Boehringer settles US lawsuits
pharmafile | May 29, 2014 | News story | Medical Communications, Sales and Marketing | Boehringer, Pradaxa, US, blood, lawsuits, warfarin
Boehringer Ingelheim has sought to bring to an end around 4,000 legal cases which have been brought against the company in the US over its blood thinner Pradaxa.
Despite its conviction that the ‘plaintiffs’ claims lacked any merit’, the German firm is paying out $650 million and expects ‘most, if not all’ to accept the terms – and vows to “vigorously defend against those who do not”.
The company says in a statement: “The settlement enables Boehringer Ingelheim to focus solely on its mission of improving patients’ lives and allows the company to avoid the distraction and uncertainty of lengthy litigation.”
Approved in 2011, Pradaxa (dabigatran etexilate) has been at the centre of these state and federal cases over allegations that it has caused severe or fatal bleeding. Bleeding is a well-known complication of all anticoagulant medicines, with their ability to prevent strokes and thus save lives balanced against this side effect.
The drug is one of three new oral blood thinners – along with Bayer’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) – looking to replace the 50-year old treatment warfarin.
The US Food and Drug Administration reaffirmed on 13 May that the benefits of Pradaxa outweigh its risks and it was a ‘tough decision’ to settle, Boehringer said.
“Time and again the benefits and safety of Pradaxa have been confirmed in many clinical trials and in real world data analyses,” said Andreas Neumann, the firm’s general counsel. “This settlement does not change the facts about Pradaxa or its importance to patients.”
Neumann launched a scathing attack on the US legal system, saying it was “described by some as a business where lawyers run advertising campaigns to find clients”. He also said that juries made up of lay people deciding about ‘very difficult scientific matters’ tended to come up with verdicts which were hard to predict.
In February, internal company documents released by a US court showed that Boehringer attempted to delay and revise the publication of important drug information. The study the firm wanted to delay showed that Pradaxa may require closer monitoring by medical staff as more patients were having bleeds than would be expected.
A key aspect of the drug’s appeal is supposed to be that it does not require such monitoring and therefore is easier for patients to take – and any data suggesting otherwise could dampen the drug’s revenue stream.
This is important information for doctors to know as patients could be at risk of haemorrhaging, but Boehringer did not release it right away.
In an email published by the court, one anonymous employee complained that the paper would harm the company’s marketing efforts and make discussions with regulatory agencies more difficult, and asked if its publication could be avoided.
Andreas Clemens, a medical team leader for the drug, wrote that he believed the findings were important and should be published – but with revision. “The world is crying for this information, but the tricky part is that we have to tailor the messages smart.”
In another email Clemens expressed concern that the paper ‘could be a liability issue’ for the company.
Boehringer itself has said that 260 cases of fatal bleeding have been linked to Pradaxa in post-marketing studies – but the frequency of occurrence was still significantly lower than that observed in the clinical trials that supported the drug’s approval.
The European Medicines Agency has suggested making advice to doctors and patients clearer – including more specific guidance on when Pradaxa must not be used, as well as advice on managing patients and reversing the anticoagulant effect of Pradaxa if bleeding occurs.
There have been other safety concerns around Pradaxa, with the EMA telling Boehringer it must alert doctors to check their patient’s kidney functions prior to using the drug.
This is because Pradaxa is mainly excreted renally, meaning that the treatment should not be prescribed to patients with severe renal impairment.
Adam Hill
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