Posts Tagged ‘FDA’

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.




Drug Companies Say the Doctor Knew and Did Not Tell You

Wednesday, September 7th, 2011

by Bob Schwartz

Product liability cases are filed against drug companies to recover compensation for serious injuries and damages from dangerous prescription drugs. These lawsuits are based on the inadequacy of the written warnings (also referred to as the label or package insert) that come with the drug to warn the patient and prescribing physician of its risks and serious side effects. The lawsuits are premised on the principle that the drug companies have the duty not to injure the patient. Drug companies fulfill that duty when their drugs’ warnings disclose all of the drugs’ risks and serious side effects. Only then can the patient exercise their absolute right to know all of the risks and serious side effects of a drug before they take the drug. When the drug companies fail to fulfill that duty and serious injuries and harm result, the drug company must be held responsible and accountable.

Notice that I said the drug company must be held responsible and accountable. That litigation may or may not involve the doctor who prescribed the dangerous drug. At Bailey & Galyen, litigation against the drug companies rarely if ever involves the prescribing doctor. Prescribing doctors are not sued because they only know what the drug companies tell them. The fact is that the prescribing doctors know little more about a drug’s risks and serious side effects than that, and the information they do have is solely from the drug company’s written warnings. So, if the warnings are inadequate, in all likelihood so is the doctor’s knowledge of the drug’s risks and serious side effects. That effectively makes both the doctors as well as their patients the victims when their patients experience serious side effects that the drug company did not adequately warn about. To add insult to injury, when a lawsuit is filed the drug companies deny any responsibility of wrongdoing and blame both the injured patient and the prescribing doctor for the patient’s injuries and damages. Here is an example of the language drug companies regularly include in their defensive pleadings:

When the drug company takes the prescribing doctor’s deposition, hoping to prove that the doctor would not have done anything differently no matter what was in its warnings and no matter what the prescribing doctor knew, it is important to clearly point out and emphasize to the prescribing doctor that his patient did not sue or make any allegations against him in the case against the drug company. The prescribing doctor must be shown any allegations against him or her, stating the prescribing doctor is responsible and at fault for his or her patient’s injuries and damages, in the drug company’s pleadings filed in the lawsuit.

The drug companies further contend:

1. Even if armed with this knowledge, it wouldn’t matter because the prescribing doctor already knew everything that a supposedly “adequate” warning would have contained

2. That the prescribing doctor didn’t read the warnings and, therefore, a different warning wouldn’t have changed the doctor’s decision to prescribe that drug for the patient

3. That even if at the time the prescribing doctor prescribed this dangerous drug to the patient he knew everything that he has since learned about this drug, he still would have prescribed the drug.

To justify this position, the drug companies use the statistics of how many patients might experience a drug’s serious side effects. Drug companies take the callous position that all drugs have side effects, and a side effect is acceptable if one in 10,000 patients experience a serious side effect from their drug because 9,999 people didn’t.

Putting the blame on another in a lawsuit is called alleging an “affirmative defense.” The affirmative defense states that if the drug company did something wrong (which it denies it did), someone else actually caused the patient’s injuries and damages. The drug company’s affirmative defense alleges that its warnings were accurate and complete, and the prescribing doctor caused the patient’s injuries because the drug company passed on to the prescribing doctor all of the information it had about the drug’s risks and serious side effects, and it was the prescribing doctor’s responsibility to then pass that information on to the patient. That works fine if the drug company did make accurate and complete disclosure of all the drug’s risks and serious side effects in its warnings. In that event, the prescribing doctor would have been fully aware of the same and could have passed those warnings on to the patient. Most often, however, that is not the case: the prescribing doctor knows only what he or she reads in the drug company’s warnings.

The fact of the matter is that a prescribing doctor’s learning about a drug’s risks and serious side effects does change his or her prescribing practices accordingly. It does affect which patients he prescribes the drug for, what doses he prescribes, what directions he gives for taking the drug and the risk/benefit discussion he has with the patient before prescribing the drug. It does change the patient’s decision whether or not to take the drug when the patient is aware of and weighs all known risks against the touted benefits of the drug.

The problem is manifold:

1. The Food and Drug Administration (FDA) approves prescription drugs solely on the information it is provided by the drug company. The FDA does no testing; it is understaffed and underfunded. The FDA relies on the drug companies to test drugs for safety or effectiveness. If the drug company does not adequately test for safety or effectiveness and does not disclose all study results to the FDA, and the FDA approves the drug, it has done so on inaccurate and incomplete information.

2. The drug company warnings only include that which the FDA makes it include based on what the drug company tells it about the drug’s safety and effectiveness. If the drug company does not disclose all known risks and side effects to the FDA, the warnings will be inaccurate and incomplete.

3. The drug company’s incentive is not to make accurate and complete disclosure of all known risks and serious side effects to the FDA and in its drug’s label. The reason: doctors will be hesitant to prescribe it and patients will be hesitant to take it, and that reduction in prescriptions written equates to a drop in the drug company’s revenue.

The solution is having the ability to hold the drug companies responsible and accountable for their failing to fulfill their duty to protect patients from known risks and serious injuries.

Fosamax: Cure or Cause?

Tuesday, September 6th, 2011

By Robert Schwartz

Merck’s Fosamax is an oral bisphosphonate and is prescribed to prevent or treat osteoporosis in postmenopausal women. There have already been prior problems prompting the Food and Drug Administration (FDA) to require Merck to make stronger warnings related to the fact that Fosamax can cause death and decay of the jaw bones. The current problem requiring FDA intervention, however, relates to the drug’s causing atypical subtrochanteric femur fractures — fractures in the bone just below the hip joint.

These atypical femur fractures can occur anywhere in the femur, from just below the hip to above the knee. The fractures can be completely through the femur bone or just hairline fractures, and may occur in both legs at the same time. Many patients report pain in the affected area, usually presenting as dull, aching thigh pain weeks or months before a complete fracture occurs. While atypical fractures are very uncommon, their incidence is increased with long-term exposure to Merck’s bisphosphonate Fosamax.

The truly disturbing thing about this very dangerous drug is that it was FDA approved, advertised and marketed to prevent bone weakening and breakage by slowing or inhibiting the loss of bone mass. Known as osteoporosis, this bone weakening disease causes very weak bones that break easily. Women are five times more likely to get osteoporosis than men. Physicians know that osteoporosis is a natural part of the aging process and that there is no way to stop or cure osteoporosis. But patients can slow down this process by taking enough calcium and vitamin D, exercising, not smoking and limiting alcohol intake to no more than one glass per day.

Merck, however, convinced the FDA that it had developed a drug that prevented this natural part of the aging process. Slow the natural loss of bone mass? Amazing discovery if true! But it turned out to be too good to be true. Merck’s Fosamax actually makes the femur bone more brittle and, thus, more susceptible to hairline fractures and breaks than the natural aging process itself.

The question regarding serious injuries from dangerous drugs like Fosamax is always the same: What did Merck know about the risk of these serious femur fracture injuries from Fosamax and how long has Merck known it? The answer to this question comes only through litigation. If you have suffered an injury due to Merck’s Fosamax, contact Bailey & Galyen to 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.