Justices remove liability protection for device makers

Article Abstract:

The U.S. Supreme Court ruled in June 1996 that Food and Drug Administration (FDA) approval does not exempt medical device manufacturers from state product-liability laws. The ruling will permit Laura Lohr, whose pacemaker failed three years after its 1987 installation, to sue Medtronic, the device's manufacturer. The court ruled 9-0 that faulty design claims were not prevented by federal law, and 5-4 that negligent manufacture and failure-to-warn claims were also permissible.

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Pacemakers, Product Safety-Medical Equip, Cases, Product liability, Medical equipment, Medical equipment and supplies industry, Medical equipment industry, Product safety, Products liability, Medtronic Inc., MDT, Lohr, Laura

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Eye treatment revolution: providers jumping on laser bandwagon

Article Abstract:

The market for laser eye surgery has burgeoned following the FDA'a approval of Summit Technology's photorefractive keratectomy (PRK) equipment. Laser surgery could become a multibillion dollar business since PRK surgery costs between $1,500 and $2,500 per eye, and an estimated 90% of the 60 mil near-sighted persons are eligible for the procedure. Summit Technology is aggressively marketing PRK procedures through cable television and print advertisements.

Laser Surgical Instruments, Management, Marketing, Surgery, Eye, Lasers in surgery, Laser surgery, Eye surgery, Laser industry, Surgical lasers, Photorefractive keratectomy, Summit Technology Inc., BEAM

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Eye surgery at center of storm

Article Abstract:

Three medical groups sued the Idaho Board of Optometry, in May 1996, because the board gave optometrists the right to perform photorefractive keratectomies. The plaintiffs claim physicians are the only group qualified to perform surgery and the laser reshaping of the eye is surgery. Professional standards and millions of dollars of medical business are at stake.

Optical Health Centers, Laws, regulations and rules, Vision centers, Radial keratotomy

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