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Law TiMes • March 24, 2014 Page 21 www.lawtimesnews.com Lawyers dispute fears about lawsuits from drug bill here's no evidence a pro- posed law would lead to lawsuits against the fed- eral health minister for recalling unsafe drugs, according to life sciences lawyers. e lawyers reject the claims made two weeks ago by a group of medical and legal academics warning bill C-17 could increase litigation and leave dangerous products on pharmacy shelves. e bill would amend the Food and Drugs Act by giving Health Canada the power to recall drugs if the minister believes a product "presents a serious or imminent risk of injury to health." Currently, the government must negotiate recalls with manufacturers. But critics have attacked bill C-17, legislation intro- duced to the House of Commons last December, for not going far enough. A Canadian Medical Associa- tion Journal article published on March 10 says the bill should explic- itly exempt the health minister from liability for lost product sales resulting from a recall or suspension. e article was by a group of authors led by Matthew Herder, assistant professor at Dalhousie University's Schulich School of Law and faculty of medicine. Without the exemption from liability, there's a "strong disin- centive to invoking the power to suspend or recall," the article states. e prospect may "co- lour" the health minister's deci- sions, it warns. But there's "no evidence" to sug- gest pharmaceutical companies would sue in the event of a recall, says Norton Rose Fulbright Cana- da LLP's Adrienne Blanchard. "As a general rule, when there's an issue with a product . . . manu- facturers do work with Health Canada to address the situation," she says. "I think it's in everyone's interests that patient safety is fi rst and foremost," she adds. Blanchard, who works with manufacturer clients, is unaware of provisions in other countries that would exempt ministers from liability when issuing recalls. Health lawyer Alan Belaiche works with hospitals and doctors among other clients. He also feels it's "a bit of a stretch" to suggest the health minister would avoid re- calls out of a fear of lawsuits. "It seems to me that if the min- ister is acting responsibly, on the grounds of evidence . . . I don't think a court is going to disturb that action," he says. Criticism of the federal gov- ernment's inability to order a drug recall goes as far back as the 1960s thalidomide scandal. alidomide, a morning sick- ness drug used by thousands of women around the world, was found to cause serious birth de- fects including missing limbs, fatal lesions on major organs, deafness, and blindness. Despite a with- drawal from European markets in December 1961, it remained legally available in Canada until March 1962 and continued to be available at some pharmacies for several more months. Gaps in Health Canada's pow- ers came to light more recently amid lawsuits sparked by the deaths of young women who took the acne drug Diane-35. ese incidents have also added to pressure on the govern- ment to release its full reasons for allowing drugs to stay on the market despite safety concerns as well as when it suspends or recalls them. A 2008 bill that died on the order paper would have allowed the health minister to "disclose to the public infor- mation about the risks or benefi ts that are associated with a therapeutic product." e omission of such a provi- sion in bill C-17 "must be recti- fi ed," according to the authors of the Canadian Medical Association Journal article. No Canadian court decision indicates information about the safety or effi cacy of a drug is proprietary, and current case law "casts doubt on any such assertion," they say. Blanchard agrees the courts have yet to test the principle, al- though she notes patient-level clinical trial data hasn't "typically been considered releasable" under access to information laws. Bill C-17 may improve trans- parency in another way as s. 28 appears to require hospitals to disclose information on serious adverse drug reactions that occur during clinical trials. In a famous case starting in the mid-1990s, Toronto hema- tologist Dr. Nancy Olivieri told clinical trial participants of her concerns about a drug's toxicity. e case led to a long legal wran- gle with the manufacturers. It's unclear whether the bill will provide additional protection to whistleblowers, says Belaiche, but he welcomes the apparent com- mitment to openness and a more patient-centred approach. Having only received its fi rst reading, the bill will likely face fur- ther rigorous scrutiny. Despite its current omissions, it's a signifi cant departure from the status quo, says Belaiche. "It's incredibly surprising that we've waited since 1962 to give the federal government the authority that bill C-17 is providing," he says. "It's long overdue." LT Unmasking the mystery. Medical malpractice litigation is one of the most difficult and challenging areas of law. At Thomson, Rogers we enjoy a reputation built on experience and skill in prosecuting these claims. Above all else, our greatest asset is a proven record of success. Contact our Medical Malpractice Litigation Group: David Neill, Craig Brown, Richard Halpern, Wendy Moore Mandel, Sloan Mandel, Aleks Mladenovic, Deanna Gilbert and Kate Cahill at 416-868-3100 or 1-888-223-0448 or visit us online at www.thomsonrogers.com. 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