Janice L. Weiner
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 51, Room 6304
Silver Spring, MD 20993-0002

 

Dear Ms. Weiner,

We are grateful for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985).

Currently, a generic drug’s design and warning label must identically match that of the name-brand version of the drug. In turn, generic manufacturers are prohibited from making any material changes to the drug’s design or warning label. As a result, generic manufacturers cannot be sued for providing consumers with unsafe medications.

It is outrageous that a generic drug manufacturer can know that a warning label is inadequate, sell the drug anyway, and escape all liability. We believe that the proposed rule, which holds both generic and brand-name manufacturers responsible for informing the public about known risks of their medications, will promote health, safety, and equality.

 The Fourteenth Amendment Supports the Proposed Rule

The Equal Protection Clause of the Fourteenth Amendment to the United States Constitution prohibits states from discriminating between the “poor” and the “rich.” A state can no more discriminate on account of financial status than on account of religion, race, or color. See Griffin v. Illinois, 351 U.S. 12, 17, 76 S. Ct. 585, 590, 100 L. Ed. 891 (1956). See also  U.S.C.A.Const. Amend. 14; S.H.A.Ill.Const. art. 2, § 19.

“Courts have confronted, in diverse settings, the ‘age-old problem’ of [p]roviding equal justice for poor and rich, weak and powerful alike.” M.L.B. v. S.L.J., 519 U.S. 102, 110, 117 S. Ct. 555, 560, 136 L. Ed. 2d 473 (1996) quoting Griffin v. Illinois, 351 U.S. 12, 16, 76 S.Ct. 585, 589, 100 L.Ed. 891 (1956). We think the pharmaceutical industry is the newest “diverse setting” where this “age-old problem” must be resolved; and we are grateful that the proposed rule seeks to do just that.

The current law, which holds manufacturers of generic drugs to a lesser legal standard than their brand-name counterparts, essentially discriminates between the poor and the rich. After all, the only difference between brand-name drugs and their generic equivalents is price. Generic brands are often significantly less expensive than their brand-name counterparts.

In fact, generic drugs were originally made in an effort to ensure that effective and safe drugs were widely and inexpensively available to citizens who could not otherwise afford medications. Thus, people who are less financially well-off are the ones who were, and are, specifically intended to purchase generic drugs. In other words, poor people buy generic brands.

If someone takes a brand-name medication and develops a disease as a result of taking the brand-name medication, she can sue the company that manufactured the drug. Those who can afford the brand-name drug in the first place are the ones—and only ones—who are allowed to be compensated for injuries sustained from ingesting an unsafe drug.

On the other hand, if a financially less-fortunate individual goes to the pharmacy and inevitably opts for the cheaper generic version of the drug, and develops the same disease or adverse side effect, she cannot sue the generic manufacturer. Instead, she is left to incur medical expenses for the harm she suffers as a result of consuming the unsafe drug, even though she is just as innocent as the financially well-off consumer.

It is heartbreaking that the very people who cannot afford brand-name drugs in the first place are singled out and deprived of the right to be justly compensated. The result is that “rich” people are protected under the current federal law, while “poor” people are not. The proposed rule, by contrast, which protects consumers of brand-name drugs as well as consumers of generic equivalents, works to conform to the Equal Protection Clause of the Fourteenth Amendment.

 The Proposed Rule Will Save Courts Time and Resources

 We had mixed feelings with regard to a recent order issued by a Federal District Judge in Illinois in the case of Dolin v. Smithkline Beecham Corporation d/b/a Glaxosmithkline, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs. The ruling was as good as anyone could hope for under the current law.

The plaintiff in the case is a woman whose husband committed suicide after taking a medication called, paroxetine, which is manufactured by Mylan, Inc. Paroxetine is the generic version of the brand-name drug, Paxil, which is owned and manufactured by GlaxoSmithKline (“GSK”). The plaintiff brought a wrongful death action against both GSK and Mylan.

The Judge had no choice but to find that Mylan could not be held liable, because federal law preempts claims against manufacturers of generic versions of brand-name drugs. However, creatively, the Judge found that the brand-name manufacturer could be held liable even though it was not the company that actually manufactured the pill that resulted in the plaintiff’s husband’s fatality.

We are pleased because at least the Judge found that the plaintiff could be compensated by one of the negligent companies. However, we believe that the Judge had to go around his hand just to get to his thumb. The Judge issued an intricate 26 page opinion, exploring vague precedent to “get around” the law that states generic manufacturers cannot be sued. It seems a great deal of the court’s time and resources were wasted as a result.

