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THE US SUPREME COURT IS “MENSING” WITH YOUR LEGAL RIGHTS


The US Supreme Court correctly held in its 2010 decision in Wyeth v Levine that state tort laws do not conflict with federal law and can be used to hold the pharmaceutical manufacturers accountable for the serious injuries and damages caused by their dangerous drugs. The legalese for the legal issue made the basis of that decision is preemption: Are claims brought on state tort laws inconsistent with and therefore preempted by federal law. The Court recognized that the FDA could not possibly shoulder all of the responsibility for determining the safety of a prescription drug during the new drug approval process. It further recognized that tort laws were not inconsistent with the federal laws and regulations that the FDA operates under, and those laws play a very important role in determining the safety and effectiveness of dangerous drugs that the FDA approves. After all, the only information the FDA has to make that decision comes from the drug’s manufacturer. No comfort level, there.

In June, 2011, the same US Supreme Court in Pliva Inc. v. Mensing held just the opposite for the manufacturers of the generic forms of these dangerous drugs. The Court found that state tort claims are inconsistent with and are preempted by federal law and are not permitted. This ruling is significant for a number of reasons. First, the company that develops and obtains FDA approval to market a drug (called the innovator) maintains that exclusive right for a ten year period. That ten year period can be extended under certain circumstances. After that ten year period and/or any extended periods run, the exclusivity is lost. Other drug companies can manufacturer and market the innovator’s exact same drug under its own name. These identical drugs are called generics. Second, the generic manufacturers do not have the same duties that the innovator has in the new drug approval process to test generics for safety and effectiveness and for full, complete and accurate disclosure of all know risks of serious side effects associated with that drug; this is the sole responsibility of the innovator. Third, if the innovator’s label for the drug is inadequate and incomplete, the generics’ label will be inadequate and incomplete. Fourth, if your physician prescribes a generic form of a drug, or worse yet if your insurance company will only approve and pay for a prescription filled with the generic form, and you suffer a serious injuries and damages from that drug, you will not be able to file suit to seek compensation against the generic manufacturer.

Since the innovator obtained FDA approval and is responsible for the drug label’s full, complete and accurate disclosure of all know risks of serious side effects, it appears that the patient may be able to bring suit against the innovator even though the patient ingested the generic and not the original form of the dangerous drug. The pharmacy, pharmacist, insurance company, and physicians are also left exposed by this ruling for their part in the patient’s injuries and damages. Prior to the Mensing decision, Bailey & Galyen did not included pharmacies, pharmacists, insurance companies, and physicians in cases filed against the drug companies for serious injuries and damages. The Supreme Court’™s decision now forces us to include them in the lawsuit.

While the ruling is consistent with Levine, its disservice is that it leaves the generic manufacturers untouched and unaccountable for serious injuries caused by their dangerous drugs. It puts the consumer between the proverbial rock and a hard place, with the fox guarding the hen house.

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Texas Auto Accident Lawyers

Texas Auto Accidents

Auto Accident Litigation Law Firm

At the Houston / Dallas law offices of Bailey & Galyen, our Texas Auto Accident Lawyers represent clients in the negotiation and litigation of serious auto accident lawsuits related to:

Catastrophic Personal Injury

Possibly the most common form of catastrophic personal injury, the negligent operation of an automobile on our roadways results in thousands of needless injuries and deaths each year.

The consequences of these accidents can be devastating to both you and your family, leaving you struggling to pay medical bills and replace lost wages while you recover. Adding insult to injury dealing with an insurance bureaucracy concerned only with its own financial well-being rather than fair compensation for your very real injuries.

  • Spinal Cord Injury
  • Brain Damage
  • Amputation
  • Paralysis
  • Burns
  • Scars
  • Paraplegia
  • Back
  • Neck Pain
  • Broken Bones
  • Blindness
  • Deafness

Car Liability Insurance

Our lawyers are intimately familiar with your state’s liability laws and insurance regulations and won’t hesitate to take a case to trial if it’s the only way to secure maximum compensation. In addition, we utilize the latest technology in the investigation of auto accident liability, including accident reconstructions and expert witnesses, in order to identify all liable parties, including:

  • Operator
  • Manufacturer
  • Repair / Maintenance
  • Government (roadway & signage issues)
  • Liquor / Alcohol establishments (“dram shop” laws)

The cost of litigating an automobile / car accident claim against an insurance company is considerable, with substantial up-front expenses related to expert witness testimony, depositions and accident reconstruction. That is why Bailey & Galyen takes all car accident lawsuits on contingency, with NO FEES until we recover a positive judgment as compensation for your injuries.

The auto accident attorneys at Bailey & Galyen offer quality legal services and representation to clients throughout Texas, including Arlington, Bedford, Dallas, Fort Worth, Grand Prairie, Carrollton, Plano, Weatherford, Mesquite, Houston, Clear Lake, TX.

Bailey & Galyen is a nationally recognized Texas law firm with a nationwide practice in the litigation of personal injury and wrongful death lawsuits on behalf of clients across the country. Our TX trial lawyers and accident attorneys provide sound legal advice and aggressive trial representation to clients at multiple satellite offices, including:

Call Our Nearest Office for Prompt HELP:

Bedford Ph 817.868.5500 | Dallas Ph 214.252.9099 : 866.378.4705 | Fort Worth : Ph 817.263.3000 | Houston : Ph 281-335-7744 : 866-715-1529 | Arlington : Ph 817.276.6000 : 877.345.6767 | Grand Prairie : Ph 972.642.7900 : 866.380.3369 | Weatherford: Ph 817.594.5428 | Mesquite: Ph 972.682.7868