US Supreme Court Rules on Immunity of Generic Drugs from Legal Liability: Where do Injured Patients Stand?

In 2004, Karen, who complained of a sore shoulder was prescribed with Sulindac, a generic anti-inflammatory drug that is manufactured by Mutual Pharmaceutical. After three weeks of medication, she started experiencing extreme pain and her skin began to peel off, exposing her raw flesh, making it look like she had a third degree burn.

The new disease that Karen developed is called toxic epidermal necrolysis, a drug’s side effect about which many drug companies fail to warn patients. Karen’s only choice was to sue Mutual Pharmaceutical (in New Hampshire state court ) for her new severe illness and for the drug firm’s failure to warn about its drug’s possible side effect. After winning the case, the US Food and Drug Administration (FDA) also took action, requiring Mutual Pharmaceutical and Merck & Co., manufacturer of the drug’s branded version, to mention (the drug’s) side effects in the warning labels.

The FDA is the government agency responsible for approving which prescription drugs (and many other kinds of products, including medical and radiological devices, food and cosmetics, biologics, veterinary drugs, and tobacco products) can be brought to the market and used as treatment for certain kinds of illnesses. Of the FDA’s six centers, it is the Center for Drug Evaluation and Research (CDER) which is directly charged in making sure that all drugs marketed in the US are safe and effective. While CDER’s Office of Testing and Research does study a drug’s quality, safety, and effectiveness before approving it, this study is only partial as the exhaustive test on the drug, including clinical trials (experiments wherein human subjects are used to determine a drug’s effectivity and the side effects it may cause), is the responsibility of the drug’s manufacturer. Clinical trials data are necessitated by the FDA as these will show whether the drug needing approval meets, or does not meet, the level of safety and effectiveness required by the FDA.

Now, considering all the studies and tests a drug is subjected to prior to actual formulation and approval, it would be very interesting to know exactly why some drugs are found and proven to be causing adverse effects, while some are even linked to patients’ death.

While some medical experts agree on the fact that a patient’s overall health condition, use of other medication, immune system and family history can directly affect a particular drug’s performance (thus while some specific drugs may work effectively in some patients, these very same medicines may cause adverse effects in others), others point out a loophole in the testing and approval process. Specifically, since clinical trials and other tests are performed and funded by the drugs’ manufacturers themselves, they have total control, therefore, of all data and test results. Due to this control some choose to commit the fraud of forwarding to the FDA only the positive results derived from the tests, while keeping or destroying the negative ones.

The two reasons stated cannot be discounted and they offer a clear proof why some drugs, including Sulindac, the generic anti-inflammatory drug mentioned above, are considered threats rather than remedy to some patients. In its website, the National Injury Law Center mentions a flaw in the FDA’s approval process and this agency’s failure to sometimes detect certain types of problems. The consequence of this flaw, however, will be seen in patients, whose health conditions may be dramatically harmed by the drug.

Another source of real worry for harmed patients is the latest US Supreme Court ruling, which exempts all manufacturers of generic drugs (which make up about 80% of all drugs consumed in the US) from any liability due to mislabeling or side effect/negative reaction that their drug/s may cause in patients.

This ruling is based on the premise that generic drugs are simply copies of their brand name counterparts, thus, they contain exactly the same formula and present the same risks. If anyone should bear liability for mislabeling or adverse effects caused by a drug, it should be, according to the Supreme Court, those who originally formulated and manufactured the brand named drugs.

Patients harmed by any type of medication should never be denied of the compensation that they have a legal right to seek due to the pains and sufferings and all other damages that they have been unjustly made to suffer. The said Supreme Court ruling, however, just made the already complex law that cover pharmaceutical products much harder to understand and deal with.

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Breast Augmentation: Is this Procedure Right for You?

