Today, Reed Smith is hosting a client roundtable in London, “Identifying and Mitigating Risk in a Changing Global Economy,” for life sciences clients.  In light of that, we thought it would be a good idea to have a blogpost that’s relevant to what’s hot in the UK.  Well, there’s nothing hotter on that side of the Pond right now than the increasingly shambollixed up approach to Brexit.  One thing we were wondering about, over here, is whether a crash out Brexit would at least get rid of, in the UK anyway, a couple of extremely unfavorable decisions from the European Court of Justice that we’d blogged about earlier.  We didn’t know, so we asked Simon Greer, a Reed Smith lawyer in our London office if he knew the answer.  He did, and below is his response.  As always our guest posters deserve all of the credit (and any blame) for their posts.

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The timing and implications of Brexit in the UK are currently one of life’s great unknowns. The latest position is that Theresa May’s latest proposed Brexit deal will be voted on by MPs in Parliament by 12 March 2019. However, the Prime Minister has also indicated that if her latest deal is rejected, MPs will be offered two separate votes shortly thereafter:

  1. Whether or not MPs would support a ‘no-deal’ Brexit, meaning that the UK would only leave without a deal on 29 March 2019 if there was consent from the House of Commons for a ‘no-deal’ Brexit; and
  2. If the prospect of a ‘no-deal’ Brexit on 29 March 2019 is rejected by MPs, they will then be given a vote by 14 March 2019 as to whether the UK should request an extension to the 2 year Article 50 process, thereby delaying the UK’s withdrawal to a date beyond 29 March 2019 (the length of such a delay is, as yet, unknown).

In the pharmaceutical industry, the impact of a potential ‘no-deal’ Brexit on 29 March 2019 on the precedential value of the decisions of the Court of Justice of the European Union (“CJEU”), will be of significant interest. This is because the CJEU’s recent decisions in the pharmaceutical sector have had a significant impact on the law in the UK, adverse to pharmaceutical companies, two examples of which we have discussed in previous blog posts:

Causation or No Causation, That Is the Question.

Bad News from Europe for Makers of Life-Saving Medical Devices

So, would a ‘no-deal’ Brexit effectively re-set the clock and eliminate the consequences of CJEU’s decisions in the UK made prior to Brexit?  The answer, unfortunately, is: no, so a ‘no deal’ Brexit would not even have this silver lining.

Whilst Theresa May on 17 January 2017 stated that: “we will take back control of our laws and bring an end to the jurisdiction of the European Court of Justice in Britain. Leaving the European Union will mean that our laws will be made in Westminster, Edinburgh, Cardiff and Belfast.  And those laws will be interpreted by judges not in Luxembourg but in courts across this country.  Because we will not have truly left the European Union if we are not in control of our own laws”, that rhetoric was hollow.  Her comments were in fact forward looking only, rather than applying to adverse CJEU decisions made prior to Brexit.

This is clear from the provisions of the EU (Withdrawal) Act 2018 (“the Act”).

In terms of CJEU decisions made after Brexit, the courts of the UK will no longer be bound by them but they will still be permitted to have regard to [Ed. Note – that’s British English for ‘follow’] them, if they are relevant to an issue that is before them. Sections 6(1) and (2) of the EU (Withdrawal) Act 2018 provide:

6 Interpretation of retained EU law

(1) A court or tribunal—

(a) is not bound by any principles laid down, or any decisions made, on or after exit day by the European Court, and

(b) cannot refer any matter to the European Court on or after exit day.

(2) Subject to this and subsections (3) to (6), a court or tribunal may have regard to anything done on or after exit day by the European Court, another EU entity or the EU so far as it is relevant to any matter before the court or tribunal.

As for CJEU decisions made before Brexit, these will form part of what is described as ‘retained’ EU law under the Act. The treatment of retained EU law after Brexit in the UK is explained in sections 6(3) to (6) of the Act (set out below). In short, whilst the Supreme Court in the UK and Scotland’s High Court of Justiciary (the supreme criminal court in Scotland) are not bound by any decisions of the CJEU made prior to Brexit, all other courts in the UK will be bound by CJEU decisions made prior to Brexit:

(3) Any question as to the validity, meaning or effect of any retained EU law is to be decided, so far as that law is unmodified on or after exit day and so far as they are relevant to it—

(a) in accordance with any retained case law and any retained general principles of EU law, and

(b) having regard (among other things) to the limits, immediately before exit day, of EU competences.

