In 2012, an article was published in Urology titled “Association between pioglitazone and urothelial bladder cancer.” by Y. Barbalat et al. that aimed to “present the current literature reporting the association between pioglitazone and bladder cancer.”  To be clear, “pioglitazone” is the chemical name for the diabetes drug, Actos, manufactured by Takeda Pharmaceutical Co. and Eli Lilly & Co.

The team writes “The U.S. Food and Drug Administration (FDA) has recently informed the public that the use of pioglitazone may be associated with an increased risk of bladder cancer. 3 The European Medicines Agency (EMA) released a similar statement 4 and some European countries, such as France and Germany, have already removed pioglitazone from the market. Clearly, this association has many implications from an oncologic and clinical standpoint.”

One study the team cites was conducted by Suzuki et al., finding “pioglitazone produced calcium-containing urinary solids, which were associated with increased urothelial cytotoxicity, necrosis, and regenerative proliferation.”  Another study cited found “pioglitazone is a PPARγ ligand used in the treatment of DMII and was found to have carcinogenic activity toward the male rat bladder.”

Concerning human subjects trials, the paper notes first a study evaluating 5,238 patients receiving Actos that found “trend toward more bladder tumors” but failed to reach statistical significance.  Another study evaluating over 30 thousand Actos users of 193 thousand members of a particular health insurance plan found “Among men only, there was a significant increase in the relative hazard of bladder cancer with >24 months of exposure (HR 1.6; 95% CI 1.2-2.3) and with a >28,000 mg cumulative dose (HR 1.8; 95% CI 1.2-2.6).”  That means that in men who used Actos for longer than two years, the risk for bladder cancer was raised by 60%, and in men who took more than 28,000 mg of Actos over time, the risk for bladder cancer was raised by 80%, nearly double the risk for bladder cancer compared with non-users.

Overall, and thankfully, the team notes that “Ninety-five percent of cancers diagnosed among pioglitazone users were detected at an early stage” and comments that “the health benefits of pioglitazone may outweigh the risk of bladder cancer associated with this drug. Nevertheless, urologists should be aware of this possible risk, especially when managing diabetic patients with hematuria or other risk factors for bladder cancer.”

Due to the fact that a number of people have used Actos unaware of the connection the drug has with bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer as a result, you too may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Actos lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

A recent article published in the August, 2013 edition of Hepatology by CH Chang et al. titled “Association of thiazolidinediones with liver cancer and colorectal cancer in type 2 diabetes mellitus” studied the connection between certain diabetes drugs and cancer.  Thiazolidinediones are a class of diabetes drugs including Actos and others.

This team of researchers wrote “The objective of this nationwide case-control study was to evaluate the risk of specific malignancy in diabetic patients who received thiazolidinediones (TZDs)” and studied a total of 606,583 patients with type II diabetes without a history of cancer.

“A total of 10,741 liver cancer cases, 7,200 colorectal cancer cases, and 70,559 diabetic controls were included. A significantly lower risk of liver cancer incidence was found for any use of rosiglitazone (OR: 0.73, 95% CI: 0.65-0.81) or pioglitazone (OR: 0.83, 95% CI: 0.72-0.95), respectively.”  This means that Actos (pioglitazone) was associated with a lower risk for liver cancer, and so was Avandia (rosiglitazone).

However, the team found that “a potential increased risk for bladder cancer with pioglitazone use 3 years could not be excluded (OR: 1.56; 95% CI: 0.51-4.74),” meaning that Actos was associated with a 56% increased risk for bladder cancer.

Due to the fact that a number of people have used Actos unaware of the risk for bladder cancer, a number of Actos bladder cancer lawsuits have been filed.  If you or a loved one used Actos and suffered bladder cancer, contact our team of Actos bladder cancer lawyers for a free consultation at the information provided below.  You and your family may be entitled to significant financial compensation, and we have the experience, resources, and skills required to win the justice you deserve.

(855) 452 – 5529

justinian@dangerousdrugs.us

Recently, a federal court has ordered that the manufacturers of the diabetes drug Actos (pioglitazone hydrochloride, by Takeda Pharmaceutical Co. and Eli Lilly & Co.) pay $9 billion in damages when it was determined that these companies failed to warn the public of cancer risks associated with their medication.

Though some legal experts believe that this penalty will be lowered by appellate courts, this federal decision marks a turning point in a years-long struggle for compensation for damages caused by Actos.  (Reuters notes that “The $9 billion in punitive damages awarded by the jury against Takeda and Eli Lilly exceed the $5 billion penalty that a jury in Alaska imposed on Exxon Mobil Corp for the Exxon Valdez oil spill in 1989.”)

For years, law firms around the country have been signing up clients injured by Actos to secure compensation from a settlement such as this, and it seems that day has come a bit closer.