We believe that the proposed rule, which holds both generic and brand-name manufacturers responsible for informing the public about known risks of their medications, will save the courts time and resources because judges will have a clear, set standard.

Conclusion

Thank you again for the opportunity to submit comments in support of the Food and Drug Administration’s (FDA) proposed rule entitled, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products (78 Fed. Reg. 67985). As explained above, in addition to saving the courts valuable time and resources, we believe the new rule will promote health, safety, and equality in our society.

 

Generic brands. Knock-offs. It’s probably safe to assume that all of us have used one at some point or another. Many of us use them on a regular basis. Why? Because, usually, a generic brand product is pretty much the same thing as its brand-name equivalent. The main (and sometimes, only) difference is price. Generic brands are often significantly less expensive than their brand-name counterparts. This holds true in many aspects of life—clothes, shoes, accessories, groceries, and medications.

But in addition to cost, when it comes to medications specifically, there is one other significant difference between generic brands and brand-name companies: Legally, manufacturers of generic brand drugs are held to a lesser standard.  For example, if you develop a disease as a result of taking a brand-name medication, you can sue the company that manufactured the drug; but on the other hand, if you go to the pharmacy and opt for the cheaper generic version of the drug, and develop the same disease or adverse side effect, you cannot sue the generic manufacturer.

The above logic seems counterintuitive. Yet, in a 5-4 decision last year, the Supreme Court ruled that generic drug companies cannot be held liable for medication design defects. The rationale goes something like this: Federal law requires generic companies to have a warning label that is identical to that of the brand-name drug.  Therefore, if a warning label on a generic drug contains false information, the generic drug company claims it isn’t responsible because it is copying the brand-name label.  The Supreme Court bought that argument, although the dissenting opinion describes the result as “absurd.”  And it is absurd that a generic drug manufacturer can know that the warning label is inadequate, sell the drug, and escape all liability.

Generic versions of drugs are beneficial to society in that they give patients the option to buy medications at a low cost, when they would otherwise simply go without filling their prescriptions at all. However, until manufacturers of generic brand drugs are held to the same legal standard as their brand-name competitors, patients are not truly protected. After all, if one is harmed by a generic drug, the cost savings of a generic drug disappears if consumers or taxpayers have to foot the bill for treatments of undisclosed-but-known side effects.

Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:

Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does not mean, and should not be taken to mean, that a drug is absolutely safe even for approved uses,” said Mura, who wrote an amicus brief for AAJ in Bartlett. “Congress didn’t intend the FDA to provide the sole level of consumer protection, and a broad preemption ruling here would ignore that clear congressional intent.”

Source:

Supreme Court grapples with generic drugs and design defects

More on generic liability:

 

During a one-hour oral argument justices questioned whether federal law, in this case the requirement that generics have same design as the name-brand version, prevents plaintiffs from making such claims under state law.

 

Some justices signaled concern about juries making sweeping judgments about the effectiveness of drugs while others questioned how to differentiate the case from another case involving generics decided in 2011.

‘U.S. high court weighs generic drugmaker liability | Reuters

Could go either way.  Probably won’t have any effect on whether or not injured consumers can sue if they took generics.

Hamburg said FDA has collected $125 million in GDUFA fees for 2013 so far. However, she noted, the budget situation and sequestration have “significant implications” for using generic user fees and budget dollars. Budget cuts under the Budget Control Act of 2011–known as sequestration–are scheduled to be implemented at the beginning of March, while legislation funding the federal government expires at the end of March. In September 2012, a report from the White House Office of Management and Budget classified all budgetary resources available to FDA, including user fees, as subject to sequestration (10 PLIR 1332, 10/12/12).

Source: FDA’s Drug Center Creating New Office Of Pharmaceutical Quality, Hamburg Says | Bloomberg BNA

Scalia fans everywhere will cringe at the thought of using an amicus brief filed by Waxman on this issue, but setting that prejudice aside, this is kind of a big deal:

Here’s even more powerful evidence of Congress’s intent: a newly filed amicus brief filed by Senator Tom Harkin (D-Iowa) and Representative Henry Waxman (D-California, and, yes, the Waxman of Hatch-Waxman) in support of Bartlett. Harkin and Waxman, who are represented by Allison Zieve of the Public Citizen Litigation Group, say lawmakers’ intentions couldn’t be clearer. If Congress wanted federal regulation to preclude personal injury suits, it would have said so. It’s no accident that Congress did not, according to the brief.

