SCRANTON, Pa. (Legal Newsline) -- A federal judge last week dismissed a lawsuit against the maker of the drug Abilify, saying pharmaceutical companies are not required to provide detailed instructions to doctors on how to monitor the signs and symptoms of dystonia, a neurological movement disorder.
Individuals with the disorder experience sustained muscle contractions, which cause twisting and repetitive movements or abnormal postures. There currently is no cure.
In his Dec. 2 memorandum, Judge Malachy E. Mannion of the U.S. District Court for the Middle District of Pennsylvania granted defendant Bristol-Myers Squibb Company's motion to dismiss plaintiff Ryan Bergstresser's amended complaint.
Bergstresser originally sued in July 2012 in Lackawanna County Common Pleas Court, alleging he suffered personal injuries as a result of taking Abilify. The drug is typically used to treat schizophrenia, bipolar disorder and depression. It also can be used to treat irritability associated with autism.
His claims included negligence, strict liability and breach of implied warranty.
Bristol-Myers had the lawsuit removed to the federal court soon after.
The plaintiff, who was prescribed the drug by his treating psychiatrist, eventually filed an amended complaint, alleging that the drugmaker knew, or should have known, that the medication was not safe for all consumers.
Bergstresser alleges that Bristol-Myers provides certain warnings and warning labels to the doctors who would prescribe the medication, but nowhere in those warnings does it warn of the potential to contract dystonia.
Instead, he alleges the defendant warns of a potential risk for tardive dyskinesia, a similar muscle disorder.
In the event that symptoms of a muscular movement develop, the defendant's warnings indicate that they may be potentially irreversible. However, the plaintiff alleges that the drugmaker's warnings fail to provide instructions to physicians on how to monitor signs and symptoms of any version of dystonia or tardive dyskinesia so as to prevent contraction of these conditions.
Bergstresser's amended complaint also alleges that Bristol-Myers failed to provide any directions, education or recommendations as to how the prescribing physician should increase or decrease the strength or dosage of the medication when prescribing it for depression-like symptoms in order to limit or prevent contraction of dystonia or tardive dyskinesia.
The drugmaker, he argues, had a duty to provide adequate warnings.
Bristol-Myers, on the other hand, argues that the plaintiff's failure to warn claim is inadequately pled because Bergstresser fails to explain how alternative warnings would have prevented his physician from prescribing Abilify.
In addition, the drugmaker argues that the plaintiff ignored the actual warnings on the Abilify label and therefore fails to point to any deficiencies in the labeling or identify the alternative warnings that the defendant should have given.
Mannion, in his 20-page memorandum, sided with Bristol-Myers.
Bergstresser fails to address the warnings, which, the judge notes, are provided on the Abilify packaging label.
"To this extent, he alleges that 'nowhere' in the Abilify package insert did the defendant warn of the potential to contract dystonia," Mannion wrote. "Despite this allegation, in the package insert, Section 6, 'Adverse Reactions,' sub-section 6.2 'Clinical Studies Experience,' extrapyramidal symptoms are indicated for patients being treated for, among other things, major depressive disorder. In addition, there is a separate section titled 'Dystonia.'"
The judge said it is "clear" that the Abilify package insert does not simply define the disorder, but identifies the contraction of it as a possible reaction to taking the drug.
"Because the plaintiff fails to allege in his amended complaint how this information was inadequate to warn his treating physician about the potential to contract dystonia as a result of taking Abilify, what additional information should have been provided or how any additional information would have prevented his physician from prescribing Abilify resulting in a prevention of his injury, this basis of his failure to warn claim is insufficient," Mannion wrote.
Also, the judge notes, the package insert does contain monitoring information with respect to tardive dyskinesia.
And although there are no specific monitoring instructions with respect to dystonia contained in the packaging label, such instructions are not required based on the Code of Federal Regulations, Mannion said.
"Such instructions are not required to be contained in the labeling information for those conditions which are listed only as 'adverse reactions,'" the judge wrote. "Instead, such instructions are only required with respect to 'the most clinically significant information' listed under the 'Warnings and Precautions' section."
Click here to read the judge's complete ruling.
From Legal Newsline: Reach Jessica Karmasek by email at firstname.lastname@example.org.