Unfortunately, Actos manufacturers continued producing the drug in light of a huge number of scientific studies connecting Actos to cancer and liver damage without warning patients, and as such, the number of patients injured by the drug has likely increased rather than decreased while the scientific community concluded the drug is unacceptably dangerous.

Here are a few studies I’ve summarized linking Actos and bladder cancer:

Large Study Shows Actos Raises Risk for Bladder Cancer 30%

Actos Shown to Increase Risk for Bladder Cancer

FDA: Actos Raises Risk for Bladder Cancer by 430%

Long-term Actos Use Doubles Risk for Bladder Cancer

 

If you or a loved one used Actos and suffered bladder cancer as a result, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Actos bladder cancer lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Published March, 2014 in BMC Medicine, a report by AF Macedo et al. titled “Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis.” aimed to “assess unintended effects of statins from observational studies in general populations with comparison of the findings where possible with those derived from randomized trials.”

Statins are class of medications prescribed to treat high cholesterol and have a reliable track record for reducing the risk of adverse cardiovascular events.  Unfortunately, the drugs (such as Lipitor, Zocor, Crestor, and others) have been linked to a 10-30% increased risk for new onset diabetes, another disease affecting millions around the world.

Evaluating 90 different studies of statin side effects, this team determined that “There was evidence of an increased risk of myopathy, raised liver enzymes and diabetes (respectively: OR 2.63 (95% CI 1.50 to 4.61); OR 1.54 (95% CI 1.47 to 1.62); OR 1.31 (95% CI 0.99 to 1.73)).”  In non-scientific terms, this means that statin use raised the risk for myopathy by 163%, raised liver enzymes 54%, and diabetes by 31%.

Sadly, the manufacturer of Lipitor and other statin drugs has failed time and again to warn users of the risks associated with their medication.  As a result, a number of Lipitor lawsuits have been filed.  If you or a loved one used Lipitor and suffered diabetes as a result, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.

In February, 2014, an article titled “Statin treatment and new-onset diabetes: A review of proposed mechanisms.” appearing in the medical journal Metabolism discusses the role of statin use in new onset diabetes.  Statin drugs are cholesterol-lowering medications including Lipitor, and are among the most widely-prescribed drugs in the world.

This research team, led by M. Brault states that “New-onset diabetes has been observed in clinical trials and meta-analyses involving statin therapy.”  In an attempt to elucidate the biochemical mechanism by which statin use contributes to diabetes onset, the team suggests that “First, certain statins affect insulin secretion through direct, indirect or combined effects on calcium channels in pancreatic β-cells. Second, reduced translocation of glucose transporter 4 in response to treatment results in hyperglycemia and hyperinsulinemia. Third, statin therapy decreases other important downstream products, such as coenzyme Q10, farnesyl pyrophosphate, geranylgeranyl pyrophosphate, and dolichol; their depletion leads to reduced intracellular signaling. Other possible mechanisms implicated in the effect of statins on new-onset diabetes are: statin interference with intracellular insulin signal transduction pathways via inhibition of necessary phosphorylation events and reduction of small GTPase action; inhibition of adipocyte differentiation leading to decreased peroxisome proliferator activated receptor gamma and CCAAT/enhancer-binding protein which are important pathways for glucose homeostasis; decreased leptin causing inhibition of β-cells proliferation and insulin secretion; and diminished adiponectin levels.”

Of course, Brault et al. (2014) are cautious to write-off statin use with the increased risk for diabetes posed considering the dramatic benefit these drugs have in relation to heart disease and cholesterol level adjustment and maintenance.  Sadly, however, a number of people have used Lipitor and other similar drugs unaware of the risk for diabetes due to a failure to warn on the part of the manufacturer.  Every patient deserves to know all possible risks and benefits associated with any drug ingested.

As a result of this failure to warn, a number of Lipitor diabetes lawsuits have been filed.  If you or a loved one used Lipitor and suffered diabetes as a result, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.

An article published in the March, 2014 edition of The American Journal of Cardiology titled “Effect of Change in Body Weight on Incident Diabetes Mellitus in Patients With Stable Coronary Artery Disease Treated With Atorvastatin (from the Treating to New Targets Study).” by KL Ong et al. aimed to further clarify the link between Lipitor use and new onset diabetes.

While Lipitor and other drugs in the statin class are highly effective in reducing the risk for adverse cardiac events, a great deal of research has come out linking Lipitor and diabetes, a risk of which patients should at the very least be aware.

This research team “investigated whether change in body weight may predict NODM in statin-treated patients” and “7,595 patients without prevalent diabetes mellitus at baseline from the Treating to New Targets (TNT) study were included in this analysis.”  After a great deal of statistical analysis, the team concluded that “1-year change in body weight is predictive of NODM in patients who underwent statin therapy from the TNT trial” and stated that “Our study highlights the importance of weight control as a lifestyle measure to prevent statin-related NODM.”

