FDA generic drugs

SCOTUS Decision on Medication Safety: No Product Liability

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Over two years ago, amidst the DOMA and Voting Rights cases, the Supreme Court of the United States (SCOTUS) quietly ruled in favor of pharmaceutical companies indicating that generic drug makers have no legal obligation to update labeling and warn patients of nasty side-effects should those reactions occur post FDA approval. The case, Mutual Pharmaceutical Co. v Bartlett is a decision that will affect medication safety, healthcare responsibility and states rights for years to come, but few in the media bothered to cover the ruling.

Background of the Case: Mutual Pharmaceutical Co. v Bartlett

In 2004 Karen Bartlett was prescribed a topical NSAID pain-reliever called Sulindac for her shoulder pain. Sulindac is generic version of Merck’s Clinoril that is manufactured by Mutual Pharmaceutical. Shortly thereafter she developed toxic epidermal necrolysis (TEN) – a severe, life threatening and debilitating adverse reaction to the drug. Sulindac caused her skin to peel away from her body, a gruesome, flesh-eating reaction that spread over most of her body.

According to documents discovered later, the drug makers, Merck originally and Mutual for the generic version, knew about the potential for TEN but failed to label it. (Merck has since changed their labeling). Ms. Bartlett sued Mutual under New Hampshire’s design-defect law and was awarded $21 million. Mutual appealed under the auspices that they were not responsible for labeling because that rested with the federal government and the FDA. Since the FDA had not, in its original approval of the drug included the warning, the generic company could not change the labeling without violating federal law. Moreover, even though not labeling the drug violated New Hampshire state law, under which the case was originally brought, state law was in conflict with federal law.

Ms. Bartlett’s case before SCOTUS rested on the fact that Mutual knew about the ‘defect’ and failed to warn consumers. In state court she won. But in the appeal, Mutual contended that even though they knew about the dangers of the drug, as a maker of generic drugs, which are essentially copies of the name-brand drugs, they were not only not responsible for the labeling, Merck and FDA were, Mutual could not change the labeling under federal law. The state’s remedy, and upon which much of the SCOTUS case rested, was to not permit the sale of the ‘defective’ product – the drug – in New Hampshire. In other words, to abide by state law, Mutual should not have sold and not be allowed to sell the product in New Hampshire. SCOTUS again disagreed, effectively forcing the sale of ‘defective’ products’ in states.

There was no question that the drug was responsible for Ms. Bartlett’s injuries, but the since the case rested on the eminence of federal versus state law and the work-around proposed by the state, there was ample precedence for SCOTUS to overturn the lower court’s ruling and they did so, 5-4, mostly along party lines.

SCOTUS documents:

We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. Because Mutual was unable to change sulindac’s composition as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs’ labels.

In an opinion written by Justice Alito:

Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are “without effect.” Maryland v. Louisiana, 451 U. S. 725, 746 (1981) .

The Court of Appeals’ solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution. Rather, adopting the Court of Appeals’ stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court’s pre-emption case law.

Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre-empted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below.

Why This Matters

SCOTUS ruled that manufacturers of generic drugs have no safety or labeling obligations beyond what was expressly given by the brand name company and the FDA approval. If the FDA approved a particular label and adverse events appear later, even when associated with the generic drug, the manufacturer of the generic drug is not liable. The makers of the brand name drug are still liable, but only for their brand name drugs. When an individual is given the generic version rather than the brand name version, even if those two compounds are exactly the same, the individual cannot sue the generic manufacturer per this new ruling, nor can he/she sue the brand name manufacturer, because the adverse event occurred with the generic and the brand name company is not responsible for the generic.

Since the majority of all prescriptions are for generic medications, this ruling effectively absolves drug manufacturers of responsibility for adverse events, once FDA approved.  What’s more, where states could have stepped in and prevented the sale of defective products within their boundaries, this ruling preempts that protection as well. If the federal agencies say it is safe, the states can do nothing. For a conservative court, this is a pretty big usurping of states rights.

Can we sue the FDA for failing to protect consumers?

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Hurt by a Generic Drug? Victims have no Recourse unless the FDA Changes Rules

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On Friday March 27, 2015 I testified before the U.S. Food and Drug Administration (FDA) asking them to change a rule that currently prohibits manufacturers of generic drugs from updating the warning labels for the drugs that they make.

Why, you may wonder, should anyone care whether or not generic drug manufacturers are able to update their warning labels?

EVERYONE should care about this issue because as long as generic drug manufacturers are unable to update drug warning labels, NO ONE who is hurt by a generic drug has any recourse against generic drug manufacturers, no matter how badly one is hurt by a generic drug. In 2013 the U.S. Supreme Court decided that, because generic drug manufacturers are required to copy the brand-name drug warning label, they cannot be held responsible for any harm done by the generic drug. People hurt by generic drugs didn’t take a name-brand drug, so they cannot sue the name-brand drug manufacturers.  This leaves people hurt by generic drugs unable to hold anyone responsible for the damage done by generic drugs, and people are left without any legal recourse.

IF YOU ARE HURT BY A GENERIC DRUG, YOU CANNOT SUE.  YOU HAVE NO RECOURSE WHATSOEVER.

This is appalling. More than 80% of the prescription drugs dispensed in America are generic. Everyone who takes a generic drug is unable to gain any sort of legal compensation, any sort of justice, when injuries are caused by those drugs. Think about that next time you take a generic drug.

Or, better yet, think about the following people, who also testified to the FDA about the harm caused by generic drugs, who are unable to gain any sort of justice or compensation for their losses.  Their stories could be your story, or your child’s story, or your parent’s story.