(4) But—

(a) the Supreme Court is not bound by any retained EU case law,

(b) the High Court of Justiciary is not bound by any retained EU case law when—

(i) sitting as a court of appeal otherwise than in relation to a compatibility issue (within the meaning given by section 288ZA(2) of the Criminal Procedure (Scotland) Act 1995) or a devolution issue (within the meaning given by paragraph 1 of Schedule 6 to the Scotland Act 1998), or

(ii) sitting on a reference under section 123(1) of the Criminal Procedure (Scotland) Act 1995, and

(c) no court or tribunal is bound by any retained domestic case law that it would not otherwise be bound by.

(5) In deciding whether to depart from any retained EU case law, the Supreme Court or the High Court of Justiciary must apply the same test as it would apply in deciding whether to depart from its own case law.

(6) Subsection (3) does not prevent the validity, meaning or effect of any retained EU law which has been modified on or after exit day from being decided as provided for in that subsection if doing so is consistent with the intention of the modifications.

In summary, pharmaceutical companies need to be mindful of the fact that existing CJEU decisions made prior to Brexit, even if it is a ‘no-deal’ Brexit, will be binding on courts in the UK, unless those decisions come before the Supreme Court and are overruled by a new, post-Brexit decision of the Supreme Court, which would then take primacy in the UK over the prior CJEU decision.

Today we feature another guest post from our European correspondents, Reed Smith partner Marilyn Moberg and associate Kathryn Bond.  There has been another significant decision from the Court of Justice (its description, not ours) of the European Union, and once again it is bad news for manufacturers of life-saving prescription products – this time vaccines.  Without stealing our guest bloggers’ thunder, let’s just say that the European attitude appears to be “Daubert?  We don’t need no stinkin’ Daubert.”  For the details, see below.  As always our guest bloggers deserve 100% of the credit (and any blame) for what they write.

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Bonjour à tous.

Now that we have completely exhausted our entire high school French vocabulary, for today’s blog post we are traveling back across the Atlantic to France and Luxembourg. Today, we examine a recent judgment of the Court of Justice of the European Union relating to the evidentiary requirements for finding a causal link between a vaccine and an unrelated disease where there is no medical proof to support the existence of such a causal link. For our American readers who are familiar with the way vaccine cases used to be litigated, one may get a feeling of “déja vu,” and not in a good way.

If we cast our minds back to the 1980s scare over the DPT vaccine, large jury awards were given to plaintiffs despite the fact that most public health officials did not believe that there was a link between the vaccine and certain autism spectrum disorders. As a result of these cases, a number of vaccine makers decided to cease production. For the United States government, this development was worrying and threatened a drop in important childhood vaccinations. In order to encourage the continued production of vaccines, Congress passed the National Childhood Vaccine Injury Act, which set up the National Vaccine Injury Compensation Program (NVICP) in 1988 to compensate individuals (or their families) allegedly injured by certain covered childhood vaccines. The compensation scheme is funded by a tax on vaccines purchased. The scheme applies only to conditions that have already been determined administratively to be associated with the vaccine, therefore relieving (i) the plaintiff of the burden of proving a general causal link between the vaccine and the injury; and (ii) the vaccine producer of the cost of defending or settling expensive civil liability cases. The plaintiff is still required to prove that, on balance, a specific causal link between the vaccine and the injury. Although this scheme is limited to certain injuries caused by certain vaccines, it significantly reduced the number of product liability claims against manufacturers for vaccines. See generally Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226-30 (2011) (describing NVICP and reasons for its enactment).

Now, back to the case at hand, which is Case C-621/15, N.W. and Others v Sanofi Pasteur MSD and Others (NW v Sanofi). The judgment has been widely reported as particularly favorable for claimants because it confirms that a claimant can establish, despite total lack of individualized corroborating medical evidence, a causal link between the vaccine and the disease where there is “serious, specific and consistent evidence” that a causal link exists.

By way of background, EU law on product liability is set out in the Product Liability Directive 85/374/EEC. Article 4 of the Directive stipulates that, in order to win a product liability claim, the claimant must prove the damage, the defect and the causal relationship between the defect and the damage. In other words, and unsurprisingly, the burden of proof is on the injured party.