Due to the fact that a number of patients have used Lipitor unaware of the increased risk for diabetes as a result of the manufacturer’s failure to warn, a number of Lipitor lawsuits have been filed.

If you or a loved one used Lipitor and received a diabetes diagnosis, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor diabetes lawyers at the information provided below.  We have the experience, resources, and skills required to win the justice you deserve.  Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.

A recent article published by M. Ruscica et al in European Journal of Internal Medicine titled “Statin therapy and related risk of new-onset type 2 diabetes mellitus.” provides unique insight into the connection between the use of statin drugs and new onset diabetes.  For clarity, statin drugs are a class of cholesterol-lowering medications including Lipitor, Crestor, Zocor, and others.

This research team states “Although statin therapy is rather well tolerated, recent data from prospective and retrospective clinical trials and related meta-analyses suggest an increased incidence of new-onset type 2 diabetes mellitus (T2DM) in association with such treatment. The incidence of this adverse effect is not negligible, especially for specific subsets of patients, such as women, elderly, presence of familial history of T2DM and Asian ethnicity.”

Some studies currently estimate that the increased risk for diabetes posed by statin use is between 10%-30%.  While statin drugs are currently very important in lowering the risk for cardiovascular disease, it is important that users be aware of all risks associated with medications used.

Unfortunately, the manufacturers of Lipitor and other statins have failed time and again to adequately inform users of this risk, and as a result, a number of Lipitor lawsuits have been filed.  If you or a loved one used Lipitor and received a diabetes diagnosis, you may be entitled to significant financial compensation.  For a free, no-obligation case consultation, contact our team of Lipitor lawyers at the information provided below.  We have the compassion, resources, and experience required to win the justice you deserve.

Call today and see how we can help.

(855) 452 – 5529

justinian@dangerousdrugs.us

Our Lipitor Lawsuit Information page is a great place to start if you have any questions about Lipitor.

Johnson & Johnson (J&J) executives are currently under the microscope as to whether or not they engaged in criminal activity when they “lost” documents critical to lawsuits filed against them.

As we noted in previous posts, on February 4th, a federal magistrate judge ruled that Ethicon, a subsidiary of J&J, destroyed or lost documents that should have been preserved in anticipation of litigation involving its pelvic mesh devices. However, the judge also found that Ethicon’s loss of evidence was negligent, rather than willful or deliberate.

Nevertheless, advocates for women injured by J&J’s products recently urged the U.S. Department of Justice to investigate whether J&J actually did intentionally destroy the documents. Specifically, on March 26, 2014, a patient advocacy consumer group called, the Corporate Action Network, filed a complaint with the Department of Justice, asking Attorney General, Eric Holder, to investigate whether or not J&J executives engaged in criminal activity by destroying records in a federal probe. In its letter, the group stated:

 “We respectfully request that you investigate Johnson and Johnson, Inc. and its top executives including Chairman and CEO, Alex Gorsky, for two possible criminal violations: first, for obstruction of a criminal investigation of health care offenses in apparent violation of 18 U.S.C. Section 1518 and second, for destruction of documents in apparent violation of 18 U.S.C. Section 1519. This request follows the recent discovery of document destruction by Johnson and Johnson as related to lawsuits brought against them by thousands of women across the United States who have been seriously injured by the corporation’s pelvic mesh implants.”

Essentially, advocates have pushed for a criminal investigation into whether J&J executives committed the crime of tampering with evidence, which includes knowingly destroying or altering documents “in contemplation of” an investigation or other proceeding by the federal government that may occur in the future. (18 U.S.C. § 1519.)

As we stated in one of our past articles entitled, Ethicon and its Faulty Pelvic Mesh Devices: Destroying Valentine’s Day…and Implicating Documents, we can only guess that the conveniently missing documents were ones that did not paint J&J in a good light. But whether J&J deliberately destroyed the documents, or lost them due to its own negligence, the outcome is the same: The documents are gone. And it’s to the plaintiffs’ detriment.

The Law Offices of Justinian Lane remain committed to helping women who have been severely injured by pelvic mesh devices. We continue to offer free consultations to prospective clients, so if you have been harmed by pelvic mesh, please contact our law firm for more information.

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.

 

We are pleased with a recent order issued by a Federal District Judge in Illinois, which found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs.

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. Among other claims, the plaintiff brought negligence claims against both defendants.

The plaintiff’s husband’s doctor wrote him a prescription for Paxil to treat work-related anxiety. However, his prescription was ultimately filled with the generic version, paroxetine. Six days after beginning to take paroxetine, the husband purposefully leaped in front of a train to his death. Blood tests taken with his biopsy were positive for paroxetine.

