Given the astronomical price of prescriptions drugs, it is no wonder that Maine residents sought relief through cross-border imports. In fact, people have routinely secured out-of-country prescription medications since the 1950s.
However, the problem has always been that such transactions were technically illegal under state and federal law, even if they weren’t strictly enforced where individual sales were concerned. From a defective drugs lawsuit standpoint, it meant that people had little recourse if the drugs they received were not made and transported safely.
Then late last year, Maine became the first state to legalize the direct purchase of mail-order drugs from certain foreign pharmacies – companies out of Canada, the U.K., New Zealand and Australia. Even so, it’s still not clear what legal liability these firms might have if their drugs turned out to be defective or harmful.
Local pharmacists have expressed alarm. Part of the problem is that large contracts with foreign providers cut into their profits. But beyond that, the pharmacists have voiced concern that these foreign drug providers weren’t subject to state regulation.
This eventually prompted the state’s attorney general to stop the drug importation program by all government entities, saying it appeared to violate state law.
However, the new law removes state licensing requirements for accredited pharmacies in the aforementioned countries. Large drug companies (i.e., Pfzer, Johnson & Johnson and the Eli Lilly & Co.) vehemently opposed the measure. They contend that important foreign drugs raise serious safety concerns because there is little ability to track safe handling and integrity.
This triggered a lawsuit filing, OUELLETTE et al v. MILLS et al, in which local pharmacy providers sued the state for injunctive relief of the importation law, citing “serious health risks to consumers.” In the complaint, filed in the U. . District Court for the District of Maine in Bangor, alleges that drugs that aren’t subject to quality and safety controls circumvent federal law and have the potential to hurt patients.
The groups tried to involve the FDA, but, according to the plaintiffs, the agency “did a little soft-shoeing around it.”
The lawsuit is still pending.
State officials continue to insist that patients are getting good medications through supply chains that are well-regulated. However, some research has revealed that certain Canadian suppliers receive their drugs from operations in India and Turkey. In some cases, certain drugs were found to be counterfeit or improperly branded.
Beyond these concerns is the fact that when patients seek international imports of drugs, they may be eliminating some of the routine consultations with doctors and pharmacists that could identify potentially problematic combinations of drugs or dangerous side effects.
From our perspective, the greatest concern is that establishing liability could be an issue when the drug supplier is an international firm. Still, those who have been harmed by defective medications should immediately contact a personal injury lawyer to discuss the options regarding their individual case.
If you are the victim of medical malpractice in Bangor, contact us at 1-800-804-2004 or read more on our website.
Maine to Allow Prescription-Drug Imports, Oct. 11, 2013, By Jennifer Levitz and Timothy W. Martin, Wall Street Journal
Implications of the Maine drug-import law, Jan. 10, 2014, By Philip E. Gaucher Jr., DrugTopics,com