In the NW v Sanofi case, NW developed multiple sclerosis a short period after being vaccinated against Hepatitis B. Although medical research has not established a connection between the Hepatitis B vaccine and multiple sclerosis, the claimant sought to rely on a provision of French case law of the Cour de Cassation (the highest French court). The case law provides that, in relation to the liability of producers of vaccines, proof of a causal link can be derived from “serious, specific and consistent presumptions” in the absence of medical research. The claimant believed that, on the basis of this case law, the French courts could take into account the following facts to find a “lien de causalité” or “causal link”: (1) the short time lapse between the administration of the vaccine and the onset of the disease; and (2) the patient’s lack of any personal or family history of the disease. Essentially, any product manufacturer becomes an insurer against any qualifying medical condition that might manifest itself during this short time lapse, regardless of scientific basis.

At first instance, the Tribunal de Grande Instance in Nanterre, France, found in favour of the claimant, but the decision was subsequently overturned on appeal by the Cour d’Appel in Versailles, France and the Cour d’Appel in Paris, France. When the case finally reached the Cour de Cassation, the judges faced some difficult questions concerning the compatibility of its case law with Article 4 of the Product Liability Directive. In particular, does Article 4 override France’s own national rules regarding the level of proof required to find a causal link between the defect and the damage? This was clearly a question of interpretation of EU law. The Cour de Cassation therefore referred this question to the Court of Justice of the European Union (“CJEU”) for a preliminary ruling.

For those (most) of you not familiar with EU procedural law, here is some important background. The CJEU is based in Luxembourg and is the highest court of the European Union. The CJEU plays an important role in the EU, which includes interpreting EU law to make sure it is applied in the same way across all 28 (soon to be 27) Member States. One of the ways in which the CJEU achieves this is through the “renvoi préjudiciel” or “reference for a preliminary ruling,” which bears some resemblance to the American procedure of federal courts certifying state-law questions to state high courts for resolution. This procedure enables the courts of each Member State to refer questions to the CJEU for a ruling on the interpretation of a specific point of EU law. When the CJEU gives its ruling, its sole mandate is to rule on the point of EU law in question only.

In the case of NW v Sanofi, the CJEU considered the following points:

Whether Article 4 precludes the French Courts from considering its own national evidentiary rules (including those described above), in circumstances where medical research has not established a causal link between the administering of the vaccine and the disease, when determining whether there is a defect in the vaccine and whether there is a causal link between that defect and the disease?

In response to this question, the CJEU gave the following analysis at paras [18]-[43]:

  1. It is ultimately the injured party’s responsibility to prove the damage, the defect and the causal relationship between the defect and the damage (para [19]).
  2. The Product Liability Directive does not contain any definition of the concept of “causal relationship” for the purposes of Article 4 (para [22]). This means that, taking into account the principle of procedural autonomy of each Member State, it is for each Member State to establish:
    1. the way in which evidence is to be provided;
    2. what evidence is admissible;
    3. the principles governing the national court’s assessment of the evidence; and
    4. the level of proof required (para [25]).
  3. The national court’s procedural autonomy should not, however, undermine the effectiveness of EU procedural rules. For example, the national rules should not bring about a reversal of the burden of proof set out in Article 4 of the Product Liability Directive (paras [26]-[27]).
  4. The national courts must ensure that the evidence provided is sufficiently serious, specific and consistent to warrant the conclusion that, notwithstanding the evidence produced by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage, with the result that the defect and the causal link may reasonably be considered to be established (see para [37]).
  5. Although the CJEU is not mandated to apply EU law to the facts of a specific case, the CJEU commented that facts such as:
    1. a short time lapse between the administration of the vaccine and the occurrence of the disease;
    2. the existence of a significant number of reported cases of the disease occurring following such vaccines being administered; and
    3. a lack of personal and familial history of the disease,Based on the above analysis, the answer to the question was a clear “non,” provided that the specific application of a national court’s evidentiary rules do not result in the burden of proof in Article 4 being disregarded or undermined.  Whether Article 4 precludes national evidentiary rules that are based on presumptions (such as a set of pre-determined causation-related facts) according to which, in circumstances where medical research has not established a causal link between the administering of the vaccine and the disease, a causal link can automatically be established?
    4. The second question raised by the Cour de Cassation was the following:
    5. could lead a national court to consider that the injured party has discharged its burden of proof under Article 4 (see para [41]).

