Negligence Claims Won't Stick to Makers of Plavix
(CN) - A man who suffered gastrointestinal bleeding after taking the blood thinner Plavix cannot sue its manufacturers for defective design and negligence, a federal judge ruled.
Ronald Solomon has dealt with cardiovascular health issues for years.
When Solomon was diagnosed with acute myocardial infraction in November 2002, he took the prescription anti-clotting medication Plavix, plus aspirin.
In July 2005, however, Solomon began suffering gastrointestinal bleeding and followed his doctor's instruction to continue taking the aspirin without the Plavix.
For more than two months, Solomon continued to experience gastrointestinal bleeding and needed blood transfusions.
In September 2005, Solomon had surgery for bowl resection, gallbladder removal and hernia repair.
Solomon sued drugmakers Bristol Myers-Squibb, Sanofi-Aventis and two subsidiaries in the District of New Jersey, asserting product liability claims under Texas law for defective design, manufacturing defect, failure to warn, and negligence.
The defendants have been sued over Plavix labels in the past, and dozens of people claimed earlier this month that their family members died from taking the costly drug.
Bristol Myers-Squibb, Sanofi-Aventis, and Sanofi-Synthelabo moved for summary judgment against Solomon, arguing that, under Texas law, the learned intermediary doctrine excuses drug manufacturers from warning patients about medication risks if they have already warned prescribing doctors.
U.S. District Judge Freda Wolfson granted the motion and dismissed the complaint entirely Thursday.
In faulting the failure-to-warn claim, Wolfson noted evidence of warning.
"Some of the medical evidence upon which plaintiff relies indicate that when taking Plavix and aspirin in combination, there is an increased risk of bleeding, which risks are already displayed on Plavix's warning label," the judge wrote.
Solomon's causation claim also failed.
Both of Solomon's doctors had determined that Plavix plus aspirin was medically necessary and appropriate "because the medical benefits for plaintiff's condition outweighed the risks," according to the ruling.
"In response, plaintiff has produced no evidence - testimonial or otherwise - to suggest that a different warning would have led these doctors to alter their treatment for plaintiff," the 35-page opinion states.
Wolfson dismissed Solomon's defective manufacturing claim, as well.
"The genesis of plaintiff's complaints about Plavix is the drug's anti-platelet properties, which allegedly caused him to suffer injuries related to massive bleeding," she wrote. "Those anti-clotting properties are the intended effects of Plavix, and therefore, by plaintiff's own allegations, the nature of his claim is not premised on whether the drug deviated from the construction or specifications of Plavix."