Posts Tagged ‘pharmaceutical manufacturers’

Over The Counter Remedies

Saturday, November 10th, 2012

By Robert A. Schwartz

Managing Attorney, Pharmaceutical Litigation

Robert A. Schwartz - Managing Attorney, Pharmaceutical Litigation

Over-the-counter (OTC) or nonprescription drugs are those that are deemed to be “safe and effective” for use without treatment or prescription by a doctor. There are over 300,000 OTC drugs. Since it is not required that the Food and Drug Administration (FDA) approve over-the-counter drugs, the manufacturer only has to make sure the drug’s labeling is consistent with the established, standardized format for the OTC drug labeling. The FDA does monitor the labeling for compliance. So, without a mandatory, pre-approval process to determine if the product is, in fact, safe and effective, the FDA can only monitor reports of adverse events related to OTCs.

On September 13, 2012, the FDA alerted the public about reports it had received regarding serious burns caused by topical (applied to the skin’s surface) muscle and joint pain relievers. In this particular instance, the FDA records showed 43 reports of such cases. Typically, these items take the form of creams, lotions, ointments and patches, and are marketed under brand names such as Bengay, Flexall, Icy Hot and Mentholatum. The majority of second- and third-degree burns occurred with the use of products containing menthol as the single active ingredient and products containing both menthol and methyl salicylate, in concentrations greater than 3 percent menthol and 10 percent methyl salicylate.

Skin reactions such as those that made the basis of the FDA’s September 13, 2012, action can be so serious that they require hospitalization. The two main injuries are Stevens-Johnson Syndrome (SJS) and Topical Epidermal Necrolysis (TEN), and they are no different from and require the same medical treatment as any other second- and third-degree burns. The injuries and treatments are extremely painful, and usually the injury will result in scarring on the affected areas.

If you have been diagnosed with a Stevens-Johnson Syndrome or Topical Epidermal Necrolysis injury from over-the-counter drugs such as Bengay, Flexall, Icy Hot or Mentholatum, you may be entitled to compensation. Call Bailey & Galyento discuss your legal rights and potential claim.





Wednesday, July 27th, 2011

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.