Fines Unlikely to End Off-Label Drug Marketing
Pfizer was slapped recently with a record $2.3 billion in fines for illegally marketing some drugs, but critics say even that eye-popping total is unlikely to end the sometimes-dangerous practice of promoting drugs for unapproved uses. The penalty pales compared to the billion dollars or more in annual revenue that blockbuster drugs generate, and new government guidelines stir worry that the marketing of medicines for unapproved uses will become easier.
Pfizer Expected to Pay Record Settlement to U.S.
Before it completes its $68 billion acquisition of Wyeth by the end of this year, Pfizer also is expected to sign a $2.3 billion settlement with the federal government over charges it illegally promoted several of its drugs. The settlement would be the largest ever paid by a drug company for such activity. Federal investigators suspect Pfizer employees promoted several products for other uses, even though drug companies can only market their products for FDA-approved uses.
High Stakes for Merck in Litigation on Fosamax
Drug executives, product liability lawyers and Wall Street analysts are closely watching a jury trial in New York over medical problems associated with Fosamax, a drug from Merck that has been taken by millions of women to offset the bone loss associated with menopause. It is the first of about 900 state and federal cases pending against Merck in which plaintiffs claims that taking Fosamax caused them to develop a rare problem called osteonecrosis of the jaw. Dental surgery is one of the triggers for the condition that can break down jawbone tissue, causing the gums to fall away and expose bone that looks moth-eaten, oral surgeons say.
Bausch & Lomb Beats Back Lens-Cleaner Lawsuits
Bausch & Lomb, rocked by the worldwide recall of its flagship contact lens solution in 2006, has beaten back scientific claims blaming ReNu with MoistureLoc cleaner for a flurry of non-fungal eye infections. The optical products maker has already paid out more than $250 million to settle roughly 600 lawsuits linking MoistureLoc to a potentially blinding fungal infection known as fusarium keratitis. But a federal judge recently found that there is no reliable scientific basis for arguing that MoistureLoc caused another 1,024 lens wearers across the United States to contract assorted bacterial, viral and parasitic infections.
13 Years Later, Medical Malpractice Case Settled
The estate of a late Erie businessman is set to receive $806,714 in a medical malpractice case - 13 years after the estate sued Hamot Medical Center and three years after the estate won at trial. The estate is finally due the money in light of the state Supreme Court denying Hamot's final appeal. The man's estate sued Hamot in 1996 after he fell at the hospital and suffered a brain injury in 1994 and died at a residential rehabilitation center in 1996. The estate argued that Hamot's level of nursing care fell below acceptable standards, a contention that Hamot disputed for the last 13 years.
Study Finds Radiation Risk for Patients
At least four million Americans under age 65 are exposed to high doses of radiation each year from medical imaging tests, according to a new study. About 400,000 of those patients receive very high doses, more than the maximum annual exposure allowed for nuclear power plant employees or anyone else who works with radioactive material. Though the study did not estimate the number of cancer cases that the radiation might cause over the next several decades, researchers estimate that it would probably result in tens of thousands of additional cancers.
Rare Side Effect Seen From Breast Cancer Drug
A new report suggests that a drug widely used to prevent the recurrence of breast cancer may have a rare but dangerous side effect, increasing the odds that long-term users may develop an uncommon but aggressive new tumor. But medical experts were quick to question the significance and methodology of the new study, saying clinical trials had repeatedly found that the drug, tamoxifen, reduced the recurrence and spread of common breast cancers and that its benefits exceeded any possible risks.
Study Finds Risk in Off-Label Prescribing
Physicians are allowed to use drugs in ways that are not specifically approved by the Food and Drug Administration, a practice called off-label prescribing. There is usually less scientific evidence to support nonapproved uses, and a new survey of physicians has found that many might not even know when they are prescribing off label. The average physician in the survey identified the FDA approval status correctly for only about half the drugs on a list provided by the researchers. Confusion was greatest with psychiatric drugs, the survey of some 600 doctors found.
Many Diabetic Foot Amputations Are Preventable
Limb-salvage experts say that many of the 80,000-plus amputations of toes, feet and lower legs that diabetics undergo each year are preventable if only patients got the right care for their feet. Yet they're frustrated that so few do until they're already on what's called the stairway to amputation, suffering escalating foot problems because of a combination of ignorance - among patients and doctors - and payment hassles.
Class Certification Denied in Fraud Suit Over Marketing of Relacore
A suit alleging that the maker of the dietary supplement Relacore fraudulently marketed it for use in cutting belly fat and stress is not right for class action treatment, a New Jersey appeals court has ruled. The judges said there are too many possible variables to satisfy the requirement that questions of law or fact common to the class predominate over questions affecting only individual members. The marketing campaign for Relacore varied over time, claiming at times that the drug reduced belly fat and that it reduced stress at others; as a result, Relacore users might have bought the product for difference reasons and been disappointed in different ways for its alleged failure to measure up to the advertised promises.
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