April 2009 Archives

April 30, 2009

Changes Coming for Pennsylvania Products Liability Law

A bystander who is injured as a result of a defective product might find it easier to contest their claim in Pennsylvania court. The current laws of Pennsylvania make it difficult for an injured victim to prove their case if the victim was not operating the defective product. Pennsylvania liability laws clearly state that if an intended user of a defective product is injured a claim can be made; however there is a gray area. There is no clear law or standard that protects a bystander from a defective product.

There is talk that the law will be rewritten to clearly define the responsibility of a manufacturer when a bystander is injured by a defective product. The Pennsylvania Supreme Court is currently reviewing the law but many in the legal community predict that the Court will adopt a more comprehensible set of product liability laws.

Continue reading "Changes Coming for Pennsylvania Products Liability Law" »

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April 22, 2009

Unapproved Medication Pulled from Shelves

A federal injunction has stopped Maryland based Neilgen Pharmaceuticals from selling more than 50 unapproved medications. Medications sold by Neilgen which also operates under the name, Unigen were mainly prescription cough and cold products. The U.S. Food and Drug Administration filed a complaint in Baltimore's U.S. District Court claiming the drugs were improperly manufactured, carried inadequate directions for use and were not FDA-approved.

Neilgen and its parent company, Advent Pharmaceuticals agreed to the injunction without admitting or denying the allegations. By agreeing to the injunction the company must destroy their existing drug supply and is prohibited them from manufacturing any new drugs without FDA approval. Outside counsel must also be hired to advise the company on complying with U.S. manufacturing standards. Any violation of the injunction will result in fines of over $1 million per year.

It is unclear on where the drugs were sold but an ongoing investigation by the Maryland U.S. attorney's office is hoping to discover where and when the drugs were sold.

The following cough and cold products were manufactured by the companies:



  • RE All 12 Suspension

  • BP Allergy Junior Suspension

  • PE Tann 20 mg/CP Tann 4 mg Suspension

  • BP New Allergy DM Suspension

  • D-Tann CT Tablets

  • B-Vex D Suspension

  • Histex SR

  • Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets

Continue reading "Unapproved Medication Pulled from Shelves" »

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April 6, 2009

Yahama Rhino ATVs Recalled

Yamaha Motor Corp. issued a recall of more than 120,000 Yahama Rhino ATVs. All Rhino 450 and 660 model vehicles are being recalled for repairs intended to prevent accidents that have resulted in 46 confirmed deaths and hundreds of injuries. These Yamaha Rhinos suffer from inherent design flaws that make them unstable and susceptible to low-speed rollovers.Yamaha-Rhino-Green-1.jpg

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April 6, 2009

Learned Intermediary Doctrine and Direct-to-Consumer Marketing

As a follow-up post to "Consumer Health and Safety Or Pharma's Bottom Line", the New York State legislature recently proposed to eliminate the learned intermediary doctrine for prescription drugs or devices that are marketed through direct-to-consumer marketing. Here is the bill. It makes complete sense. From the text of the Bill: "Historically, with regard to prescription drugs, our courts have created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with their products because they warned health care providers of those risks. This made sense in an era of "doctor knows best," when pharmaceutical manufacturers directed all of their sales efforts at physicians and never at consumers.

In light of the recent, and expensive, mass marketing of prescription drugs, manufacturers should no longer be relieved of the duty to properly warn their advertising targets about the dangers of their products. Just as the manufacturer can make direct claims about the efficacy of its products, so should that manufacturer warn of its risks. By advertising directly to the patient, manufacturers make the patient an active participant in the decision to use the drug and cannot, therefore, claim the potential adverse effects of using the drug are so complex that they can only be communicated to physicians." We'll have to wait and see how the New York State legislature responds to this bill. In the meantime, call your local state representative and encourage them to introduce a similar, common sense, consumer friendly bill in your home state.

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