According to the complaint, the plaintiff and her husband were financially secure, owned their home outright, and had no pressing debts. What caused such a drastic change in the husband’s mind that he would take his own life within six days? He took paroxetine. Besides work-related stress, it seems that, up until the time the husband took paroxetine, he enjoyed tranquility in his life, and never showed any signs of suicide whatsoever.

The paroxetine label in existence at the time of the husband’s death did not warn of the medication’s association with increased risk of suicidal behavior in adults. Instead, the label specifically stated the exact opposite—that no risk of suicide existed beyond the age of 24. However, the plaintiff asserts that the defendant companies had concrete knowledge that paroxetine use carried a substantial risk of suicidal behavior in adults above the age of 24, and yet promoted the medication as safe and effective.

The issue is whether either of the defendant companies can be held liable for damages caused by the medication that resulted in the plaintiff’s husband’s fatality. Here lies the difficult “catch” for the plaintiff in the case at hand, and other similarly situated plaintiffs: GSK argues that because it did not manufacture the actual pill that the husband ingested, it cannot be held responsible, and is entitled to judgment as a matter of law. Mylan, on the other hand, too, argues that it cannot be held liable, because federal law preempts claims against manufacturers of generic versions of brand-name drugs.

Although absurd, Mylan is correct. Due to a ruling by the United States Supreme Court, if you are harmed by a generic version of a brand-name drug, you cannot sue the manufacturer of the generic version. This is because, under federal law, the generic drug’s design and warning label must be identical to that of the name-brand version of the drug. As the Supreme Court recently summarized:

“First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same “active ingredient” or “active ingredients,” “route of administration,” “dosage form,” and “strength” as its brand-name counterpart.  21 U.S.C. §§ 355(j)(2)(A)(ii) and (iii).  Second, a proposed generic must be “bioequivalent” to an approved brand-name drug.  § 355(j)(2)(A)(iv). That is, it must have the same “rate and extent of absorption” as the brand-name drug. § 355(j)(8)(B).  Third, the generic drug manufacturer must show that “the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug.” § 355(j)(2)(A)(v). Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466, 2471 (2013).

In accordance with the above ruling, the Illinois Federal Judge in the case at hand had no choice but to grant Mylan’s motion to dismiss, concluding that, “with respect to any alleged defects in connection with a generic drug’s warning label, a generic manufacturer’s hands are simply tied.” With regard to Mylan, the generic manufacturer, federal law simply preempted the plaintiff’s claims. As a result, the plaintiff’s only hope for any sort of compensation hinged on whether the court found that GSK, the brand-name manufacturer, was somehow liable.

Fortunately—and a bit creatively—the court found that, under Illinois law, a brand-name manufacturer owes a duty to consumers of generic versions of its drugs, and thereby denied GSK’s motion for summary judgment with regard to the plaintiff’s negligence claims.

In order to constitute a common law negligence claim, a plaintiff must allege facts establishing (1) a duty of care owed by the defendant to the plaintiff; (2) a breach of that duty; and (3) an  injury (4) proximately caused by the breach. Simpkins v. CSX Transportation, Inc., 965 N.E.2d 1092, 1096 (Ill. 2012). The court found that GSK did indeed owe a duty of care to the plaintiff and her husband, stating:

“[I]t is well understood that any generic manufacturer would be required by law to use GSK’s design and warning label, and that any defects later discovered could only be  cured by GSK.  Under such circumstances, it was entirely foreseeable that negligence on the part of GSK with respect to paroxetine’s design and warning label could result in injury to a consumer ingesting a subsequent generic version of the drug. Continuing with the duty inquiry described above, and again construing all facts and drawing all reasonable inferences in Plaintiff’s favor, GSK has not shown why the likelihood of injury was so remote as to undo GSK’s duty of care.  The principal distinction GSK insists upon – that Mr. Dolin did not ingest a product that GSK manufactured – does not lessen the likelihood that GSK’s allegedly tortious conduct would lead to Plaintiff’s injury. Under the regulatory scheme created by the Hatch-Waxman Act, whether a consumer ingests the name-brand or generic version of a given drug is immaterial as to the likelihood that negligence in the design or warning label of that drug will cause injury.”

As the patent holder, GSK was responsible for paroxetine’s design and warning label. Under the Hatch-Waxman Act, only GSK was legally permitted to cure any warning label defects. We applaud the court for finding that a brand-name manufacturer owes a duty to a patient who fills his or her prescriptions with the generic equivalent of the medication. The plaintiff in this case raised a genuine issue of material fact as to whether GSK, through negligent conduct, breached this duty, proximately causing her injuries.

It is our firm’s stance that a patient should be able to recover for injuries obtained as a result of taking an unsafe medication—whether the medication is the brand-name version or a generic equivalent. We hope that other courts will follow the Illinois Federal court’s example and ensure that plaintiffs harmed by generic versions of medications have an avenue by which to be compensated.