“The notion that FDA regulation broadly pre-empts design-defect claims against prescription drug manufacturers finds no support in the text or purpose of the FDCA, runs counter to the … provision addressing product liability law and ignores more than 75 years of history in which damages suits and federal drug approval have co-existed,” the brief said. “Congress is well aware of its authority to pre-empt state damages actions, and with respect to prescription drugs, as with (over-the-counter) drugs, it has not done so. Moreover, in recent years, following litigation addressing whether federal regulation pre-empts state-law claims regarding injuries caused by drugs, both chambers of Congress have considered pre-emption of state-law claims concerning drugs. Yet Congress has taken no action to change the historical framework through which state law controls whether injured patients have a tort remedy.”

Source: Victim in SCOTUS generics case has powerful amici: Harkin and Waxman

Longtime readers of this (or any drug-related blog) know that the U.S. Supreme Court ruled that manufacturers of generic drugs cannot be sued for failure-to-warn claims.  The ruling created a legal injustice for those injured by generic drugs.

While every plaintiff’s lawyer has secretly hoped that Congress would fix the law, we’re all savvy enough to know that this polarized and partisan Congress would never do so.  And honestly, I’m not even sure if Obama would sign it – screeds from the right notwithstanding, Obama has not been a friend of lawyers or the injured.

But there is hope!  Pharmalot noted that the U.S. Department of Justice filed a court brief that indicates that the FDA is considering changing the very rule that the Supreme Court based its ruling on.  If the FDA does change the rule, generic drug manufacturers will once again be held accountable for the same conduct brand-name manufacturers are held accountable for:

“This is what the footnotes states: “This office has been informed that FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances. If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers“ (see page 15 of this brief).

To short, if the FDA were to make such a change in regulations, generic drugmakers could be sued in state courts if they become aware of evidence of serious side effects but do not take action to update the product labeling. We were alerted to this by Bob Pollock, a senior advisor at Lachman Consultants, and a former acting deputy director of the FDA Office of Generic Drugs.”

Source: FDA May Change Warning Regs For Generic Labels // Pharmalot

In a study published in a 2007 edition of the New England Journal of Medicine, Sura Alwan et al. evaluates the effect of maternal use of selective serotonin reuptake inhibitor medications (SSRIs) during pregnancy on the likelihood of bearing children with congenital malformations.  The study, titled “Use of Selective Serotonin Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects,” made several startling findings.

From data collected from the (U.S.) National Birth Defects Prevention Study, the Alwan team was able to evaluate the medication history of 9,266 mothers whose children were born with birth defects along with 4,092 control infants.[1]

And although it ought to be noted that the absolute risk of developing these ailments remains low, Alwan found that maternal use of SSRIs during pregnancy dramatically increases the risk for anencephaly (2.4 fold), craniosynostosis (2.5 fold), and omphalocele (2.8 fold).[2]

PubMed Health, a service of the U.S. National Library of Medicine, states that anencephaly is a birth defect characterized by the “absence of a large part of the brain and the skull,”[3] a condition that results from the underdevelopment of the neural tube before birth and is almost always fatal.[4]  Thankfully, maternal ingestion of a daily multivitamin can reduce the risk of anencephaly by 50%.[5]

Craniosynostosis is “a birth defect that causes one or more structures on a baby’s head to close earlier than normal.”[6]  PubMed Health explains, stating “The skull of an infant or young child is made up of bony plates that allow for growth of the skull.  The borders at which these plates intersect are called structures or structure lines.  The structures between these bony plates normally close by the time the child is 2 or 3 years old.  Early closing of a structure causes the baby to have an abnormally shaped head.”[7]

Here, we can see the bones of a growing child’s skull.

Paxil Lawyer Prozac Lawyer Zoloft Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Skull of a Newborn

Most often, surgery done while the child is young can relieve any undue pressure on the brain,[8] “make sure there is enough room in the skull to allow the brain to properly grow,”[9] and “improve the appearance of the child’s head.”[10]  If surgery goes well, complications such as “increased intracranial pressure, seizures, and developmental delay,”[11] may well be avoided.