Fluoxetine (Prozac) and Cardiac Malformations

Emily, a 29 year old who was taking fluoxetine, generic Prozac, throughout her pregnancy, gave birth to a baby boy who had a serious heart defect.  Her son died when he was 2 weeks old.  In 2011, Eli Lilly, the manufacturer of Prozac, admitted that, “there is some evidence of a possible small increase in the risk of cardiac malformations (eg ventricular and septal defects) associated with use of fluoxetine” (source). If Emily had taken Prozac, she would have been able to sue Eli Lilly, and possibly gain some sort of compensation for her losses. However, Emily took generic fluoxetine, so she has no recourse, no possibility of compensation, and no justice.

Metoclopramide (Reglan) and Tardive Dyskinesia

Anthony testified about his partner of 40 years who is suffering from severe tardive dyskinesia after taking metoclopramide, generic Reglan, for 11 years. Anthony’s partner can no longer speak or function independently. He is 100% dependent on Anthony for his care. “Tardive dyskinesia typically affects someone’s face, often causing uncontrolled grimaces and movement in the eyes, lips, tongue and jaw. Arms, fingers, toes, legs, hips and torso are also affected and may twitch and move rapidly and uncontrollably. These random body movements can be uncomfortable and painful as well as embarrassing and difficult to control, making it a social handicap. Severe cases of this disorder can be debilitating and make it difficult to perform simple tasks like talking, walking and eating.” (source)  Because generic metoclopramide is what caused harm, neither Anthony nor his partner have any possibility of legal recourse.

Birth Control and Blood Clots

Taylor suffered from life-threatening blood clots at the age of 14 after taking generic birth-control pills. She is now 17 and suffers from permanent health complications because of the blood clots.

Levofloxacin (Levaquin), Tendon Ruptures, Neuropathy and More

Rachel spoke about how levofloxacin, generic Levaquin, caused her to have multiple tendon ruptures, and contributed to her developing a neurodegenerative condition called neurosarcoidosis. In addition to losing her health, Rachel “can no longer afford my home because of increasingly skyrocketing medical expenses and surgeries and I was forced to move. I lost my career that I loved with immeasurable passion and lost good income.”  She has no legal recourse because she took generic levofloxacin.

I testified about how Heather was hurt by ciprofloxacin, generic Cipro, and moxifloxacin, generic Avelox. After taking ciprofloxacin and moxifloxacin, Heather suffered from severe nerve pain, central nervous system issues such as panic attacks and brain fog. She had blood sugar regulation problems, irregular heartbeats and more. She lost her career as a massage therapist and had to declare bankruptcy. Her life was devastated because of her severe adverse reaction to these drugs. She is unable to sue the manufacturers of the drugs that hurt her though, because she took the generic versions of the drugs.

I also testified about how Sarah reported this about the effects of ciprofloxacin on her life, “Still suffering and disabled; can’t work, lost profession, lost financial security, lost marriage, lost hope for any reasonable quality of life. Denied by medical profession due to no known diagnostic biomarkers; denied legal recourse due to generic; denied SSDI due to the first two and denial by the FDA and everyone involved, and ultimately, will be denied as the most probable cause of my death.”

Clinoril (Sulindac) and Stevens-Johnson Syndrome

There are many more cases of death and injury caused by generic drugs. Clinoril, generic Sulindac, can cause horrific injuries, such as those suffered by Karen Bartlett, “who lost nearly two-thirds of her skin, was placed in a medically induced coma and is legally blind after suffering a reaction to the medication she took for a sore shoulder” (source). Over-the-counter pain relief pills and antibiotics can cause Stevens-Johnson Syndrome, a severe and life-threatening skin condition in which cell death causes the epidermis to separate from the dermis.

Acetaminphen, Ergotamine, Montelukast and More

Acetaminophen can cause liver injuries that can lead to death. Ergotamine, a drug used to treat migraine headaches, when administered improperly, can cause gangrene and loss of limbs. Montelukast, generic Singulair, can cause Churg–Strauss syndrome, rare form of eosinophilic vasculitis associated with asthma.  There are hundreds of other examples of damage that can be caused by drugs.

Adverse Reactions and Generic Drugs – The FDA’s Role

Generic drugs are just as dangerous as name-brand drugs. Those who are hurt by drugs deserve recourse and compensation for their losses. To arbitrarily take away a person’s opportunity for justice, simply because he or she took a generic drug, is ridiculous and wrong. Currently, there is no justice for people who suffer from adverse effects of generic drugs. DO NOT take a generic drug until this situation changes.

The FDA can nullify the Supreme Court’s ruling, and enable those who are hurt by generic drugs to gain justice, simply by changing their rules so that generic drug manufacturers can update their warning labels just like name-brand drug manufacturers can.  I hope they do so.  I encouraged them to do so in my testimony.

The generic drug manufacturers are arguing that it would be onerous and costly for them to update the warning labels. Seeing as even generic drug manufacturers have billions in profits, that argument seems a bit shallow and disingenuous. The pharmaceutical industry as a whole has proposed to stop the discrepancy in justice between generic and name-brand drug manufacturers by making name-brand drug manufacturers equally inculpable for damage done by their drugs as generic drug manufacturers currently are.  If the FDA “fixes” this situation by making all drug manufacturers unable to update their warning labels and therefore exempt from lawsuits, no victim of a pharmaceutical will have any legal recourse against the companies that hurt them, and a vital check on the power of the pharmaceutical industry will be lost.

I hope that the FDA does the right thing, and closes this loophole that is keeping millions of victims of pharmaceuticals from getting justice.

The FDA testimony can be viewed through these links:

Information about Fluoroquinolone Toxicity

Information about the author, and adverse reactions to fluoroquinolone antibiotics (Cipro/ciprofloxacin, Levaquin/levofloxacin, Avelox/moxifloxacin and Floxin/ofloxacin) can be found on Lisa Bloomquist’s site, www.floxiehope.com.

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