According to the American Society of Plastic Surgeons, the total count of breast augmentation procedures performed in the US in 2014 was 286,254. Breast augmentation, clinically called augmentation mammoplasty, which has been the number one cosmetic surgical procedure in the US since 2005, is the surgical placement of implants in a woman’s breasts. It is intended to improve/restore symmetry or increase fullness of the breasts, enlarge naturally small breasts, or restore breast volume which is greatly affected by pregnancy, weight reduction, breast cancer surgery or mastectomy. Besides these reconstructive or medical reasons, there are also personal ones which make some women decide to undergo the procedure, like the desire to look younger, boost their self-esteem, boost their sex life and, according to some, to make their clothes fit better.

Augmenting the breasts may be done through the use of implants that are placed under the breast tissue or chest muscles. Implants, which last about 10 years, has an outer layer that is made of firm silicone, while its inside may be filled with silicone gel, saline solution or salt water, or a composite of alternative substances.

On its website, Bergman and Folkers Plastic Surgery mentions how highly individualized a procedure breast augmentation is; however, though it can be performed for corrective purposes, it cannot correct pendulous or sagging breasts. To restore the youthful firmness and shape of breasts, breast mastopexy or a breast lift will first be required; only after this breast lift may breast augmentation be performed.

Despite some of the risks associated with breast augmentation procedures (the fact is, any surgical procedure poses some kind of risk), this type of cosmetic surgery is safe, thus, the more than quarter of a million women undergoing it every year.

However, before finally deciding whether one should undergo breast augmentation and which implant to choose, it is necessary to discuss things first with your trained and certified cosmetic surgeon, especially if one wants it simply because she wants to look better and she has seen how the procedure has really had great results in others.

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The Effects of a DUI Offense to Service Members

Driving under the influence of alcohol or any type of impairing drug (whether prescription or illegal) is a crime in all 50 states as well as in the District of Columbia. Regardless of how it is referred to, DUI, for driving under the influence, DWI, for driving while intoxicated, or some other name, it is a serious offense that is met with costly fines and harsh punishments. According to the National Highway Traffic Safety Administration (NHTSA), alcohol impairment is the cause of about 40% of all traffic deaths in the US.

While the effects of a DUI charge to a civilian can be devastating, to uniformed service members it can be doubly overwhelming since facing a civilian or a military DUI, or both, can impact their personal lives and military career. This is because even if a DUI incident and arrest have taken place off a military base and will be heard in a civilian court, the charge can be filed by both civilian and military authorities. Worse, even if the civilian court acquits a service member, he or she can still be subjected to punitive actions (based on the same incident and arrest) from the military, since the military normally has jurisdiction over any crimes committed anywhere by active duty service members.

Getting arrested for a DUI on base, however, can possibly result to the following, even worse, consequences:

  • First, though saved from facing a civilian criminal charge, the state is authorized, if it wishes to do so, to suspend one’s driving privileges or require the installation of an interlock device in his or her vehicle;
  • Second, be charged with drunken or reckless driving, which is stipulated under Section 911: Art. 111 of the Uniform Code of Military Justice (UCMJ), and be subjected to a court martial and administrative actions. A court martial can result to imprisonment, grade reduction, forfeiture of pay, or dismissal from service; an administrative action, on the other hand, can result to revocation of driving privileges, cancellation of pass, letter of reprimand, mandatory treatment for substance abuse, reduction in grade (depends on rank), corrective training (like a mandatory refresher course on military laws), or getting barred from being reenlisted. Repeated alcohol-related misconduct within a year can result to separation from service; or,
  • Third, be offered a non-judicial punishment (NJP), which is authorized by Article 15 of the UCMJ. Non-judicial punishment (or “Article 15” in the US Armed Forces and US Air Force; “Captain’s Mast” in the US Navy and the US Coast Guard; and, “Office Hours” in the Marine Corps) is a form of military justice which allows commanders to discipline the members of his troops.

According to Flaherty Defense Firm, uniformed service member can either accept non-judicial punishment or refuse it and choose a court-martial trial instead (in like manner, one loses his or her right to a court-martial trial if he or she opts for the NJP). Regardless of how service members choose to defend themselves, though, be it in a civilian court, a military court or before a commander, after choosing NJP, it will always be better if, during the preparation of their personal testimony and evidences, they are represented or assisted by a lawyer, who has extensive experience in litigating military cases.

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