Lastly, omphalocele is “a birth defect in which the infant’s intestine or other abdominal organs stick out of the belly button (navel).  In babies with an omphalocele, the intestines are covered only by a thin layer of tissue and can be easily seen.”[12]

Paxil Lawyer Prozac Lawyer Zoloft Lawyer Celexa Lawyer SSRI Birth Defect Lawsuit SSRI Attorney - Omphalocele - A.D.A.M 2012

Usually, surgery can correct omphalocele completely,[13] but complications may occur including “death of intestinal tissue,”[14] and “intestinal infection.”[15]

Though there is no surefire way to avoid these birth defects entirely, one way to help reduce the chance your child is born with one of these ailments is to avoid the use of SSRI medications during pregnancy such as Zoloft®, Paxil®, Prozac®, Celexa®, Lexapro® and others.

Due to the fact that none of these SSRI medications have included adequate warnings regarding increased risk for anencephaly, craniosynostosis, or omphalocele, expecting mothers have in large numbers been unknowingly exposing their unborn children to undue risk.  Because of this, the manufacturers of these medications may be liable for the injuries their products incur, and many SSRI birth defect lawsuits are currently being filed.

If you or a loved one used SSRIs during pregnancy and your child was born with anencephaly, craniosynostosis, or omphalocele, please do not hesitate to contact Justinian Lane for a free, no obligation case consultation at (855) 452-5529 or e-mail me personally at justinian@dangerousdrugs.us.  We are here to help.  We can secure the justice you and your family deserve.


[1] Alwan, S., et al. (2007) “Use of Selective Serotonin Reuptake Inhibitors in Pregnancy and the Risk of Birth Defects” The New England Journal of Medicine Vol. 356; pp. 2684-2692

[2] Ibid.

[3] “Anencephaly” PubMed Health.  U.S. National Library of Medicine. © 2012 A.D.A.M., Inc. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002547/> Accessed 29 January 2013

[4] Ibid.

[5] Ibid.

[6] “Craniosynostosis” PubMed Health. U.S. National Library of Medicine © 2012 A.D.A.M., Inc. Availavle at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002557/> Accessed 29 January 2013

[7] Ibid.

[8] Ibid.

[9] Ibid.

[10] Ibid.

[11] Ibid.

[12] “Omphalocele” PubMed Health. U.S. National Library of Medicine. © 2012 A.D.A.M. Available at <http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001989/> Accessed 29 January 2013

[13] Ibid.

[14] Ibid.

[15] Ibid.

I’ve been engrossed in a mesothelioma trial and have fallen behind in blogging. Frequent readers will snarkily note that this is not an uncommon occurrence. However, there has been a major development in generic pharmaceutical litigation. The Supreme Court has granted certiorari (that means accepted) in three Reglan lawsuits. If the Supreme Court rules in favor of the Reglan manufacturers, Reglan litigation will basically disappear. More importantly, so will most litigation regarding failure-to-warn claims against manufacturers of generic drugs.

In the Mensing case, the question the Court will answer is: “Whether the Eighth Circuit abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the labeling approved by the Food and Drug Administration for the listed (or branded) drug.” (The Mensing case is actually two of the three cases.)

The third case, Actavis v. Demahy, asks this question: “Whether the states are preempted under the Supremacy Clause of the Constitution from requiring additional safety information n a generic product label when the brand has not changed its label.”

My gut feeling is that the Supreme Court is going to kill litigation against generic drug manufacturers. Of course, I also thought it was going to go the other way in Wyeth v. Levine. So maybe I’m wrong.

I hope so, because otherwise the American taxpayers will become the insurers for generic drug manufacturers. (If you can’t sue the manufacturer, Uncle Sam through Medicare and Medicaid will likely foot the bill for any injuries.)

A common but unfounded criticism of product liability lawyers is that they keep needed drugs off the market.  Actually, it’s the drug companies who do so by engaging in pay-to-delay.  Here’s how that works: Big pharmaceutical companies pay generic manufacturers not to sell generic versions of brand-name drugs.  And unfortunately, this practice has now been blessed by the 2nd Circuit Court of Appeals:

The 2nd U.S. Circuit Court of Appeals has refused to reconsider en banc its holding that the antitrust laws are not violated when drug patent holders pay manufacturers of generic alternatives to keep competing products off the market.

The active members of the circuit issued a brief ruling Tuesday saying they had voted to deny rehearing en banc the case of Arkansas Carpenters Health and Welfare Fund v. Bayer AG, 05-2851-cv, in which a three-judge panel in April affirmed summary judgment for Bayer AG on a Sherman Act challenge concerning a so-called "pay-for-delay" agreement involving the antibiotic drug Cipro.

Source: Law.com – 2nd Circuit Declines En Banc Review of Drug ‘Pay-to-Delay’ Ruling