In response to this question, the CJEU raised strong concerns. In particular, the CJEU held that establishing a set of pre-determined facts to automatically establish a causal link would make such presumptions irrefutable. This would therefore deprive the defendant from adducing evidence or putting forward arguments (such as scientific arguments) to rebut that presumption, which would not be a fair or effective result. Even if the defendant could rebut the presumption, the burden of proof would effectively be on the defendant rather than the injured party. This would therefore undermine the burden of proof of the injured party set out in Article 4 of the Product Liability Directive.

Based on the above analysis, the answer to the question was a strong “oui.”

There is no general Daubert requirement of verifiable scientific basis for causation in the EU. The CJEU’s judgment is a disturbing development as it lowers even further the standard of proof required from the injured party. However, as highlighted above, the national courts must ensure that the evidence provided is sufficiently serious, specific and consistent (however that might be interpreted) to warrant the conclusion that, notwithstanding the producer’s evidence, a defect in the product appears to be the most plausible explanation for the occurrence of the damage. Although the standard is lower, it is still a threshold. If the CJEU were to find causation without medical proof, the evidence brought by the injured party would have to be very compelling.

Now the pessimists – or perhaps “realists” – out there who remember the pre-NVICP vaccine litigation cases may think that this could make it too easy for plaintiffs to establish causation where there is no corroborating medical evidence and, as happened in the United States, result in a downturn in the availability of vaccines in Europe. Experts in the field are clearly concerned.

However, the full implications of this case are still unclear, and will perhaps remain unclear for some time. The case clearly reduces the burden of proof on the plaintiff, thus raising the spectre of adverse market consequences, but it remains to be seen how this will be adopted in practice by the national courts of the Member States.

In terms of the case at hand, the CJEU did not appear to contradict the most recent decision of the Cour d’Appel in Paris, which found that the plaintiff had not proved causation. It could (we wish) be a Pyrrhic victory for the plaintiff who, ironically, will likely be found by the relevant French court to have not proved causation.

We should also remember that this CJEU case concerns the application of national evidentiary rules. In this case, the French law of evidence set out in its Civil Code. As each Member State will have its own national evidentiary rules, the impact of the CJEU decision will vary depending on the relevant Member State’s own evidentiary rules.

Causation or no causation, that remains the question

As Voltaire so intelligently put:

« Le hasard est un mot vide; rien ne peut exister sans une cause »

(“Chance is a word void of sense; nothing can exist without a cause”)

In over eight years, we’ve never before blogged about a European development in prescription medical product liability.  The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt – Die Gesundheitskasse, Nos. C‑503/13, -504/13, slip op. (4th Chamber March 5, 2015) (that’s a mouthful, so we’ll call it “BSMG” for short), causes us to make an exception.

First, a bit about the court.  According to the EU’s website, one of the functions of the CJEU is to “interpret[] EU law to make sure it is applied in the same way in all EU countries.”  So this is essentially the highest EU court for all matters governed by EU legal directives.  Wikipedia adds that the CJEU almost always sits in “chambers” – units of less than the whole – so the “Fourth Chamber” designation is as far as this case is going to go, since it was not assigned to the en banc “Grand Chamber” at the outset.  Thus the BSMG decision is a final, high-court legal interpretation that will apply throughout Europe.

BSMG interpreted “Directive 85/374/EEC,” id. at ¶1, which is the general EU product liability directive enacted back in 1985.  While BSMG involved medical devices, the decision rests entirely on the general product liability directive, and does not even reference the later EU directive for medical devices, Directive 93/42/EEC.  To us, that’s the first takeaway from BSMG – since it is based entirely on the general product liability directive, it could potentially apply to any product:  prescription drugs, or even automobiles, presenting the same sort of acute risks at issue in the decision.

The important facts are these.  BSMG is actually two cases, both brought by European third party payors (“TPPs”) seeking reimbursement of medical costs that they incurred as a result of “defective” medical devices – and not just any medical devices, electronically operated implants, specifically pacemakers and implantable cardioverter defibrillators.  Thus, these devices were both:  (1) life sustaining, and (2) presented life threatening risks should they fail to function properly.  The risk of potential fatal consequences was extremely important to the opinion.

Continue Reading Bad News from Europe for Makers of Life-Saving Medical Devices