The withdrawal of Roaccutane, the anti-acne drug, in the US has a huge effect on legal cases against its manufacturer here, writes KITTY HOLLAND.
THE WITHDRAWAL last week of the anti-acne drug, Roaccutane, from the US market has “relevance” for up to 10 pending cases here against the drug manufacturer, Roche Pharmaceuticals, according to the main solicitor taking the cases.
David Harris, of Ivor Fitzpatrick Co, said yesterday he had just heard of the withdrawal and would be keen to see “clarity” on the reasons for it.
Roche Pharmaceuticals last week notified the Food and Drug Administration (FDA) it was taking its dermatological drug Accutane, as it is known in the US, off the market. It said its decision had nothing to do with the thousands of personal injuries cases against it and it was a purely commercial decision.
The company told the FDA a “re-evaluation” of the product indicated it had faced severe competition from generic competitors since the patent expired in 2002.
Roche’s prescription share of the US market had dropped to about 5 per cent. Roche says it will continue to supply the drug here.
Cases against Roche involve claims that the drug caused inflammatory bowel disease as well as depression and birth defects. Though it continues to contend that legal cases against it have nothing to do with the decision to stop supplying it in America, the company says as well as the challenge from generic competitors, it “has been faced with high costs from personal injury lawsuits that the company continues to defend vigorously”.
About 13 million people have taken the drug since it went on the market in 1982 and it is now the basis for up to 5,000 personal injury claims, according to Michael Hook, an attorney based in Pensacola, Florida.
Commenting on the drug’s withdrawal, he said: “We’ve been winning the cases with the drug still on the market but this move certainly isn’t going to hurt us going forward.” He also said Roche had lost six of the cases that went to trial.
Similarly, Mr Harris said his cases were based on the marketing and sales advice given by the company in the past – ie whether there were adequate warnings about possible psychiatric side effects, given the knowledge available to the company at the time.
“Roche does now include warnings in its literature while at the same time denying there is any possibility of these side effects, which is a curious position to take, though they say it’s better to err on the side of caution.
“It’s common sense that when a drug is taken off the market and it’s one that’s involved in our cases, there may be implications for the cases. Obviously we would like clarity.”
Asked how many cases his legal team was preparing, he said “in around the 10”. They were being taken “mainly by individuals” and mainly involved psychiatric side effects.
None was ready for full trial, he said, though the case taken by Dublin businessman Liam Grant against Roche is due to go to trial shortly.
Mr Grant is convinced his once happy 20-year-old son, also named Liam, became depressed and died by suicide in 1997 as a consequence of taking Roaccutane for four months. Roche denies the claims and fought Mr Grant’s efforts to bring his case to trial all the way to the Supreme Court.
In May last year the three-judge court upheld a High Court decision and ruled the proceedings against Roche should proceed. At one stage it sought a restraint on the proceedings, offering to pay Mr Grant just over €25,000 to settle without admission of liability. He rejected this as a “cynical attempt to avoid a public trial”.
While the majority of the cases in the US relate to personal injuries, a number of murder trials have heard defence attorneys argue taking Accutane was a factor in their clients’ actions.
Most recent was the trial last week of John Mullarkey, a 20- year-old Pennsylvanian, who was convicted of the first degree murder of his 16-year-old girlfriend, in August 2007. He was sentenced to life without parole.
According to the trial report in the Pittsburgh Post-Gazette, the defence attorney, Robert Stewart, opened his case with a plea to jurors that his client's emotional balance had been upset by the anti-acne drug: "I'm not standing here and saying that this is it, that Accutane did it. No, that is one component."
Mullarkey is reported to have stabbed his girlfriend, Demi Cuccia, 16 times at her home in the town of Monroeville late in the afternoon of August 15th, 2007.
Mr Stewart’s case had been that his client was unable to form a specific intent to kill Ms Cuccia, because of the effect of Accutane, and so should be convicted of third-degree murder, which would have carried only a 20-year sentence.
Mullarkey had started taking Accutane in spring 2007. Less than a week before the killing he is reported to have stopped taking the drug as it was affecting his mood. He had also broken up with Ms Cuccia.
On the day in question he went to Ms Cuccia’s house hoping for a reconciliation. His attorney told the jury: “Something went horribly wrong. He doesn’t know why. You will hear experts testify that he has no recollection of the event itself.”
A year earlier Chicago dermatologist Dr David Cornbleet was killed by a patient, Hans Peterson, at his offices. He later confessed to the killing, also by stabbing, to French authorities. He had left the US after the killing, claiming his French citizenship through his mother and so hoping he would be protected from extradition and trial.
Peterson is reported to have given a four-page statement, confessing the killing and focusing on Accutane, prescribed to him by Dr Cornbleet in 2002.
He told the authorities he had massive headaches as soon as he started taking the drug and stopped taking it. He also said it caused impotence.
Four years later, for reasons that remain unclear, he went to Dr Cornbleet’s rooms to “torture” him. When he fought back, said Peterson, he had to kill him instead. Peterson’s father, Dr Thomas Peterson, is blaming the side effects of the anti-acne medication for his son’s actions.
Roche in Ireland says the drug is staying on the Irish market because no generic equivalents has been launched here.
“If we got to the same situation as in the US with an erosion in the market share we would evaluate the situation again,” said a spokeswoman.
No compensation has been paid out in Ireland on foot of claims in relation to the drug, the company points out.
Mr Grant’s case will be the first Roaccutane case to be heard here.