December 2010 Archives

December 27, 2010

Product Liability Claims Arising Out Of DePuy Hip Replacements

As reported in the Wall Street Journal - as the result of a loophole in the Food and Drug Administrations regulation of medical implants - many potentially faulty hip implants are on the market.

New drugs must undergo clinical trials before receiving FDA approval, however if a medical implant resembles a product already on the market, testing may not be required. This is what happened with the Articular Surface Replacement, a hip replacement device made by DePuy Orthopaedics.

Many patients who received the implant have developed pain. Upon replacement, physicians have located masses of dead tissue in the patient's thighs. Other patients claim high levels of cobalt ions in their blood, leading to fears of poisoning. According to a recent lawsuit, as the result of the DePuy hips, "many suffer severe pain, inflammation, death to surrounding tissue and bone, a partial or complete lack of mobility and the need for surgery to remove and replace the device, leading to a potentially increased risk of complications."

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December 13, 2010

Supreme Court Agrees To Hear Generic Reglan Drug Label Suit

The U.S. Supreme Court has agreed to hear argument over whether generic drug makers can be sued for the failure to warn about dangerous side effects on their drug label even when they follow federal rules.

In PLIVA, Inc. v. Mensing a woman took metoclopramide - the generic equivalent of Reglan - for four years to fight diabetic gastroparesis. She claims that the drug caused a severe neurological movement disorder - tardive dyskinesia - not warned about by the drug's manufacturers and distributors.

The 8th U.S. Circuit Court of Appeals found in favor of the woman, noting that more should have been done to warn consumers about possible risks. The court reasoned, "If they realized their label was insufficient but did not believe they could propose a label change, they could have simply stopped selling the product. Instead they ...placed a drug with inadequate labeling on the market and profited from its sale."

The FDA has now required Reglan to add warnings about tardive dyskinesia in February 2009.

The Supreme Court will hear argument in the spring.

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December 6, 2010

American Dangerous Drug Trials Being Conducted Overseas

A recent investigative article has disclosed some scary statistics. Even with FDA approval, prescription drugs kill nearly 200,000 Americans each year. As a result of consumer backlash and the raised awareness of the potential risks of dangerous drugs such as Avandia, Reglan and Darvon/Darvocet, many U.S. drug companies have now moved their clinical trials overseas to Russian, Poland and China where regulation is virtually non-existent and the F.D.A. has no authority. In fact, the 20 largest U.S.-based pharmaceutical companies now conduct one-third of their clinical trials at foreign sites.

According to reports, pharmaceutical representatives are now scouring the world to find people willing undergo clinical trials for new drugs in order to help persuade the F.D.A. to declare drugs safe and effective for Americans. Additionally, if a U.S. study finds a drug has no benefit, a foreign study can be used to secure F.D.A. approval.

One drug being tested in foreign cities is Celebrex, an anti-inflammatory drug that has been heavily promoted in the U.S. for more than a decade. Although Pfizer, the manufacturer of Celebrex has reported 290 trials for the drug, with 107 in other countries, an informal polling revealed at least 207 trials in other countries.

Recently, it has been disclosed that Celebrex patients were more likely to suffer heart attacks and strokes than those consumers who took older and cheaper painkillers. Further, reports indicate that Pfizer knew of these problems.

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