It took a year after the initial announcement, but Johnson & Johnson ($JNJ) has finally gained European regulatory approval for its $21.3 billion bid to buy Synthes.
Still to come: U.S. regulatory approval, which is expected sometime during the first half of this year.
Of course, the EU approval came with a catch. For the price of acquiring Synthes and making a massive addition to its orthopedic products line, J&J agreed to sell its DePuy global trauma business to Biomet for $280 million in cash. Announced earlier this month, the deal gives Biomet various DePuy products used to treat bone fractures as well as the business line's supporting infrastructure.
The Biomet transaction was enough to address competitive concerns regarding bone fracture treatment, the European Commission told Bloomberg in an emailed statement. Last November, worries that the J&J/Synthes deal would hike prices for orthopedic medical devices led European regulators to launch a widespread investigation, according to the story.
J&J's bid to buy Switzerland's Synthes was FierceMedicalDevice's top medical device deal of 2011, and is J&J's biggest purchase ever. The megatransaction will also help J&J become the biggest player by far in the $5.5 billion trauma device market. But Synthes also comes with plenty of baggage. The FDA issued a warning letter to the company last month regarding the handling of complaints and production standards at the company's West Chester, PA, plant. The families of two patients who died after receiving Synthes bone cement in an illegal clinical study are also suing the company and four former Synthes executives, alleging wrongful death and elder abuse.
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