative work before being enacted, possibly
in 2024. Then, the new rules will need to be
transposed into the member states’ national
product liability systems.
For the European legislator, the reform
aims at reducing legal uncertainty and
fragmentation of the product liability regime
throughout Europe. However, the proposed
changes including the novel procedural
mechanisms to be introduced, may well first
have an opposite effect. They could result in:
• forum shopping in Member States where
judges are known to have a more proplaintiff approach;
• more complex and burdensome disputes
from both procedural and substantial
standpoints; and
• shifting the battlefield from defect, fault
and causation to application and rebuttal
of corresponding presumptions.
Businesses operating in the EU life sciences
and health care sector should carefully
continue to monitor this changing landscape.
• rebuttable presumptions for the
defectiveness of the product and/or for the
causal link between the alleged defect and
damage may apply.
Charles-Henri Caron
Counsel, Paris
Nicole Saurin
Counsel, Munich
Benjamin Schulte
Counsel, Munich