In a case which in some respects seemed more like a John Grisham novel than a serious piece of Australian litigation, as well publicised, on 5 March 2010 Justice Jessup of the Federal Court found in favour of Graham Peterson (and in relevant respects, in favour of the other members of his representative class) in his case against Merck Sharpe and Dohme, the Australian manufacturer of the anti-inflammatory drug Vioxx.
Mr Peterson had suffered from back pain for many years prior to being prescribed Vioxx by his GP, Dr Dickman in May 2001. He found, as did many other patients, that Vioxx provided relief from his pain without the adverse gastro-intestinal side effects which were encountered with other drugs providing similar pain relief.
In December 2003 whilst still continuing to regularly take Vioxx, Mr Peterson suffered a serious heart attack for which he received prompt and effective medical treatment leading to his making an uncomplicated medical recovery. At the time this heart attack occurred neither he nor his GP or the cardiac team considered that his heart attack was related to his consumption of Vioxx. This all changed following the withdrawal of Vioxx from the market in September 2004 and subsequent revelations as to its potential side-effect.
Interestingly, the basis upon which Justice Jessup found in favour of Mr Peterson was in many ways the least contentious.
Justice Jessup found that the Australian manufacturer had breached key (and long standing) provisions of the Trade Practices Act, in that he found Vioxx:
- was not reasonably fit for the purpose implicitly made known for it’s use;and
- was not of “merchantable quality”
Both of these conclusions followed Justice Jessup’s finding that Vioxx doubled the risk of heart attack (and in fact, as he found, caused Mr Peterson’s heart attack).
Justice Jessup did not accept more onerous allegations made by Mr Peterson, including his claim that the manufacturer had breached a duty of care owed to Mr Peterson as a consumer of its product by failing to carry out sufficient research and investigation in response to the results of an initial trial, or that it ought in view of such findings to have withdrawn Vioxx from the market at such time.
Justice Jessup did find that the manufacturer had engaged in misleading and deceptive conduct contrary to Section 52 of the Trade Practices Act in the information it provided to general practitioners, including Mr Peterson’s, as to the safety of Vioxx. He was not satisfied however that such misleading conduct had caused or contributed to Mr Peterson’s heart attack. This was because he was not convinced that had the manufacturer made more appropriate disclosure of risks to Mr Peterson’s GP and not overemphasised its safety, that this would have resulted in his not taking the Vioxx that caused his heart attack.
Also significantly, although ultimately he found this was not breached, Judge Jessup accepted (against the claims of the manufacturer) that a duty of care was owed by the manufacturer of Vioxx to the ultimate consumers (in Mr Peterson’s position) and this was not negated by the fact such medication was a prescription drug and so only available upon provision of a medical practitioner’s prescription. In other words a duty was owed by the manufacturer to the consumer of the medication despite a “learned intermediary” being involved in the drug’s use. With respect, this is clearly the right decision.
It followed this finding that the manufacturer, Merck Sharpe & Dohme owed Mr Peterson (and any other user of it’s drug) a duty to complete appropriate research into the drug’s safety, side-effects etc.
Interestingly Judge Jessup rejected a defective product liability claim brought in the matter. Whilst he accepted Vioxx was defective in accordance with the definition provided by Section 75 of the Trade Practices Act, being “not as safe as persons generally were entitled to expect,” he accepted the manufacturer’s defence that the state of scientific knowledge at the relevant time was not such as to enable such defect to be discovered. With respect, this appears to me to have been a generous finding in favour of the relevant manufacturer and a contrary conclusion could have been reached.
Points from the Case
The key points from the case are it seems to me:
- The case makes clear that a pharmaceutical company owes a duty of care to consumers of prescription (and other) medication to complete appropriate research into the drug’s safety. If such research/investigation is flawed, liability can arise.
- Pharmaceutical companies can be scrutinised in relation to their marketing of drugs to the medical profession and otherwise, and any misleading or deceptive conduct in their comments about drugs can be actionable under our Trade Practices Act. Such action can be by the eventual consumer of medicine prescribed for them, not just the direct ‘victim’ of the misleading or deceptive conduct, the heath professional. Apart from in the context of side-effects, it occurs to me this could operate in circumstances should a pharmaceutical company claim (falsely) that a particular medication or treatment is ‘safer’ or ‘more effective’ than its competitors’ equivalent product(s).